December 2007
Posted on December 21, 2007 @ 07:34 am
Abbott has received marketing authorization from the European Commission for the use of Humira as a treatment for moderate-to-severe plaque psoriasis. In one clinical trial, more than 80% of patients taking Humira achieved skin clearance of 75% or better and in another, almost three quarters of patients achieved 75% clearance. In both trials, nearly half of the patients taking HUMIRA achieved 90% clearance as early as 16 weeks into treatment.
Psoriasis is the fifth approved indication for Humira in the EU. Humira is the first fully human, self-injectable biologic for the treatment of psoriasis. The FDA is reviewing the drug for the same indiciation.
Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than painful skin lesions; data also suggest an association with other health conditions, including psoriatic arthritis.
Posted on December 21, 2007 @ 07:30 am
BASi (Bioanalytical Systems)
4Q Revenues: $10.4 million (-3%)
4Q Loss: $203,000 (net loss of $736,000 in 4Q06)
FY07 Revenues: $45.2 million (+5%)
FY07 Earnings: $926,000 (net loss of $2.7 million in FY06)
Comments: Sales declined in 4Q07 due to a drop in bioanalytical revenues, partly offset by growth in toxicology services and sales of the company's Culex automated pharmacology systems. Net loss in the quarter included $354,000 in severance charges to several company officers and directors.
Richard M. Shepperd, BASi's president and chief executive officer, commented, "We are pleased that we can report progress in our performance for the fiscal year ended September 30, 2007, the company's first profitable year in four years. Had we not had the severance costs associated with completing our management change in the fourth quarter of this year, we would have shown profitable results in each quarter of the year. Our people worked hard to make this happen; however, major efforts remain to build consistently profitable operations in our Baltimore clinic and UK operations. Both of these operations have new management and new or renovated facilities where we will continue our effort to match their performance to the strength of the markets in which they do business. Our work is cut out for us, to build on the turnaround we began this past year."
Posted on December 21, 2007 @ 07:20 am
Akorn, Inc. has received a satisfactory inspection from the FDA as part of a pre-approval inspection of the company's lyophilization facilities in Decatur, IL. Akorn had cGMP issues in the past, but the recent inspection led the Chicago office of CDER to conclude that Akorn's responses to the problems are acceptable.
As a result of the inspection, Akorn is now eligible for pending product approvals in its ophthalmic, ampoule, liquid vial and lyophilization production filling suites in the Decatur site.
Arthur S. Przybyl, Akorn's president and chief executive officer stated, "We are pleased to announce the results from the latest FDA inspection of our Decatur, IL manufacturing facility. Akorn remains committed to maintaining a comprehensive and robust quality system in order to remain in compliance with current good manufacturing practice regulations. This positive result is a significant event for Akorn. The results of this recent inspection allow us to commercialize our lyophilization manufacturing capabilities. We believe a shortage of lyophilization manufacturing capacity still exists in the market place."
Posted on December 20, 2007 @ 03:26 am
Merck Serono and
Flamel Technologies have entered into a collaboration to investigate the applicability of Flamel's Medusa technology for the extended release of a therapeutic protein of Merck Serono’s portfolio. Merck Serono will make an upfront payment of $2.8 million to Flamel for investigating the therapeutic protein and will fund R&D efforts performed by Flamel. Financial terms, including a license agreement to cover potential commercialization, were not disclosed.
"We are delighted to enter into this partnership with Flamel, as it gives Merck Serono access to a technology that may further improve the therapeutic potential of compounds in our portfolio," said Bernhard Kirschbaum, Merck Serono's head of research. "As Flamel's Medusa technology allows for longer intervals between administrations of injectable proteins compared to standard formulations, we hope to offer an improved convenience for patients requiring treatment by injection. As a consequence, we anticipate that employing this technology will lead to better treatment outcomes for patients."
Stephen H. Willard, Flamel's chief executive officer, remarked, "We are pleased to have reached an agreement with Merck Serono. The Medusa platform is a best-in-class technology for the controlled delivery of proteins, peptides, and other molecules. This applicability to a wide range of molecules is a key strength of the platform, as is the ability to sustain release without affecting bioactivity. Merck Serono is the ideal partner for this project and we look forward to working together on such an exciting opportunity."
Posted on December 20, 2007 @ 03:22 am
MPI Research and
Shanghai Medicilon have formed a joint venture in preclinical services. Medicilon-MPI Preclinical Research (Shanghai) LLC will be located initially at the Zhangjiang Hi-Tech Park in Shanghai, China. The group will open a 50,000-sq.-ft. preclinical testing facility in the Chuansha Economic Park in early 2008. This new facility will meet the regulatory standards set forth by the US FDA and other regulatory agencies worldwide, according to a joint statement.
The JV is intended to provide current and future customers access to a broad range of both GLP and non-GLP preclinical services. By 2009, the new company will be fully operational, in terms of conducting FDA/IND enabling studies, offering additional preclinical support services, submitting INDs and NDAs, and will have AAALAC accreditation.
"With one fourth of the world's population, China is an important force in shaping the global pharmaceutical and biotechnology markets," said William U. Parfet, chairman and chief executive officer of MPI Research. "We have carefully looked for more than three years to find a CRO partner that shares our values and commitment to excellence, and we have finally found one in Shanghai Medicilon. We look forward to forging a future together as a worldwide leader of preclinical research services."
Dr. Chun-Lin Chen, co-founder of Medicilon, Inc. and Shanghai Medicilon, will serve as the chief executive officer of Medicilon-MPI Preclinical Research. Dr. Chen received his Ph.D. from Oklahoma State University and completed post-doctoral training in the U.S.
A multidisciplinary team of experts originating from MPI Research headquarters will relocate to Shanghai and form a GLP Advisory Board to oversee FDA GLP compliance. This team will have a broad range of experience in small and large animal toxicology, safety pharmacology, pharmacokinetics, animal care, quality assurance, report writing, pathology, and study direction. In partnership with the MPI Research team, more than 70 Shanghai Medicilon professionals will be joining the newly formed organization.
Posted on December 19, 2007 @ 06:29 am
Bilcare recently inaugurated its Centre of Excellence in Pune, India. The site has dedicated R&D sections for Packaging Research, Material Research, Analytical Research, Drug Sensitivity Studies and Package Design. The opening was attended by Dr. APJ Abdul Kalam, India's former president, and Dr. John L. LaMattina, president of Pfizer Global R&D. Drs. Kalam and LaMattina have recently helped Bilcare develop an anti-counterfeiting product to increase product warrant and traceability, according to a press statement.
Mohan Bhandari, chairman and managing director of Bilcare Limited, remarked, "Bilcare is emerging fast as a knowledge company with unique research capabilities to address the critical challenges of the pharmaceutical industry. With this product and the R&D center launch, we are now in a position to offer complete solutions to our global customers on counterfeiting and ensure better healthcare for tomorrow."
The Centre is also equipped with Asia's first integrated Flexo Printing machine, as well as a state-of-the art pilot plant, which was inaugurated by Dr. R Chidambaram, principal scientific advisor to the government of India, according to a press statement.
Posted on December 19, 2007 @ 06:16 am
Wendel Barr has been named to the role of chief operating officer at
Covance. Mr. Barr, who is currently president of Early Development North America, will assume operating responsibility for Covance's business units worldwide and will report to
Joe Herring, Covance's chairman and chief executive officer. In addition,
Mike Lehmann, currently general manager of the preclinical laboratory facility in Madison, WI, was named president of labs North America and will serve on Covance's Global Leadership Council.
Mr. Barr joined Covance in 2000 as Vice President and General Manager of Labs North America. In 2003, he was promoted to his current role, overseeing the expansion of the Early Development North America operations in Madison, as well as planned construction in Chandler, AZ, and Manassas, VA. Prior to joining Covance, Mr. Barr was global vice president and general manager of Marconi Medical Systems. He also spent 15 years at GE in a broad variety of positions of increasing responsibility.
"These moves reflect the depth and strength of our leadership talent that enables us to promote executives from within Covance," said Mr. Herring. "Wendel is a proven leader who has demonstrated exemplary management capabilities, a track record of accomplishment, and strong client focus, as reflected by the impressive growth and expansion of our Early Development North America operations. Wendel's appointment will allow me to further focus on strategies that would continue to drive growth and deliver value to our clients, employees, and shareholders."
Posted on December 18, 2007 @ 02:21 pm
Pfizer has agreed to acquire
CovX, a privately-held biotherapeutics company specializing in preclinical oncology and metabolic research and a developer of a biotherapeutics technology platform. The price was not disclosed.
Based in La Jolla, CA, CovX will operate as a division of Pfizer’s new Biotherapeutic and Bioinnovation Center.
Said Jeffrey Kindler, chairman and chief executive officer of Pfizer, "The acquisition of CovX is a further step in Pfizer's strategy to acquire and identify new product candidates that we can put into development, leveraging both Pfizer's expertise and that of world-class scientists charged with discovering and bringing in new compounds. We are looking for the best science wherever we can find it, with a special focus in our priority areas, such as biotherapeutics."
CovX's biotherapeutic platform is a technology that links therapeutic peptides to an antibody scaffold. The peptide targets the disease while the antibody scaffold allows the peptide to remain in the body long enough to achieve therapeutic benefit. The technology thereby allows half-life extension and bioavailability to support optimal dosing regimens for peptide therapeutics. CovX has generated three early-stage compounds, one diabetes and two oncology compounds, that are expected to strengthen Pfizer’s biologic pipeline portfolio.
"This deal demonstrates Pfizer’s ongoing commitment to build a competitive biotherapeutics enterprise through the acquisition of talented scientists, promising product candidates and a cutting edge technology platform," said Dr. Corey Goodman, president of Pfizer's Biotherapeutic and Bioinnovation Center. "CovX scientists will remain in place, which reflects our decision to partner differently and maximize the productivity of the research initiatives underway outside of our walls."
Posted on December 18, 2007 @ 06:46 am
Sidney Taurel, chief executive officer and chairman of
Eli Lilly & Co., will retire as CEO at the end of March, 2008. He will remain chairman until December 31, 2008, at which time he will retire from the board and from the company.
John C. Lechleiter, Ph.D., currently president and chief operating officer, will assume the role of president and chief executive officer as of April 1, 2008.
Mr. Taurel has been the company's chief executive officer since July, 1998, and the chairman of its board of directors since January 1, 1999. He joined Lilly in 1971 as a marketing associate in Eli Lilly International. After sales and marketing experiences in Brazil, Eastern Europe and France, he became general manager of the company's affiliate in Brazil in 1981. He subsequently assumed the London-based role of vice president of Lilly's European Operations in 1983, and then moved to Indianapolis in 1986 as president of Lilly International. In 1993 he was named an executive vice president of the company and president of the pharmaceutical division, and in 1996 was promoted to president and chief operating officer of the corporation.
"I am grateful to have spent nearly 37 years with this great company, and deeply honored to have had the opportunity to lead it for the last 10. I am very proud of what my Lilly colleagues around the world have accomplished together during a decade of both successes and challenges," said Mr. Taurel. "I believe that 2008 is the right time for me to retire for a number of reasons. First, the company has executed very well over the past couple of years, exceeding both our and our shareholders' expectations. As a result, the company is operationally very sound and positioned for continued success. Second, I and the senior leadership team have laid out a vision for the company that will guide Lilly for many years to come, and this gives me great confidence about Lilly's future success. And third, John has been preparing for his new role as my successor for several years, and 2008 is the right time for him to assume his place as the leader of the company."
Mr. Taurel's successor, Mr. Lechleiter, has served as president and chief operating officer since October 2005. He joined Lilly in 1979 as a senior organic chemist in process R&D, and he became a head in that department in 1982. In 1984 he began serving as director of pharmaceutical product development for the Lilly Research Center (Erl Wood) in Windlesham, England, and he subsequently returned to the U.S. in 1986 as manager of R&D projects for Europe. In 1988, he became director of development projects management, and in 1989 assumed additional responsibility for pharmaceutical regulatory affairs, chemistry, manufacturing and control. In 1991 he was named executive director of pharmaceutical product development and became vice president in 1993. Mr. Lechleiter was appointed vice president of regulatory affairs in 1994, vice president of Lilly Research Laboratories in 1996, and senior vice president of pharmaceutical products in 1998. In 2001 he became executive vice president for pharmaceutical products and corporate development, and then became executive vice president of pharmaceutical operations in early 2004.
"I am humbled and excited by this opportunity to lead Eli Lilly and Co., particularly during a time of profound challenge and unprecedented opportunity. We will stand firm by the timeless values laid down by our founders, yet act decisively to maintain our strong competitive position," said Mr. Lechleiter. "We will be guided by an exciting new vision for our future that places individual patient outcomes at the core of our endeavors."
Posted on December 18, 2007 @ 06:14 am
Celltrion, Inc., a Korean biopharmaceutical company, has received approval from the FDA to serve as a CMO for
Bristol-Myers Squibb to produce Orencia, a treatment of rheumatoid arthritis. BMS submitted an sBLA to meet expected long-term demand for the biologic drug.
"We are pleased to continue our strategic business partnership with BMS. Achieving sBLA approval from the FDA to manufacture Orencia is an important milestone that reinforces our vision to become a fully integrated global biotechnology company," said Jung-Jin Seo, chairman and chief executive officer of Celltrion. "Celltrion is dedicated to working with our business partners to exceed their quality requirements while providing manufacturing value. It is our commitment to quality service that will attract other global biopharmaceutical companies to our manufacturing capabilities."
In a press statement, Celltrion noted that it "the only Asian large-scale cell-culture contract manufacturing facility which has successfully obtained approval from the U.S. FDA."
Posted on December 17, 2007 @ 08:25 am
Bristol-Myers Squibb has signed an agreement with
Avista Capital Partners, a private equity firm, to sell BMS Medical Imaging for $525 million. BMS MI is a leading supplier of medical imaging products for nuclear and ultrasound cardiovascular diagnostic imaging procedures.
"As Bristol-Myers Squibb continues to focus on evolving into a next- generation BioPharma company, we determined the best way to maximize the value of Medical Imaging for shareholders was to sell this business and reinvest the proceeds into our pharmaceutical research, development and commercialization efforts," said James M. Cornelius, chief executive officer, BMS. "At the same time, we believe that Medical Imaging can maximize its potential under new ownership, and Avista has a proven track record of success in the healthcare field."
David Burgstahler, a partner at Avista Capital Partners, said, "BMS MI is widely recognized as a pioneer in cardiovascular imaging agents, and for its strong technical manufacturing expertise. BMS MI is a great fit for our healthcare portfolio, as it addresses the healthcare industry's increasing need for improved diagnostic tools. We believe it is well-positioned for continued success."
The transaction is expected to be completed by the end of January 2008, subject to customary regulatory approvals, at which time BMS MI will operate as an independent company under a new name. Don Kiepert, the founder and former chairman, chief executive officer, and president of Point Therapeutics, will become the chief executive officer of the company upon completion of the transaction. "I am thrilled to be partnering with the existing management team of BMS MI and Avista Capital as we transition BMS MI to an independent company," said Kiepert.
BMS MI will be Avista's sixth investment in the healthcare industry. On December 13, 2007, Avista agreed to acquire from Boston Scientific its Fluid Management and Venous Access businesses. Also in 2007, Avista made healthcare investments in
BioReliance and
VWR International, and in 2006 Avista announced investments in
Nycomed and
MedServe.
Posted on December 17, 2007 @ 08:22 am
Lilly and
Ambrx Inc. have entered into a collaboration to discover and develop novel treatments in several therapeutic areas, including metabolic diseases, central nervous system disorders and other diseases. The collaboration will apply Ambrx's unique protein optimization technology, ReCODE, with Lilly's expertise in biologics discovery, development and commercialization to pursue drug candidates, including therapeutic antibodies and improved variants of native proteins.
Under the terms of the agreement, Ambrx will receive an initial upfront payment and ongoing research support payments. Ambrx may also receive potential R&D milestones and, if assets resulting from the collaboration are successfully commercialized, Ambrx would receive additional milestones and royalties. Other terms of the deal were not disclosed. This collaboration builds on an earlier agreement signed between the two companies in January 2007.
Stephen W. Kaldor, Ph.D., Ambrx's president and chief executive officer, remarked, "This new collaboration allows us to use our existing ReCODE technology to produce high quality protein clinical candidates while simultaneously affording us the ability to expand our reach into new areas such as therapeutic antibodies. In addition, this agreement will further solidify Ambrx's financial condition for the next several years."
Posted on December 17, 2007 @ 08:15 am
Amgen and
Oxford Genome Sciences (UK) have entered into a strategic collaboration to discover, develop and commercialize novel therapeutic antibodies for the treatment of cancer. This collaboration will enable OGS to strengthen its pipeline of fully human therapeutic antibodies (mAbs) in cancer based on the target discovery capabilities of its unique OGAP database.
OGS and Amgen will jointly discover novel antibodies for the treatment of cancer. The companies will generate fully human antibodies using Amgen's XenoMouse technology, which was acquired through its acquisition of Abgenix. These antibodies will be raised against the novel druggable targets that OGeS has identified through its unique Oxford Genome Anatomy Project (OGAP) database.
The agreement covers as many as six oncology programs. Amgen will have the right to select as many as three programs, while OGS will retain rights to the remainder. Once Amgen has produced the initial antibody leads, OGeS will carry out the initial preclinical assessment of each antibody program.
Posted on December 14, 2007 @ 07:10 am
Patheon announced that it plans to sell its facility in Carolina, PR, while retaining two other sites in Caguas and Manati. The announcement came during the company's 4Q07 financial statement. The quarter ended October 31.
The Carolina site is a 230,000-square-foot facility with 200 employees, and specializes in the manufacture of oral cephalosporin solid dosage forms, including tablets, capsules and powders for suspension. The facility currently manufactures four products for six clients. Said outgoing chief executive officer Riccardo Trecroce, "We have concluded that Carolina -- a high-quality site with specialized capabilities and expertise - would be of greater strategic value to another company with a focus on manufacturing oral cephalosporins. This divestiture will allow us to focus on improving operating performance and growing our business at the Caguas and Manati facilities." During the quarter, the company announced the sale of its Niagara-Burlington OTC facility to Pharmetics.
For the quarter, revenues from continuing operations grew 1% to $167 million. The company posted a net loss (including discontinued units) of $9.1 million in the quarter, down from a loss of $22.2 million in 4Q06. For FY07, revenues from continuing operations was up 1% to $677 million, with a net loss of $94.6 million, compared to a loss of $288.2 million in FY06. Patheon took a goodwill writeoff of $255 million in FY06, which accounts for much of that year's net loss.
Strong revenue growth in its European operations was offset by deteriorating revenues in PR (attributed to generic competition for Omnicef and Zocor) and a decline in Canadian sales (attributed to API delivery delays for a major prodct).
Posted on December 14, 2007 @ 07:09 am
Neurocrine Biosciences announced that it will lay off approximately 130 employees at its San Diego campus, as a part of its restructuring program to prioritize its R&D programs and associated costs and expenses after an FDA delay on insomnia treatment indiplon. Following the firings, Neurocrine will have approximately 120 employees.
One Dec. 13, the FDA issued Neurocrine an "approvable letter" for indiplon, requesting additional clinical and preclinical data on the drug before it will consider approval. The company's NDA covered 5mg and 10mg doses of the drug. In May 2006, Neurocrine submitted a filing for a 15mg dose of the drug, but the FDA asked for reanalysis of safety and efficacy data; development partner
Pfizer pulled out of the project after that. The company is preparing a formal meeting request to the FDA to discuss the most recent approvable Letter.
Gary Lyons, president and chief executive officer of Neurocrine, remarked, "It is with great disappointment that we have to make this difficult decision that will have such an effect on so many of our employees and their families. We are greatly saddened to move in this direction after our employees have continually demonstrated only the highest level of dedication and commitment. However, in order to meet our goals on other high priority programs, we have to refocus our resources as quickly as possible. I want to sincerely thank the departing employees for their tremendous efforts and wish them great success in the future."
Posted on December 14, 2007 @ 07:02 am
GlaxoSmithKline has exercised its option to exclusively license XL880 from
Exelixis for further development and commercialization. XL880 is a small molecule compound currently being evaluated in Phase II trials in patients with papillary renal cell carcinoma (PRC), gastric cancer and head and neck cancer. Under the terms of the collaboration between Exelixis and GSK initiated in October 2002 and amended in January 2005, GSK's selection of XL880 entitles Exelixis to a selection milestone of $35 million and additional payments upon the attainment of specific development and commercialization milestones. The $35 million milestone will be applied to repayment of an advance that GSK paid to Exelixis in 2005. Exelixis is also entitled to receive double-digit royalties on product sales if the compound is approved for marketing and commercialized. Exelixis will have certain co-promotion rights to XL880 in North America.
George A. Scangos, Ph.D., president and chief executive officer of Exelixis, remarked, "We believe that XL880 has substantial potential as a first- and best-in-class therapy, and GSK and Exelixis look forward to the completion of the ongoing XL880 Phase II trials and evaluation of pivotal trial options. We believe that GSK's selection of XL880 validates our strategy of building a franchise in the area of MET inhibition to exploit the potential of this promising target."
The collaboration between Exelixis and GSK, which is managed by GSK's Center of Excellence for External Drug Discovery (CEEDD), covers seven compounds and their back-up and follow-up compounds currently in the Exelixis development pipeline. Under the terms of the collaboration, Exelixis submits the covered compounds to GSK as they achieve clinical proof-of-concept, which is a pre-determined measure of efficacy, generally based on Phase II trial data, and GSK has the option to select two compounds, and potentially a third compound, for further clinical development and commercialization. However, in the case of XL880, GSK requested in August 2007 to review the compound's data prior to achievement of proof-of-concept. Exelixis agreed to the request and submitted the XL880 data package to GSK in September 2007.
Posted on December 13, 2007 @ 06:26 am
The board of directors at
Biogen Idec have elected to keep the company independent, after a two-month flirtation with selling out to a larger company. The company announced that it did not receive "any definitive offers" for an acquisition. Company shares dropped 28% in value after the announcement
Refocused on its independent status, the company reiterated its year-end 2010 goals:
- Get 100,000 patients on Tysabri;
- Derive more than 40% of the its revenue from international business;
- Launch four new products and/or existing products in new indications;
- Have six programs in late-stage clinical development; and
- Generate revenue growth at a 15% compound annual growth rate (CAGR) and non-GAAP EPS at a 20% CAGR from 2007 through 2010.
Elan, BI's collaborator in Tysabri, announced that it will continue to work with BI on gaining FDA approval of Tysabri for Crohn's disease and building the drug's presence among multiple sclerosis patients.
Posted on December 13, 2007 @ 06:19 am
Merck has initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, PEDVAXHIB, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, COMVAX . The recall is specific to these 13 lots and does not affect any other vaccines manufactured by Merck. The affected doses of PEDVAXHIB and COMVAX were distributed starting in April 2007.
The company is conducting this recall because it can not assure sterility of these specific vaccine lots. Routine evaluation of manufacturing processes revealed the potential contamination of the lots in question. Sterility tests of the vaccine lots that are the subject of this recall have thus far not found any contamination in the vaccine.
"The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low," according to a company statement. Still, the company contends that the risk is large enough to warrant a recall.
Merck is working closely with the FDA and CDC to inform affected healthcare providers of this recall. The company is also in the process of communicating with public health authorities and healthcare providers in the U.S. and in other countries where these lots were distributed, as appropriate.
"We are taking this action because we are committed to ensuring the quality of our vaccines," said Mark Feinberg, M.D., Ph.D., vice president, Medical and Policy Affairs, Merck Vaccines and Infectious Diseases. "We know that our vaccines can play an important role in the nation's public health system, and we are committed to resolving this issue as quickly as possible to ensure that our vaccines are readily available."
Physicians are advised not to administer any vaccine from the vaccine lots being recalled. Individuals who received vaccine from these lots should complete their immunization series with a Haemophilus b conjugate-containing vaccine not affected by this recall, but do not need to be revaccinated to replace a dose they received from a recalled lot. The efficacy of the vaccine was not affected.
Posted on December 13, 2007 @ 06:14 am
Novartis has announced a restructuring plan called, "Forward," to reduce costs and improve efficiencies. According to a company statement, the plan "is expected to simplify working processes and decision making by eliminating layers, concentrating on core activities and systematically capturing growth opportunities, particularly in emerging markets." This will include firing 2,500 staffers -- out of a total of 100,000 -- as part of its strategy to generate $1.6 billion in annual savings. Novartis will take a $450 million charge in 4Q07 to pay for the restructuring.
The company cited the standard set of "industry challenges" to explain the need for a restructuring: price pressures on drugs, growing R&D costs, a risk-averse regulatory environment and more aggressive generic competitors, the latter of which Novartis benefits from, thanks to its generics division, Sandoz.
"Forward" will include the following initiatives, as quoted from Novartis' press statement:
- Organizational structures will be streamlined in corporate functions as well as in the Pharmaceuticals and Consumer Health Divisions, particularly involving general management and administrative areas.
- In the Pharmaceuticals Division, the effectiveness of the worldwide sales forces will be improved with a more geographic-tailored marketing approach. Duplication between global, regional and local activities will be eliminated, while certain non-core support activities will be outsourced.
- The Consumer Health Division will remove organizational layers to streamline processes and eliminate duplications, while some product supply chains will be restructured to optimize capacity utilization. In certain business units, regional management structures will be modified in order to better focus resources on global or local activities.
- The Novartis Institutes for BioMedical Research will focus on disease areas with significant new opportunities and review its research activities globally to take advantage of synergies among disease areas and locations to increase efficiency.
- Initiatives are underway to capture savings from the creation of Group-wide shared functions, including procurement and information technology, that will provide greater economies of scale and leverage opportunities in low-cost countries.
- Novartis will form a new cross-divisional operation to accelerate growth in small emerging markets, expanding the presence of all Novartis products in regions that include Northern and Sub-Saharan Africa, Central Asia and parts of Southeast Asia.
The company announced that firings "will be handled in a socially responsible manner with fair and respectful treatment of associates," and that it will with works councils and comply with local labor laws.
Posted on December 12, 2007 @ 08:58 am
Merck has filed an IND with the FDA for a cancer vaccine candidate that targets telomerase. Merck is developing the vaccine under a July, 2005 Research, Development and Commercialization License Agreement with
Geron Corp., which provided exclusive worldwide rights to develop and commercialize non-dendritic cell-based vaccines targeting telomerase. Geron received a $4 million milestone payment from Merck after the IND filing, and is eligible to receive additional development milestones as well as royalties on worldwide product sales.
"We are pleased with the progress that Merck has made in advancing this program towards the clinic," said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. "We appreciate the collaborative nature of our relationship with Merck and look forward to working with them to realize the therapeutic potential of this cancer vaccine candidate."
Posted on December 12, 2007 @ 08:47 am
West Pharmaceutical Services will implement a restructuring plan for its
Tech Group segment. The restructuring "addresses the recent reduction in business due to changes in customers' marketing plans by reducing the operating costs and increasing the manufacturing efficiency of the segment," according to a West statement. The unit was involved in manufacturing the delivery device for Exubera, a product that Pfizer abandoned in October.
The company will reduce spending throughout the Tech Group segment by consolidating two tool production operations into one facility in Scottsdale, AZ, and by reducing and consolidating other production, engineering and administrative operations in North America. The plan is expected to be completed by December, 2008. As a result of the restructuring, the Tech Group workforce will be reduced by approximately 250 workers, or 13%.
West will incur as much as $12 million in restructuring charges, consisting primarily of severance costs and fixed asset write-downs. The company expects to gain $3 million of cost savings in 2008 and annual operating savings of approximately $7 million from 2009 on.
"These actions, while difficult, are essential to West to create the right operational footprint for the level of business we have today and ensure we remain competitive and financially strong for the future," said Donald E. Morel, Jr. Ph.D., West's chairman and chief executive officer. "The restructuring will match the size of our operations to Tech's forecasted business and allows us to focus our human and financial resources on our strategic goal of expanding Tech's proprietary product portfolio."
Posted on December 11, 2007 @ 09:58 am
Bristol-Myers Squibb and
Gilead Sciences have formed an agreement to commercialize Atripla in Europe for the treatment of virologically suppressed adults with HIV-1 infection. If approved in the EU, Atripla would represent that region's the first and only once-daily single tablet regimen for HIV-1 infection. The companies expect the European Commission to issue its decision by the end of the year.
BMS and Gilead have agreed to share responsibility for commercializing the drug throughout the EU and certain other European countries. Gilead will record revenues from future net sales of Atripla in most of the European countries, while Bristol-Myers Squibb will record revenues in most of the European countries at percentages relative to the contribution represented by its individual product.
BMS recently concluded an agreement with
Merck (U.S.) granting BMS rights to co-commercialize Atripla with Gilead in all of the European Union and certain other European countries. Previously, Merck had the exclusive right to market any product containing efavirenz (a component of ATRIPLA) in all European countries other than the UK, Germany, France, Italy, Spain and the Republic of Ireland.
Atripla is a combo of three drugs: Sustiva (BMS), Emtriva (Gilead) and Viread (Gilead). The latter two are marketed as a single pill under the name Truvada. Atrpla is currently sold in the U.S. and Canada through a joint venture between BMS and Gilead. ATRIPLA was approved by the FDA in July 2006 and by Health Canada in October 2007. Gilead and Merck previously announced a collaboration to distribute Atripla in developing countries.
Posted on December 11, 2007 @ 09:53 am
John Goodacre has been named executive vice president and general counsel of
Quintiles Transnational Corp. Previously senior vice president, Global Risk Management and Quality Assurance, Mr. Goodacre joined Quintiles in 1998 as vice president, European legal affairs.
In his new role, Mr. Goodacre is responsible for Quintiles' global legal function and risk management, and has also been named to the company's Executive Committee. He reports to Mike Mortimer, executive vice president and chief administrative officer.
"John has a thorough understanding of Quintiles and the clinical research industry, having served the company in various capacities over the past 20 years -- including as outside counsel when we formed Quintiles (UK) Limited, our first international subsidiary, in 1987," said
Dennis Gillings, CBE, chairman and chief executive officer of Quintiles. "With his strong legal background and experience in leading our risk management and QA group, John will help Quintiles continue to grow and protect our interests."
Posted on December 11, 2007 @ 06:17 am
Shareholders of
Gene Logic have approved the sale of the company's genomics assets to
Ocimum Biosolutions and the subsequent renaming of the company as Ore Pharmaceuticals. The genomics sale is expected to close later this week and will effectively launch Ore Pharmaceuticals as a new company focused on drug repositioning and development. After the filing of necessary legal documents later this week, the company will be renamed officially.
"Effective with the closing of the Ocimum transaction, we will inaugurate a new company with a clearly defined purpose," stated Charles L. Dimmler, III, president and chief executive officer of Gene Logic. "As a drug repositioning and development company, our sole purpose is to supply the demand of pharmaceutical companies for product innovation to enrich their development pipelines. Our shareholders' votes signify their endorsement of our strategy to transform the company, a transformation we have been engaged in for the past year. We are positioned well, with the industry's leading indication-seeking program, partnerships with eight pharmaceutical companies, and a drug candidate of our own, GL1001, for which we are seeking a development partner."
Ore Pharmaceuticals will be engaged exclusively in repositioning clinical-stage drug candidates that have stalled in development for reasons other than safety.
Posted on December 10, 2007 @ 08:21 am
GlaxoSmithKline and
OncoMed Pharmaceuticals have formed a strategic alliance to discover, develop and market novel antibody therapeutics to target cancer stem cells. These cells are believed to play a key role in the establishment, metastasis and recurrence of cancer. The alliance will be conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).
The alliance leverages OncoMed's expertise in the discovery and development of cancer stem cell antibody therapeutics and provides GSK with an option to license four product candidates directed at multiple cancer stem cell targets from OncoMed's broad library of monoclonal antibodies. OncoMed will receive an undisclosed initial payment that includes cash and an equity investment. In addition, OncoMed is eligible to earn milestone payments of as much as $1.4 billion from GSK based on the achievement of specified discovery, development, regulatory and commercial milestones. OncoMed will also receive double-digit royalties on all collaboration product sales. GSK will have an option to invest in a future initial public offering by OncoMed.
OncoMed has established a diverse pipeline of monoclonal antibodies to target multiple pathways important in the activity of cancer stem cells. The alliance with GSK includes OncoMed's lead antibody product candidate, OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008.
In the alliance, OncoMed will utilize its proprietary in vivo xenograft cancer stem cell models to identify MAbs in a specific, undisclosed cancer stem cell pathway. OncoMed will develop the most promising of these monoclonal antibodies, including OMP-21M18, through clinical proof of concept across multiple indications. Upon achievement of clinical proof of concept in an agreed indication, GSK will have an exclusive option to license that MAb. GSK would then assume responsibility for funding of further clinical development and commercialisation on a worldwide basis. OncoMed retains the option to participate in development and commercialization of OMP-21M18 on pre-agreed terms.
Posted on December 10, 2007 @ 06:09 am
Eisai Co., Ltd. will acquire
MGI Pharma for approximately $3.9 billion in an all-cash transaction. The acquisition has been unanimously approved by MGI's board; it is expected to occur by means of a tender offer followed by a cash merger, is subject to customary closing conditions and regulatory approvals, and is expected to be completed during the first quarter of 2008.
According to a press statement, Eisai "expects MGI's marketed and pipeline products in oncology and acute care, as well as its R&D and commercial capabilities, including field sales specialists, together with Eisai's existing oncology products, global infrastructure and R&D capabilities, will create a base for continued sales growth, pipeline enhancement and the opportunity for synergies." The acquisition is also intended to boost Eisai's presence in the U.S.
Mr. Haruo Naito, Eisai's president and chief executive officer, said, "Strategically, we expect this transaction to allow Eisai to significantly strengthen its oncology business and increase the likelihood of achieving our current strategic plan targets and our future revenue and earnings growth."
Eisai is currently in the midst of a "Dramatic Leap Plan" (DLP), its fifth midterm strategic plan. Under the DLP, which spans April 1, 2006 to March 31, 2012, Eisai has continued to achieve steady growth in all regions, including Japan, the U.S., Europe and Asia, with a special focus on integrative oncology. Eisai has strengthened its oncology R&D and marketing infrastructure in the U.S. through the October 2006 acquisition of four oncology products from Ligand Pharmaceuticals and the April 2007 acquisition of Morphotek, Inc. In addition, Eisai is building a new oncology facility for manufacturing and formulation R&D at its North Carolina site.
To facilitate the acquisition, Eisai has established a subsidiary, Jaguar Acquisition Corp., which is wholly-owned by Eisai Corp. of North America. Subsequent to the completion of the tender offer, Jaguar will be merged into MGI and the combined entity will then become a wholly-owned subsidiary of Eisai Corp. of North America.
The acquisition price represents a premium of approximately 38.7% to MGI's closing share price of $29.55 on November 28, 2007. Eisai intends to finance the acquisition through existing internal financial resources, as well as bank loan financing, and has secured commitment for the debt required to consummate the transaction.
Posted on December 7, 2007 @ 01:09 pm
Janssen-Cilag has submitted an MAA for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The MAA was submitted under the decentralised procedure, in which Sweden will act as the Reference Member State, and Austria, Finland, Germany, Italy, Portugal and Spain will act as the Concerned Member States for the application. Regulatory submissions in other regions of the world are expected to follow.
Dapoxetine is the first oral pharmacologic agent developed specifically for the treatment of men with PE. The safety and efficacy of dapoxetine for the treatment of men with PE were studied in five, double-blind, placebo- controlled, Phase III clinical trials involving more than 6,000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa.
The most common adverse drug reactions reported during clinical trials were headache, dizziness, nausea, diarrhea, insomnia and fatigue.
Posted on December 7, 2007 @ 11:46 am
Seattle Genetics has begun a Phase IIb trial of SGN-40 in combination with Rituxan plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company's collaboration agreement with Genentech, Inc., Seattle Genetics will receive a $12 million milestone payment for initiating the study.
"This trial will provide key data on the safety and potential efficacy of adding SGN-40 to standard second-line therapy for the treatment of patients with relapsed diffuse large B-cell lymphoma," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are moving forward with this global trial based on the encouraging safety profile and clinical activity observed in our phase I single-agent trial in patients with DLBCL, together with preclinical data demonstrating enhanced efficacy of SGN-40 when combined with chemotherapy."
The phase IIb, randomized, double-blind, placebo-controlled clinical trial, named SeaGen MARINER, is expected to enroll approximately 200 relapsed or refractory DLBCL patients at more than 60 medical centers worldwide. Patients will receive either Rituxan, ifosfamide, carboplatin and etoposide (R-ICE) plus SGN-40 or R-ICE plus placebo. The primary endpoint of the study is complete response rate. Additional endpoints include safety, tolerability, failure-free and overall survival.
Posted on December 6, 2007 @ 10:11 am
Urigen Pharmaceuticals has established a partnerships with
Hyaluron Contract Manufacturing (HCM) to develop URG101, Urigen's proprietary fixed dose combination of FDA-approved drugs targeting painful bladder syndrome (PBS).
"Urigen's development program with Hyaluron is a critical step forward for URG101," commented William J. Garner, M.D., president and chief executive officer of Urigen. "Hyaluron, with its quality-focused and innovative drug development team, makes an excellent partner for us as URG101 progresses through its development. We look forward to working with the drug development team at Hyaluron to provide a solution to PBS through the commercialization of our product."
"We are very pleased to have been selected by Urigen to undertake the development of their kit targeting PBS," stated Shawn Kinney, HCM's president. "The collaborative spirit already demonstrated by both companies’ employees bodes well for a successful development program."
Posted on December 6, 2007 @ 09:36 am
Bristol-Myers Squibb has publicized the details of its restructuring initiative as it works to become a "next-generation BioPharma company." With the aim of generating $1.5 billion in annual pre-tax savings by 2010 (the year that top-seller Plavix loses patent protection), the company plans to fire 4,300 staffers -- approximately 10% of its workforce -- in the process of reducing its roster of manufacturing sites by 50% by the end of 2010 and reducing the number of brands in its "mature products portfolio" by 2011.
Costs for the firings and closings are projected to be between $900,000 and $1.1 million. Said chief executive officer James M. Cornelius, "It is difficult to see our valued colleagues leave the company, but right-sizing our workforce across all areas is critical to achieving our productivity goals and enhancing the competitive position of the company. While we are reducing headcount in certain functions, we will continue to invest in R&D, biologics and commercialization talent."
The company plans to sell its medical imaging business and is also looking at "strategic alternatives" for its ConvaTec (ostomy supplies) and Mead Johnson (baby nutritionals) units.
Posted on December 6, 2007 @ 08:12 am
Pharmetics, Inc. has entered into an agreement to acquire the Niagara-Burlington commercial manufacturing business of
Patheon for approximately $5.75 million. Pharmetics will acquire the assets -- including equipment, facilities and land -- at Patheon's facilities in Fort Erie and Burlington (Gateway Drive) in Ontario.
The two sites currently serve 14 clients, manufacturing and packaging about 60 OTC pharmaceutical products in a range of dosage forms, including tablets, liquids and powders. Laval, Quebec-based Pharmetics will continue to employ the entire active workforce of about 250 commercial manufacturing employees at the two sites and, subject to assignment of third-party contracts, will continue to manufacture and supply all products currently manufactured at the sites. Pharmetics is a privately owned contract manufacturer of vitamins, herbal products, supplements and OTC pharmaceutical products.
"Once the decision was made to seek a buyer for our OTC business, we had three key priorities: continuity of service for our clients, continuity of employment for our staff, and the sale of the facilities to a purchaser who could capitalize on the strategic value of these assets," said Riccardo Trecroce, outgoing chief executive officer of Patheon. "We are very pleased that in this transaction with Pharmetics, all three of these objectives will be achieved."
"These sites will provide Pharmetics with conveniently located, high-quality capacity and expertise with which to expand our business and serve our growing client base," said Ephriam Kandelshein, co-president of Pharmetics.
The transaction is expected to be completed on or about January 31, 2008.
Posted on December 5, 2007 @ 07:42 am
Edward J. Schutter has been appointed to president and chief operating officer of
Sciele Pharma. In his new position, Mr. Schutter will continue to report directly to chief exeutive officer
Patrick Fourteau and will be responsible for day-to-day operations of the company in addition to his sales and marketing duties.
Mr. Schutter joined Sciele in April 2006 as executive vice president and chief commercial officer. Prior to that, he was employed by Solvay Pharmaceuticals in a variety of management positions during his 15-year tenure there, most recently as vice president, global business development and licensing.
Mr. Fourteau said, "Since joining the company, Ed has been a key member of our executive team and came to Sciele with a strong record of driving business development, sales growth and improved operations. Ed's primary focus will be on implementing our sales and marketing strategies, optimizing growth, and launching two to three new products each year beginning in 2008."
Posted on December 5, 2007 @ 07:39 am
Pfizer and
Adolor Corp. have signed an exclusive collaboration to develop and commercialize novel compounds, ADL5859 and ADL5747, for the treatment of pain. Both compounds are proprietary Delta opioid receptor agonist candidates with the potential to treat a wide range of inflammatory, neuropathic and acute pain conditions.
The companies will form a Joint Steering Committee to guide the development and commercialization of products resulting from the collaboration. Pfizer will be responsible for securing regulatory approvals and commercialization on a worldwide basis.
The terms of the agreement provide for Pfizer and Adolor to share revenues and expenses 60/40 in the U.S. Outside the U.S., Pfizer will fund development activities and, upon commercialization, Adolor will receive royalties on Pfizer net sales. Adolor will receive an upfront, non-refundable payment of $30 million, plus $1.9 million reimbursement for prior Phase II development costs. Adolor may also receive payments of as much as $232.5 million upon the achievement of development and regulatory milestones for its Delta compounds. More than 50% of these milestones may be earned prior to regulatory approval of the compounds, with the first milestone payment available to be earned on commencement of Phase IIb clinical studies.
"We are pleased to be partnering with Pfizer in this very exciting program," said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. "Our vision for the Delta agonists has been to develop a new class of opioids, delivering analgesia without some of the complicating side effects of traditional mu agonists. Pfizer brings extensive pain management development and commercial expertise to this collaboration and we look forward to working with Pfizer in the pursuit of this vision."
ADL5859 is in a Phase II development program exploring analgesic efficacy in inflammatory pain associated with rheumatoid arthritis and acute post-dental surgery pain. Additional programs are planned to evaluate ADL5859 in patients with diabetic peripheral neuropathy and osteoarthritis. All future development work is subject to a Joint Development Committee. Adolor expects to begin Phase I clinical testing of ADL5747 in the first quarter of 2008.
"This collaboration demonstrates our commitment to executing against the R&D plan we outlined, including expanding our Phase II portfolio with a strong focus in our key therapeutic areas," said Dr. Martin Mackay, president of Pfizer Global R&D. "Pfizer has a strong history in bringing to market novel pain solutions including Lyrica, Neurontin and Celebrex. However, there still remains a significant unmet medical need for patients suffering from a variety of debilitating pain conditions."
Posted on December 5, 2007 @ 07:35 am
Avid Bioservices has signed a manufacturing supply and technology transfer agreement with
Arius Research. The agreement covers Arius' lead cancer stem cell antibody, which targets a novel epitope of CD44 found in breast, colon and prostate cancers. Avid will begin manufacturing drug supply under cGMP for human trials that Arius plans to initiate in 2008.
"This new agreement reflects our extensive experience and broad capabilities in manufacturing monoclonal antibodies, as well as the good working relationship we have already developed with the Arius team," said F. David King, vice president of business development of Avid.
"Avid's proven expertise in the scale-up and manufacture of clinical and commercial grade antibodies should further support the significant progress we are achieving with our CD44 Cancer Stem Cell program," said Dr. David Young, chairman, president and chief exeutive officer of ARIUS. "Avid will provide us with a supply of our CD44 targeting drug to initiate human clinical trials in 2008, subject to the clearance of our IND by the FDA."
ARIUS is advancing the formal preclinical toxicology program for the program, an anti-cancer antibody targeting a novel epitope of CD44 found in breast, colon and prostate cancers.
Avid Bioservices is a wholly owned subsidiary of
Peregrine Pharmaceuticals Inc.
Posted on December 4, 2007 @ 10:27 am
Quest Pharmaceutical Services, LLC, a GLP-compliant CRO providing testing services to support preclinical and clinical research and development, has formally changed its name to QPS, LLC.
The company commissioned independent market research to evaluate the pharmaceutical research industry's recognition and perception of both the Quest Pharmaceutical Services and QPS names. The name change "supports the company's mission to provide meticulous quality, performance driven by an adherence to client timelines and impeccable client service," according to a company statement.
Founded in 1995, QPS has bioanalytical and DMPK facilities at its Newark, DE headquarters and a bioanalytical laboratory in Taipei, Taiwan. Regional sales offices are maintained in Boston, Connecticut, Pennsylvania, California, New Jersey, and Texas.
Posted on December 4, 2007 @ 09:04 am
Two
Johnson & Johnson subsidiaries,
Centocor, Inc. and
Janssen-Cilag International NV, have submitted marketing approval applications for ustekinumab (CNTO 1275) in the U.S. and Europe for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Centocor has submitted a BLA wit the FDA and Janssen-Cilag International an MAA to the EMEA. Ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis, according to a joint statement.
It is estimated that 125 million people worldwide have psoriasis, including 2% of both the U.S. and European populations, or some 7.5 million Americans and 10 million Europeans. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe.
"We are very encouraged by the promising results that we have seen through the ustekinumab clinical development program evaluating the efficacy and safety of this novel biologic in the treatment of moderate to severe plaque psoriasis," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc.
Posted on December 4, 2007 @ 08:49 am
CMC Biopharmaceuticals A/S has reached an agreement with
Lilly to buy the biologics development and manufacturing operation of ICOS Corp., which Lilly bought on in January 2007. CMC, a Copenhagen, Denmark-based bio-CMO, will purchase the biologics facility in Bothell, WA. The new operation, CMC ICOS Biologics Inc., will develop and manufacture therapeutic proteins for early clinical trials.
In a statement, the company said that it is planning "significant investment in the facility to enable production of late-stage clinical trial and commercial biopharmaceuticals." CMC plans to retain the 127 employees currently working at the Bothell facility.
"We're extremely excited about our acquisition of ICOS Biologics. We feel strongly that the skills inherent in the employees that work here are of great value to the biologics industry and will complement the abilities of our expert workforce in Europe," said David Kauffmann, CMC's chairman.
Mads Laustsen, CMC's chief executive officer, remarked, "Our plans to upgrade the facility in order to manufacture commercial product will mean that we can provide additional services to both existing and new clients. Moreover, by establishing a presence in the USA, we've placed CMC in an enhanced position to actively seek opportunities to grow our business."
Posted on December 3, 2007 @ 11:44 am
David A. Dodd has been named president, chief executive officer and chairman at
BioReliance Corp. From 2000 through 2006, Mr. Dodd served as president and chief executive officer of Serologicals Corp., a publicly traded company that was sold to Millipore Corporation in 2006 for $1.4 billion. From 1995 to 2000, he was pPresident and chief executive officer of Solvay Pharmaceuticals, a subsidiary of the Solvay Group. Mr. Dodd entered the pharmaceutical industry in 1977 with Abbott Laboratories and served at McDonnell-Douglas Healthcare Systems, Bristol-Myers Squibb and Wyeth. Mr. Dodd currently serves as non-executive chairman at Stem Cell Sciences plc.
"David brings an impressive record of maximizing the potential and competitive impact of the companies he manages," said David Burgstahler, a partner at Avista Capital Partners, the private equity firm that acquired BioReliance from Invitrogen in April 2007. "He is a compelling and focused leader with proven ability at not only expanding revenues and profits at a rapid pace, but at the same time building very strong organizations with dedicated management teams. We look forward to working with David to continue to advance BioReliance’s leadership in its industry space."
Posted on December 3, 2007 @ 05:58 am
Novartis and
MorphoSys AG have formed a comprehensive, 10-year, $600 million strategic alliance for the discovery and development of biopharmaceuticals. The deal is aimed at establishing a pipeline of innovative drugs, and establishes Novartis as MorphoSys's preferred collaborator for HuCAL-based drug discovery. According to a MorphoSys statement, this will allow the company to focus on drug discovery and development and help it wean itself from new or extended fee-for-service discovery deals. The agreement supersedes the existing one between the companies.
Under the agreement, Novartis will make a major long-term commitment to MorphoSys's human antibody technology, HuCAL. Over the 10-year lifetime of the agreement, the parties will engage in approximately double the annual number of therapeutic antibody discovery programs as compared to their previous alliance, encompassing a wide range of diseases. MorphoSys also has options to participate in certain development activities in various programs, with part of the early stage costs being funded by Novartis. Under the co-development options, MorphoSys may elect to participate in these projects through cost and profit sharing with financial participation reflecting its level of investment in the respective programs.
The alliance also includes rights to co-promote products in specific territories through creation of MorphoSys's own sales force. In addition to programs pursued jointly, Novartis has accelerated its plan to internalize HuCAL at its research sites under the option agreed in the original contract between the companies.
Based on a 10-year term, committed total annual payments sum to more than $600 million in technology access, internalization fees and R&D funding, not including reimbursement of R&D costs related to early stage development activities. Including development milestones, total payments could exceed $1 billion, assuming the collaboration successfully runs its maximum term (Novartis has the option to end the alliance after seven years or extend it to 12 years). MorphoSys is also entitled to royalty payments and/or profit sharing on any future product sales.
"This is a transforming deal for MorphoSys. This alliance heralds a new chapter in our corporate development as it offers us the perfect construct to increase significantly the value of our proprietary drug development pipeline while simultaneously maximizing our financial interest in partnered programs," commented Dr. Simon Moroney, chief executive officer of MorphoSys AG. "The first antibody from our collaboration with Novartis entered the clinic three years after signature. The proven success of our relationship and demonstrated commitment of the collaborator was a key factor in our decision to enter this substantially expanded new deal. This deal maximizes the value of our partnered antibody pipeline and the additional cash-flows within the strategic partnership with Novartis will become a major value driver for MorphoSys."
"Over the past three years MorphoSys has been an instrumental collaborator in the build up of Novartis internal biologics discovery and development efforts," said Abbie Celniker, Global Head, Novartis Biologics. "We look forward to continuing our collaboration with the MorphoSys team under this expanded alliance."
Posted on December 3, 2007 @ 05:46 am
Aptuit, Inc. has completed the acquisition of
Evotec's Chemical and Pharmaceutical Development (CPD) business. The move allows Aptuit to integrate an API facility in Oxford, England and a recently expanded parenteral fill/finish facility in Glasgow, Scotland into its global network.
According to an Aptuit statement, "The integration of these development and small-scale manufacturing facilities in Europe completes a unique global API supply chain where small scale development takes place in the U.S. and Europe with commercial scale undertaken in new state-of-the-art facilities in India."
"Over the past 18 months we've assembled by strategic acquisitions the core competencies that are key to reducing the time and cost burdens of drug development for our customers, and that also build on our commitment to operate an efficient, integrated global network. This particular acquisition is an important building block for Aptuit as we move toward completing that network," said Michael A. Griffith, Aptuit's chief executive officer and founder.
November 2007
Posted on November 30, 2007 @ 08:28 am
AstraZeneca has completed enrollment of patients in the ZEST (Zactima Efficacy Study versus Tarceva) study, the first of four Phase III trials for the investigational once-daily oral anti-cancer drug vandetanib. Data from the study is expected in 2008.
ZEST is a randomized, double-blind, multi-center Phase III study to assess the efficacy of vandetanib versus erlotinib in overall survival (OS) and progression-free survival (PFS) in more than 1,150 patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line anti-cancer therapy.
"Non-small cell lung cancer is an area of high unmet medical need, and we hope vandetanib will offer a beneficial new treatment option for people with lung cancer," said Dr. Peter Langmuir, Medical Science Director at AstraZeneca.
ZEST is part of a Phase III clinical trial program to gain a broad understanding of how vandetanib may benefit people with lung cancer. The other studies also have punchy names:
- ZODIAC (vandetanib + docetaxel versus docetaxel alone)
- ZEAL (vandetanib + pemetrexed versus placebo + pemetrexed); and,
- ZEPHYR (vandetanib + best supportive care (BSC) versus placebo + BSC).
Posted on November 30, 2007 @ 06:22 am
Hans Christian Teisen has been named senior vice president and chief financial officer at
LifeCycle Pharma. He replaces Michael Wolff Jensen, executive vice president and chief financial officer, who has decided to leave the company, effective March 2008, to pursue other opportunities.
Mr. Teisen is currently the chief financial officer of Bavarian Nordic. Previously, he served as vice president of finance, IT, procurement & strategy at Rockwool A/S Denmark. He has worked for The Ministry of Foreign Affairs, where he served as Head of Section, Foreign Policy Department in Denmark; First Secretary of Embassy, Royal Danish Embassy, London; and Head of Section - EU, Maastricht Treaty, EMU and Economic Cooperation.
"I would like to thank Michael for his significant efforts and contributions to the success of LifeCycle Pharma," said Dr. Flemming Ørnskov, President and CEO of LifeCycle Pharma. "We are pleased to have attracted a qualified replacement for Michael well before his departure and we look forward to having the wealth of knowledge and deep financial experience that Hans has to offer our growing organization."
Posted on November 30, 2007 @ 06:03 am
ImmunoVaccine Technologies Inc. (IVT) has successfully scaled-up the manufacturing process for its vaccine platform, Vaccimax. The manufacturing development was performed by
Dalton Pharma Services.
VacciMax is a vaccine-enhancement platform comprised of a special emulsion of liposomes, antigens, adjuvants and oil, according to IVT. To prepare VacciMax for human cancer clinical trials, IVT has been developing its platform to meet all regulatory requirements, including manufacturing in a GMP setting. Having successfully produced VacciMax at a commercially relevant batch size, the company plans to license the technology worldwide for the therapy and prevention of cancer and infectious diseases.
"We are pleased to collaborate with IVT and wish to congratulate the entire team on meeting such an important milestone. The successful scale-up of VacciMax was a direct result of the Dalton and IVT teams' strong technical capabilities and project management skills," remarked Peter Pekos, president and chief executive officer of Dalton Pharma Services.
IVT's testing verified that development batches produced at Dalton at an increasing scale retained their expected biological activity. Analytical testing also showed that the various elements of the platform are chemically stable. The latest batch produced at the 50-litre scale also met manufacturing and chemical specifications.
Posted on November 29, 2007 @ 07:09 am
Regeneron Pharmaceuticals and
Sanofi-Aventis have entered a new collaboration, which will include a greater SA stake in the biopharma. The companies will work to discover, develop, and commercialize fully-human therapeutic antibodies utilizing Regeneron's proprietary VelociSuite of technologies.
SA will also make an $85 million upfront payment to Regeneron and will fund as much as $475 million of research during the next five years. SA will have an option to extend the research agreement for as many as three additional years.
As part of the agreement, SA will boost its ownership of Regeneron from approximately 4% to 19% by purchasing 12 million newly issued shares. SA has an option to expand its ownership to 30% in the next four years. Like most major pharma companies, SA aims to expand its presence in biologics.
SA will have the exclusive option to co-develop with Regeneron each drug candidate in the collaboration portfolio. Development costs will be shared between the two companies, with SA funding drug candidate development costs up front and Regeneron reimbursing half of the development costs from its share of future profits.
The first therapeutic antibody to enter clinical development under the collaboration is an antibody to the Interleukin-6 receptor (IL-6R), which has started clinical trials in rheumatoid arthritis. The second is expected to be an antibody to Delta-like ligand-4 (Dll4), which is currently slated to start its clinical development in 2008.
For any new product successfully developed as part of the collaboration, SA will take the lead in commercialization activities and will consolidate the sales. Regeneron will have the right to co-promote any and all collaboration products worldwide. In the U.S., profits will be shared equally. Outside the U.S., profits will be split on a pre-determined sliding scale with sanofi-aventis’ share ranging from 65% to 55%. Regeneron will also be entitled to receive as much as $250 million in sales milestone payments when the collaboration achieves certain aggregate annual ex-U.S. sales levels, starting at $1 billion.
Posted on November 28, 2007 @ 08:34 am
QLT Inc. has formed a Special Committee to "review all strategic alternatives available," according to a company statement. The committee, comprised of three independent directors from the board, has appointed
Morrison & Foerster, LLP as legal counsel. The committee has been charged, among other things with the responsibility for "exploring alternative ways to maximize shareholder value," including a selloff of all or part of the company.
QLT's board is reviewing proposals from several investment bankers and expects to appoint a Financial Advisor in the near future to assist the committee in the evaluation of strategic alternatives.
Boyd Clarke, QLT's chairman, remarked, "The board of directors believes that the net value of the assets of the company exceeds the value represented by the stock price. We had hoped to address that disconnect through the deployment of our current strategic plan. However, as the gap continues to widen we have decided that, other than as contractually required, making significant additional investments in all of our current products and technologies would be inconsistent with our objective of maximizing shareholder value."
Visudyne, the company's lead product for age-related macular degeneration (AMD), has seen sales deteriorate in the face of competition. The company also took a $110 million charge in 2Q07 related to a patent dispute.
Posted on November 28, 2007 @ 08:22 am
DynPort Vaccine Co. and
Baxter International have received a $201.2 million contract modification from the U.S. Department of Health and Human Services (HHS) for the development of Baxter's cell-cultured seasonal and pandemic influenza candidate vaccines.
The contract funds development of the seasonal influenza vaccine through FDA licensure, and the pandemic vaccine candidate through Phase II clinical trials in adults and pediatric Phase I clinical trials. DVC, the prime contractor for this effort, is providing overall management of the clinical trials. Baxter is developing the candidate vaccines, and will manufacture the vaccines and own all clinical data and licenses.
The clinical portion of a Phase I/II clinical trial to test the safety and immunogenicity of Baxter's cell-culture-derived split virus seasonal influenza vaccine candidate in Europe was recently completed. Preliminary data announced in July 2007 indicate that the vaccine induced strong antibody responses and good tolerability in all study populations. DVC and Baxter vaccinated the first volunteers of a Phase III trial in healthy adults using the seasonal vaccine candidate in the U.S. on Nov. 26, and plan to enroll patients in a Phase I clinical trial for a pandemic influenza clade 2 strain vaccine candidate in 2008. This trial will also be conducted in the U.S.
"The progress made on the pandemic and seasonal influenza programs in such a short time reflects the priority and importance of this development program for both companies," said Dr. Robert V. House, president and chief scientific officer of DVC. "By combining Baxter's technology with DVC's biologics life-cycle and contract management expertise, the team has made great progress in advancing these two influenza vaccine candidates."
Posted on November 28, 2007 @ 06:02 am
Bethany Mancilla has been promoted to senior vice president, business development at
Gene Logic, where she will lead the company's partnering and licensing efforts. Since July 2004, Ms. Mancilla has been involved in the formation and development of Gene Logic's Drug Repositioning partnerships with pharmaceutical companies including Pfizer, Roche, Abbott, Merck-Serono, Organon, and Solvay. She is also leading the company's efforts to secure a development partner for its proprietary drug candidate, GL1001, for inflammatory bowel disease (IBD).
Ms. Mancilla has more than 15 years of business development experience in the biotechnology sector, including more than nine years with Gene Logic. Prior to her assignment to the Drug Repositioning Business, she was responsible for spearheading the development of the company's toxicogenomics business and, to advance the program’s development, she formed a consortium with major pharmaceutical companies such as Pfizer and Wyeth. Before joining Gene Logic, Ms. Mancilla was director of business development at BCM Technologies the venture and technology transfer subsidiary of Baylor College of Medicine, where she was involved in the creation and financing of four start-ups: GeneMedicine, Meretek Diagnostics, Sennes Drug Innovations, and Receptor Pharmaceuticals.
Posted on November 27, 2007 @ 07:26 am
Pharmacopeia has identified a pair of new lead compounds for advancement in its alliance with
GlaxoSmithKline. The first of the lead compounds forms the basis of a new lead optimization program focused on identifying a treatment for respiratory disease. The other newly identified lead compound is the second from a program in inflammatory pain. As a result of the identification of these new lead compounds, Pharmacopeia will receive milestone payments totaling $1 million from GSK, which is conducting the work through its Center of Excellence for External Drug Discovery (CEEDD)
Pharmacopeia has received $10 million from GSK in connection with early discovery activities and is entitled to an additional $5 million payment upon the completion. Pharmacopeia is also entitled to success-based milestone payments totaling as much as $83 million per program and potential double-digit royalties on the sales of any product commercialized by GSK under the multi-program alliance. Should GSK decline its option to complete pivotal trials of alliance programs, Pharmacopeia may independently pursue them, subject to its obligations to GSK under the agreement.
"With the identification of these two compounds, our collaboration has now identified a total of three new leads this year," said Hugh Cowley, senior vice president of GSK and head of the CEEDD at GSK. "We are extremely pleased to see the continued rapid and impressive achievements of the team driving this successful collaboration."
"Since entering into this collaboration just over 18 months ago, we have advanced multiple programs focusing on compelling targets toward development candidates," said David Floyd, Ph.D., executive vice president and chief scientific officer of Pharmacopeia. "We are very pleased that progress within the collaboration exceeds our initial estimates and that compounds are coming from multiple programs in multiple therapeutic areas. We're particularly happy to have added a second lead to our ongoing pain program as this significantly increases its chances of overall success."
Posted on November 27, 2007 @ 07:20 am
Valeant Pharmaceuticals has reached full enrollment in RESTORE2, its second Phase III study of retigabine in the treatment of epilepsy. Retigabine is a first-in-class neuronal potassium channel opener demonstrated to be effective in a recently published Phase IIb epilepsy study. The two RESTORE trials (Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy) are designed to evaluate the efficacy and safety of retigabine as an adjunctive therapy in patients with refractory partial-onset seizures who are receiving one, two or three concomitant antiepileptic drugs (AEDs). RESTORE2 is investigating retigabine at 600 and 900 milligrams per day while RESTORE1 is investigating retigabine at 1,200 milligrams per day.
"More than 50 million people worldwide have epilepsy and the global market for AEDs is more than $13 billion and growing," said Timothy C. Tyson, Valeant's president and chief executive officer. "The development of retigabine, which will be the first and only potassium channel opener for the treatment of refractory epilepsy, is our highest R&D priority at Valeant. We are pleased to be leading the way in the research and development of potassium channel openers for the treatment of important neurological disorders such as epilepsy and neuropathic pain."
Five hundred and thirty-nine patients have enrolled in RESTORE2, which is being conducted in 69 sites across Europe, Israel, Australia, South Africa and the United States. The RESTORE1 trial is being conducted in 49 sites across the United States, Argentina, Mexico, Brazil and Canada. To date, more than 85% of eligible patients involved in RESTORE trials have chosen to enter into ongoing open-label extension studies.
Following the anticipated completion of the RESTORE trials in 2Q08, Valeant plans to file an NDA and MAA for retigabine, with an anticipated launch in 2009.
Posted on November 27, 2007 @ 07:17 am
Genzyme and
Fovea Pharmaceuticals SA have entered into a collaborative research pact centered on Fovea's proprietary high content technology platform that allows the identification of new targets involved in photoreceptor degeneration in retinal dystrophies. The companies will collaborate to develop gene-related therapies using Fovea's selected targets and Genzyme's gene delivery technologies.
Fovea's scientific, clinical and pharmaceutical expertise in retinal diseases and Genzyme's extensive know-how in protein production and gene delivery will offer customized solutions for the understanding of the disease mechanisms, with the goal to develop new therapeutic strategies to prevent or reduce the severity of blindness, according to a Fovea statement.
"This first research partnership signed with Genzyme demonstrates the interest of our proprietary discovery platform," said Bernard Gilly, chairman and chief executive officer of Fovea. "This collaboration underscores the substantial opportunity that our expertise in retinal diseases and unique platform provide to increase the efficiency and probability of success in ophthalmology drug discovery and development."
Posted on November 26, 2007 @ 08:50 am
Santen Pharmaceutical Co., Ltd., of Osaka, Japan has begun Phase I/IIa trials of DE-102, its steroidal treatment for macular edema, employing
Oakwood Laboratories' Chroniject™ sustained release delivery technology. The product's microsphere formulation and its sterile filling was accomplished at Oakwood's Cleveland manufacturing facility.
"Oakwood is very pleased to have been able to solve some difficult technical issues in order to bring this product to commercial manufacturing scale, and to the point of clinical use," said Mark Smith, Oakwood's president. “We look forward to the continued development of this product.”
According to Mr. Smith, the company's Chroniject technology has been shown to offer an adaptable and easily scaleable system for the development and manufacture of injectable sustained release dosage forms of multiple drug classes.
Posted on November 26, 2007 @ 08:42 am
Akorn, Inc. has received approval from the FDA for its supplemental BLA for a unit-dose preservative-free Tetanus Diphtheria vaccine. The company expects to launch the vaccine in 1Q08.
In March 2007, Akorn announced that it had entered into an exclusive distribution agreement with
Massachusetts Biologic Laboratories for Tetanus Diphtheria vaccine. Since September 2007, Akorn has been marketing a multi-dose preserved version of the Tetanus Diphtheria vaccine. This new approval will allow Akorn to effectively compete in the estimated $225 million U.S. market, according to the company.
Posted on November 26, 2007 @ 08:34 am
MedImmune has begun dosing patients in the first Phase I trial of CAM- 3001, a fully human MAb targeting the alpha subunit of the granulocyte-macrophage colony stimulating factor receptor (GM-CSFR). The study is designed to evaluate the safety and tolerability of single doses of CAM-3001 in patients with rheumatoid arthritis (RA), and represents the first clinical trial in which a MAb targeting GM-CSFR is being investigated in this population. MedImmune currently holds exclusive, worldwide rights to develop and market CAM-3001 under an agreement with
CSL Limited.
"Commencing this trial demonstrates that researchers at MedImmune are at the forefront of innovation using monoclonal antibodies and evaluating their potential to serve as new treatment options for patients with chronic, debilitating inflammatory diseases, including RA," said Ian Anderson, Ph.D., vice president of research - respiratory, inflammation and autoimmunity.
In the trial, patients will receive CAM-3001 at Charite Research Organisation in Berlin, Germany across a range of escalating doses and will be monitored for as long as seven months. Dose escalation will stop if maximum tolerated doses are reached.
Posted on November 21, 2007 @ 08:59 am
GlaxoSmithKline has entered an agreement to acquire
Reliant Pharmaceuticals Inc. for $1.65 billion in cash. Reliant is a privately held specialty pharma company focused on cardiovascular therapies. In the nine months ending September 30, 2007, the company's net sales were $341 million, up 62% YTD.
Through its strategic in-licensing strategy, Reliant has developed a portfolio of specialty drugs for heart disease, including U.S. rights to Lovaza, a treatment for adult patients with very high levels of triglycerides. Launched in late 2005, Lovaza achieved $206 million in sales, up 115% in the nine months ending September 30, 2007. Reliant currently markets three other in-licensed cardiovascular products: high blood pressure treatments DynaCirc CR and InnoPran XL, and Rythmol SR, which treats abnormal heart rhythms, or arrhythmia.
Chris Viehbacher, president, U.S. Pharmaceuticals, GSK, said, "The addition of Lovaza to the GSK portfolio adds a new driver of sales growth in the US business. It represents a strong strategic fit, complementing Coreg CR, a leading treatment for heart failure and hypertension, and adds to our growing profile in the cardiovascular disease area."
"Today is a momentous date for Reliant," said Bradley T. Sheares, chief executive officer of Reliant. "We are very proud of the work that our employees have done to build this company, particularly the energy and perseverance of our sales teams, who have demonstrated their worth in building a formidable Lovaza franchise in less than 24 months. We see great additional potential through this acquisition for Lovaza and the patients who could benefit from it."
The acquisition is subject to approval by the U.S. FT C and is expected to close before year-end.
Posted on November 21, 2007 @ 08:54 am
Wesley P. Wheeler has been appointed chief executive officer of
Patheon Inc., effective December 10, 2007. Mr. Wheeler will succeed Riccardo Trecroce, who plans to leave the company in 2008, following a transition period.
"With Patheon's restructuring initiatives well underway, we are focused on taking the company forward to the next phase of growth and profitability," said Ramsey Frank, managing director of JLL Partners, the company's largest shareholder, and chairman of Patheon Inc.'s corporate governance committee. "Wes Wheeler is a highly experienced pharmaceutical executive with a proven record of leading successful, international businesses. His in-depth knowledge of the industry and breadth of pharmaceutical experience will serve Patheon well as we move forward to grow and deliver improved value to our stakeholders."
"We would like to thank Riccardo Trecroce for his commitment and contributions to Patheon over his seven years with the Company," said Peter Green, chairman of Patheon's board of directors. "Riccardo led Patheon through a particularly challenging time in its evolution, successfully recapitalizing the company earlier this year and launching restructuring and operational initiatives to improve the Company's profitability. We thank him for his dedication and wish him every success in his future endeavours."
Mr. Wheeler has 29 years of multinational experience in pharmaceutical manufacturing, sales and marketing, R&D and engineering, with three global pharmaceutical companies. He joins the company from Valeant Pharmaceuticals International, where he served most recently as president, North America, R&D and global manufacturing. Prior to joining Valeant in 2003, he served as president and chief executive officer of DSM Pharmaceuticals, Inc., where he led the company through a business turnaround, significantly increasing new business, compliance and profitability in approximately 13 months. Prior to DSM, Mr. Wheeler was senior vice president of logistics and strategy for GlaxoSmithKline, where he was responsible for managing the manufacturing rationalization of Glaxo Wellcome and SmithKline Beecham. He also served as vice president of marketing for Glaxo Wellcome, responsible for antibiotic, antiviral, gastrointestinal and metabolic products as well as developing the marketing services infrastructure for the company.
Posted on November 21, 2007 @ 08:52 am
Merck has suspended enrollment in clinical trials for the investigational Aurora kinase inhibitor, MK-0457, pending analysis of all efficacy and safety data for the drug. The decision was based on preliminary safety data, in which a clinical safety finding of QTc prolongation was observed in one patient. Merck and collaborative partner
Vertex Pharmaceuticals, Inc. have a broad R&D program underway to evaluate Aurora kinase inhibitors targeting cancer.
MK-0457 is being studied in a Phase II trial in patients with treatment-refractory chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), as well as a Phase I trial in patients with advanced leukemias. Patients currently enrolled in these trials may continue to be treated with the drug, with additional monitoring for QTc prolongation. A recently initiated Phase I trial of MK-0457 in combination with dasatinib in patients with CML or Ph+ALL has also been suspended. Also, development of the Aurora kinase inhibitor MK-6592 has been discontinued after the compound did not meet pharmacokinetic objectives in a Phase I study.
Posted on November 21, 2007 @ 08:50 am
Covance, Inc. purchased a partially constructed manufacturing facility in Prince William County's Technology Park from
Eli Lilly. The company intends to transform the current facility into a 410,000-sq.-ft. state-of-the-art early drug development lab offering safety testing and chemistry analysis services.
"The increased demand from our biopharmaceutical clients for our preclinical safety service offerings has led Covance to seek opportunities to enhance and expand our operations in Northern Virginia and build upon our multi-year global expansion plans," said Wendel Barr, Covance senior vice president and president of early development North America. "For 60 years, Covance operations in Northern Virginia have made significant contributions to the development of new medicines for HIV/AIDS, breast cancer, heart disease, leukemia, diabetes, Alzheimer's, multiple sclerosis, cystic fibrosis, deadly infections, and many other debilitating diseases. With our long history in the area, we are looking forward to continuing our relationships as a member of the community as well as contributing to the diversification of the local economy."
Covance plans to relocate approximately 450 current employees from its existing operations in Vienna, VA and Chantilly, VA by 2011, and hire an additional 100 employees by 2014. The company plans to invest approximately $175 million in the project. Covance expects to receive approximately $3.7 million in financial incentives from the Commonwealth of Virginia and Prince William County.
Posted on November 20, 2007 @ 08:38 am
Biogen Idec and
Neurimmune Therapeutics AG entered an agreement for the worldwide development and commercialization of fully human antibodies for the treatment of Alzheimer’s disease (AD). The alliance will focus on the development of antibodies that bind to amyloid beta (Aβ), a pathogenic molecule thought to cause neurodegeneration and loss of cognitive function in AD patients. Currently there are no therapies for AD approved to slow or stop disease progression.
Neurimmune will conduct research to identify potential therapeutic antibodies using the company’s Reverse Translational Medicine (RTM) platform. Biogen Idec will be responsible for the development and commercialization of all products. Neurimmune could receive as much as $380 million in upfront and success-based milestone payments, as well as a royalty on sales of any products.
“Biogen Idec has the manufacturing, development and commercialization capabilities to leverage our discovery and technology expertise. With their extraordinary experience in the development of biopharmaceuticals as well as their deep history in neuroscience, Biogen Idec is the perfect partner for Neurimmune,” said Edward Stuart, Ph.D., chief executive officer of Neurimmune. “Our RTM platform is well suited to the identification of novel, safe immunotherapies for the treatment of human disease and we are particularly proud to have entered into this deal less than one year after the founding of the company.”
“Biogen Idec has built a leading position in the development and commercialization of treatments for neurological diseases such as multiple sclerosis. This alliance with Neurimmune enables us to be at the forefront of applied Alzheimer’s research, with access to an outstanding team of researchers and a remarkable technology platform,” said Alfred Sandrock, M.D., Ph.D., senior vice president, Neurology R&D, Biogen Idec.
Posted on November 20, 2007 @ 08:36 am
Dr. Victor Kiri has been appointed director of pharmacoepidemiology within
Parexel International's Clinical Research Services business. Dr. Kiri will be responsible for advising clients in the design and conduct of comparative observational studies, offering epidemiological analysis for compounds in development, and guiding strategic decisions regarding future areas of research and product development.
"Regulatory pressures are increasing client demand for pharmacoepidemiological assessments and related studies as part of late phase clinical development," said Mark A. Goldberg, M.D., president of Clinical Research Services and Perceptive Informatics at Parexel. "One of Parexel 's strengths is our late phase development service offering that we call Peri-Approval Clinical Excellence or PACE. Dr. Kiri's in-depth experience in late phase study design and safety-related issues further expands our capabilities to provide clients with integrated pharmacoepidemiology and pharmacovigilance solutions."
Prior to joining the company, Dr. Kiri managed epidemiology research at GlaxoSmithKline. He previously served as a consultant on health outcomes to the U.K. Department of Health for more than 15 years. Dr. Kiri has been appointed as Adjunct Professor of Biostatistical Epidemiology at the University of Limerick in Ireland. He also served as a lecturer at the London School of Hygiene and Tropical Medicine and at the Department of Epidemiology at the University of Surrey, in the U.K. Dr. Kiri has been elected as a Chartered Statistician by the U.K. Royal Statistical Society.
Posted on November 20, 2007 @ 08:31 am
Genmab and
GlaxoSmithKline initiated a Phase III program with ofatumumab to treat rheumatoid arthritis (RA). The program will begin with two studies (GEN410/OFA110635 and GEN411/OFA110634) in two patient populations. One study will include patients who have had an inadequate response to methotrexate therapy and the other in patients who had an inadequate response to TNF-alpha antagonist therapy. Additional studies are planned for 2008.
The studies will evaluate the efficacy of ofatumumab in reducing the clinical signs and symptoms in RA patients after a single course of the drug. The studies will include a 24-week double-blind period followed by a 120-week open-label period. The primary endpoint in each study is ACR20 at 24 weeks.
"This brings us closer to our goal of broadening the treatment options for patients with this painful and debilitating disease," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "From the data to date, we believe that ofatumumab has real potential. Now that Phase III studies are underway in multiple indications, we are moving closer to realizing this potential and bringing this important treatment to patients."
"We are very pleased that our collaboration with Genmab has progressed so that we can now move to the next step of the clinical trial program," said Dr. Moncef Slaoui, chairman of R&D, GSK. Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. This epitope is different than other anti-CD20 antibodies currently available or in development.
Posted on November 19, 2007 @ 01:31 pm
Cook Pharmica has signed an agreement with
Inspiration Biopharmaceuticals to conduct development work for its lead biologic therapy, an intravenous Factor IX product for patients with hemophilia B. Activities will be performed in Cook Pharmica's development laboratory within its Bloomington, Ind. facility. Cook Pharmica is the contract biopharmaceutical manufacturing and development services division of Cook Medical.
"We are very excited to join with Inspiration Biopharmaceuticals as their contract service provider and help bring this crucial therapy to patients," said Jerry Arthur, president of Cook Pharmica. "This is another significant milestone for Cook Pharmica and we look forward to partnering with this innovative company."
Terms of the agreement were not released.
Posted on November 19, 2007 @ 05:54 am
Celgene Corp. will acquire
Pharmion Corp. for $2.9 billion in a move intended to advance Celgene’s strategy to become a global leader in the hematology/oncology field. The transaction brings together Revlimid, Thalomid and Vidaza, products expected to generate multiple global revenue streams for accelerated revenue and earnings growth during the next five years.
"The acquisition of Pharmion is an exceptional strategic fit that will expand our role as a leader in hematology and oncology," said Sol J. Barer, Ph.D., chairman and chief executive officer of Celgene. "Our combined global infrastructure will leverage the therapeutic and commercial potential of Pharmion's products, particularly Vidaza, which has the potential to become a major global therapy. By bringing together the talents and resources of both companies, we move closer to our vision of becoming a leading hematology and oncology company in the world, expanding our industry leading programs for safety, access and patient support."
Pharmion has four products on the market and several in development focused on hematological and solid tumor cancers. Vidaza is approved in the U.S. for myelodysplastic syndromes (MDS) and has demonstrated unprecedented overall survival benefit for higher-risk MDS patients based on a Phase III trial. Pharmion previously reported that its Phase III study demonstrated that Vidaza extended overall survival by 74% as compared to conventional care regimens. Pharmion planned to file an MAA in Europe for Vidaza in higher-risk MDS before the end of the year.
Celgene had licensed its thalidomide product to Pharmion for development and commercialization in Europe and other countries. The product is under review by the EMEA as a therapy in newly diagnosed multiple myeloma, with an action expected in late 2007 to early 2008. Pharmion's pipeline includes Amrubicin, a third generation synthetic anthracycline, which is in Phase III development for the treatment of small-cell lung cancer (SCLC) under an approved Special Protocol Assessment (SPA). MGCD0103, a selective histone deacetylase (HDAC) inhibitor is being evaluated in Phase II studies in hematological malignancies as well as in solid tumors.
"The combination of our two product portfolios and organizations represents the opportunity to create a leading global hematology/oncology company,” said Patrick J. Mahaffy, president and chief executive officer of Pharmion.
Posted on November 19, 2007 @ 05:47 am
A Phase II trial of
Genentech's Avastin showed that the MAb, administered alone or in combination with irinotecan chemotherapy, demonstrated encouraging six-month progression-free survival (PFS) and objective response rate in patients with relapsed glioblastoma multiforme (GBM), the most common and aggressive type of brain cancer. As assessed by independent radiological review, 36% of GBM patients treated with Avastin alone, and 51% of patients treated with Avastin in combination with chemotherapy, lived without the disease advancing within six months. No new or unexpected safety events related to Avastin have been observed in the study. The data were presented at the 12th Annual Scientific Meeting of the Society for Neuro-Oncology.
"Historical estimates suggest that only 15% of patients with this aggressive type of brain cancer live without their cancer progressing within six months," said Timothy Cloughesy, M.D., director, Neuro-Oncology Program of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles and lead investigator for the study. "The findings suggested that at six months, more patients had lived without their cancer advancing when Avastin was administered as a single-agent or in combination with chemotherapy, than what we would normally expect."
"These findings exceeded our expectations, and due to the high unmet medical need of patients with relapsed GBM we plan to discuss these data with the FDA to determine next steps," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer.
According to the American Cancer Society (ACS), the five-year survival rate for patients with GBM is 3%, and has not changed in more than 25 years. The ACS estimates there will be 20,500 new cases of brain cancer and 12,740 brain cancer deaths in 2007.
Posted on November 16, 2007 @ 11:31 am
Schering-Plough has received antitrust clearance from the U.S. Federal Trade Commission (FTC) regarding its acquisition of
Organon BioSciences from
Akzo Nobel. SP received approval from The European Commission on Oct. 11, 2007.
Organon BioSciences is comprised mainly of Organon (human pharmaceuticals), Intervet (animal health), Nobilon (human vaccine development), and Diosynth (contract manufacturing). In connection with the conditional clearance, SP and Intervet will divest three poultry vaccines in the U.S. The divestitures are not material to the company's financial results, according to SP. No divestitures of human health products are required. The acquisition should be completed by year-end 2007.
Posted on November 16, 2007 @ 09:16 am
Pfizer has announced that it will spend $164 million to acquire
Coley Pharmaceutical Group, a publicly-held biopharmaceutical company specializing in vaccine adjuvant technology and a new class of immunomodulatory drug candidates designed to fight cancers, allergy and asthma disorders, and autoimmune diseases. The acquisition is expected to close early in 2008.
"This acquisition is an important component of Pfizer's vaccine strategy and reflects our commitment to research new and more effective vaccines to prevent infectious diseases and to treat cancers and other debilitating conditions. Coley's innovative product candidate portfolio and technology have the potential to significantly enhance future vaccine and immunotherapeutic approaches to a broad range of diseases including Alzheimer's, asthma, infectious disease and oncology, where we already have strong collaborative research in place," said Jeffrey B. Kindler, Pfizer's chairman and chief executive officer.
Coley is developing a new class of drug candidates called TLR Therapeutics which work by stimulating or blocking important immune system receptors, called Toll-like receptors (TLRs), which, in turn, direct the immune system to fight disease. Coley has discovered proprietary clinical stage drug candidates targeting TLRs 7, 8 and 9.
"As a pioneer in the field of TLR-based vaccine adjuvants and immunomodulators, Coley is delighted to enter into this agreement with Pfizer, a partner who has demonstrated that they share our vision," stated Robert L. Bratzler, president and chief executive officer, Coley Pharmaceutical Group. "We believe this transaction is a strong testament to the therapeutic potential of targeting TLR pathways and reflects Pfizer's commitment to discovering and advancing TLR Therapeutic candidates that may be capable of directing the immune system to treat a wide range of diseases."
Posted on November 15, 2007 @ 08:53 am
Trimeris has appointed
Martin A. Mattingly, Pharm.D. as chief executive officer. Dr. Mattingly will also join the Company's board of directors.
Julian Baker, a member of the company's board of directors, remarked, "The Trimeris Board is extremely excited by Martin's decision to join the Company. His hands-on experience in commercializing HIV products in crowded markets and in maximizing the value of these products as they mature is an ideal fit for Trimeris. During his tenure at Agouron and Pfizer, Martin was actively involved in both the successful launch of Viracept and its life-cycle management as numerous competitors entered the market."
Dr. Mattingly was most recently president and chief executive officer of Ambrx Pharmaceuticals. Prior to that, he served as executive vice president and chief operating officer at CancerVax. From 1996 to 2003, he provided senior leadership in various management positions at Agouron Pharmaceuticals and Pfizer. These assignments included general manager for the Agouron HIV division; vice president, Product Development Group; and vice president, Global Marketing Planning. From 1983 to 1996, Dr. Mattingly held various positions in oncology marketing and sales management at Lilly.
Posted on November 15, 2007 @ 07:14 am
GPC Biotech has announced plans to restructure, a process that will include layoffs of approximately 44% of the company’s current active workforce. Both the German and U.S. workforce will be cut. The company is "retaining key personnel needed to achieve the Company’s medium- and longer-term goals," according to a GPC statement.
Bernd R. Seizinger, M.D., Ph.D., chief executive officer, said, "Our goal of having approximately two years of operating cash on hand at the end of 2007 has sadly necessitated very significant staff reductions on both sides of the Atlantic. I would like to express my sincere appreciation to our affected employees for their contributions to GPC Biotech."
The company plans to lay off 103 employees: 60 employees in Munich and 43 in Princeton. The remaining work force will comprise 56 staffers in Munich and 58 in Princeton, following the shutdown of the company’s Waltham, MA facility in a few weeks.
GPC plans to focus its internal efforts on a limited number of development-stage oncology projects, while increasing licensing efforts and actively exploring M&A opportunities. To that end, the company has retained a core drug development team that is headquartered in the U.S., with a small group of development people retained in Germany to support ongoing and future work in Europe. The company has also retained a core drug discovery group in Munich that will support drug development in addition to continuing late-stage drug discovery efforts focused on kinase inhibitors. General and administrative staff also has been reduced. A small group of commercialization team members has been retained in the U.S. to support drug development and business development activities.
Posted on November 14, 2007 @ 12:16 pm
Pfizer CentreSource (PCS) has named Jeff Frazier to vice president, Fine Chemicals, and named Kenneth Ball to Marketing Manager. Mr. Frazier previously served as director, Strategic Initiatives and Business Planning and Mr. Ball served as technical development manager.
Mr. Frazier will assume overall responsibility for PCS Fine Chemicals marketing and business support; his team leadership role encompasses marketing, materials management, and customer service, as well as commercial leadership to PCS' ongoing Capturing Global Advantage (CGA) Steroid Project. Reporting to Mr. Frazier in the newly created position of marketing manager, Mr. Ball's responsibilities include providing commercial market research and business/strategy development support.
Mr. Frazier, who joined Pfizer Global Manufacturing (PGM) in 1988 as Research Chemist, Chemical Process R&D, joined PCS as Business Development Specialist in 1992. His subsequent PCS positions include Business Development Manager, and most recently, Director, Strategic Initiatives and Business Planning.
Mr. Ball joined PGM in 1989 as an Associate Scientist, Bioprocess R&D; in 1994 he joined PCS as Technical Development Specialist. Most recently, he was promoted to Technical Development Manager, in 2001.
Posted on November 14, 2007 @ 12:07 pm
Azopharma has added a pair of companies to its Azopharma Product Development Group: ApiCross Drug Delivery Technologies and AvivoClin Clinical Services. Based in Hollywood, FL, ApiCross's technology platforms focus on bioavailability enhancement, customized drug release, taste masking and cytotoxic and highly potent compounds. AvivoClin, which will launch in early 2008, is a clinical pharmacology unit designed to accommodate short- and long-term studies. The unit will offer customized solutions for early Phase I and IIa clinical research studies.
The two units will join Cyanta Analytical Laboratories, IQsynthesis and AniClin Preclinical Services, along with Azopharma Contract Pharmaceutical Services. Said Azopharma chief executive officer Phil Meeks, "With these two additions to our service line, Azopharma can now provide the full spectrum of solutions for product development in the pharmaceutical, biotechnology and medical device industries from discovery through Phase I/IIa clinical studies."
Posted on November 14, 2007 @ 11:53 am
Nastech Pharmaceutical plans to restructure in order to reduce operating expenses. The company will launch a subsidiary, MDRNA, Inc., as an independent, separately financed company, while the main company will concentrate on Phase II clinical and partnered programs.
Steven C. Quay, M.D., Ph.D., chairman, president and chief executive officer of Nastech, remarked, "The establishment of MDRNA as an independent company will better serve our shareholders by providing a structure that will help unlock the value of Nastech's RNAi assets as well as expedite the development of new therapeutics based on this exciting new technology. Furthermore, by having Nastech concentrate on our core drug delivery technologies and our most advanced clinical programs it will enable us to make the greatest progress with the resources that are available."
Nastech plans to concentrate its resources on its Phase II clinical development programs that are currently ongoing or planned, including PYY3-36 Nasal Spray for obesity, Insulin Nasal Spray for type 2 diabetes, and PTH1-34 Nasal Spray for osteoporosis.
The planned change in corporate structure will enable Nastech to continue its focus on the development of peptide and protein drug delivery technologies while better positioning MDRNA for strategic alliances and direct investment as it develops RNAi therapeutics targeting a broad range of diseases.
Finally, Nastech is implementing a workforce reduction plan "as soon as feasible," according to a company statement.
Posted on November 13, 2007 @ 08:53 am
VaxGen Inc. and
Raven biotechnologies have agreed to merge. The merger is expected to create a drug development company with a "robust pipeline of monoclonal antibody candidates in oncology, proprietary antibody discovery platforms, biopharmaceutical manufacturing capabilities and sufficient cash to fund operations at least through the end of 2009," according to a VaxGen statement.
VaxGen shareholders will wind up with 51% of the shares in the new company, while Raven -- a privately held firm -- will distribute 49% of the shares to its Series D preferred stockholders. VaxGen will also assume Raven's debt and equipment lease obligations of approximately $1.8 million. The merger is expected to close in the first half of 2008.
"We believe that the proposed merger of Raven and VaxGen will create a new company that can deliver value through its promising pipeline and technology platforms in one of the most scientifically and commercially promising areas of drug development," said George F. Schreiner, M.D., Ph.D., chief executive officer of Raven biotechnologies. "We expect that the transaction will allow the new company to accomplish three objectives: first, to initiate Phase II clinical trails for RAV12, our lead oncology product; second, to move our lead antibodies targeting cancer stem cells into the clinic; and third, to advance our discovery platforms in cancer stem cell biology. We further expect that the new company will be well positioned to pursue collaborations with pharmaceutical companies and other strategic alliances."
James P. Panek, VaxGen's president and chief executive officer, added, "During the past 10 months, VaxGen evaluated a wide range of strategic alternatives and determined that Raven's strong pipeline, technology and complementary capabilities distinguished it from the alternatives. We are confident that this proposed transaction with Raven will achieve our goal to build value for our stockholders through the creation of a broadly based biotechnology company with a promising future."
Upon closing, Dr. Schreiner will serve as CEO and a director of the combined company. Mr. Panek will assume the title of president and chief operating officer and will serve as a director. The company's board of directors will include four members from VaxGen's current board of directors and three from Raven's. The combined company will be based in Raven's offices in South San Francisco, CA.
Posted on November 13, 2007 @ 08:43 am
Catalent Pharma Solutions
1Q Revenues: $438 million (+10%)
1Q Loss: $11.3 million ($1.1 million in 1Q06 earnings)
Comments: Oral Technologies net revenue grew 9% to $235 million, while Sterile Technologies was up 26% to $71 million, fueled by higher utilization and throughput, along with new facilities in Brussels and North Carolina. The weakened U.S. dollar accounted for approximately 5% of sales growth.
Posted on November 13, 2007 @ 08:34 am
Pfizer and
Nektar Therapeutics have reached an agreement settling their contractual issues regarding Exubera and Nektar's new inhaled insulin product, which is currently in Phase I. Nektar will receive a one-time payment of $135 million from Pfizer to end all obligations under existing agreements relating to Exubera and the new product.
Also, if Nektar finds a new partner, Pfizer will transfer its remaining rights and all economic benefits for Exubera and the new product. This would include the transfer of the Exubera NDA and INDs and all ex-U.S. regulatory filings and applications, continuation of ongoing Exubera clinical trials and certain supply chain transition activities.
Jeffrey B. Kindler, chairman and chief executive officer of Pfizer and Howard W. Robin, president and chief executive officer of Nektar issued a joint statement about the settlement, "This agreement demonstrates the industry leadership of Pfizer and the company's desire to work with world-class biotechnology partners like Nektar. The agreement strengthens our relationship and demonstrates our ability to work together to craft a solution that allows Nektar the ability to pursue additional commercial opportunities for the Exubera and its next generation inhaled insulin franchises. Further, we look forward to advancing our joint development of PEGylated human growth hormone therapy to treat short stature and growth problems."
Posted on November 12, 2007 @ 11:12 am
Synairgen, a company developing novel therapies for asthma and COPD, has selected
Alpha Biologics to help with the advancement of its growth factor drug development program. Alpha will develop a scaleable manufacturing process for Synairgen's optimized growth factor to support preclinical and clinical development. Richard Marsden, Synairgen's managing director, said, "We have significant confidence in our growth factor drug development program for asthma to restore barrier function in patients. Initiating the development of a scaleable manufacturing process is another significant milestone for the program."
Cambridge, UK-based Alpha Biologics is an independent contract biomanufacturing organisation offering FDA/EMEA cGMP compliant services to the worldwide pharmaceutical and biotechnology industry.
Posted on November 12, 2007 @ 11:08 am
Cephalon has submitted an sNDA to the FDA to market Fentora for the management of breakthrough pain in opioid tolerant patients with chronic pain conditions. Breakthrough pain is characterized by its rapid onset, moderate-to-severe intensity, and relatively short duration. According to a study published in the August 2006 issue of The Journal of Pain, as many as 74%of patients with non-cancer chronic pain conditions treated for persistent pain, such as chronic low back and chronic neuropathic pain, will experience breakthrough pain. Currently Fentora is approved for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent pain.
"The clinical trials supporting this submission mark the first time a pain medication has been evaluated as a treatment for breakthrough pain associated with serious chronic pain conditions other than cancer," said Dr. Lesley Russell, Cephalon's executive vice president, Worldwide Medical and Regulatory Operations. "We look forward to working with FDA to broaden the use of Fentora to opioid tolerant patients with unresolved debilitating breakthrough pain."
The sNDA includes data from three randomized, placebo-controlled clinical trials and one long-term open-label safety study with a total of 941 opioid tolerant patients. The patients in the trials were treated for as long as 18 months and had a broad range of underlying chronic pain conditions, including chronic low back and chronic neuropathic pain. Opioid-tolerant patients with chronic pain treated with Fentora experienced statistically significant improvements in relief from breakthrough pain with an onset and duration of relief similar to that seen in studies of FENTORA in patients with cancer pain. The FDA's typical review period for a sNDA is 10 to 12 months.
Posted on November 12, 2007 @ 11:04 am
Advion BioServices, the bioanalytical services division of
Advion BioSciences, Inc., will expand its capacity with the recent acquisition of two Applied Biosystems/MDS Sciex API 5000 mass spectrometers and Waters Acquity UPLC capability. In addition, the company has hired 17 employees since relocating to its new laboratory facility in late April of this year.
"The addition of API 5000 and Acquity UPLC systems provides our scientists with technology to meet the needs of our clients for LC/MS/MS assays with improved sensitivity," remarked Tom Kurz, Advion BioServices’ president. "Not only does this new equipment improve our capability, but in combination with the recent expansion of our scientific staff provides us with increased capacity to serve our clients.'"
Posted on November 9, 2007 @ 01:03 pm
PharmEng International has opened its $15 million pharmaceutical manufacturing facility in Cape Breton, Nova Scotia, Canada. The 46,400-sq.ft. facility, which operates under the name of Keata Pharma, includes offices for PharmEng's pharmaceutical consulting division, pilot laboratories for formulation development, rooms with various capabilities such as high shear mixing, container blending and equipment for modified release technology in a control environment that meets all cGMP requirements.
The facility will have the necessary equipment and approvals to provide formulation development and testing services to manufacture and package products in solid and liquid dosage forms. Keata's long-term goal is to develop capabilities in other dosage forms, such as suppositories, topicals and injectables, according to a PharmEng statement. The facility is located on five acres in the Northside Industrial Park, a 300-acre business park in North Sydney, NS.
"We are committed to delivering the best value to all of our customers and are proud of the role Keata and its employees will play in the Cape Breton community," said Alan Kwong, President of PharmEng "Cape Breton's readily available infrastructure, skilled workforce and government support, coupled with PharmEng's technology leadership and expertise, gives us the confidence in delivering the best value in manufacturing services to our customers."
The facility will initially employ 65 workers and is anticipated to grow to more than 150 workers within three years. It is the only plant of its kind in Nova Scotia and one of the few plants in Canada that offers modified release manufacturing capabilities, according to the company. Production is expected to commence in early Q1 of 2008.
The Government of Canada has invested $6.25 million in repayable contributions for the construction of the facility through the Cape Breton Growth Fund ($5 million), Enterprise Cape Breton Corporation ($750,000), and ACOA's Business Development Program ($500,000).
Posted on November 9, 2007 @ 08:49 am
Merck has agreed to make a $4.85 billion settlement fund to end a vast number of Vioxx lawsuits from U.S. patients. The company stressed that this does not constitute a class-action settlement, but that the fund will cover qualified claims on a case-by-case basis.
Merck will set aside $4 billion for myocardial infarction (MI) claims and $850 million for ischemic stroke claims. The fund "is a fixed amount to be allocated among qualifying claimants based on their individual evaluation," according to a company statement. The settlement requires enrollment of at least 85% of qualifying plaintiffs. The company says ot will continue to defend all claims that are not included in the resolution process. The company has spent $600 million in each of the past two years on legal costs related to Vioxx cases, so the fixed cost of this
"This is a good and responsible agreement that will allow the company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines," said Richard T. Clark, chairman, president and chief executive officer of Merck. "The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding Vioxx product liability claims in the United States for a fixed amount."
Quoting Merck's announcement, terms of the agreement include:
- To qualify, claimants will have to pass three gates: an injury gate requiring objective, medical proof of MI or ischemic stroke (as defined in the agreement), a duration gate based on documented receipt of at least 30 VIOXX pills, and a proximity gate requiring receipt of pills in sufficient number and proximity to the event to support a presumption of ingestion of VIOXX within 14 days before the claimed injury;
- Individual cases will be examined by administrators of the resolution process to determine qualification based on objective, documented facts provided by claimants, including records sufficient for a scientific evaluation of independent risk factors;
- The agreement provides that Merck does not admit causation or fault;
- Neither stroke claims that are hemorrhagic in nature nor transient ischemic attacks will qualify;
- Law firms on the federal and state Plaintiffs' Steering Committees and firms that have tried cases in the coordinated proceedings must recommend enrollment in the program to 100 percent of their clients who allege either MI or ischemic stroke;
- The parties agree to seek court orders from the four coordination judges requiring plaintiffs' attorneys to promptly register all of their VIOXX claims, whether filed or tolled, and to identify the alleged injury - in order to establish the universe of all existing claims in the United States;
- Participation conditions: payment obligations under the agreement will be triggered only if, by March 1, 2008 (subject to extension by Merck), plaintiffs enroll in the settlement process: (a) 85 percent or more of all currently pending and tolled MI claims, (b) 85 percent or more of all currently pending and tolled ischemic stroke claims; (c) 85 percent or more of all eligible claims involving a death; and (d) 85 percent or more of all eligible claims alleging more than 12 months of use; and
- This agreement applies only to U.S. legal residents and those who allege that their MI or ischemic stroke occurred in the United States.
"This agreement is the product of our defense strategy in the United States during the past three years and is consistent with our commitment to defend each claim individually through rigorous scientific scrutiny. Under the agreement, there will be an orderly, documented and objective process to examine individual claims to determine if they qualify for payment," said Bruce N. Kuhlik, senior vice president and general counsel of Merck.
"Creating a process to look at individual claims is the fairest way to efficiently and quickly provide payment to qualified claimants," said Russ Herman, liaison counsel in the federal multidistrict Vioxx litigation and chair of the Plaintiffs' Negotiating Committee. "Specific causation has been a very difficult issue. This is an opportunity to end a long and difficult litigation that has stretched on for more than three years. A fair resolution is in everybody's best interest. This agreement would only apply to claims already filed or tolled."
Posted on November 9, 2007 @ 06:14 am
Catalent Pharma Solutions, has completed the first influenza vaccine manufacturing campaign at its new prefilled syringe manufacturing facility in Neder-Over-Heembeek, Belgium.
The production campaign exceeded 21 million prefilled syringes for the 2007 campaign. The facility replaces existing operations in Brussels. Catalent received initial European regulatory approval for this facility in July 2006, and expects to have the first FDA product approved at the facility in 2008.
"We are pleased to be able to partner with our customers for products with such far-reaching public health benefit," said Richard Yarwood, the Group President of Catalent’s Sterile Technologies segment. "Our new facility gives us substantial additional capacity to serve the high-demand prefilled syringe market globally."
Posted on November 8, 2007 @ 10:15 am
Shire plc has licensed three drugs in development from
Amicus Therapeutics. The non-U.S. rights cover Amigal for Fabry disease (Phase II), Plicera for Gaucher disease (Phase II) and AT2220 for Pompe disease (Phase I).
Shire's chief executive officer, Matthew Emmens, remarked, "Amicus' pharmacological chaperone compounds have the potential to be an excellent addition to our current enzyme replacement therapy business, which includes Replagal for Fabry disease, Elaprase for Hunter syndrome, and GA-GCB in Phase III development for Gaucher disease. In addition, it provides an opportunity for Shire to enter the market for Pompe disease. This technology should provide significant benefit to patients with these serious genetic diseases."
Financial terms of the license are dependent on the successful development and commercialization of the products. Shire will pay Amicus an upfront fee of $50 million, along with development and sales-based milestones adding up to $390 million. Shire will also pay royalties on net sales of the products, with tiered, double-digit royalty rates. The companies will pursue a joint development program toward market approval in the U.S. and Europe; expenses for this program will be shared 50/50.
Posted on November 8, 2007 @ 08:57 am
Merck Serono, a division of Merck KGaA, has submitted an MAA to the EMEA for sapropterin dihydrochloride (Kuvan in the U.S.) as an oral treatment for patients suffering from significant hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.
The compound is being developed in collaboration with
BioMarin Pharma. Acceptance of the MAA filing triggered a $15 million milestone payment to BioMarin. Sapropterin has received orphan medicinal product designation in the European Union. In the EU, orphan medicinal product designation is conferred upon investigational products for diseases that affect fewer than five in 10,000 patients.
"The MAA filing for sapropterin represents a notable milestone in our joint effort with Merck Serono to bring the first treatment option to PKU and HPA patients around the world," said Jean-Jacques Bienaime, BioMarin's chief executive officer. "We are working with the FDA on the Kuvan NDA, including label discussions, and gearing up for the anticipated U.S. launch of the product in the fourth quarter of 2007."
Posted on November 8, 2007 @ 08:53 am
Hospira
3Q Revenues: $838 million (+30%)
3Q Earnings: $59 million (+6%)
YTD Revenues: $2.5 billion (+26%)
YTD Earnings: $61 million (-68%)
Comments: Integration of Mayne Pharma helped drive revenue growth, while restructuring costs drove down earnings. Injectable Pharmaceutical Contract Manufacturing revenues were down 12% to $33.5 million in 3Q and down 20% to $111.6 million YTD.
Posted on November 7, 2007 @ 01:04 pm
Wacker has announced plans to invest $30 million to expand its facility in Jena, Germany. The expansion will cover the GMP production facility as well as the construction of a new building for process development and quality control.
"The new facilities will enable us to greatly accelerate our growth in the attractive biologics market," states Dr. Gerhard Schmid, president of Wacker Fine Chemicals, the Group's biotech and fine chemicals division.
The investment involves two expansion projects. The first project will double the manufacturing space at the existing GMP facility, partly by adding a completely new purification station to help ease bottlenecks. This station will also comply with GMP pharmaceutical manufacturing standards, in accordance with FDA and EMEA regulations, the company assures. The expansion will give Wacker Biotech the capacity customers need for biologics that are almost ready for market supply. The new facility is scheduled to come on stream at the end of 2009.
The second project concerns a new process-development and quality-control building. The focus here is on a proprietary E. coli-based protein secretion technology developed by Wacker. The company's Wacker Biotech subsidiary is expanding its process-development facilities to meet increasing customer demand. Wacker Biotech's quality control labs are being expanded, as well, to enable the company to satisfy demand for detailed product and process characterization. The new building is scheduled for completion in late 2008.
Posted on November 7, 2007 @ 12:52 pm
PsychoGenics and
Cephalon have entered into a drug discovery agreement. Cephalon will supply compounds that are prospectively suitable for neuropsychiatric disorders to PsychoGenics for evaluation using its proprietary drug discovery technologies.
The companies aim to jointly identify drug candidates suitable for clinical development. If Cephalon undertakes further development of the candidates, PsychoGenics will receive milestone payments and royalties. If PsychoGenics undertakes further development, it will make milestone and royalty payments to Cephalon.
Dr. Emer Leahy, president and chief executive officer of PsychoGenics, said, "We are delighted to partner with Cephalon and look forward to a successful collaboration. We are confident that combining Cephalon's and PsychoGenics' complementary strengths and expertise will enable us to identify a new generation of treatments for neuropsychiatric disorders."
Posted on November 7, 2007 @ 12:50 pm
AAIPharma has expanded its operations in Central and Eastern Europe with the addition of a team in Hungary. The new office is in Budapest and will initially consist of seven staff.
The group in Hungary has therapeutic expertise in the areas of oncology, cardiovascular, respiratory, gastrointestinal and anti-infective clinical trials, along with particular specialist knowledge of pediatric trials. They will provide clinical monitoring, project management and regulatory affairs services across Phase II-IV. AAIPharma already has two other offices in Central and Eastern Europe with operations in Croatia and Russia. With the recent addition of an office in South Africa, AAIPharma now has operations in 14 countries worldwide.
"Central and Eastern Europe is one of most dynamic regions to run clinical trials," said Ludo Reynders. Ph.D., AAIPharma's president and chief executive officer. "Hungary with its population of ten million, good hospital infrastructure and the availability of patients is recognised as a key country in this region. As the needs of our biotechnology and pharmaceutical customers to run global clinical trials are ever increasing, it is important that we continue to expand our international presence in key regions such as this to meet these demands."
Posted on November 6, 2007 @ 09:04 am
Bayer AG has suspended sales of Trasylol, an anti-bleeding drug, at the request of the FDA and foreign health officials pending further analysis of a Canadian study that suggests it's linked to a 50% higher risk of death than the other drugs in the trial.
Trasylol, also known as aprotinin, is used to prevent excessive bleeding during heart bypass surgery. The Canadian study comparing the safety and efficacy of Trasylol with two other drugs was stopped when preliminary results suggested Trasylol exposed patients to a greater risk of death.
"FDA cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk," said Dr. John Jenkins, director of the agency's Office of New Drugs.
Bayer, based in Leverkusen, Germany, made the decision to suspend sales after talks with FDA, the German Federal Institute for Drugs and Medicine Products, and the Canadian health department.
The suspension may be temporary for some patients. The FDA and Bayer are determining whether to make the drug available on a restricted basis for use by physicians in certain patients they believe could benefit from the drug.
Bayer estimates worldwide sales of the injection drug were roughly $135 million for the nine months through September. The U.S. accounted for about $91 million of that total.
The FDA approved the drug in 1993 and began re-evaluating the drug's safety after the January 2006 publication of two studies that linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes. More recent studies further suggested the drug also raises the risk of death.
"Once the study is complete, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol," according to a company statement. "At that time the temporary marketing suspension will be reevaluated."
Posted on November 6, 2007 @ 08:55 am
MedImmune, Inc. has made several new senior appointments across the organization. Alexander A. Zukiwski, M.D., senior vice president, clinical research; Timothy J. Hahn, Ph.D., vice president, antibody manufacturing; and Timothy J. Maines, vice president, corporate quality assurance have recently joined the company. New executive promotions include Max Donley, vice president, human resources; Jonathan Klein-Evans, J.D., vice president, intellectual property; Timothy Pearson, vice president and chief financial officer; and Paul Williams, vice president, sales operations.
"As MedImmune transitions into its new role as the global biologics unit of AstraZeneca, it is imperative to strengthen the company's leadership platform across all facets of our business. Alex, Tim Hahn and Tim Maines add an additional depth of expertise in the areas of clinical research, antibody manufacturing, and quality assurance, respectively, which are each critical to our ability to deliver new drugs to patients in need," said David M. Mott, chief executive officer and president. "The new vice presidential appointments of Max, Jonathan, Tim Pearson and Paul foster MedImmune's ability to continue to recruit and grow talent, protect our intellectual properties, manage our financial reporting obligations to our parent company AstraZeneca and serve our customers to the highest possible standards."
Dr. Zukiwski will be responsible for the company's strategy for clinical trials of its drug candidates. Prior to joining the company, he held several roles of increasing responsibility in support of Johnson & Johnson's (J&J) medical affairs and clinical development functions at Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD); Centocor R&D; and Ortho Biotech, including therapeutic area head for oncology and acting head of oncology R&D. Most recently he served as vice president, head of clinical oncology, responsible for strategic oversight and portfolio management of therapeutic oncology, hematology and supportive care clinical development programs for J&JPRD and Centocor's oncology development group. Before joining J&J, Dr. Zukiwski served in clinical oncology positions at pharmaceutical companies such as Hoffmann-LaRoche, Glaxo Wellcome and Rhone-Poulenc Rorer.
Dr. Hahn will be responsible for the antibody manufacturing strategy, including overall operations at MedImmune's cell culture manufacturing facility currently under construction in Frederick, MD, as well as existing sites in Frederick and Nijmegen, Netherlands. He has more than 15 years experience in cell culture and live virus vaccine manufacturing with Merck & Co.
Mr. Maines will be responsible for quality systems to improve the infrastructure of quality assurance operations in support of future growth, for ensuring the company's products meet corporate and government standards and that quality assurance activities comply with applicable regulations, and for providing enhanced expertise and guidance in interpreting government regulations and guidelines. He joins the company with more than 20 years of pharmaceutical, medical device and biologics industry experience as a microbiologist and quality professional. He most recently held positions at GTC Biotherapeutics, where he served as vice president of corporate quality, and Stryker Corp., where he was director of quality assurance.
Mr. Donley will be responsible for providing business-integrated leadership and delivering professional tools, programs and services to optimize the company's human capital investments through the HR function across all sites to drive business results. Prior to joining the company in 2000 as a senior manager, he led field HR and development at Bed Bath & Beyond.
Mr. Klein-Evans will be responsible for overseeing all intellectual property issues for the company. He has 15 years of experience working on all aspects of patent law, including prosecution, litigation, opinions, interferences, oppositions and licensing. He joined the company in 2002 as director, intellectual property. Previously, he was an in-house patent attorney at Human Genome Sciences, Inc. (HGS). Prior to that, he worked for the law firm of Pennie & Edmonds, LLP.
Mr. Pearson will be responsible for overseeing the company's financial and accounting obligations. Since joining the company in 1998, Mr. Pearson has raised more than $1.6 billion in debt throughout the course of his tenure, and served as corporate secretary from 2000-2004. Previously, he worked at Integrated Health Services, Inc., most recently as assistant treasurer; at CIGNA Insurance as treasury manager; and at First National Bank of Maryland as a commercial lending officer.
Mr. Paul Williams will be responsible for overseeing market research and marketing operations as well as for managing core sales operations competencies. Prior to joining the company he was a senior director at Centocor, Inc., guiding trade sales, customer supply chain and channel strategy.
Posted on November 6, 2007 @ 08:52 am
DSM Pharmaceuticals Inc. has expanded its service offerings to include formulation development and clinical trial manufacturing for solid dosage form products.
“This expansion of services will have significant value-added benefits to our customers in terms of reducing cost and accelerating time to market as they will be able to avoid the high cost of tech transfers required for commercial launch by conducting development, CTM and commercial manufacturing all at DSM’s Greenville, NC facilities,” said Terry Novak, president and business unit director of DSM Pharmaceuticals, Inc.
Pharmaceutical development services will include: preformulation, analytical development, stability studies, formulation development, NCE formulation development, reformulations for line extensions, controlled and modified release, controlled substances, clinical trial supply – Phase I-III regulatory support.
Posted on November 5, 2007 @ 08:45 am
Bilcare Global Clinical Supplies opened five state-of-the-art primary packaging rooms at its Phoenixville, PA facility as part of the company's expansion and modernization program. During 4Q2007 the company will complete the next phase of upgrades with the release of five additional primary rooms, totaling 10 primary and 16 secondary packaging rooms at its 153,000 sq.-ft. U.S. operation.
"The ongoing expansion and upgrading of our facilities and equipment is part of a comprehensive effort to provide world class service to our customers," said Bilcare, Inc. president Vincent Santa Maria. "Now more than ever Bilcare has the capability to provide quality beyond compliance."
The program to upgrade its facilities and equipment includes increasing the size of its storage and distribution facility to 72,000 sq. ft., adding six new packaging rooms, upgrading 20 packaging rooms; installing PRISYM Medica label and design production software and upgrading its IVRS capabilities.
"With the sophisticated systems required to manage the production and logistics of clinical trial supplies on a global basis, our expanded and upgraded U.S. facilities combined with our strong foothold in India, UK and Singapore, leave Bilcare well-positioned to take advantage of the trend toward global clinical trials," said Mr. Santa Maria.
Posted on November 5, 2007 @ 08:43 am
Daiichi Sankyo Co., Ltd. and
Eli Lilly plan to begin a large Phase III trial in 2Q2008 to compare prasugrel, an investigational oral antiplatelet agent, against Bristol-Myers Squibb's clopidogrel (Plavix/Iscover) in medically managed patients with acute coronary syndrome (ACS), a group of common heart conditions that includes unstable angina (chest pain) and heart attacks.
The multi-center, double-blind, randomized trial will include approximately 10,000 patients in 35 countries. TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes) will evaluate the safety and efficacy of prasugrel against clopidogrel in reducing the risk of cardiovascular death, heart attack or stroke in ACS patients who are to be medically managed without revascularization (a procedure to reopen blocked arteries). Currently, more than 50% of patients with ACS worldwide are managed without acute intervention.
Posted on November 5, 2007 @ 08:37 am
SGS received the 2007 European Outsourcing Award for Best Contract Analytical Project. The award was sponsored by Via Media, Ltd., a UK-based company that sponsors ten award categories ranging from Best New Product to Best Merger/Acquisition. The awards were presented October 3, 2007, at the European CPhI/ICSE Meeting in Milan.
SGS received the award based on a global project involving an analytical service contract with an international client, located in Europe that was performing its own analyses, as well as testing for its Shanghai manufacturing facility. SGS developed a project that qualified itself to be the analytical testing provider in Europe, and also mapped out a plan to deliver the same tests via its SGS Shanghai lab.
Criteria for the award included: clarity of objectives, effective resource allocation, the quality of implementation, customer focus, innovation, impact on customer perceptions, evaluation criteria, and results. The judging panel included members from PharmSource International, Pfizer, Novartis, ThermoFisher, Pharmbiosys, R5 Pharma, Fresenius Product Partnering and Novozymes.
“Because most contract analytical laboratories are regional, the award illustrates how SGS leveraged its global network of Quality Control laboratories to offer the same services to a European client and it’s Shanghai operations” said Ferdinand Dabu, marketing director for Life Science Services – Quality Control Testing. “The result was that the customer had a harmonized solution that spanned two continents.”
Posted on November 2, 2007 @ 09:15 am
Charles River Laboratories International, Inc. has made several appointments.
Brian Bathgate, Ph.D. has been named corporate senior vice president and president, European Preclinical Services.
Jorg Geller, D.V.M., Ph.D. has been named corporate senior vice president, Japanese Operations and Global Large Research Model and Avian Operations.
Christopher Perkin has been named corporate senior vice president and president, Canadian Preclinical Services.
Dr. Bathgate joined CRL in December 2004, following its merger with Inveresk. Since joining the organization, he has assumed responsibility for its global biopharmaceutical business, as well as drug discovery and development services in Ireland. In addition, Dr. Bathgate is also responsible for the Phase I clinical business in Edinburgh.
Dr. Geller joined Charles River Germany in 1986, overseeing its research model production operations. In 1997, he became responsible for Avian operations on a global basis. In 2004, Dr. Geller was given responsibility for global large research model operations. In his expanded role, Dr. Geller will also assume responsibility for Charles River Japan.
Mr. Perkin also joined Charles River in 2004, after the Inveresk merger, and was named corporate vice president and president, Canadian Preclinical Services. He manages Charles River's largest facility, which will soon be expanded. In addition, he oversees the preclinical services operations in Pennsylvania. Under his direction, Charles River also established preclinical operations in China this year.
"The managerial expertise and impressive track records of Brian, Jorg and Chris have played an integral role in our company's growth and success. Their ability to anticipate and exceed customer expectations enables us to remain steadfast in our commitment to providing superior products and services," said
James C. Foster, chairman, president and chief executive officer of CRL.
Posted on November 2, 2007 @ 08:59 am
Hovione's Technology Transfer Center (TTC) in New Jersey has passed successfully a pre-approval inspection by FDA. The three-day inspection was carried out by Ms. Joy R. Kozlowski-Klena, a compliance officer at FDA's Center for Drug Evaluation and Research (CDER). No form 483 was issued.
This inspection covered the center's first commercial product, a high potency small molecule API for an injectable formulation. The NDA was filed in May and approval is expected in Q1 2008, with a launch foreseen later in the year.
Hovione plants have been object of 15 FDA inspections. This inspection is the first at the New Jersey since it started to operate as an R&D facility in September 2002. Ms. Kozlowski-Klena's Establishment Inspection Report stated, "This inspection covered the NDA under evaluation, as well as limited GMP coverage of systems in place at this time, including Quality, Laboratory, Production, Facilities and Equipment. The inspection did not reveal any significant deficiencies."
The site serves as Hovione's U.S. Operations HQ, and consist of process chemistry R&D labs, cGMP kilo and scale-up labs and a cGMP pilot plant, as well as Hovione’s commercial offices. The cGMP facility is designed to prepare small-quantity NCEs to support preclinical and early-phase clinical development, demonstrating processes locally before transferring them to Hovione's full-scale manufacturing plants, in Europe and Asia.
Posted on November 2, 2007 @ 05:59 am
Laureate Pharma, Inc. has entered into a contract manufacturing agreement with
ImmunoGen, Inc. to manufacture the huC242 antibody used in production of ImmunoGen's huC242-DM4 Tumor-Activated Prodrug (TAP) compound, now in Phase II clinical testing. Terms of the manufacturing agreement were not disclosed.
"ImmunoGen is well known for its proprietary TAP technology, which uses tumor-targeting antibodies to deliver a potent cell-killing agent specifically to cancer cells," noted Robert J. Broeze, Ph.D., president and chief executive officer of Laureate Pharma. "Laureate Pharma has an established track record in the manufacture of protein based biopharmaceuticals. We are pleased that ImmunoGen chose us to manufacture their antibody and we are excited to be working with them."
Posted on November 1, 2007 @ 09:50 am
AstraZeneca
3Q Revenues: $7.2 billion (+10%, +6% at Constant Exchange Rates)
3Q Earnings: $1.4 billion (-15%)
YTD Revenues: $21.4 billion (+11%, +7% CER)
YTD Earnings: $4.4 billion (-6%)
Comments: In a deliberately obfuscatory earnings note, AZ posted revenue growth of approximately $600 million in 3Q7, reaching $7.1 billion. Global sales of Crestor grew 39% (CER) to $691 million, but the company reported that a generic challenge to AZ's patent was issued on Oct. 30. Nexium sales dropped 1% (CER) to $1.3 billion, due to generic competition. Seroquel sales grew 22% (CER) to $1.1 billion, including $80 million in stocking sales for the XR formulation. Seloken/Toprol XL sales fell 33% (CER) to $328 million, due to generic competition. The company posted $146 million in restructuring costs in 3Q07 and $604 million YTD.
Posted on November 1, 2007 @ 09:11 am
Millennium Pharmaceuticals
3Q Revenues: $122 million (+18%)
3Q Loss: $1.7 million (loss of $13.7 million in 3Q06)
YTD Revenues: $346 million (flat)
YTD Loss: $26.2 million (loss of $52.2 million in YTD06)
Comments: U.S. net sales of Velcade grew 32% to $70 million in 3Q07 and royalty revenues were up 23% to $41.3 million. The company attributes some of its net YTD loss to amortization of intangibles ($34 million), stock-based compensation ($25 million) and restructuring charges ($15 million).
Posted on November 1, 2007 @ 09:01 am
Dr. Martin Barkin will retire as president and chief executive officer of
Draxis Health at the end of the year. Dr. Barkin joined the senior management of Draxis in 1992.
Dan Brazier, presently chief operating officer, will immediately take on the roles and responsibilities currently held by Dr. Barkin until a successor is appointed. Dr. Barkin said, "I have worked closely together with Dan Brazier for the last several months in the office of the president and he has been assuming more and more of my responsibilities. I have become very comfortable with his abilities."
October 2007
Posted on October 31, 2007 @ 08:50 am
MedImmune has exercised an option to obtain an exclusive license to an antigen target under its antibody-drug conjugate (ADC) collaboration with
Seattle Genetics, triggering a $1.5 million payment. This is the second target MedImmune has licensed through the agreement.
Seattle Genetics and MedImmune entered into the ADC collaboration in April 2005 to provide MedImmune with access to Seattle Genetics' ADC technology for antibodies targeting as many as two antigens. MedImmune paid an upfront fee of $2.0 million for the first target and obtained an option to license a second antigen for an additional fee of $1.5 million. MedImmune has also agreed to pay ongoing technology access fees, progress-dependent milestone payments and royalties on net sales of ADC products. MedImmune is responsible for research, product development, manufacturing and commercialization of product candidates under the collaboration.
"MedImmune has made substantial progress with its first ADC program, and we look forward to collaborating with them further on a second target," said Eric L. Dobmeier, chief business officer of Seattle Genetics. "Through momentum with our own ADC programs, such as SGN-35, and continued progress by our collaborators, our ADC technology is demonstrating its significant potential to impact the way cancer is treated."
Posted on October 31, 2007 @ 08:34 am
Emisphere Technologies, Inc. will move its corporate headquarters from Tarrytown, NY to Cedar Knolls, NJ. Emisphere will retain its scientific staff and laboratory facilities in Tarrytown.
"This move allows us to better serve all of our customers and enhance collaborations with leading pharmaceutical companies," said Michael V. Novinski, president and chief executive officer. "The move will keep Emisphere agile and competitive for our partners, and be particularly advantageous as we take the Company in new and exciting directions."
The move to New Jersey is one of several real estate initiatives that, cumulatively, could result in long-term savings of over $1 million, according to the company. The move into these offices will be initiated November 2007 and completed by the first quarter of 2008.
Posted on October 31, 2007 @ 08:29 am
Kendle International
3Q Revenues: $142 million (+47%)
3Q Earnings: $3.7 million (-5%)
YTD Revenues: $414 million (+62%)
YTD Earnings: $12.3 million (-6%)
Comments: Net service revenues grew 33% in 3Q07 to $100 million, and 49% YTD to $293 million. The company gained a record $175 million in new business awards in the quarter, up 18%.
Posted on October 30, 2007 @ 09:24 am
Lilly has entered into an agreement with
Glenmark Pharmaceuticals S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India, to acquire the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinical compound, GRC 6211. GRC 6211 is currently in early clinical Phase II development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain.
Glenmark will receive an upfront fee of $45 million and could receive as much as $215 million more in potential development and sales milestones for the initial indication, as well as royalties on sales if GRC 6211 is successfully commercialized. If other indications are successfully developed, Glenmark would be entitled to additional milestones of as much as $90 million. Lilly will have marketing rights for North America, Europe and Japan, while Glenmark will retain the marketing rights in all other countries. Glenmark will also have the right to co- promote GRC 6211 in the U.S. Other terms of the deal were not disclosed.
"This agreement is further evidence of Lilly's commitment to seek out novel treatments for important medical conditions, such as osteoarthritic pain," commented William Chin, M.D., Lilly vice president, discovery research and clinical investigation. "We believe that TRPV1 represents a promising pathway for pain research. GRC 6211 has shown good potential in early-phase development and will be a strong addition to our own internal pipeline of potential pain molecules."
According to Glenn Saldanha, Managing Director and CEO of GPL, "This agreement further validates that Indian companies have the ability to do world class innovative R&D and Glenmark's leadership in the Indian drug discovery arena. We have made excellent progress in our TRPV1 program at Glenmark and are very excited to be partnering with Lilly, a world-class research-driven global pharmaceutical company."
Posted on October 30, 2007 @ 09:17 am
Pfizer has nominated a second compound for clinical development in its collaboration with
Coley Pharmaceutical Group. Coley is developing a novel class of drug candidates known as TLR Therapeutics. This second generation drug candidate is expected to complement Pfizer's ongoing clinical programs for PF-3512676, Coley's lead therapeutic TLR9 agonist drug candidate, for the treatment of cancer.
Under the agreement, Pfizer has exclusive rights to two novel compounds discovered in the collaboration, while Coley retains the rights to all other molecules. To date, Coley has designed and characterized nearly 60 unique compounds, each of which elicits a distinct immune stimulatory profile based on its interaction with TLR9. The newly nominated compound, which is the first of two development candidates, will now undergo preclinical studies to further assess its pharmacokinetic and toxicology profiles before advancing into clinical trials.
Pfizer is currently investigating PF-3512676 in combination with non-cytotoxic anti-cancer agents. A Phase II clinical trial evaluating PF-3512676 in combination with Tarceva for the treatment of refractory non-small cell lung cancer, and a Phase I clinical trial evaluating PF-3512676 in combination with Pfizer's anti-CTLA4 antibody, tremelimumab, for the treatment of advanced melanoma are both underway. Pfizer is currently planning additional clinical trials with PF-3512676 to evaluate its safety and potential efficacy in other cancer indications.
Posted on October 30, 2007 @ 08:40 am
MDS Pharma Services has moved its central lab services to a new, larger facility in Beijing to meet growing demands from pharmaceutical and biotech companies conducting clinical trials in China.
With almost 25,000 sq. ft., the new facility offers a fivefold increase in testing capacity, four times the space to produce clinical trial kits, and a wider range of specialized clinical trial testing services, according to MDS. This new facility's proximity to the Beijing airport also facilitates faster transportation of clinical trial samples.
Said MDS Pharma Services president David Spaight, "With many pharmaceutical and biotech companies now making China part of their global clinical trial programs, we recognized the need to expand our central lab operations and offer more diverse testing options."
This new central lab facility specializes in molecular biology testing for infectious diseases, DNA banking and pharmacogenomics. It also offers enhanced molecular biology techniques, a microbiology lab and flow cytometry capabilities. MDS Pharma Services continues to offer project and data management from this new facility.
The company has been in China for more than 10 years, and was the first western CRO to own its facility in China.
Posted on October 29, 2007 @ 08:34 am
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted an NDA for paliperidone palmitate to the FDA. The drug -- a once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia -- is a long-acting injectable ester of the API in Invega, which utilizes NanoCrystal Technology developed by
Elan. Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, L.P.
Under the terms of Elan’s license agreement with J&JPRD, Elan is eligible to receive payments upon the achievement of certain milestones, as well as royalty payments based on sales of the injectable formulation, if the product is successfully commercialized.
"We are very pleased to see this product application being filed with the U.S. regulatory authorities," commented Shane Cooke, chief financial officer and head of Elan Drug Technologies. "If the product is approved for marketing by the regulators, we look forward to the successful launch of this product in the U.S. and other territories. This is the first long-acting injectable product developed and submitted to a health authority using Elan’s NanoCrystal Technology and marks a significant milestone in the advancement of the technology."
Posted on October 29, 2007 @ 08:24 am
Cambridge Antibody Technology (CAT), owned by
AstraZeneca, will be folded into
MedImmune and will adopt its name. The new MedImmune business unit will unite the resources and expertise from CAT, the pre-existing MedImmune and other biologics activities within the AstraZeneca Group, under the "MedImmune" name.
With this structure, AZ has immediately created one of the world's leading vertically integrated biotechnology businesses, with more than $1.3 billion in revenues in 2006, a pipeline of approximately 100 research projects and more than one dozen clinical product candidates, and more than 3,000 employees worldwide, according to AZ.
"The new MedImmune is now the operationally independent and strategically aligned biologics business unit of AstraZeneca," said David M. Mott, MedImmune president and chief executive officer. "Bringing together the biologics expertise of CAT, MedImmune and AstraZeneca allows us to preserve MedImmune's traditional biotech agility and entrepreneurial spirit while encouraging strategic collaboration and cross fertilization of ideas under AstraZeneca's world-class research umbrella."
As part of the integration, John Stageman, Ph.D., vice president of AstraZeneca biopharmaceutical strategic planning, will assume the role of interim site head in Cambridge. Dr. Stageman commented, "AstraZeneca's biologics capabilities have been enhanced significantly by the acquisitions of CAT and MedImmune to create a more robust, highly competitive and fully integrated biotechnology business. The scientific, technical and medical expertise that this team brings together is world class in discovering, developing, manufacturing and commercializing biopharmaceutical products."
AstraZeneca acquired CAT, a biopharmaceutical company committed to developing human monoclonal antibody therapeutics, in June 2006. At the time, AZ's goal was for biologics to account for 25% of its product pipeline by 2010. The company got a jump on this strategy in 2007, when it acquired MedImmune.
Posted on October 29, 2007 @ 08:17 am
Gibraltar Laboratories Inc., (GBL) a life science CGMP/ISO 17025 testing and consulting firm, has completed the first phase of a 14,000-sq.-ft. expansion of its laboratory facilities.
The company currently owns and occupies 12,000 square feet at 122 Fairfield Rd. in Fairfield, NJ. The expansion, to a nearby wholly owned cite provides Gibraltar with new microbiology laboratories to perform compendial pharmaceutical, medical device, virus testing, Mycoplasma, cell culture, packaging and biotechnology services. It includes both a large cleanroom for USP <71> Sterility Testing and a large BSL-3 laboratory for microbial/viral control.
The new laboratory affords Gibraltar an additional 4,000 sq. ft. of chemistry analytical laboratory space at the 122 Fairfield Rd. site. This analytical space will house raw materials testing and Atomic Absorption.
The expansion, to be completed in December 2007, is expected to generate approximately 10-20 new jobs for skilled professionals in areas of Microbiology, Chemistry and Quality Assurance, according to Dr. Daniel Prince, GBL's president.
Posted on October 25, 2007 @ 08:14 am
Akorn, Inc. has signed a 10-year operating lease for a newly constructed product development facility located in Gurnee, IL. This site, a Center for Excellence, will centralize Akorn's new product development activities, consolidating development efforts that are presently managed in Decatur, IL and Somerset, NJ.
Shawn L. Silvestri, Ph.D., vice president, new product development, stated, "This new, state-of-the art facility will position Akorn to compete on a global basis, enabling us to attract and recruit top-tier scientific talent. The facility will conform to the tenets of cGLP (current Good Laboratory Practices) for R&D activities and will fulfill all requirements for the development of Akorn's pipeline of NDA and ANDA filings for prescription drug products."
Posted on October 25, 2007 @ 08:12 am
Bristol-Myers Squibb
3Q Revenues: $5.1 billion (+22%)
3Q Earnings: $858 million (+154%)
YTD Revenues: $14.5 billion (+5%)
YTD Earnings: $2.3 billion (+35%)
Comments: Earnings for 3Q07 were boosted by $247 million from the sell-off of the Bufferin and Excedrin brands in Japan. Worldwide pharma sales grew 24% to $3.9 billion, but that growth rate is affected by the 3Q06 sales of generic Plavix by Apotex. The company estimated that the generic competitor sapped $525-$600 million from 3Q06 sales. Plavix sales in the U.S. were up 128% to $1.1 billion. Sales of schizophrenia/bipoolar treatment Abilify grew 34% to $420 million worldwide.
Posted on October 25, 2007 @ 04:32 am
Covance
3Q Revenues: $415 mlllion (+16%)
3Q Earnings: $45 million (+17%)
YTD Revenues: $1.2 billion (+14%)
YTD Earnings: $125 million (+17%)
Comments: Early development results were up 19% to $200 million, while late-stage services rose 13% to $197 million. During the quarter, the company opened four new facilities: a preclinical ABSL-2 vaccine facility in North America, a preclinical facility expansion in Europe, and two sites in Aisa, a central laboratory and a nutritional chemistry laboratory.
Posted on October 25, 2007 @ 04:31 am
Amgen
3Q Revenues: $3.6 billion (flat)
3Q Earnings: $201 million (-81%)
YTD Revenues: $11.0 billion (+6%)
YTD Earnings: $2.3 billion (+10%)
Comments: Overall U.S. sales diminished 2% as Medicare reimbursement for Aranesp was lowered, while dosing questions impaired EU sales of the drug. Enbrel sales were up 16% to $821 million. Earnings took a $590 million hit to write off in-process R&D from a pair of acquisitions, as well as a $293 million charge as part of the company's restructuring program, and a $90 million inventory writeoff. Total restructuring charges are expected to reach $775-$850 million.
Posted on October 24, 2007 @ 08:35 am
PPD, Inc. has opened offices in Sydney, Australia; Copenhagen, Denmark; Lisbon, Portugal; and Lima, Peru. The company says the moves reflect "continued expansion of its Phase II-IV services in key therapeutic areas."
The four new offices broaden the company's global footprint for delivering clinical services in response to increasing client demand. Sydney marks PPD's second location in Australia, while the locations in Copenhagen, Lisbon and Lima establish PPD's first offices in those countries.
"With the biopharmaceutical industry increasingly relying on outsourcing, these new offices are important to our strategic growth in areas where there is high demand for our global experience and therapeutic expertise," said Fred Eshelman, chief executive officer of PPD. "We will continue to execute our globalization strategy by positioning our people, systems and infrastructure in locations that meet the needs of our clients."
Posted on October 24, 2007 @ 08:29 am
Genzyme Corp.
3Q Revenues: $960 million (+19%)
3Q Earnings: $159 million (up from $16 million in 3Q06)
YTD Revenues: $2.8 billion (+19%)
YTD Earnings: $401 million (+60%)
Comments: Myzozyme sales rose 162% to $54 million in 3Q07, and the company is hoping to gain approval for a new large-scale manufacturing process in the U.S. Fabrazyme sales grew 12% to $105 million and Cerezyme was up 13% to $286 million. Genzyme expanded its line this quarter by acquiring several new products and gaining new labels for others. During the quarter, the company also took a $12 million writeoff for four batches of its transplantation product Thymoglobulin which "did not meet the company's specifications."
Posted on October 24, 2007 @ 06:54 am
GlaxoSmithKline
3Q Revenues: $11.1 billion (+5% in USD, -3% in local currency)
3Q Earnings: $2.7 billion (+2% in USD, -6% in local currency)
YTD Revenues: $33.3 billion (+6% in USD, -3% in local currency)
YTD Earnings: $8.4 billion (+8% in USD, -1% local currency)
Comments: The weak dollar bolstered the appearance of GSK's results, but the numbers in GBP show a down quarter. Avandia's safety concerns walloped GSK's pharma growth in 3Q, with sales dropping 51% to GBP 153 million ($311 million). Avandia sales have dropped 28% in local currency to GBP 717 million ($1.4 billion). Generic competition damaged sales of Zofran (-86%), Flonase (-23%), Wellbutrin XL (-41%), and Coreg IR/CR (-20%). Overall, 3Q pharma sales were down 2% in local currency to GBP 4.6 billion ($9.3 billion), leading the company to announce a new $3.0 billion Operational Excellence series of cuts to improve the bottom line. This will include streamlining its manufacturing network and salesforce, along with "simplification and streamlining of support infrastructure" to cut R&D costs. The program is expected to deliver pre-tax savings of $1.4 billion by 2010.
Posted on October 23, 2007 @ 08:56 am
Almac, a provider of R&D and manufacturing services based in Craigavon, Northern Ireland, announced plans to invest $100 million to build its North American headquarters. The new facility will add approximately 260 jobs within three years.
Said Almac chairman Sir Allen McClay, "We are proud to announce the location of our new US facility here in Pennsylvania. Almac is a Northern Ireland company with our global headquarters in County Armagh. We have come a long way and Almac is now a global business, a global family, and our presence here today demonstrates that the economic relationship between our two countries is no longer a one-way street -- I am delighted that Almac is at the center of this important relationship.
"We have had operations in the state over the last decade and we have always been able to recruit excellent employees who have proven to be an important part of the Almac family. Our positive experience to date in Pennsylvania and especially the availability of a skilled and committed workforce was a major factor in this decision, as was the support we have received from the Governor and the state authorities."
Almac received approximately $9 million in infrastructure and jobs creation funding from the county and state, and Gov. Rendell (D-PA) mentioned the potential for another $3 million. The project will be competed in several phases. Initially, the company will construct a 240,000-sq.-ft. building in Lower Salford Township, PA and combine its two Pennsylvania divisions located in Audubon, Montgomery County, and Yardley, Bucks County. Construction is scheduled to begin in 2008 with the facility expected to be fully operationally in 2010.
Posted on October 23, 2007 @ 08:31 am
GlaxoSmithKline and
Tolerx, Inc. have formed a worldwide alliance to develop and commercialize otelixizumab (TRX4), a novel humanized anti-CD3 monoclonal antibody that has potential across a broad range of autoimmune and immune-mediated inflammatory diseases, including type 1 diabetes.
Tolerx will have responsibility for the Phase III clinical program for type 1 diabetes in the U.S. as far as and including regulatory submission of the BLA. Tolerx has the option to co-promote otelixizumab in type 1 diabetes in the U.S. with GSK, while GSK will have exclusive rights to develop and commercialize it in all other indications in the rest of the world. GSK also has the exclusive right to develop the pediatric indication for type 1 diabetes in the U.S.
Tolerx will receive an upfront payment, equity and advance R&D funding totaling $70 million. In addition, Tolerx may receive as much as $155 million in future development costs of otelixizumab in type 1 diabetes, and may earn as much as $350 million in milestone payments, assuming successful development and approvals of otelixizumab for type 1 diabetes and multiple additional indications. Tolerx may also receive as much as $175 million in sales milestone payments based on tiered net sales thresholds of otelixizumab. Tolerx will be entitled to receive tiered, double-digit royalty payments on worldwide sales of otelixizumab in all indications. At the time of an initial public offering of Tolerx's common stock and at the request of Tolerx and certain other conditions, GSK will invest up to an additional $10 million in Tolerx's common stock.
Otelixizumab has been evaluated in type 1 diabetes in two Phase II studies and in psoriasis in two Phase I studies. In clinical trials, otelixizumab has been shown to preserve the function of insulin-producing beta cells in the pancreas in patients with type 1 diabetes, reducing the amount of administered insulin needed to control blood glucose levels.
Posted on October 23, 2007 @ 08:10 am
Biogen Idec
3Q Revenues: $789 million (+12%)
3Q Earnings: $119 million (-24%)
YTD Revenues: $2.3 billion (+15%)
YTD Earnings: $437 million (+301%)
Comments: Avonex sales leveled off, up 2% to $455 million, while BI's share of Rituxan revenues rose 15% to $235 million. During the quarter, the company's named Paul Clancy to the role of chief financial officer. Two months later, BI's board authorized management to look for a buyer for the company.
Posted on October 22, 2007 @ 08:28 am
Merck
3Q Revenues: $6.1 billion (+12%)
3Q Earnings: $1.5 billion (+62%)
YTD Revenues: $18.0 billion (+8%)
YTD Earnings: $4.9 billion (+24%)
Comments: Singulair sales rose 17% to $1 billion. Diabetes treatment Januvia, launched in October 2006, posted $185 million in 3Q07 sales. Gardasil, the HPV vaccine approved in the U.S. in June 2006, posted worldwide sales of $418 million. Sales of Zetia and Vytorin are not recognized as revenues, but as equity from a joint venture. The cholesterol treatments products reached all-time highs in prescriptions in 3Q07, and posted combined sales of $1.3 billion (+26%), of which Merck recognizes approximately half.
Posted on October 22, 2007 @ 08:18 am
Schering-Plough
3Q Revenues: $2.8 billion (+9%)
3Q Earnings: $750 million (+142%)
YTD Revenues: $9.0 billion (+13%)
YTD Earnings: $1.9 billion (+97%)
Comments: Revenues do not reflect sales of Vytorin and Zetia, which are accounted as "equity income from a joint venture". SP's share of that income was $639 million in 3Q (+27%) and $1.8 billion YTD (+34%). Global pharma sales rose 10% to $2.3 billion in 3Q07, driven by Remicade ($426 million / +34%), Nasonex ($242 million / +10%), and Temodar ($215 million / +20%).
Posted on October 22, 2007 @ 05:28 am
Schering-Plough released not-bad news about its novel oral thrombin receptor antagonist (TRA), as two Phase II studies in patients with vascular disease showed that TRA does not increase the rate of major or minor bleeding in patients with acute coronary syndrome or prior ischemic stroke when added to standard antiplatelet therapy. The trials were conducted in Japan as part of the global registration program for TRA.
"These findings confirm the results of the TRA-PCI Phase II trial, which were presented at the American College of Cardiology/i2 Summit earlier this year," said Rick Veltri, M.D., group vice president of global clinical research, cardiovascular and metabolic disease, Schering-Plough Research Institute. "We now have three Phase II trials involving a total of more than 1,200 patients with vascular disease which consistently demonstrate that TRA is well-tolerated and not associated with an increased rate of bleeding compared to patients who received standard of care therapy alone."
The trials had the secondary objective of assessing whether patients treated with TRA in addition to standard of care therapy had fewer major adverse cardiovascular events such as myocardial infarction compared to patients treated with the standard of care alone. According to an SP statement, "While not powered to establish efficacy, in the acute coronary syndrome study patients undergoing percutaneous coronary intervention (PCI) treated with TRA had a statistically significant reduction in myocardial infarctions during the periprocedural period compared to standard of care alone."
The company has begun dosing in patients in the global phase III development program, which includes nearly 30,000 patients with vascular disease. The first trial, in secondary prevention, involves approximately 19,500 patients with prior myocardial infarction or stroke, as well as patients with existing peripheral arterial disease. The second trial, in acute coronary syndrome, involves approximately 10,000 patients with non-ST segment elevation acute coronary syndrome.
Posted on October 19, 2007 @ 08:31 am
Gilead Sciences
3Q Revenues: $1.1 billion (+41%)
3Q Earnings: $398 million (net loss of $52 million in 3Q06)
YTD Revenues: $3.1 billion (+47%)
YTD Earnings: $1.2 billion (+155%)
Comments: Sales of new HIV medication Atripla reached $241 million, after posting $68 million in 3Q06. Sales of top product Truvada increased 30% to $409 million. Overall, the HIV franchise was up 45% to $806 million, while non-HIV products Hepsera (hepatitis B) and Ambisome (severe fungal infection) contributed $148 million to 3Q revenues, up from $110 million in 3Q06.
Posted on October 19, 2007 @ 08:15 am
King Pharmaceuticals plans to lay off 20% of its workforce in an effort to speed up its strategic focus in neuroscience and hospital/acute care. The company estimates that the firings and other reductions in general and administrative expenses will save $75 million to $90 million in 2008
In September 2007, the U.S. Court of Appeals ruled against the continued validity of the patent covering King’s Altace product. The company has filed a petition with the court seeking reconsideration of the decision, asserting it involves significant errors.
"We believe the expense reduction measures announced today will enable us to continue generating strong cash flow to invest in our pipeline and business development opportunities, further strengthening our neuroscience and hospital/acute care platforms," said Joseph Squicciarino, King's chief financial officer.
In recent years, King has developed a pain management franchise, which includes existing products like Skelaxin and Avinza, as well as products in development like Remoxy, a long-acting oral oxycodone. In the hospital/acute care area, King's portfolio of products is led by Thrombin-JMI and auto-injector products, including Epipen.
Brian A. Markison, King's chairman, president and chief executive officer, remarked, "We remain committed to expanding our product portfolio through investing in R&D, acquiring exciting late-stage compounds and continuing as a partner of choice for promising products and technologies."
King will incur special charges during 2007 of approximately $150 million to recognize the impaired value of its intangible assets associated with Altace and approximately $90 million primarily related to the impaired value of raw material inventory and related contracts associated with the drug. The company will also incur a one-time charge of approximately $70 million during 2007 related to this restructuring.
Posted on October 18, 2007 @ 06:17 am
Pfizer
3Q Revenues: $12.0 billion (-2%)
3Q Earnings: $761 million (-77%)
YTD Revenues: $35.6 billion (-1%)
YTD Earnings: $5.4 billion (-45%)
Comments: 3Q Pharma sales dropped 4% to $11.0 billion. Ongoing generic erosion from Zoloft (June 2006) and Norvasc (March 2007) hurt revenues for 3Q and YTD. Sales for those products dropped from $1.6 billion in 3Q06 to $764 million in 3Q07 and $5.5 billion YTD06 to $2.8 billion in YTD07. Lipitor sales decreased 5% to $3.2 billion due to competition from generic statins. Lyrica sales grew 37% to $465 million and Chantix grew from $33 million to $241 million. Earnings were pounded by a $2.8 billion writeoff from the company's decision to drop Exubera inhaled insulin.
Posted on October 18, 2007 @ 06:08 am
Wyeth
3Q Revenues: $5.6 billion (+9%)
3Q Earnings: $1.1 billion (flat)
YTD Revenues: $16.6 billion (+10%)
YTD Earnings: $3.6 billion (+8%)
Comments: 3Q pharma revenues were up 10% to $4.7 billion, driven by a 24% boost in sales of Prevnar vaccine to $634 million and a 39% rise in ex-NA sales of Enbrel to $527 million. Top-seller Effexor posted a 4% increasse to $958 million. Earnings were impaired by a $117 million charge related to Wyeth's ongoing restructuring.
Posted on October 18, 2007 @ 05:11 am
Novartis
3Q Revenues: $9.6 billion (+9%)
3Q Earnings: $6.8 billion (+267%)
YTD Revenues: $28.1 billion (+13%)
YTD Earnings: $11.0 billion (+100%)
Comments: Net earnings included $5.2 billion from the sale of the Medical Nutrition and Gerber units. Without that boost, net earnings for 3Q would have been $1.6 billion (-12%) and $5.6 billion YTD (+7%). Pharma sales were up 2% in 3Q to $5.9 billion, and up 8% to $17.9 billion YTD. With the earnings announcement, Novartis announced layoffs of 1,260 U.S. employees (240 positions in U.S. HQ and 1020 sales reps and 3rd party reps) and that Pharma division leader
Thomas Ebeling has been moved to the Consumer Health Division.
Joe Jimenez will now lead the Pharma division.
Posted on October 17, 2007 @ 08:52 am
Ricerca Biosciences has named
James R. Szabo, D.V.M., Ph.D., DACVP, to the role of vice president - Biology Services. In this capacity Dr. Szabo will oversee the new primate facility under construction at Ricerca as well as direct the day-to-day operations of the Toxicology & Pharmacology, Bioanalytical, and Metabolism groups.
Dr. Szabo joined Ricerca from Bridge Global Pharmaceutical Services (formerly Gene Logic, Inc.) where he served as vice president of toxicology. He brings extensive experience in veterinary pathology and toxicology services to Ricerca. Dr. Szabo has held positions as senior veterinary pathologist, director of pathology, acting director of toxicology services, and senior director of pathology services at Gene Logic and has also served as a consultant to the Dow Chemical Company.
"We are extremely pleased with the opportunity to have Jim Szabo on our team," said
Ian Lennox, Ricerca's executive chairman. "His broad experience in toxicology, and especially in the veterinary pathology field, will be a tremendous resource to draw on when Ricerca's new primate capability is on-line at the beginning of next year."
Posted on October 17, 2007 @ 08:44 am
ImClone and
Bristol-Myers Squibb have established an agreement with
Merck KgA to co-develop and co-commercialize Erbitux in Japan. The three companies will collaborate on a joint effort to develop and, following regulatory approval, market the drug in Japan for the treatment of epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC), as well as for the treatment of any other cancers the parties agree to pursue. BMS and Merck will utilize their respective sales forces in Japan, and the three companies will share profits/losses realized as a result of the agreement. Merck Serono Japan will distribute the product and record the sales for the collaboration.
Merck will receive 50% of the profit/loss from sales in Japan, and ImClone Systems and BMS will each receive 25 percent. The sharing of profit/loss reflect the co-exclusive rights to Erbitux in Japan, previously granted by ImClone to the other two companies. In addition to its percentage of profits, ImClone will receive from a royalty from Merck of approximately 4.75% of total net sales in Japan.
The companies submitted an application in Japan earlier, based on results from studies conducted in North America, Europe and Japan. Erbitux is the first EGFR-inhibiting MAb to be submitted for marketing authorization in Japan.
"This agreement further strengthens our partnership with ImClone Systems and Merck KGaA as we focus on maximizing the global potential of Erbitux," said Lamberto Andreotti, executive vice president and chief operating officer, Worldwide Pharmaceuticals, BMS. "If approved in Japan, Erbitux would be an important new addition to the treatments available to Japanese patients with EGFR-expressing metastatic colorectal cancer."
Posted on October 17, 2007 @ 08:39 am
Abbott Laboratories
3Q Revenues: $6.4 billion (+14%)
3Q Earnings: $717 million (flat)
YTD Revenues: $18.7 billion (+15%)
YTD Earnings: $2.4 billion (+10%)
Comments: Pharma sales grew 20% to $3.5 billion in 3Q07, driven by growth in Humira, Kaletra and TriCor sales. Earnings were impaired by costs related to a buyout of Guidant's stent business.
Posted on October 16, 2007 @ 09:14 am
Genentech
3Q Revenues: $2.9 billion (+22%)
3Q Earnings: $685 million (+33%)
YTD Revenues: $8.8 billion (+21%)
YTD Earnings: $2.1 billion (+41%)
Comments: U.S. product sales were $2.2 billion in the quarter, up 18%. Avastin sales were up 37% to $597 million. Rituxan sales were $572 million, up 12%. Lucentis sales were up 29% to $198 million. R&D expenses were up 35% in the quarter to $615 million, which includes an employee stock-based compensation expense of $37 million. Results in the quarter also include a one-time in-process research and development (IPR&D) charge of $77 million associated with the Tanox Acquisition.
Posted on October 16, 2007 @ 09:13 am
Johnson & Johnson
3Q Revenues: $15 billion (+13%)
3Q Earnings: $2.5 billion (-8%)
YTD Revenues: $45.1 billion (+14%)
YTD Earnings: $8.2 billion (-8%)
Comments: Worldwide pharmaceutical sales were $6.1 billion in the quarter, up 4%. Growth reflects the strong performance of Topamax, Remicade, and antipsychotic franchise, which includes Risperdal, Risperdal Consta and Invega. Earnings for the quarter include an after-tax restructuring charge of $528 million associated with a cost improvement program.
Posted on October 16, 2007 @ 09:10 am
Genentech has initiated an expansion cohort in Phase I trial of a Hedgehog antagonist, triggering a $3 million cash payment to Curis, Inc. under the companies' June 2003 collaboration agreement. The Phase I trial expansion satisfies the criteria for a Phase II trial.
Genentech began the open-label Phase I trial in January 2007 to study a systemic Hedgehog antagonist in patients with locally advanced or metastatic cancers that have not responded to standard therapy or for whom no standard therapies exist. The primary objectives of the trial are to evaluate the safety and tolerability of escalating doses of the drug, to establish the maximum tolerated dose and dose limiting toxicities and to characterize pharmacokinetic and pharmacodynamic properties. The Phase I trial objectives have been achieved and the trial expansion cohort is expected to enroll additional patients.
"We are pleased that the Phase I systemic Hedgehog antagonist drug candidate has achieved its primary Phase I trial objectives and that Genentech has elected to initiate a Phase I expansion cohort," said Curis president and chief executive officer Dan Passeri. "While we realize that we are still in an early phase of human clinical testing, we continue to remain optimistic that this Hedgehog antagonist drug candidate may provide an effective therapeutic benefit to cancer patients in the future. We are also pleased with the receipt of $3 million in additional capital."
Posted on October 16, 2007 @ 09:07 am
Baxter International, Inc. has signed an agreement with Kaketsuken, the Chemo-Sero-Therapeutic Research Institute based in Kumamoto Japan, for the worldwide rights to develop, manufacture and market the recombinant protein ADAMTS13 for the treatment of thrombotic thrombocytopenic purpura (TTP) and related disorders.
ADAMTS13 is a bio-engineered version of a naturally occurring enzyme that plays a critical role in blood coagulation. TTP is a severe, often life-threatening condition marked by the formation of platelet-rich blood clots in blood vessels throughout the body.
"We are very excited to add recombinant ADAMTS13 to our development pipeline," said Hartmut J. Ehrlich, M.D., vice president of global R&D for Baxter's BioScience business. "Elucidating the role of recombinant ADAMTS13 in TTP and other blood-clotting disorders might provide us with a new treatment modality for thrombotic diseases, which is a substantial addition to our R&D pipeline."
Under the terms of the agreement, Baxter will have access to Kaketsuken's intellectual property rights for ADAMTS13 as well as an exclusive license worldwide, except for Japan where Baxter has a co-exclusive license to commercialize the drug with Kaketsuken. In addition to an upfront payment, Kaketsuken will receive development milestone payments.
Posted on October 15, 2007 @ 09:58 am
Biogen Idec's board of directors has authorized management to evaluate the potential sale of the company.
BI's business outlook, released on September 6, expressed the company's quest to generate strong operating and financial performance by the end of 2010. The company's strategy included the following goals: getting 100,000 patients on MS treatment Tysabri; having more than 40% of revenue coming from its International business; launching four new products and/or existing products in new indications; having six programs in late-stage clinical development; and generating revenue growth at a 15% compound annual growth rate (CAGR) and non-GAAP EPS at a 20% CAGR from 2007 through 2010.
According to the company, investor Carl Icahn has expressed an interest in acquiring the company.
In related news, the FDA announced that it's extending its regulatory review of Tysabri as a treatment for Crohn’s disease by as long as three months. Under this revised timeline, Biogen Idec and Elan Corp. anticipate action from FDA by January 13, 2008.
Posted on October 15, 2007 @ 09:56 am
Gene Logic, Inc. signed an agreement to sell its Genomics assets to
Ocimum Biosolutions Ltd. for $10 million in cash. Under the terms of the agreement, Gene Logic retains full rights to use the existing information databases of its former Genomics business in building its drug repositioning and development business and will retain specified assets related to molecular diagnostics. Ocimum will assume certain liabilities associated with the Genomics assets and business. The sale is subject to certain conditions, including the approval of the Gene Logic shareholders.
“This is a transforming event of significant strategic proportion,” said Charles L. Dimmler, III, president and chief executive officer of Gene Logic. “This agreement stands as another major milestone on the company’s path to build a drug repositioning and development business. This event marks a turning point in the transitional phase of Gene Logic’s strategic redesign and enables the company to execute with singular focus: to concentrate its proprietary know-how in this newly emerging segment of drug development, a business the Company believes will produce great value potentially for our shareholders.”
Gene Logic’s development work will now focus on its clinical-stage small molecule drug candidate, GL1001. The company is preparing to manufacture the drug for research in treating gastrointestinal disease, and plans to file an IND application for additional clinical trials. Also, the company recently announced positive in vivo model results for GL1001 in inflammatory bowel disease (IBD). Gene Logic is pursuing potential partnerships for the drug in order to maximize the full commercial potential in gastrointestinal disorders.
Posted on October 15, 2007 @ 09:53 am
Genzyme Corp. and the FDA's Cardiovascular and Renal Products Advisory Committee will meet to consider the use of phosphate binders in patients with chronic kidney disease (CKD) who are not on dialysis.
The FDA has also requested that
Shire and
Fresenius -- companies that currently market phosphate binders for patients on dialysis -- provide information that will help the agency make a decision regarding the use of phosphate binders in CKD.
In a briefing package provided to the FDA, the companies have outlined the following arguments in favor of the expanded use: phosphate imbalance precedes the need for dialysis in patients with CKD, and should be treated at the time that patients begin to experience hyperphosphatemia; left untreated, patients experiencing hyperphosphatemia prior to the initiation of dialysis may experience progression of renal disease, bone disorders and vascular calcification; hyperphosphatemia is an independent risk factor for cardiovascular morbidity and mortality, and for the progression of renal failure in the pre-dialysis population; and the risk-benefit profile of early treatment of hyperphosphatemia in CKD patients not on dialysis is favorable.
Posted on October 12, 2007 @ 09:11 am
Thermo Fisher Scientific, Inc. has plans to construct an $11 million, state-of-the-art BioCenter for the manufacture of single-use bioprocess containers (BPCs) and related products at its existing bioprocess production unit in Logan, UT.
The investment is in response to the increasing demand for disposable bioprocessing technology from the pharma/biopharma industries. Bioprocess containers are used in cell-culture applications and protein-based drug production for mixing, storage and transportation of bioprocess fluids and bioreactors (used to grow cells, proteins and other biochemically active substances). Single-use bioprocessing components eliminate the risk of batch-to-batch cross contamination and significantly reduce startup costs for customers, according to the company.
"We are excited about the expanded capabilities that our BioCenter will provide," said Marc N. Casper, executive vice president of Thermo Fisher Scientific. "The market outlook for the bioprocessing industry continues to be very bright as there are thousands of biotech products under development. This investment will allow us to better meet the needs of our customers as they work toward new therapies for treating disease and improving health."
The three-phase construction plan will create a 94,000-sq.-ft. BioCenter over the course of the next four years, replacing and expanding existing operations in Logan. The first phase includes a 37,000-sq.-ft. facility, which is expected to be complete by the fall of 2008. The new operation will include an administration building, sera and liquid-media processing facility, powdered-media facility, warehouse and the existing BPC facility. The initial project is expected to create 75 new jobs in production and management functions.
The new facility will manufacture the Thermo Scientific HyClone BPC line that includes simple bioprocess containers, complex bioprocessing systems and custom-designed units for various applications. This offering includes sterile fluid-handling bags, bag manifold systems, tank liners, chambers, biopharmaceutical tubing and other accessories, as well as the Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.) and Single-Use Mixer (S.U.M.).
Posted on October 12, 2007 @ 09:07 am
Gilead Sciences, Inc. has submitted a sNDA to the FDA and a Type II variation to the EMEA for marketing approval of Viread for the treatment of chronic hepatitis B in adults. Viread is currently approved in the U.S. and EU for the treatment of HIV as part of a combination antiretroviral therapy.
The submissions include data from two Phase III trials, Studies 102 and 103, in patients chronically infected with the hepatitis B virus (HBV). These studies evaluate the safety, efficacy and tolerability of Viread compared to Gilead's Hepsera.
"The active ingredient in Viread—tenofovir disoproxil fumarate—is the most widely prescribed molecule for the treatment of HIV in the U.S.," said Franck Rousseau, M.D., vice president, clinical research, Gilead Sciences. "With positive data from two pivotal studies now available, we look forward to extending the use of this important therapy to patients with chronic hepatitis B."
Chronic hepatitis B affects more than 400 million people worldwide. Complications include liver cancer and cirrhosis and kills as many as 1.2 million people each year. Anti-HBV drugs can have beneficial effects on chronic hepatitis B throughout the course of infection, potentially preventing liver damage and liver cancer.
Posted on October 12, 2007 @ 09:00 am
Pharm-Olam International Ltd. (POI) will open an additional U.S. office in Princeton, NJ this November.
"With the opening of our Princeton office, Pharm-Olam is even better positioned to serve the needs of pharma and biotech sponsors in the Eastern U.S.", said Iain Gordon, vice president of global business development. "Although Pharm-Olam has been known for its work in ex-U.S. markets, we are experiencing rapid growth of our U.S.-based operations and decided to open a second office to complement our headquarters in Houston. We continue to hire experienced staff throughout North America to meet the increasing demand of sponsors wanting to conduct Canadian and U.S. trials.
POI provides a range of clinical research services to the pharmaceutical, biotechnology and medical device industries, from pre-clinical to Phase IV.
Posted on October 11, 2007 @ 09:26 am
Paul D. Colvin has been appointed senior vice president of clinical operations for North America,
PPD, Inc. and
Simon J. Britton has been named vice president of clinical operations for Asia.
Mr. Colvin joins the company from Eli Lilly and Co. where he most recently directed clinical operations and global patient enrollment optimization. During his 14 years at Lilly, he held a series of leadership positions including chief operations officer for the global cardiovascular brand team; European clinical operations senior manager for the oncology, critical care, primary care and neuroscience business units; global clinical operations manager for oncology project teams; and clinical project management leader for the oncology project team.
"Paul Colvin brings extensive global development experience across a wide range of therapeutic areas garnered during an impressive tenure with Lilly," said William Sharbaugh, chief operating officer of PPD. "His experience as a leader in the trenches of clinical drug development will serve him well in overseeing our North American Phase II-IV operational unit."
Mr. Britton assumes the newly created senior management position created specifically for the company's business in Asia. Mr. Britton has more than 16 years of experience having served in various leadership roles in the biopharmaceutical industry. He spent the last seven years at GlaxoSmithKline where he most recently served as head of international clinical operations, managing the company's global clinical operations group across 25 countries.
With Mr. Britton's appointment, PPD has divided its Phase II-IV operational units into four distinct territories: North America; Latin America; Europe, Middle East and Africa (EMEA); and Asia.
"With Asia's escalating importance to global drug development, additional leadership will enable us to drive PPD's continued growth in the region," Mr. Sharbaugh said. "We are pleased to gain Simon Britton as a member of our team with his comprehensive international experience and proven ability to expand business scope and deliver quality results. This strategic restructuring of our business units geographically will enhance our ability to leverage PPD talent globally, strengthen internal standardization of our processes and further our ability to manage complex multinational trials efficiently," Mr. Sharbaugh added.
Posted on October 11, 2007 @ 09:23 am
Akorn, Inc. has signed an exclusive licensing, development and supply agreement with Sofgen Pharmaceuticals for the development of an ANDA oral drug product for women's healthcare. Financial terms of the agreement were not disclosed.
Sofgen will be responsible for development and manufacturing of the drug and Akorn will be responsible for the regulatory submission, marketing and distribution in the U.S. and PR. The two companies are expected to begin a Bioequivalence study this October with a projected launch date in late 2009.
Arthur S. Przybyl, Akorn's president and chief executive officer stated, "On September 7, 2007 we previously announced an ANDA filing in collaboration with Sofgen. Building upon that success, we look forward to working together again. This soft gel oral drug product will be the second addition to our pipeline in women's healthcare and potentially a significant revenue contributor for both companies."
Posted on October 11, 2007 @ 09:21 am
Bioxel Pharma received a paclitaxel order valued at $700,000 from a generic manufacturer in the EU. The order will be used in a generic paclitaxel drug currently marketed in Europe. Product deliveries under the order will begin this quarter.
"This is the second major paclitaxel order for Bioxel in the past month," said Pascal Delmas, president and chief executive officer of Bioxel. "We are clearly earning customer confidence and building revenue momentum with a combination of product quality, availability and value. Since June, Bioxel has landed major Paclitaxel orders with both leading generic and second generation taxane manufacturers that total $1.8 million."
Bioxel's product meets the new European quality standards, effective since July 2007. Bioxel's Drug Master File (DMF), which is registered in more than 25 countries including the U.S., Canada, and Europe, allows the company to sell paclitaxel throughout this territory.
Posted on October 10, 2007 @ 09:53 am
GlaxoSmithKline and
Synta Pharmaceuticals Corp. have entered a global collaboration for the development and commercialization of STA-4783, a small-molecule oxidative stress inducer in Phase III development for the treatment of metastatic melanoma.
Under the terms of the agreement, the companies will share responsibility for development and commercialization of STA-4783 in the U.S. and GSK will be responsible for development and commercialization outside the U.S. Synta will receive an upfront payment of $80 million and is eligible to receive as much as $135 million for success-based milestones in metastatic melanoma, further development and regulatory milestones of as much as $450 million across various indications, and as much as $300 million in commercial milestone payments based on net sales.
Synta will continue to fund all development for metastatic melanoma in the U.S. and the companies will share development costs for STA-4783 in other indications both in the U.S. as well as costs outside of the U.S. Also, GSK may have the option to purchase as much as $45 million of Synta's common stock based on the achievement of specified development and regulatory milestones.
"The data we have seen from the Phase II trials conducted by Synta have given us confidence in the potential of STA-4783 as a novel means of treating metastatic melanoma, a disease for which there is high unmet medical need," said Moncef Slaoui, chairman R&D, GSK.
Posted on October 10, 2007 @ 09:50 am
Zealand Pharma received an undisclosed milestone payment from
Wyeth for the advancement of an orally available gap junction modifier ZP1609 (GAP-134) into Phase I trials in the U.S.
This is the second gap junction modifier in clinical trials developed by the two companies. ZP1609 has shown pharmacological effects in animal models of both ventricular and atrial arrhythmias, and with its oral formulation, the molecule represents a novel example for the potential prevention of cardiac arrhythmias, according to the companies. In the heart, gap junctions are responsible for conducting electrical impulses between cells to maintain the heart's normal rhythm. Gap junction modulation is considered a promising mechanism of action for the treatment of cardiovascular disorders.
The two companies entered into a development and license agreement in 2003 to develop gap junction modifiers for the treatment of cardiovascular diseases. Since then the companies signed two expanded R&D agreements. Under the 2005 agreement, Wyeth was granted rights to the Zealand compound library for novel compounds with potential gap junction modifying properties and from this library ZP1609 was identified.
Posted on October 10, 2007 @ 09:44 am
UCB has opened a new manufacturing facility in Shannon. The new facility will enable the production of Fesoterodin for over-active bladder, which has been developed by Schwarz Pharma, now part of the UCB Group, and is licensed exclusively to Pfizer. Construction and other site upgrades at the facility will be completed by the end of this year and the plant will be in operation in 1Q2008.
Dr. Roch Doliveux, chief executive officer and chairman of the executive committee of UCB, said, "This new facility will enable the production of an important new drug here. With worldwide investments in R&D and the full integration of Schwarz Pharma, UCB is actively building the next generation biopharma leader. UCB today is large enough to advance an especially rich pipeline and to launch our new products to specialists first. The recent launches of Neupro and Xyzal in the U.S. demonstrate the power to execute our projects"
Posted on October 9, 2007 @ 09:47 am
Tandem Labs increased its discovery support capacity at its New England facility in Woburn, MA with the acquisition of additional MDS SCIEX API 5000 and 4000 LC/MS/MS systems. The acquisition doubles the facility's current triple quadrupole LC/MS/MS capacity.
"Tandem Labs acquired these additional instruments to further increase our capacity in the critical New England region," said Denis C.K. Lin, Ph.D., president and chief executive officer. "These assets will significantly enhance our reach within the drug discovery and development industry, particularly in Massachusetts as well as other Northeast states."
The New England operation provides non-GLP discovery PK/PD services, metabolite identification and biomarker services. The facility also uses proprietary informatics to help reduce the difficulty, complexity, and the time it takes to develop and launch a drug to market.
DMDiscovery is a drug metabolism technology that increases the productivity of drug metabolite identification and quantification. MarkerScan is a biomarker discovery and screening process that identifies potential biomarkers that can be used to help understand disease, diagnosis, and predictive models as well as drug safety, efficacy, and side-effect profiles.
Tandem Labs has additional facilities in UT that focus on GLP bioanalytical services and discovery support, and in NJ that specialize in GLP-compliant bioanalysis on LC/MS/MS and immunoanalytical platforms.
Posted on October 9, 2007 @ 09:45 am
Thermal packaging manufacturer
TCP Reliable, and
DDL, a package testing services firm, have merged to create a packaging engineering group specializing in the medical device and biopharmaceutical industries. The two companies will continue to operate testing and manufacturing separately, with DDL as a wholly owned subsidiary of TCP Reliable.
“The true benefit of this merger for our clients is access to a wider array of services custom suited to their growing needs,” states Patrick Nolan, chief operating officer of DDL. “Particularly, our clients will be able to confidently consolidate both their testing and manufacturing objectives.”
“The TCP and DDL combination offers the most complete range of distribution packaging engineering services and solutions to the fast growing medical device and the biopharmaceutical segments of the health care industry” states Maurice Barakat, president and chief executive officer of TCP Reliable. “Our increased technical depth and size will allow us to provide coast-to-coast service in meeting the requirements of the most demanding players in the health care industry through our six company owned sites in the US and Canada."
Posted on October 9, 2007 @ 09:19 am
Philip Vorwald has been appointed vice president and general manager of
Celsis International's In Vitro Technologies (Celsis IVT) division. He will be responsible for setting and overseeing the long-term growth strategy of the company's ADME-Tox products, which include fresh and cryopreserved cells, enzymes and other media produced for drug development. He will report to Jay LeCoque, Celsis International's chief executive officer.
"Philip's extensive life science, international management and business development experience will prove integral in the growth of Celsis IVT," said Mr. LeCoque. "I'm confident that with Phil's leadership, Celsis IVT will significantly expand its presence in the ADME-Tox drug development market."
Mr. Vorwald has 25 years of experience in the global life science industry. Prior to joining the company, he served as senior vice president of commercial operations for Cytonome, Inc., a medical device company, where he was responsible for creating a global customer support division, sales policies and procedures and overseas market entry strategies. Prior to Cytonome, he served in numerous domestic and overseas management positions at Becton Dickinson's Biosciences division, overseeing the company's European, Asia-Pacific and Latin American markets. He has also worked for Guava Technologies and Delphi Corp. in business development capacities.
Posted on October 8, 2007 @ 09:38 am
Andrew Witty has been appointed chief executive officer designate,
GlaxoSmithKline. Mr. Witty, currently president, Pharmaceuticals Europe for GSK, will succeed
Dr. Jean-Pierre Garnier following his retirement as chief executive officer at the end of May 2008.
Sir Christopher Gent, chairman, GlaxoSmithKline said, “Andrew’s appointment follows a rigorous selection process by the board of directors. The fact that we have been able to select a successor to JP from three strong internal candidates is a testament to the quality of management at GSK. The Board is confident that Andrew will build on JP’s considerable achievements which have positioned GSK as a leader of the pharmaceutical industry.”
Dr. Garnier said, “Andrew has made many significant contributions to GSK and I am very pleased that he is to be our next CEO. I look forward to working with him during our handover and wish him every success.”
Posted on October 8, 2007 @ 09:33 am
Shire has agreed to sell a portfolio of non-core products to
Almirall for $213 million in cash in order to pursue its new market strategy. The portfolio includes the dermatology products, Solaraze for the treatment of common skin lesions caused by sun damage, Vaniqa, a topical prescription medicine for treating unwanted facial hair, and six other non-promoted products across a range of indications, which are Shire sells in the UK, France, Germany, Italy, Spain and Ireland.
Shire's new market strategy is focused on building its attention deficit hyperactivity disorder (ADHD), human genetic therapies, gastrointestinal and renal diseases businesses. The company also recently in-licensed Juvista from Renovo and intends to build a new specialty area of regenerative medicine. Shire aims to expand its ADHD expertise to markets outside the U.S. within the next two years, with an initial focus on the EU.
Matthew Emmens, Shire's chief executive, said, "Our strategic focus is clear and our emphasis in the international markets is on developing competitive positions for our global products that meet the needs of the specialist physicians and their patients, in our chosen areas of expertise. Almirall is well positioned to ensure future development and investment in the products we are divesting, which are no longer core to our strategy."
Almirall chairman and chief executive officer Dr. Jorge Gallardo said, "We are very satisfied with this acquisition since it expands our international presence in a critical market like the UK and reinforces our position as one of the key European specialty pharmaceutical companies."
Other products divested included: Lodine for treatment of rheumatoid arthritis and osteoarthritis, Colazide for mild to active ulcerative colitis, Meptid for treatment of pain, Cebutid for the symptoms of rheumatoid arthritis and osteoarthritis, Robaxin for relief of pain from muscle injuries, spasms, sprains and strains, and Mintec for the relief of discomfort associated with irritable bowel syndrome.
Posted on October 8, 2007 @ 09:30 am
Jay D. Norman has been appointed president of
Quintiles Consulting business. The unit's offerings include strategic product development, regulatory compliance, and pricing and reimbursement. The company is investing in the growth of its consulting business to help customers with increasingly complex regulatory, development and market challenges.
"As the world's largest CRO, Quintiles is uniquely positioned to provide our clients with competitive advantages and insight as they navigate the development process and look to expand the financial and therapeutic potential of their products," said John Ratliff, chief operating officer of Quintiles Transnational. "With Jay's experience in developing consultancies, and the industry and former FDA experts we already have on staff, Quintiles is poised to expand its footprint in the consulting arena."
Mr. Norman has 25 years of experience in the consulting industry and a strong track record of growth. He most recently served as president and chief operating officer, Diamond Management and Technology Consultants. While at Diamond, he was recognized by Consulting Magazine as "Top 25 Consultant" in 2006. Mr. Norman's background also includes positions of increasing leadership responsibility at firms such as PricewaterhouseCoopers Consulting, McKinsey and Co., Inc. and Accenture.
Posted on October 5, 2007 @ 09:10 am
Dr. Martin Mackay has been named president of
Pfizer Global Research and Development (PGRD), an independent biotherapeutics and bioinnovation center under the direction of scientist Dr. Corey Goodman. Also,
Dr. Briggs Morrison has been named head of clinical development for the PGRD pipeline.
“As the leader of PGRD, Martin Mackay will bring Pfizer’s talent, drug discovery and development experience, capital and technology to bear on increasing the value of our near-term pipeline and bringing new compounds forward to approval,” said Jeff Kindler, chairman and chief executive officer. “Martin will drive changes in PGRD’s goals, performance measurements, allocation of resources, culture and leadership so that Pfizer delivers a steady stream of new medicines that represent compelling value to our customers and payers.”
“We are also launching a new biotherapeutics and bioinnovation center with a unique structure to discover, license and acquire more new product candidates that we can put into development,” said Mr. Kindler. “With this strategy, we are leveraging Pfizer’s excellence in drug discovery and development by complementing it with a distinct, California-based enterprise led by world-class scientists charged with discovering and bringing in new compounds."
Dr. Mackay has been with the company for 12 years and most recently served as vice president of global R&D. He succeeds John LaMattina, who announced plans to retire by year-end after 30 years with the company.
Dr. Morrison joins the company from Merck, where he most recently served as senior vice president of research planning and integration. Previously, he was Merck's head of clinical development.
Posted on October 5, 2007 @ 09:05 am
Wyeth Pharmaceuticals signed a definitive agreement to acquire
Haptogen Ltd., a Scottish biopharmaceutical company based in Aberdeen. Haptogen will become part of Wyeth Discovery Research.
Haptogen has developed technologies that allow for the discovery and optimization of protein therapeutics with improved profiles over the current generation of protein therapies. The benefits include the potential for more convenient routes of administration as well as cell and organ penetration, addressing diseases that are not treatable with first generation protein therapeutics.
"Haptogen brings to Wyeth a suite of next-generation biotechnology discovery technologies that complement Wyeth's ongoing biotherapeutic discovery efforts," says Frank Walsh, Ph.D., executive vice president of discovery, Wyeth Research. "In addition to the exciting technology and first- rate research team that we are bringing into our organization, we consider the opportunity to conduct biopharmaceutical drug discovery in Scotland particularly important because of the rich pool of scientific and technological talent."
"Since Haptogen started its discussions with Wyeth, we have been impressed by the quality and commitment of the people we have met," says Jim Reid, founder and chief executive officer of Haptogen Ltd. "We believe that combining Haptogen's technology platforms with Wyeth's existing discovery and development capabilities creates the greatest opportunity for realizing the potential to bring new treatments to patients."
Posted on October 5, 2007 @ 09:00 am
AMRI and
Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) entered a four-year research collaboration aimed at identifying novel treatments that address the core defect in cystic fibrosis. Under the collaboration, CFFT will commit as much as $23.7 million, if specific clinical development milestones are met.
Under the agreement, AMRI will screen its natural-product based libraries to find compounds that improve the function of the defective protein in CF, known as the cystic fibrosis transmembrane conductance regulator (CFTR). AMRI will also conduct a drug discovery program that includes chemistry and in vitro biology on promising compounds that result from the screening program. AMRI has the option to provide chemical development and GMP manufacturing services to CFFT on any compounds identified under the agreement that progress into preclinical or clinical testing.
"With this collaboration, we are proving once again that we will explore every promising avenue to find new therapies for people with CF," said Robert J. Beall, Ph.D., president and chief executive officer of the Cystic Fibrosis Foundation. "We are excited about the potential of AMRI's cutting-edge natural products capabilities to complement our existing small molecule drug discovery strategy."
"AMRI is committed to working with CFFT to discover and develop new therapeutics and advance the care and treatment of persons stricken with this fatal illness," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra, Ph.D. "With our diverse natural product collections, integrated with follow-on technologies in high throughput screening, medicinal chemistry lead optimization and fermentation scale up, AMRI is uniquely and ideally suited to help the Foundation identify and develop potential new medicines."
Posted on October 4, 2007 @ 09:46 am
Sancilio & Company, Inc. (SCI) has established 21 CFR Part 210/211 Compliance Auditing Services for drug manufacturers importing materials, supplies, products and excipients from Asia. The new service is based in Shanghai.
According to Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of SCI, “Recent quality issues discovered in a variety of products from Asia are urging U.S. companies to increase their vigilance in quality while importing when importing materials from overseas. American pharmaceutical, nutritional and food manufacturers typically have responded by physically sending auditors from the U.S. to Asia. Our new facility obviates this approach, as our Chinese auditors—fully fluent in English and Mandarin and trained in U.S. cGMP procedures—are already on the ground.”
Dr. Sancilio added, “Offering hands-on compliance auditing experience, our China-based auditing experts provide extremely fast turnaround, at a small fraction of the present costs to U.S. companies. Direct benefits of our new 21 CFR Part 210/211 Compliance Audit Service are enhanced assurance of compliance, integrity of product, cost effective redundant review of the quality of supply, elimination of long delays at U.S. ports of entry, and drop-in audits at any time.”
Posted on October 4, 2007 @ 09:00 am
Targeted Genetics Corp. received an undisclosed milestone payment from
Amsterdam Molecular Therapeutics B.V. (AMT) under a licensing agreement that provides AMT with non-exclusive rights to Adeno-Associated Virus type 1 (AAV1), a serotype of AAV with the potential to treat lipoprotein lipase (LPL) deficiency. AMT recently initiated a pre-registration trial for AMT-011, an AAV1-based therapy for LPL deficiency, and anticipates commercialization of the product in 2009. LPL deficiency is a severe and debilitating disease associated with extremely high serum triglyceride concentrations, high morbidity, and increased mortality.
"This milestone payment provides continuing validation of our strategy to leverage our intellectual property as an industry leader in AAV technology," said H. Stewart Parker, president and chief executive officer of Targeted Genetics. "As AMT advances its LPL development programs, we will realize value through potential future milestones and royalties on product sales. This strategy provides us with incremental revenue from our broad and deep patent estate, even as we stay focused on our core product development programs in inflammatory arthritis, AIDS prophylaxis, congestive heart failure and Huntington's disease."
As announced in December 2006, the U.S. patents issued to the University of Pennsylvania and exclusively licensed to Targeted Genetics, provides AMT with the rights to use AAV1 in the development and commercialization of therapeutic products for treating type I and type V LPL deficiencies.
Posted on October 4, 2007 @ 08:57 am
Hollings C. Renton,
Onyx Pharmaceuticals' chief executive officer, announced plans to retire next year. Mr. Renton will remain chairman of the board of directors. The company has initiated a search for a successor. The company has promoted Laura A. Brege to the newly created position of executive vice president and chief operating officer and Randy A. Kelley to senior vice president of sales and marketing.
"With Nexavar established as an effective and well tolerated anti-cancer drug and with broad development and commercial plans in place, Onyx is poised to enter a new phase of corporate growth," said Renton. "After almost 15 years as CEO, it's the perfect time for me to relinquish my operating role so I can spend more time with my family. I am committed to the company and its continued success, and will remain closely involved until a successor is appointed, and subsequently as chairman."
Ms. Brege joined the company in June 2006 as executive vice president and chief business officer. In her new role, she will be responsible for the sales and marketing, medical affairs, legal, business development, and compliance functions. Ms. Brege has overseen the expansion of key corporate capabilities and strengthened Onyx's financial position by significantly adding to its cash reserves. Before joining the company, she was a general partner at Red Rock Management, a venture capital firm. She was previously the senior vice president and chief financial officer at COR Therapeutics. Earlier in her career, Ms. Brege served as vice president and chief financial officer at Flextronics and vice president and treasurer of The Cooper Companies.
"Since her arrival at Onyx, Laura has overseen the expansion of key corporate capabilities, guided our business planning, and strengthened our financial position," said Mr. Renton. "Laura's superb leadership skills and diverse experience will help ensure Onyx continues to deliver on our mission to improve the lives of people living with cancer."
Mr. Kelley, previously vice president of sales, joined the company in September 2004. While at Onyx, he established its U.S. sales organization and managed, with the company's collaborator, Bayer, the successful launch of the kidney cancer drug, Nexavar. From 1994 to 2004, Mr. Kelley served in various senior sales and marketing positions at Chiron Corp., including vice president, North American sales for the company's biopharmaceutical division. Previously he was vice president of sales at Immunex Corp. and held various sales management positions at Adria Laboratories.
Posted on October 3, 2007 @ 09:05 am
Steve Jennings has been named senior vice president of sales, marketing and business development,
AMRI. Mr. Jennings will be responsible for all of AMRI's global sales efforts, including sales teams in the U.S., Asia and Europe.
He has more than 30 years of leadership and global sales experience, with a background in business development and licensing in both the pharmaceutical and medical device sectors. He spent 10 years at Solvay Pharmaceuticals in domestic and international sales management roles. He rose from regional sales director to vice president of global marketing for the Gastroenterology and Women's Health business units. He led a 450-person sales force and managed the launch of several products, including one with annual revenue of $200 million.
Prior to Solvay, Mr. Jennings held sales leadership roles with both Ciba Geigy (currently Novartis) and Reed and Carnick Pharmaceuticals. Most recently, he was vice president of sales at Cyberonics, Inc., a medical device company specializing in neurological and psychiatric illness.
"We are pleased to announce the addition of Steve Jennings to AMRI's senior leadership team," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra. "Steve has an exceptional track record in sales and marketing in the pharmaceutical and medical device industry. We expect him to play a key leadership role in the continued growth of our sales force to support our expanding operations and technologies around the globe. His prior experience in building, training and directing differentiated sales teams will be a key skill as we continue to rapidly expand AMRI's sales presence around the world. His depth of knowledge in the due diligence process of potential product and company acquisitions will bring additional expertise to AMRI's leadership team in its strategic planning process."
Posted on October 3, 2007 @ 09:01 am
Cangene Corp. is consolidating its R&D activities within the Winnipeg head office location. The company recently instituted several strategic changes in its R&D processes to formalize and enhance new product development. Having a consolidated group is part of the company's efforts to help strengthen the links between research, product development and manufacturing activities, and increase operational effectiveness.
A large portion of the activities in Cangene's Mississauga R&D operation related to a contract research project with the Apotex Group, is now concluded and to two products (Accretropin and Leucotropin) have been submitted for licensure. Ongoing responsibility for any additional development of these two products will be transferred to the Winnipeg group.
The reorganization includes a reduction of 4% of the staff and an expected operating savings of approximately $1.5 million annually.
Posted on October 3, 2007 @ 08:52 am
Molecular Insight Pharmaceuticals, Inc. has completed the purchase of a commercial-scale radiopharmaceutical manufacturing facility in Denton, TX. The company purchased the facility from NeoRx Manufacturing Group, Inc., a subsidiary of Poniard Pharmaceuticals, for $3 million. The facility provides more than 80,000 sq. ft. of pharmaceutical manufacturing, warehouse, clean room and administrative office space.
"We are extremely pleased to complete this important strategic acquisition as it significantly expands our capability to manufacture our robust portfolio of product candidates efficiently and cost effectively," said David S. Barlow, chairman and chief executive officer of Molecular Insight. "Initially, we intend to use a portion of this facility to manufacture Azedra, our lead radiotherapeutic candidate for the treatment of neuroendocrine cancer, and we anticipate it being fully operational prior to the potential launch of Zemiva, our lead molecular imaging candidate for the detection of cardiac ischemia. The facility's location near three airports and metro Dallas should facilitate the timely development and distribution of other pipeline candidates in our portfolio, including Trofex, a molecular imaging for the detection of prostate cancer, and Onalta and Solazed, targeted molecular radiotherapeutics for cancer."
Posted on October 2, 2007 @ 08:57 am
Eddie Montoya has been appointed director of IVRS,
Bilcare Global Clinical Supplies. In his new role, Mr. Montoya will be responsible leading the expansion of IVRS/IWRS technology in the U.S. and globally for the benefit of Bilcare's clients.
Mr. Montoya has more than 30 years of national and international experience in the medical and clinical industry having worked in the Middle East and most recently as IVRS director for Covance. He spent more than 12 years at Covance, where he designed and managed hundreds of IVRS projects and developed the company's inventory forecasting system, Foresite.
"Eddie brings a wealth of IVRS experience to Bilcare having worked in this capacity for well over a decade. His industry knowledge and experience will be an asset to our customers and to Bilcare," says Bilcare America's president, Vincent Santa Maria. "Enhancing our IVRS capabilities is another important milestone in our ongoing effort to provide state-of-the-art technology to our customers. The recent expansion and upgrading of our packaging rooms, storage facility and the installation of the PRISYM Medica labeling system sends a clear message to the industry that Bilcare is committed to service and quality beyond compliance."
Posted on October 2, 2007 @ 08:51 am
SAFC, a member of the Sigma-Aldrich Group, plans to begin construction of a new cGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its St. Louis manufacturing site. This addition will support oncology drug substance requirements for a combination of small molecule chemistry, containment engineering, highly regulated biologics manufacturing and extensive quality control capabilities.
The new suite will enable the conjugation of highly potent active pharmaceutical ingredients (HPAPIs) to a variety of targeted delivery molecules, including monoclonal antibodies for the anti-cancer market. The new 600-sq.-ft. conjugation suite, expected to be operational in late 2007, will be SafeBridge certified and will accommodate early-stage clinical supplies of potent conjugated APIs, with capabilities to expand production into commercial-scale, handling multi-Kg quantities of conjugated HPAPIs per batch.
SAFC president, Frank Wicks, said, "High potency conjugation is an exciting new technology that demands a very special combination of specific skills. Adding HPAPI conjugation capacity enables SAFC to further vertically integrate our contract manufacturing services to pharmaceutical companies that are developing novel cures for cancer. SAFC is a leading producer of many small molecule HPAPIs and has been performing non-potent conjugations for over 30 years. Adding specialized high-containment biologic capacity for performing potent conjugations was a logical extension to our business."
Posted on October 2, 2007 @ 08:48 am
Isis Pharmaceuticals, Inc. earned $5 million from
Ortho-McNeil, Inc. (OMI), a Johnson & Johnson company, for achieving the first development milestone of initializing the Phase I trial of ISIS 325568.
The collaboration, announced in September 2007, includes the licensing of two second-generation antisense drugs, ISIS 325568 and ISIS 377131, for the treatment of metabolic disease. ISIS 325568 was designed to selectively inhibit the production of glucagon receptor and has demonstrated improved glucose control in animal models of Type 2 diabetes.
"We are pleased to have achieved this milestone so early in our collaboration with Ortho-McNeil, Inc.," said Jeffrey Jonas, M.D., executive vice president, Isis Pharmaceuticals. "OMI will be providing all funding for this study, while Isis will be managing the study through to completion before handing all additional development responsibilities over to our partner."
September 2007
Posted on September 28, 2007 @ 10:33 am
Bernard Poussot has been appointed president and chief executive officer,
Wyeth, effective January 1, 2008. He replaces
Robert Essner, who will continue as chairman of the board of directors for the transition period.
Mr. Poussot joined the company in 1986 and was appointed president of Wyeth-Ayerst International in 1996. He was promoted to president of the worldwide pharmaceutical business in 1997 and in 2002 he was promoted to executive vice president, Wyeth, responsible for Wyeth R&D. In April 2006, Mr. Poussot was promoted to president and vice chairman, Wyeth, and in January 2007 to the position of president, chief operating officer and vice chairman, Wyeth.
“The election of Mr. Poussot is a result of the company’s ongoing succession management process that has been an important focus of the Wyeth board of directors and management. Bernard is exceptionally well-qualified for this role, and we have built a world-class management team to support him and the Company,” said Robert Essner.
Posted on September 28, 2007 @ 09:09 am
Novartis and the
Massachusetts Institute of Technology (MIT) have entered a 10-year research collaboration with the goal of transforming the pharmaceutical production process.
The partnership, known as the Novartis-MIT Center for Continuous Manufacturing, will work to develop new technologies to replace the conventional batch-based system, which often includes many interruptions and work at separate sites, with continuous manufacturing processes from start to finish. The partnership combines Novartis' industrial expertise with MIT's scientific and technological expertise. Novartis will invest $65 million in research activities at MIT during the next 10 years.
"This partnership demonstrates our commitment to lead not only in discovering innovative treatments for patients but also in improving manufacturing processes, which are critical to ensuring a high-quality, efficient and reliable supply of medicines to patients. Our collaboration with MIT, a worldwide leader in developing cutting edge technologies, holds the promise to achieve a quantum leap in the production of pharmaceuticals, a field which has received rather little attention in the past," said Dr. Daniel Vasella, chairman and chief executive officer of Novartis.
"The Novartis-MIT Center for Continuous Manufacturing has the potential to revolutionize drug development and production," said Susan Hockfield, MIT president. "We are delighted to collaborate with Novartis to help improve the way that drugs are manufactured so that patients have quicker and more reliable access to the medications they need. The new educational opportunities that this program will provide for our students make this partnership even more exciting."
Batch-based manufacturing involves the following process: pharmaceutical active ingredients are synthesized in a chemical manufacturing plant and these ingredients are then shipped to a manufacturing facility where they are converted through defined processes into large batches of pills, liquid or cream. This process involves multiple interruptions, including transport to separate locations, and each batch may take weeks to produce. Also, manufacturing design and scale-up for a new drug are expensive and time-consuming.
The anticipated benefits of continuous manufacturing include: accelerating the introduction of new drugs by designing production processes earlier; using smaller production facilities, with lower building and capital costs; minimizing waste, energy consumption and raw material use; monitoring quality assurance on a continuous basis instead of post-production batch-based testing; and enhancing process reliability and flexibility to respond to market needs.
The initial research of the Novartis-MIT Center for Continuous Manufacturing will be conducted primarily through Ph.D. programs at MIT labs, and then transferred to Novartis for further development to industrial-scale projects. Novartis will use its manufacturing and R&D resources and will pilot new manufacturing processes with one of its products.
Posted on September 28, 2007 @ 09:03 am
Celera, an Applera Corp. business, earned a $2 million clinical milestone payment from
Merck & Co. under the two companies cathepsin K inhibitor collaboration agreement.
This payment recognizes Merck's advancement of odanacatib (formerly MK-0822), an orally available highly selective inhibitor of the cathepsin K enzyme, into a Phase III trial as a potential treatment for osteoporosis. Should the candidate or others developed under the cathepsin K pact advance further, Celera will receive additional milestone payments and potentially royalties on sales from Merck.
"We are encouraged by the progress that Merck described recently concerning this promising investigational drug being studied for the treatment of osteoporosis," said Kathy Ordonez, president of Celera. "We're pleased to have made a contribution to Merck's cathepsin K program for this important disease indication."
The multi-year collaboration with Merck was initiated in November 1996 and the two companies extended the research collaboration in December 2001. Celera has provided a series of candidate compounds to support Merck's research programs and Merck has been responsible for further R&D related to collaboration compounds.
Posted on September 28, 2007 @ 09:00 am
Patrick M. Sullivan has been named vice president of R&D for the Research Biotech business unit of
Sigma-Aldrich. In this role, he will help expand the company's leadership position through the development of new and innovative products for life science researchers. Mr. Sullivan has been a member of the company's scientific advisory board, since 2005 and provided a large pharmaceutical perspective on new strategic plans and product offerings in the company's Research Biotech business unit. He will report to
David A. Smoller, Ph.D., president of Research Biotech.
Mr. Sullivan has more than 19 years of experience using and developing genomic-based solutions for the pharma and biopharma industries. He worked at Monsanto/Searle/Pharmacia for 12 years, where he provided molecular biology support for Inflammation and angiogenesis new target/biomarker discovery projects. In 2000, he joined Incyte Genomics as vice president of global operations, responsible for managing all genomic products and services. Most recently, Mr. Sullivan led efforts to identify new therapeutic opportunities in osteoarthritis and cardiovascular diseases at Pfizer.
"We are pleased to have such an strong and experienced leader join our organization," Dr. Smoller. "Patrick's combination of technical expertise, strong ability to analyze complex business operations and implement strategies to improve performance will be an immediate asset to our Research Biotech business unit's mission of bringing innovative technologies and solutions to life science researchers. We look forward to having him join us in making these valuable contributions to our life science community."
Posted on September 27, 2007 @ 09:12 am
PAREXEL International Corp. has completed the acquisition of Taiwan-based
APEX International Clinical Research Co., Ltd. for approximately $51 million. The acquisition adds to PAREXEL's clinical research service offerings in the Asia-Pacific region, including China, Hong Kong, India, Taiwan, Singapore, Indonesia, South Korea, Malaysia, Thailand, the Philippines, New Zealand, and Australia. The name of the new entity is PAREXEL APEX International.
"The Asia-Pacific region is becoming increasingly important and attractive for a wide range of clinical development activities," stated Josef von Rickenbach, chairman and chief executive officer of PAREXEL International. "Several factors are driving client demand for clinical research services in the Asia-Pacific region including established and sophisticated healthcare systems in many countries, the availability of highly trained professionals, and attractive end markets for biopharmaceutical products. We believe that the acquisition of APEX is of great strategic value, and combined with PAREXEL's existing presence in Japan, India, and Australia, will make PAREXEL a formidable competitor and one of the leading providers of biopharmaceutical services in the Asia-Pacific region."
"Our diverse client base will greatly benefit from the combination with PAREXEL, which will provide a broader global scope and the ability to offer a wider array of capabilities for clinical programs," said Albert Liou, founder of APEX and newly appointed corporate vice president and general manager of PAREXEL APEX International. "The APEX team is eager to combine PAREXEL's deep experience in clinical development with APEX's extensive knowledge of medical and clinical development practices and approaches that are specific to the Asia-Pacific region."
Posted on September 27, 2007 @ 09:09 am
Galapagos NV and
ProStrakan Group achieved the third milestone under Galapagos' collaboration with
Novartis in antibodies for bone-related diseases. This milestone triggers a payment of $1.5 million to Galapagos, of which Galapagos will pay $1.1 million to ProStrakan per their December 2006 agreement.
The collaboration was initially formed between Novartis and ProSkelia SASU (formerly a subsidiary of ProStrakan) in September 2006. Under the terms of the original agreement with Novartis, total milestones could exceed $100 million, with royalties payable on commercialization. The first milestone payment, related to intellectual property, was announced in December 2006. The collaboration was transferred to Galapagos as part of its acquisition of ProSkelia from ProStrakan in December 2006. Under the terms of Galapagos' acquisition of ProSkelia, Galapagos and ProStrakan split milestone and royalty income from agreements existing at the time of the acquisition 25% for Galapagos and 75% for ProStrakan, while Galapagos retains all R&D fees.
Dr. Wilson Totten, chief executive of ProStrakan, remarked, "In addition to the commercialization of existing products, we continue to benefit from ongoing milestone payments associated with our ongoing arrangement with Novartis and Galapagos. I look forward to further revenues in due course as a result of this collaboration."
Posted on September 27, 2007 @ 09:08 am
SAFC will invest $29 million to expand its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel. The site expansion will allow SAFC Pharma to provide process development and cGMP manufacturing for large-scale, high-potency, toxic or hazardous drug substances (large molecule HPAPIs).
The 50,000-sq.-ft. high-potency fermentation expansion will focus on production of secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. The project is scheduled for completion in 1Q2009. A 30,000-sq.-ft. area of the new facility will be Biosafety Level 2 compliant—enabling manipulation of human pathogens. Site capabilities include 1,000 and 4,000-liter tank capacities for bacterial and fungal fermentation.
Frank Wicks, SAFC president, said, "This expansion builds on the fermentation track record of our Jerusalem facility while adding significantly to our HPAPI capacity. It is consistent with SAFC's strategy to extend the range and scope of coverage in niche technologies and APIs for biologics sectors."
Posted on September 26, 2007 @ 08:38 am
Baxter BioPharma Solutions recently completed the lyophilization capacity expansion at their cytotoxic contract manufacturing facility in Halle, Germany. The expansion increased their total cytotoxic lyophilization capacity to four dedicated lyophilizers and more than 1,100 sq.-ft. The expansion was designed to meet EU, U.S. and JP requirements.
Two large-scale lyophilization units were added to freeze-dry clients’ cancer therapy drugs. The expansion includes technologies to safely handle organic solvents including a state-of-the-art fully automated loading cart and in-process quality analysis technology. The cart navigates in the building with sensors, transporting the cytotoxic vials from filling without human attendance, and auto-loads the freeze driers.
“Our customers benefit from the expanded capacity, leading edge technology, and 50 years of experience in handling cytotoxic parenterals. This investment reflects Baxter`s commitment to ensure customer focus on high quality services with state of the art technology,” said Dr. Burkhard Wichert, vice president of manufacturing for Baxter’s Halle facility.
Posted on September 26, 2007 @ 08:33 am
Genzyme Corp. and
Bayer Schering Pharma AG began the first of two planned Phase III trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).
The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomized study, will compare alemtuzumab to Rebif (interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (MS). Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but who have not yet begun treatment with any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.
This Phase III program follows positive interim results from the Phase II trial that indicate alemtuzumab-treated patients experienced a statistically significant reduction compared with Rebif-treated patients in the risk for sustained accumulation of disability and the risk for relapse for 24 months.
The CARE-MS I study will enroll as many as 525 patients at approximately 60 medical centers throughout North America, Australia, Latin America, and Europe. The companies anticipate filing for marketing approval of alemtuzumab for MS in 2011.
Posted on September 25, 2007 @ 09:53 am
Bristol-Myers Squibb has signed a definitive agreement to acquire
Adnexus Therapeutics for $430 million in cash. Adnexus has developed a new therapeutic class of biologics called Adnectins, which BMS plans to use to advance its biologics strategy in several therapeutic areas. The program includes a Phase I oncology biologic, Angiocept. Adnexus Therapeutics will become a subsidiary of BMS and remain based in Waltham, MA.
Under the terms of the agreement BMS will acquire all of Adnexus' issued and outstanding shares. Based on an earn-out structure, BMS may pay an additional $75 million in the event certain development and regulatory milestones are achieved. The closing of the transaction is subject to customary regulatory approvals.
Adnectins are a class of targeted biologics developed by Adnexus and PROfusion, its proprietary protein design engine, allows trillions of protein variations to be engineered at one time. Angiocept, currently in Phase I development, is an Adnectin designed to be an anti-angiogenic drug.
"Bringing Adnexus into the Bristol-Myers Squibb family builds upon a successful and productive collaboration between the two companies in oncology and is an important step in accelerating the strategic transformation of our pharmaceutical business to a biopharma business model," said Jim Cornelius, chief executive officer, Bristol-Myers Squibb. "Biologics are one cornerstone of our growth strategy. This investment in biologics discovery complements our continued investment in a growing biologics pipeline and portfolio, and will benefit from our expanding biologics manufacturing capabilities, both at our existing site in Syracuse, NY, and our future large-scale bulk biologics facility in Devens, MA."
"This is an exciting milestone for our scientists, investors, and company and is a unique opportunity to further accelerate advancement of Adnectin-based medicines and our lead product, Angiocept," said John Mendlein, Ph.D., J.D., chief executive officer of Adnexus. "We are proud to bring the strength of our science, team, and intellectual property to Bristol-Myers Squibb. We have enjoyed a highly productive and collaborative relationship to date, and look forward to helping Bristol-Myers Squibb advance its innovative pipeline."
Posted on September 25, 2007 @ 09:50 am
GlaxoSmithKline has licensed
MedImmune's reverse genetics technology for the development of new vaccine strains to produce non-live human influenza vaccines. Reverse genetics allows manufacturers to avoid working directly with the infectious, circulating pandemic strains, such as H5N1, by generating viruses such as influenza from segments of DNA.
"MedImmune is pleased to enter into a fourth agreement to license our reverse genetics technology to manufacturers," said Jonathan Klein-Evans, J.D., MedImmune's vice president, intellectual property. "Making this important technology available to the vaccine development team at GlaxoSmithKline and their peers at other companies may have a significant positive impact on the manufacturing of influenza vaccines due to the efficiency and reliability of the process."
MedImmune will receive an upfront payment and has the potential to receive royalties on certain vaccine stockpiles or sales of other flu products developed using the reverse genetics technology.
Posted on September 25, 2007 @ 09:31 am
DSM Venturing, the corporate unit of Royal DSM N.V., has made an equity investment in
Upfront Chromatography, a developer of customized industrial protein chromatography processes. According to DSM, Upfront's downstream processing platform has the potential to contribute to all biotechnology-derived products from DSM.
DSM Pharmaceutical Products provides custom manufacturing services to the pharmaceutical and biopharmaceutical industries with services in protein production and in clinical, commercial and fill and finish areas. According to the company, its involvement in biopharmaceutical production has created a need for breakthroughs in downstream processing for more efficient purification of monoclonal antibodies and other biopharmaceutical proteins. Leendert Staal, chief executive officer of DSM Pharmaceutical Products, said, "Upfront is at the forefront of technological breakthroughs in downstream processing. Through our investment we want to support further developments in the company which will benefit both DSM and Upfront."
Upfront's Rhobust technology platform focuses on two major application areas, bioprocess and biomine. The bioprocess offers recovery and purification of monoclonal antibodies, therapeutic proteins and other biomolecules from blood plasma or bioreactors, under cGMP-compliant conditions. Biomine Rhobust enables the isolation of functional proteins and other biomolecules from bioreactors or industrial process side-streams for use as food ingredients, industrial enzymes, nutraceuticals and healthcare products.
DSM and Upfront have also signed a collaboration agreement for further developing the Rhobust technology for the purification of monoclonal antibodies.
Posted on September 24, 2007 @ 08:51 am
Verus Pharmaceuticals, Inc. sold its pediatric asthma development programs to
AstraZeneca. This includes the North American rights to a Captisol enabled budesonide solution (controller medication), a short-acting beta agonist solution (rescue medication), a customized version of eFlow (novel nebulizer delivery device) for use with both medications, and other intellectual property and related assets from Verus.
Under the terms of the agreement, Verus will receive an upfront payment of $30 million, development expense reimbursements, and a potential earn-out payment of $280 million.
"We are excited to have completed this transaction with AstraZeneca, the North American leader in pediatric asthma treatment innovation, and are eager to collaborate with them to address the multiple unmet medical needs in this rapidly expanding patient population," said Robert W. Keith, president and chief operating officer of Verus. "This transaction allows us to refocus our time and resources on our other emerging development programs, including those targeting unmet needs associated with related atopic diseases and conditions."
"AstraZeneca is proud to be a part of these next generation development programs that hold the potential to help millions of children suffering from asthma and may positively impact their quality of life," said Jim Helm, vice president respiratory primary care at AstraZeneca.
Posted on September 24, 2007 @ 08:49 am
Array BioPharma and
Celgene Corp. entered a strategic R&D collaboration focused on novel therapeutics in cancer and inflammation. Under the agreement, Array will receive an upfront payment of $40 million and will grant Celgene an option to select two of four mutually selected discovery targets developed under the collaboration. Array will be responsible for all discovery and clinical development through Phase I or Phase IIa. Celgene will then have the option to select drugs resulting from two of the four programs and will receive exclusive worldwide rights to those drugs, except for Array's limited co-promotional rights in the U.S.
Array is also entitled to receive milestone payments of approximately $200 million, if certain discovery, development and regulatory milestones are met and $300 million if certain commercial milestones are achieved, as well as royalties on sales. Array will retain all rights to the other programs.
"We are very pleased to collaborate with Celgene on the discovery and development of novel targeted drugs," said Kevin Koch, Ph.D., president and chief scientific officer, Array BioPharma. "With Celgene's global leadership and expertise in discovery, development and commercialization of innovative therapies, and Array's solid track record of inventing and progressing targeted drugs into clinical development, we are forming a strong alliance to bring new therapies to patients."
"This collaboration with Array BioPharma is a strategic opportunity for Celgene to work with a demonstrated leader in the discovery and early development of small molecule drugs. Our collaboration illustrates Celgene's commitment to address unmet medical need in cancer and immune-inflammatory disease, while maximizing our clinical, regulatory and commercial potential worldwide," said Tom Daniel, M.D., Celgene's president of research.
Posted on September 24, 2007 @ 08:48 am
Pfizer received approval from the European Commission (EC) for Celsentri (maraviroc) for treatment-experienced HIV patients. Maraviroc, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 virus detectable.
Maraviroc is the first of a new class of oral HIV medicines that works by blocking viral entry into human cells rather than fighting HIV inside white blood cells. Maraviroc prevents the virus from entering white blood cells by blocking its predominant entry route, the CCR5 co-receptor.
The approval is based on the following data from two ongoing double-blind, placebo-controlled trials that show: Maraviroc and optimized background therapy (OBT) provided greater viral load reduction compared to patients receiving OBT alone; twice as many patients receiving maraviroc plus OBT achieved undetectable viral load at 48 weeks; and the maraviroc and OBT group demonstrated greater increases in CD4 white cells compared to the group receiving OBT alone.
Posted on September 21, 2007 @ 09:08 am
Exelixis, Inc. has signed an extension of its research collaboration with
Bristol-Myers Squibb Co. to develop and commercialize therapies targeted against the Liver X Receptor (LXR), a hormone receptor associated with a variety of cardiovascular and metabolic disorders.
The collaboration, established in January 2005 for a period of two years, has been extended through January 2009. BMS also has retained the option to further extend the research collaboration an additional year. Under the terms of the new agreement, Exelixis will receive $7.5 million of additional research funding.
"Exelixis and BMS have a history of working efficiently and productively together, and we have maintained this positive dynamic in our LXR collaboration," said Michael Morrissey, Ph.D., president of R&D at Exelixis. "In less than two years, we have made substantial progress in identifying and optimizing compounds that activate LXR, potentially providing new treatments for cardiovascular and metabolic diseases, which are diseases with increasing impact."
Under the terms of the collaboration, the two companies will identify drug candidates that are ready for IND application-enabling studies. BMS will then undertake further preclinical development and has responsibility for clinical development, regulatory, manufacturing and sales/marketing activities.
Posted on September 21, 2007 @ 09:06 am
Bioxel Pharma, Inc. has won its largest paclitaxel order—valued at about $800,000—from a multinational pharmaceutical company that is currently completing Phase III trials for a paclitaxel-based product. Paclitaxel deliveries under the order will be completed in October 2007, with repeat orders expected in the coming months.
Bioxel's paclitaxel will be incorporated in the client's NDA, allowing its use in commercial manufacturing and distribution once the product gains marketing approval. Bioxel estimates that, for its primary indication in the U.S. market, paclitaxel volume requirements could exceed 50 kg annually. Sales and volumes for this client are expected to begin in 2008, in preparation for commercial launch of its NDA product.
"This was a very important win for Bioxel on many levels," said Pascal Delmas, president and chief executive officer of Bioxel Pharma. "This represents repeat business with a customer that has used our paclitaxel product in its previous clinical development. It validates the quality and consistency of our product and the faith that our customers have in Bioxel's ability to deliver on an ongoing commercial basis. Bioxel has proven that it can compete in this market and differentiate itself by offering the highest quality paclitaxel API together with superior customer and regulatory services." Mr. Delmas added, "We have implemented an aggressive marketing push over the past 18 months and this has begun to pay off with substantial orders. We remain committed to the growth of our paclitaxel franchise through customer diversification in both generic and next generation products, as well as through steady geographic expansion."
Posted on September 21, 2007 @ 08:58 am
DSM Pharmaceutical Products has made several management appointments.
Mr. Leendert Staal, currently business group director DSM Pharmaceutical Products, will be appointed president of DSM Nutritional Products, reporting to
Stephan Tanda, member of the managing board of DSM.
Mr. Bob Hartmayer will succeed Mr. Staal as business group director, president and chief executive officer of DSM Pharmaceutical Products, reporting to
Jan Zuidam, also a member of the managing board. Mr. Hartmayer is currently business group director DSM Elastomers.
Also, the following management appointments will take effect on October 1, 2007:
Mr. Luca Mantovani, vice president citric acid, DSM Nutritional Products, will be appointed business unit director, president DSM Pharma Chemicals;
Mr. Terry Novak, chief marketing officer DSM Pharmaceuticals & Biologics, will be appointed business unit director, president DSM Pharmaceuticals, Inc.;
Ms. Karen King, senior vice president strategic business development, will be appointed business unit director, president DSM Biologics;
Mr. Hans Engels, chief operating officer DSM Pharmaceuticals & Biologics will be appointed chief operating officer, DSM Pharmaceutical Products Business Group. Mr. Mantovani, Mr. Novak, Ms. King, and Mr. Engels, will report to Mr. Hartmayer.
Also,
Mr. Stephen Lijoi, vice president of operations in Greenville, will be appointed vice president and site director for DSM Pharmaceuticals Greenville, NC site reporting to Mr. Novak.
Posted on September 20, 2007 @ 09:46 am
Millennium Pharmaceuticals achieved positive interim results from an international Phase III VISTA trial in patients with newly diagnosed multiple myeloma that showed Velcade therapy, melphalan and prednisone (VMP), demonstrated a statistically significant improvement in all efficacy measures, including time-to-disease progression, complete remission rate, progression-free survival and overall survival, compared to melphalan and prednisone (MP) alone.
Based on the recommendation of an independent data monitoring committee (IDMC), the control arm of the trial was stopped early to allow patients being treated with MP to have Velcade added to their therapy.
The company plans to file a sNDA in 1Q2008 for the use of Velcade in patients with newly diagnosed multiple myeloma, based on the data from this trial, which was conducted under the SPA process with the FDA.
Velcade is being co-developed by Millennium Pharmaceuticals and JJPRD. Millennium is responsible for commercialization in the U.S., and Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan.
Posted on September 20, 2007 @ 09:44 am
MedImmune, Inc. received approval from the FDA for the expanded use of FluMist (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of influenza A and B viruses in individuals two to 49 years of age. The company expects to ship FluMist with the expanded label in the next few days.
FluMist is different from the flu shot in that it uses live, attenuated -- or weakened -- viruses within the vaccine to help stimulate an immune response that is designed to closely resemble the body’s natural response to a flu infection.
In a study that included more than 4,000 children between the ages of two and five years of age during the 2004-2005 flu season, there was a 54% reduction in cases of flu in children who received FluMist compared with those who received the traditional flu shot (4.5% vs. 9.8%, respectively). In the study, FluMist demonstrated a reduction in flu rates compared to the inactivated vaccine against strains that were both matched and mismatched to the vaccine.
Posted on September 20, 2007 @ 09:40 am
I
mClone Systems' anti-insulin-like growth factor-1 receptor (IGR-IR) monoclonal antibody (known as IMC-A12) has received 10 proposals for Phase I/II trials from the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI).
The proposed trials follow NCI's request for specific disease-directed studies among NCI investigators at academic institutions, clinical trial consortia and NCI-sponsored oncology cooperative clinical trial groups in the U.S. The 10 trials are the first stage of clinical evaluations of IMC-A12 sponsored by CTEP, NCI under a Clinical Trials Agreement between ImClone and DCTD, to facilitate the development of the drug.
The Phase II trials sponsored by CTEP will explore the clinical activity, pharmacology and biological effects of IMC-A12 as a single agent or combined with other relevant anticancer agents in a wide range of malignancies including breast, lung, pancreas and liver cancers, as well as both adult and pediatric sarcomas. Phase I/II studies will evaluate the safety, pharmacology, anticancer activity and biological effects of IMC-A12 in children and adolescents with cancer, as well as in combination with other targeting agents.
ImClone's IMC-A12 is designed to target the human insulin-like growth factor type 1 receptor and inhibit certain ligands known as insulin-like growth factors I and II from binding to and activating the receptor. This action blocks the pathway that enables tumor cell growth.
Posted on September 19, 2007 @ 08:39 am
Genzyme Corp. broke ground on a $150 million expansion project at its Allston Landing manufacturing facility in Boston that will add space for manufacturing support functions and will create 90 jobs.
Commercial production at Allston Landing, which began in 1996, was initially intended to produce Cerezyme and has grown to include four additional products: Fabrazyme for Fabry disease, Myozyme for Pompe disease, as well as the filling and packaging for Aldurazyme for MPS I disease and Thyrogen, used for screening patients who have had thyroid cancer. This growth in manufacturing capacity now requires additional space for manufacturing support operations, offices and mechanical equipment.
"The expansion of Allston Landing will help sustain the continued growth of Genzyme's products," said Henri A. Termeer, chairman and chief executive officer of Genzyme. "It will enable us to continue to fulfill our long-term commitment to deliver these life-saving treatments to patients around the world."
The expansion project includes 86,000 sq. ft. of new office and manufacturing-support space. The company is also building a 26,000-sq.-ft. underground co-generation facility, which will generate steam to run the plant's process operations and will also produce electricity. The company plans to seek certification for the expansion under the U.S. Green Building Council's LEED (Leadership in Energy and Environmental Design) Green Building Rating System.
Posted on September 19, 2007 @ 08:36 am
Catalent Pharma Solutions
4Q Revenues: $451.3 million (+5%)
4Q Loss: $168.7 million (earnings were $27.6 million 4Q2006)
FY Revenues: $1.7 billion (+6%)
FY Loss: $127.3 million (earnings were $51 million FY2006)
Comments: FY and 4Q revenue growth was primarily driven by the Packaging Services segment, particularly within Europe, as well as from continued strong demand for Zydis products within the Oral Technologies segment. Packaging Services revenue was $138 million in the quarter, up 11% and for the year was $552 million, up 14%. In April 2007, an affiliate of The Blackstone Group acquired the company from Cardinal Health for approximately $3.3 billion.
Posted on September 19, 2007 @ 08:34 am
Robert J. Heine, M.D., Ph.D., F.R.C.P., will join Eli Lilly and Co. in January, 2008, as executive medical director for the diabetes and endocrine division responsible for development of Lilly's expanding diabetes and obesity R&D portfolio. Dr. Heine replaces Dr. Meng Hee Tan, who will retire at the end of September after 8 years of service to the company.
“Lilly has a growing and exciting diabetes and obesity R&D portfolio that demands exceptional clinical leadership to guide and successfully develop," said Vince Mihalik, vice president and global brand development platform leader, diabetes, obesity and endocrine. "Robert is widely recognized and respected in the diabetes community for his scientific and clinical excellence and his considerable leadership abilities. He'll be a fantastic addition to the Lilly team."
Dr. Heine is currently professor of diabetology in the Department of Endocrinology and director of the Diabetes Centre at the VU (Vrije Universiteit) University Medical Center in Amsterdam, Netherlands. He also holds positions within the European Association for the Study of Diabetes (EASD), the European Foundation for the Study of Diabetes (EFSD) and the American Diabetes Association (ADA), including chair of the EASD subcommittee for Clinical Research Training, president of the organizing committee for the 2007 EASD annual meeting, and a member of the ADA Expert Committee on guidelines for the treatment of hyperglycemia in type 2 diabetes. Dr. Heine's primary research interests include the epidemiology and pathophysiology of type 2 diabetes.
Posted on September 17, 2007 @ 09:26 am
AstraZeneca is planning to outsource all drug manufacturing activities within 10 years, according to a company statement. "Manufacturing for AstraZeneca is not a core activity," said David Smith, AstraZeneca's executive vice-president of operations. "AstraZeneca is about innovation and brand-building. There are lots of people and organizations that can manufacture better than we can," Mr. Smith said.
Mr. Smith is leading restructuring initiatives in an effort to reduce costs and improve profitability before patent expirations on key drugs. According to Mr. Smith, the group plans to become strictly a research, development and marketing organization and the priority is to outsource all of the company's API manufacturing.
Posted on September 17, 2007 @ 09:25 am
Celera has entered into a research collaboration with
Merck to develop biomarker and pharmacogenomic tests for cancer patients. Under the terms of the agreement, Celera will evaluate certain gene expression profiles identified by Merck with the goal of developing diagnostic predictors for use in Merck's clinical trials, and to potentially form the basis for commercial diagnostic tests for oncology therapies.
Celera will receive an undisclosed payment for this collaboration and is eligible to receive an additional payment if Merck transfers a Celera validated gene expression assay to a clinical reference lab upon completion.
"This collaboration with Merck is a strong validation of Celera's diagnostic expertise in targeted medicine and our development capabilities," said Thomas White, Ph.D., chief scientific officer at Celera. "The potential outcomes from this collaboration could lead to the development of tests that may improve individualized therapy for the treatment of cancer."
Posted on September 17, 2007 @ 09:23 am
The FDA has approved use of
J&J's five-day, once-daily regimen of Levaquin 750 mg I.V. and oral, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).
The approval is based on results from a double-blind, randomized trial involving 1,109 patients with either cUTI or AP, which assessed the efficacy and safety of Levaquin versus ciprofloxacin (Cipro). Clinical success rates were similar in both treatment groups demonstrating the resolution of, or improvement in, urinary symptoms for both Levaquin and Cipro groups.
Ortho-McNeil, Inc., along with Johnson & Johnson PRD, conducted the trial and the safety profile of Levaquin is similar across doses. Levaquin is marketed by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil.
Posted on September 14, 2007 @ 10:24 am
Accenture and
Bristol-Myers Squibb have launched a joint center for pharmacovigilance in Chennai, India. The new center will be operated by more than 140 Accenture employees and will undertake the processing and coding of adverse event data and the generation of regulatory reports on safety as well as physician medical review of adverse events.
Pharmacovigilance, safety data monitoring to ensure optimal use of medicines, entails the capture, assessment, and reporting of potential side effects to medicines. The collaboration is for 'end-to-end' safety case processing and includes specialized activities, such as medical review of the reported adverse reactions. The team is organized as an extension of the BMS pharmacovigilance headquarters' operations and allows for the seamless handling of data between Accenture and BMS while not compromising patient safety, according to the two companies.
"Building a joint team with a specialized focus will support the continued growth of our robust product pipeline, improving scalability and increasing overall productivity," said John Balian, M.D., senior vice president, global pharmacovigilance and epidemiology, BMS. "Working with Accenture, BMS will continue to access world-class talent to deliver on our regulatory obligations, while enhancing our focus on patient safety."
"Leading companies are re-thinking their operating model to drive sustainable growth and productivity," said Eric Sandor, managing director of Accenture Pharmacovigilance Services. "Through a truly collaborative partnership with BMS we have established an industry leading operation that is delivering substantial efficiency and improved flexibility for BMS's pharmacovigilance organization."
The pharmacovigilance center is part of Accenture's Life Sciences Centers of Excellence in Bangalore and Chennai that BMS already uses. As part of the multi-year R&D agreement signed in April, the pharmacovigilance center furthers BMS's efforts to expand its R&D capabilities in India.
Posted on September 14, 2007 @ 10:21 am
Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA's Critical Path Initiative, an effort to facilitate the use of new scientific and technical methods—such as computer-based predictive models and biomarkers for safety and effectiveness—intended to improve the predictability and efficiency of drug development. There are currently no federal or industry standards in place for assessing the quality of genomic data submissions to the FDA.
Gene Logic obtains and analyzes genomic data in the pharma and biopharma industries and has assembled detailed knowledge bases of gene expression profiles from human tissues and cells. The company has processed more than 200,000 microarrays to obtain genomic data and has developed methods and software to ensure those data are accurate, including more than 40 quality metrics, according to the company.
Donna Mendrick, Ph.D., a Gene Logic scientific fellow and the company's vice president of toxicogenomics, said, "Industry and FDA consensus is that biomarkers are valuable tools for assessing the safety and efficacy of drug candidates. This collaboration between Gene Logic and the FDA is a step on the path to achieving a common understanding of key microarray QC procedures that may lead to the development of preliminary microarray data standards for the submission of microarray data to the FDA."
A senior FDA official commented, "Currently there are no industry standards in place for microarray data submission to the FDA, and projects focused on understanding the QC issues will help drive the development of baseline standards for the submission of microarray data to the FDA in the future."
Posted on September 14, 2007 @ 10:20 am
Eli Lilly and Co. received approval from the FDA for its osteoporosis drug Evista for a new use to reduce the risk of invasive breast cancer in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer.
Evista, a selective estrogen receptor modulator or SERM (recently classified by the FDA as an estrogen agonist/antagonist), is currently approved for the prevention and treatment of osteoporosis in postmenopausal women. The approval was based on data submitted in November 2006 in a NDA evaluating clinical results from approximately 37,000 postmenopausal women that spanned nearly 10 years.
Earlier this year, the osteoporosis label for Evista was updated to include safety information from the Raloxifene Use for The Heart (RUTH) trial, which evaluated postmenopausal women with known or at increased risk for coronary disease taking Evista. This trial found no increase in the incidence of stroke, but an increase in the incidence of death due to stroke.
Posted on September 13, 2007 @ 08:14 am
Daniel G. Darazsdi has been appointed chief financial officer,
PPD, Inc., effective October 1. Mr. Darazsdi joins the company after 25 years with Honeywell International, where he most recently served as vice president and chief financial officer of finance transformation and operations. He also served as chief financial officer of the company's global specialty materials business segment and held various leadership roles in finance. In addition, Mr. Darazsdi provided finance, information technology and business development leadership for Honeywell's performance polymers strategic business unit; served in Hong Kong as vice president for the company's Asia-Pacific finance and information technology organizations across 12 countries; and spent several years in Sydney, Australia, directing finance and administration for the company's operations in that country.
"Dan Darazsdi is a seasoned professional whose career portfolio includes extensive experience in business unit finance, corporate treasury and international management," said Fred Eshelman, chief executive officer of PPD. "We are delighted he is joining our organization and look forward to the addition of his strategic leadership to our executive team."
Posted on September 13, 2007 @ 08:09 am
BioReliance Corp. has partnered with
Gentronix to offer their GreenScreen HC in vitro assay as part of its genotoxicity screening services. GreenScreen HC, in conjunction with Ames II assays, allows pharmaceutical companies to test for genotoxic potential earlier in the preclinical development process, using only a few milligrams of test compound, according to the company.
John Nicholson, chairman and chief executive officer of Gentronix, said, "We are delighted to complete this agreement with BioReliance, a company regarded as a global leader in genetic toxicology testing services."
"This new high-throughput assay from Gentronix furthers BioReliance’s ability to meet customer demand for faster and more-effective genotoxic screening services,” said David Bruning, senior director, toxicology operations at BioReliance. “The GreenScreen HC and Ames II assays, when combined, offer highly predictive and sensitive detection of genotoxic compounds while minimizing false positives seen with other in vitro assays, accelerating the development process.”
GreenScreen HC is a human cell-based genotoxicity screening assay that links the regulation of the human Growth Arrest and DNA Damage (GADD45a) gene to the production of Green Fluorescent Protein (GFP). Cells that have incurred DNA damage upon exposure to a test compound express higher levels of detectable GFP.
Posted on September 12, 2007 @ 09:39 am
SAFC is investing $10 million to increase cGMP commercial-scale API manufacturing capacity at its SAFC Pharma, Arklow, Ireland facility, and to expand capacity to enhance manufacturing operations at its Buchs, Switzerland facilities.
The company will invest $4.7 million at the Arklow facility and will increase production capacity and capability. The site will upgrade the pilot plant and add additional vessels to increase chemistry capacity for API products. Additional enhancements are expected to increase utility capacity and further increase the site's environmental performance. The expansion is scheduled for 1Q2008.
At the Buchs site, the company will invest $5.4 million to extend its existing cGMP production facility with a 17,200-sq.-ft. expansion designed to enhance production capacity by 25% through improved materials flow and separation, and increased materials storage. The new two-level storage facility is expected to become fully operational in spring 2008. The site supports manufacturing operations for the SAFC Pharma and SAFC Supply Solutions business sectors.
SAFC president Frank Wicks commented, "These significant investments enhance our determination to support SAFC Pharma's rapid growth and help us reduce our environmental footprint, maintaining our position as one of the most responsible companies in the industry. The expansion of the Arklow facility underlines the desire of our customers to have their API manufactured to a reassuringly high quality standard in a superior technical environment, partnered with a premium company that can ensure a security of supply."
Posted on September 12, 2007 @ 09:37 am
Nabi Biopharmaceuticals will sell its Biologics unit to Biotest Pharmaceuticals Corp. for $185 million. The purchase includes the unit's products, including Nabi-HB (Hepatitis B Immune Globulin (Human)), and other plasma business assets, as well as Nabi's state-of-the-art plasma protein production plant, and nine FDA-certified plasma collection centers across the U.S. The acquisition will include certain of Nabi's Corporate Shared Services group assets and the company's Boca Raton, FL headquarters and other facilities, along with the assumption of certain liabilities.
"With the acquisition of Nabi Biologics, we have found the ideal complement for our European plasma protein business and have become a global player in the industry," said Professor Dr. Gregor Schulz, chairman of Biotest AG. "We have an immediate share in the highly attractive and growing U.S. plasma protein market and are substantially expanding our capacities, extending our product range and consolidating our clinical development portfolio." Biotest researches and manufactures pharmaceutical, biotherapeutic and diagnostic products and has more than 1,200 employees worldwide.
"This agreement definitively puts us on the final path to a successful outcome of our strategic alternatives process," said Dr. Leslie Hudson, Nabi's interim president and chief executive officer. "We feel this transaction not only will realize value for Nabi shareholders but also will allow us to build on the promise of our Pharmaceuticals pipeline."
Once the transaction closes, Nabi Biopharmaceuticals will operate its Pharmaceuticals unit from its existing Rockville, MD facility, which will become its new corporate headquarters. The company has an on-going trial with NicVax, its innovative and proprietary investigational vaccine for nicotine addiction and the prevention of smoking relapse. The company will continue its efforts to secure a strategic partner for its NicVax and StaphVax programs. Nabi also will retain the right to receive up to an additional $75 million in milestone and royalty payments related to the divestiture of PhosLo in November 2006.
Posted on September 12, 2007 @ 09:35 am
Integrated Project Services (IPS) has appointed a new leadership team for its New Jersey operations.
David J. Brown has been named regional office manager and will continue to lead the project services and project controls teams that support client projects. Mr. Brown has 23 years of experience in project controls and mechanical engineering serving a variety of clients in the pharmaceutical, commercial, institutional, healthcare, government, and life sciences industries. His expertise includes bulk API manufacturing, fill and finish oral solid dosage, biotechnology, cell culture, purification, aseptic manufacturing, laboratories, pilot plants, central plants and utilities.
Patrick N. Boccio, PE was named director, project management and will lead key account management and project development activities for the NJ operations. Mr. Boccio has more than 20 years of experience in the design of pharmaceutical, commercial, retail, industrial and governmental facilities, as well as experience in the overall engineering/architectural designs and project management for over seventy high tech projects. His expertise includes pharmaceutical intermediate production facilities, high performance laboratories, pilot plant facilities, compressed air plants, chilled water plants, hazardous storage facilities, site wide fire alarm system upgrades, security control facilities, and data center critical systems.
Aaron Weinstein was named manager, compliance for the NJ operations. He has a broad range of experience in the areas of biopharmaceutical and API manufacturing, including facility, utility, and process equipment validation. He also has experience with thin-films manufacturing and medical device validation. He has audited validation programs for compliance with FDA and corporate requirements.
Mark A. Butler will continue as general manager, engineering and principal-in-charge of NJ operations. Mr. Butler has more than 24 years of experience in facility design, construction, and operations. His expertise is in the engineering and leadership of large, technically complex, engineering-intensive facilities. He is also a member of ISPE's Baseline Guide for Laboratories committee.
"Positioning our regional New Jersey office to expand our service offerings for the benefit of pharmaceutical and biotechnology clients is very exciting," said Dave Goswami, president of IPS. "We are confident that this talented Leadership Team will continue to offer the same level of expertise they are accustomed to—knowledge-driven, cost effective solutions. We remain committed to delivering high performance, technically complex facilities for all of our clients on time and on budget."
Posted on September 11, 2007 @ 09:14 am
Aptuit, Inc. has agreed to acquire
Evotec AG's Chemical and Pharmaceutical Development (CPD) business, which includes an API facility in Oxford, England and a recently-expanded parenteral fill/finish facility in Glasgow, Scotland. The acquisition provides Aptuit with an established European presence in API development services. The CPD business provides small molecule API development labs, kilo labs and pilot plants as well as clinical scale parenteral fill/finish including two lyophilization suites.
"This acquisition continues Aptuit's momentum as we assemble a complete suite of drug development services in all three major geographies in Europe, North America and Asia," said Michael A. Griffith, chief executive officer and founder of Aptuit. "We will integrate the highly-regarded scientific staff and two pilot plants in Oxford and state-of-the-art parenteral fill/finish capabilities in Glasgow into our existing global network. We will then leverage those capabilities to drive our commercial-scale capabilities in India, providing our clients with world-class drug development services from discovery to commercialization."
The two companies have also entered into a long-term supply agreement under which Aptuit will provide API and its full range of development services in support of Evotec's pharmaceutical pipeline. "The deal we announced today will position our Chemical and Pharmaceutical Development business within an environment where it can thrive, and with a global company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators," said Jorn Aldag, president and chief executive officer of Evotec.
Aptuit plans to retain all of the employees of the CPD business and, Paul McGee, Evotec's senior vice president of chemical development in Oxford and Dr. Sandy Allan Evotec's senior vice president of formulation sciences in Glasgow, will continue in their roles within Aptuit.
The acquisition is expected to close within 75 days and is not subject to financing or other contingencies.
Posted on September 11, 2007 @ 09:12 am
Sepracor and
GlaxoSmithKline entered an agreement for the commercialization of Sepracor's eszopiclone product for all markets outside the U.S., Canada, Mexico and Japan. Sepracor's eszopiclone, known as Lunesta in the U.S., will be marketed by GSK in these areas as Lunivia for the treatment of insomnia. Under the agreement, Sepracor is entitled to receive an initial payment of $20 million plus success-based milestones totaling $155 million. Sepracor will also receive royalties based on increased product sales and compensation for supplying the product to GSK.
Lunivia is currently under EMEA review for marketing approval under the Centralized Procedure, which allows the EMEA to conduct a single, scientific evaluation on behalf of all EU member states, using experts from national regulatory authorities. Approval of the MAA would authorize the marketing of Lunivia for insomnia in as many as 27 EU member countries.
"GSK is one of the world's largest pharmaceutical companies, and we are delighted to have established this alliance with such a renowned organization that has a strong presence in the EU and other global markets," said Adrian Adams, president and chief executive officer of Sepracor. "GSK's knowledge, experience and success in the central nervous system area, together with its broad commercialization infrastructure, provide an optimal launch platform from which to expand our Lunivia franchise to European and additional international markets."
Lunesta has been available in the U.S. since April 2005 and had product revenues of approximately $566.8 million in 2006.
Posted on September 11, 2007 @ 09:09 am
Wyeth and
Progenics Pharmaceuticals initiated three new clinical studies for their investigational drug, methylnaltrexone, a peripherally acting mu-opioid receptor antagonist. Two of these trials will study the use of subcutaneous methylnaltrexone for treating opioid-induced constipation (OIC) in patients outside of the palliative care population included in the first NDA submission. The third trial will investigate methylnaltrexone for managing post-operative ileus (POI). The companies are currently studying intravenous methylnaltrexone in Phase III trials to manage POI in patients undergoing segmental colectomy surgical procedures. All of the studies will investigate additional patient populations for the drug.
The first of the two subcutaneous methylnaltrexone trials, a Phase III study in OIC patients with chronic pain not related to cancer, is being conducted by Wyeth and is scheduled to enroll approximately 470 patients at approximately 100 centers worldwide. The primary efficacy endpoints are the proportion of methylnaltrexone injections resulting in bowel movements within four hours and the evaluation of the number of bowel movements per week, compared to placebo. The trial is expected to be complete by late 2008.
Progenics will conduct the second subcutaneous methylnaltrexone trial, a Phase II study in OIC patients rehabilitating from an orthopedic surgical procedure when opioids are used to control post-operative pain. This trial is scheduled to enroll approximately 260 patients at approximately 50 centers in the U.S. The clinical efficacy endpoints include relief of constipation as measured by laxation response. The trial is scheduled to begin in 4Q2007.
Wyeth will conduct the third Phase III intravenous methylnaltrexone study in patients with POI following a ventral hernia repair via laparotomy or laparoscopy. This trial is scheduled to enroll approximately 500 patients at 90 to 120 centers worldwide. The primary efficacy endpoint is measured by time to first bowel movement after the surgical repair. The trial is expected to be complete by the middle of 2008.
Posted on September 10, 2007 @ 09:10 am
AMRI opened its new 50,000-sq.-ft. R&D center at the Shapoorji Pallonji Biotech Park in Hyderabad, India. The new facility will provide additional space for the company's laboratory-scale operations in India.
The new facility includes labs for conducting early stage research such as custom chemical synthesis and analytical chemistry. Additional scale-up labs for preparing preclinical and clinical trial supply active ingredients are expected to open later this year and 2008, respectively. The larger labs will be used to develop efficient methods to produce APIs and intermediates and are equipped with environmental controls and a state-of-the-art wastewater treatment unit. The company invested approximately $8 million in the facility.
"In addition to expanding our capabilities in India, this new state-of-the-art research facility increases our capacity to provide customers with a flexible range of drug discovery and development services out of Asia -- all with the same quality they have come to expect from AMRI around the world," said chairman, chief executive officer and president, Thomas E. D'Ambra, Ph.D. "Moreover, as we increase our presence in Asia, AMRI is proud to be contributing to improving work practices for employee opportunities within our industry, as well as setting a high standard and positive example of environmental stewardship."
Posted on September 10, 2007 @ 09:09 am
Merck & Co., Inc. has exercised an option for the exclusive use of
Crucell N.V.'s PER.C6 technology and an option for access to its AdVac vaccine technology in two infectious disease areas.
Dr. Jaap Goudsmit, Crucell's chief scientific officer, said, "We are excited about this technology agreement which represents a further expansion of the relationship between our company and Merck. Crucell's vaccine technologies, PER.C6 and AdVac, are increasingly used by the vaccine industry to develop important novel vaccines for infectious diseases. This agreement further broadens the number of disease areas in which our technologies are used."
Under the terms of the agreement, Crucell acquires rights to certain cell-line technology developed by Merck for the manufacturing of recombinant proteins. The option and rights to technology developed by Merck are related to a cross-license agreement signed by the two companies in December 2006.
Posted on September 10, 2007 @ 09:07 am
MedImmune has resolved the observations made by the FDA during an annual inspection of its influenza vaccine manufacturing facility in Speke, UK, according to the company. The company had received a Warning Letter from the FDA in May. The UK facility is the bulk manufacturing site for FluMist (Influenza Virus Vaccine Live, Intranasal). MedImmune will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance concerns.
MedImmune is currently working with the FDA on the standard annual lot release process so that FluMist shipments can begin for the upcoming flu season. The company can now proceed in seeking the FDA's final approval of its sBLA requesting expansion of the vaccine's indication to include children under five years old.
Posted on September 7, 2007 @ 08:53 am
Pozen, Inc. and
AstraZeneca began the Phase III program for PN 400, a fixed dose combination of the proton pump inhibitor (PPI), esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen, in a single tablet. An NDA is targeted for 1H2009. The two companies have also amended terms of their August 2006 collaboration and license agreement.
Under the terms of the amended agreement, AZ will pay Pozen as much as $345 million for the achievement of development, regulatory, and sales milestones. Pozen will receive an immediate $30 million payment for successful proof of concept, $55 million upon achievement of certain development and regulatory milestones, and $260 million as sales performance milestones are achieved. Under the original agreement, development and regulatory milestones totaled $160 million, of which $20 million was to be paid upon the successful completion of the proof of concept studies, and sales performance milestones totaled $175 million.
Dr. John R. Plachetka, Pozen's chairman, president and chief executive officer said, "We are pleased that PN 400 studies conducted to date have met expectations at both companies, that the interim results of the PN 200-301 study were positive, and that AstraZeneca has agreed to move forward with this program. Our goal now is to move as quickly as possible to deliver the development program agreed with the FDA under the Special Protocol Assessment procedure, and file the NDA on schedule."
"AstraZeneca is pleased to announce that we are progressing PN 400 into Phase III development in collaboration with Pozen. Millions of people worldwide suffer from arthritis and we are excited about the prospect of developing and bringing an important new therapy to these patients," said Mr. Tony P. Zook, president and chief executive officer, AstraZeneca LP, U.S. "We are committed to working with Pozen to develop this innovative product and hope to bring it to market as quickly as possible."
Interim results of PN 200-301, a recent pilot study for the PN 400 program, demonstrated a significant reduction in gastric ulcers relative to naproxen, and the anti-secretory profile of PN 400 met expectations for the target product profile.
Posted on September 7, 2007 @ 08:46 am
Alnylam Pharmaceuticals, Inc. and
Isis Pharmaceuticals, Inc. launched Regulus Therapeutics LLC, a joint venture focused on the discovery, development, and commercialization of microRNA (miRNA) therapeutics. These therapeutics represent a new approach to target the pathways of human disease. Regulus will combine Isis' and Alnylam's technologies and intellectual property with leadership from a management team and Scientific Advisory Board to be chaired by Nobel laureate David Baltimore and include key pioneers in the miRNA field.
Regulus will have exclusive licenses to Isis and Alnylam's miRNA therapeutic applications, as well as certain patents in the miRNA field including the "Tuschl III" patent. Alnylam will make an initial investment of $10 million and thereafter Isis and Alnylam will share funding of Regulus. Alnylam and Isis will retain rights to develop and commercialize miRNA therapeutic products that Regulus decides not to develop. Regulus will be operated as an independent company.
"The emerging biology of microRNAs points to a completely new understanding of cellular mechanisms for regulation of gene expression," said Dr. Baltimore, of California Institute of Technology. "I believe that microRNAs represent previously unexplored disease targets where pharmacological approaches could lead to the emergence of novel therapies for many human disorders. Accordingly, I'm very excited to join in the formation of Regulus and to help build the leading microRNA therapeutics company."
"The opportunity to antagonize microRNAs could create a new frontier for pharmaceutical research where an entire disease pathway is targeted for intervention, not just a single disease target. We believe microRNA therapeutics could have profound implications for the treatment of a broad range of diseases including cancer, viral infection, and metabolic disorders," said John Maraganore, Ph.D., president and chief executive officer of Alnylam. "Isis' and Alnylam's intellectual property and technologies open the door to these new opportunities and, when combined to form Regulus, create an unmatched effort to establish the leading microRNA therapeutics company."
"We are excited to embark on this venture, which represents an opportunity to invest in a focused expansion of our ongoing microRNA research efforts through Regulus' application of our antisense technology platform to create microRNA therapeutics. It is timely to extend our know-how and clinical advances with antisense drugs to the field of microRNAs, an area that stands at the forefront of modern biology," said Stanley Crooke, M.D., Ph.D., chairman and chief executive officer of Isis. "Regulus will be fully enabled to create a bold and successful new venture."
Regulus' new Scientific Advisory Board will be chaired by Dr. Baltimore, who will also serve as director, and initially will comprise the following members: David Baltimore, Ph.D., Professor of Biology at California Institute of Technology and the recipient of the 1975 Nobel Prize in Physiology of Medicine; David Bartel, Ph.D., Professor of Biology at MIT and a member of the Whitehead Institute for Biomedical Research; Scott Hammond, Ph.D., Assistant Professor of Cell and Developmental Biology at the University of North Carolina School of Medicine; Markus Stoffel, M.D., Ph.D., Professor for Metabolic Diseases at the Institute of Molecular Systems Biology, Swiss Federal Institute of Technology (ETH); Thomas Tuschl, Ph.D., Associate Professor at the Rockefeller University; and Phillip D. Zamore, Ph.D., Gretchen Stone Cook Professor of Biomedical Sciences at the University of Massachusetts Medical School.
Posted on September 7, 2007 @ 08:43 am
Patheon
3Q Revenues: $175.5 million (-2%)
3Q Loss: $63.1 million (loss of $257.2 million in 3Q2006)
YTD Revenues: $510.3 million (flat)
YTD Loss: $87.1 million (loss of $265.7 million YTD2006)
Comments: Rx manufacturing revenues increased by $5.6 million or 4% in the quarter, driven by growth in Europe, partially offset by declines in Canada and PR. PDS revenues increased by $3.2 million, or 12%, due to growth at the Swindon and Cincinnati operations. OTC revenues declined $11.9 million at the Whitby and Cincinnati manufacturing operations. In the quarter, the company recognized a $48.6 million non-cash asset impairment charge related to its operations in Carolina, PR and an asset impairment charge of $13 million for the facilities in Niagara and Burlington, which the company is in the process of divesting.
Posted on September 6, 2007 @ 09:26 am
Pfizer has initiated a large, global Phase III trial to evaluate the efficacy and safety of sunitinib malate, in combination with erlotinib, in previously treated patients with advanced non-small cell lung cancer (NSCLC).
Preliminary results from a Phase II study on the safety and tolerability of sunitinib in combination with erlotinib in patients with advanced NSCLC, indicate that adverse events were mild to moderate in severity. Also, two patients experienced a partial response (PR); one patient demonstrated a PR after two cycles of therapy, which was maintained for more than three months, and the second patient has a documented durable PR and continues on the study.
The Phase III, randomized, double-blind trial of 956 patients is designed to compare the overall survival of patients taking sunitinib combined with erlotinib (a targeted therapy used to treat NSCLC) with those taking erlotinib plus placebo. Secondary endpoints of the study include progression-free survival, objective response rate, one-year survival, duration of response, adverse events and patient-reported outcomes.
Posted on September 6, 2007 @ 09:25 am
Crucell N.V. has entered a non-exclusive STAR research license agreement with
Invitrogen Corp.'s PD-Direct Bioprocess Services. The license covers the production of monoclonal antibodies.
According to Crucell, STAR technology is useful for the production of recombinant human antibodies and proteins. It has a potentially broad application and is effective for production of antibodies and proteins on mammalian cell lines such as Crucell's PER.C6 human cell technology. The technology has the potential to reduce production costs by increasing production yields.
Posted on September 6, 2007 @ 09:23 am
Nancy J. Wysenski has been appointed chief operating officer,
Endo Pharmaceuticals Inc., effective immediately. Ms. Wysenski will oversee the integration and execution of Endo's operating strategy, sourcing and commercializing its product portfolio, and advancing the company's organizational capabilities. She will have direct responsibility for business development, strategic alliances, sales and marketing, technical operations and supply chain, and corporate services, including human resources and information management.
Ms. Wysenski most recently served as president of EMD Pharmaceuticals, Inc., the U.S. subsidiary Merck KGaA of Darmstadt, Germany. In this role, she was responsible for U.S. operations for this division and for Dey Laboratories, a specialty respiratory pharmaceutical business. Ms. Wysenski was also responsible for leading the team that secured approval for EMD's first U.S. product, and served as a member of the Merck KGaA Ethical Pharmaceuticals Executive Committee. She led a variety of global business initiatives, including the Portfolio Management Team based in Germany.
Previous positions include senior vice president of operations at NetGenics and a number of positions of increasing scope and responsibility at Astra Merck. Prior to joining Astra Merck in 1990, she held various positions at Merck Human Health.
Posted on September 5, 2007 @ 09:32 am
Draxis Pharma has expanded its existing contract manufacturing relationship with
Johnson & Johnson Consumer Companies, Inc. to provide commercial manufacturing services for multiple non-sterile specialty semi-solid products currently marketed in the U.S.
The new contract runs to the end of 2013 and includes approximately two years of manufacturing site transfer and process validation activities followed by five years of commercial production, which is scheduled to begin in 2009. Commercial production during this five-year period is expected to generate more than $120 million in revenues. The transfer of equipment and production technologies is expected to generate approximately $6 to $8 million in revenues during 2007 and 2008.
"The signing of this contract is a reflection of the solid business model at Draxis," said Dr. Martin Barkin, president and chief executive officer of Draxis Health. "We are honored to have been selected from more than 80 international contract manufacturers under a rigorous and comprehensive global selection process conducted over an extended multi-year period."
Dr. Barkin added, "This contract includes prescription and non-prescription products and will significantly improve capacity utilization in the semi-solids section of our non-sterile operations. The confidence shown in DRAXIS demonstrates our ability to deliver top quality, market leading products in a highly regulated industry, which supports our efforts to build shareholder value."
Commercial production of the products is scheduled to start in late 2008 and ramp up to achieve near full utilization of existing capacity for non-sterile semi-solid products by mid-2009. A second Draxis facility in the Montreal area will be required to meet increased logistics and secondary packaging activities and is expected to open during the summer of 2008. All products will be formulated and filled in the existing facility in Kirkland, Quebec.
Posted on September 5, 2007 @ 09:29 am
Medarex, Inc. and licensing partner, J&J subsidiary
Centocor R&D, Inc., have extended their antibody development relationship, providing Centocor with continued access to Medarex's UltiMAb Human Antibody Development System for the generation of fully human antibodies to an unlimited number of targets.
Under the terms of the new agreement, Centocor will license Medarex's UltiMAb technology to discover and potentially develop and commercialize antibody therapeutics. Medarex expects to receive license fees and milestone payments as well as royalties on commercial sales of any products that may result from this agreement. Financial terms of the agreement were not disclosed.
"We are delighted with the opportunity to continue our relationship with Centocor," said Howard H. Pien, president and chief executive officer of Medarex. "We have been pleased to be a partner to Centocor in its development of UltiMAb antibodies into potentially very important products, and we look forward to the extension of this partnership into the future."
Posted on September 5, 2007 @ 09:26 am
Dr. Susan C. Stansfield has been appointed executive vice president, with responsibility for product registration activities in Europe, Africa and Asia-Pacific for
PRA International.
David Dockhorn, executive vice president, will continue to have responsibility for product registration activities for the Americas.
"We are very pleased to continue the process of strengthening our management team with the addition of Dr. Stansfield," said Terrance J. Bieker, chief executive officer of PRA International. "The appointment of an executive dedicated to Product Registration activities in Europe, Africa and Asia-Pacific reflects the growing scale of our international operations and the additional opportunities we have to continue growing this part of our business. Dr. Stansfield has built an exceptional track record for managing world-class clinical research organizations and delivering results. Dr. Stansfield shares the client-centric focus that is a core value of PRA, and we believe she is well suited to take our international operations to the next level."
Dr. Stansfield has more than 20 years of experience in the clinical research industry. She joins the company from Pharmaceutical Product Development, Inc. (PPD), where she most recently served as senior vice president, project management and clinical operations, Europe. Under her management, the European operations achieved substantial increases in revenue, gross profit and operating margin.
Dr. Stansfield has also held senior management positions at Quintiles and Innovex, where she was responsible for business process improvement and managing full-service clinical research projects.
Posted on September 4, 2007 @ 09:50 am
Abbott and
AstraZeneca will advance the development of Abbott's next-generation fenofibrate ABT-335 and AZ's Crestor (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III trials. The single pill would target all three major blood lipids: LDL-C "bad" cholesterol, HDL-C "good" cholesterol, and triglycerides.
Abbott's ABT-335, currently in late-stage clinical trials, is part of a class of medications called fibrates, which have been shown to raise HDL-C, reduce triglycerides and moderately lower LDL-C. Based on the progress with the ABT-335 and Crestor fixed-dose combination program, the companies have decided to move forward with this combination therapy. The studies are proceeding on schedule.
"AstraZeneca is committed to continually investigate new treatment options for patients at risk for cardiovascular disease," said James Blasetto M.D., vice president, strategic development, AstraZeneca. "The combination of Crestor and ABT-335 may be an important option to help patients with mixed dyslipidemia achieve their treatment goals."
Abbott will continue the clinical trial program and is responsible for regulatory registration of the combination drug, which is targeted for submission in 2009. AZ will hold the NDA. The collaboration pertains to the U.S. market.
Posted on September 4, 2007 @ 09:44 am
Jerzy Gruhn has been named president of
Novo Nordisk, Inc., the company's U.S. affiliate, and senior vice president of Novo Nordisk North America. Mr. Gruhn will replace
Martin Soeters, who has been named senior vice president, European region, overseeing the company's operations in 35 countries. Mr. Gruhn is currently vice president of the Eastern Europe region. The appointments will take effect on January 1, 2008.
"We are making these changes at a time when Novo Nordisk is doing well in both Europe and North America and are confident that we have the right leadership to secure our future growth in the two regions," said Kare Schultz, executive vice president and chief operating officer.
Mr. Gruhn has been with the company for 11 years and has played an important role in gaining the company a leading position in Eastern and Central Europe. In his current position as vice president of the Europe East region, he overcame competitive pressures and adverse market conditions caused by pricing reforms and reimbursement issues to expand the company's business in the region to 16 countries.
Martin Soeters has more than 27 years' experience at Novo Nordisk in executive management, sales and marketing. Since taking over responsibility for the company's operations in the North American region in 2000 he has grown annual sales from $500 million in 2000 to $2.1 billion in 2006. Under his leadership, the company has successfully launched its portfolio of modern insulin, enhancing its position as a diabetes care leader in North America and at the same time built a strong biopharmaceuticals business.
Posted on September 4, 2007 @ 09:43 am
The first phase of
Millipore Corp.'s plant modernization project is complete at its facility in Kankakee, IL. The plant manufactures certain key products including Probumin brand Bovine Serum Albumin and other products derived from bovine serum or plasma.
The project included installation of new, state-of-the-art-control and processing equipment, helping the company to enhance control over product quality and existing proprietary and validated processes. Critical equipment was replaced with modern equivalents of the same configuration and processing characteristics, so there will be no change in the reactivity or other characteristics of the affected products. This initiative does not impact the Ex-Cyte focus factory also located at the Kankakee facility.
“This modernization to our Kankakee processing plant demonstrates Millipore’s commitment to delivering the highest product quality through enhanced process control to meet the on-going needs of our life science customers,” said Andrew Bulpin Ph.D, vice president of Millipore’s Bio-Products and Technologies Business Unit. “Our many customers expect Millipore to maintain leadership in the area.”
Phase 2 of the modernization project will begin immediately and will include enhancements to plant capacity and to filling and packaging capabilities.
August 2007
Posted on August 31, 2007 @ 07:35 am
SAFC, a member of the Sigma-Aldrich Group, has announced a $4.5 million capacity expansion program at its SAFC Pharma high-potency API (HPAPI) facility in Madison, WI. The program will add cGMP pilot plant and kilo lab capacity and complement the new XRPD (X-ray Powder Diffraction) analytical equipment for advanced solid form testing, which the company expects to be operational this month. The expansion is scheduled to start in early 2008.
SAFC is adding two 400-liter cGMP pilot plant reactors and two 100-liter cGMP portable jacketed reactors into a 1200-sq.-ft. large-scale kilo lab. The addition will enable larger-scale chromatography for process purification. The company also installed and qualified a Bruker D8 Advance X-ray Diffractometer for solid-form testing and analysis, providing U.S. customers with on-site cGMP and XRPD analysis of potent compounds. Rapid sample testing at the Madison site combines with data analysis and evaluation performed at SAFC Pharmorphix facilities in the U.K.
SAFC Pharmorphix specializes in solid-form research and is completing a multi-phase, $1.2 million expansion program at its labs. SAFC president, Frank Wicks, commented, “As regulatory requirements align with the increasing complexity of drugs, solid-form testing, analysis and optimization are becoming key elements in the drug development process. Additional and enhanced capabilities at SAFC Pharma’s Madison facility mark a timely expansion to the scope and value of our HPAPI offering and are reflective of SAFC’s ability to support its customers throughout the drug development cycle.”
Posted on August 30, 2007 @ 08:33 am
Merck's NDA for Cordaptive (ER niacin/laropiprant), formerly known as MK-0524A, has been accepted for review by the FDA. Cordaptive is an investigational drug containing Merck's extended-release niacin and laropiprant, a flushing pathway inhibitor designed to reduce flushing associated with niacin treatment.
The application supports the use of Cordaptive, either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol (LDL-C or "bad" cholesterol), low HDL cholesterol (HDL-C or "good" cholesterol) and elevated triglycerides levels. All are conditions associated with increased risk of heart disease.
Merck anticipates FDA action in 2Q2008. The company is also moving forward with filings outside the U.S.
Posted on August 30, 2007 @ 08:31 am
AAIPharma, Inc. has entered a multi-year alliance agreement with
Phase Forward. Under the terms of the contract, AAIPharma will offer services centered around two Phase Forward products as part of its solution set: the InForm Integrated Trial Management (ITM) electronic data capture (EDC) system and the Clintrial clinical data management product that can be used to collect, manage and review electronic and paper-based study data.
"After an intense review process we felt Phase Forward's dedicated services organization, combined with its trusted product set, made our decision an easy one," said Anne Wiles, senior vice president, data systems and processes, AAIPharma. "The company's flexible partner program will allow us to expand and customize our offerings at a pace that best suits our growing organization, as well as our clients. As EDC adoption continues, it is important that we offer the technology that sponsors view as an industry standard, while also supporting those clients requiring a solution that supports both electronic and paper-based trials. Phase Forward remains the vendor of choice for organizations at every stage of EDC implementation."
"CROs continue to play a critical role in bringing the efficiencies of electronic data capture and management to clinical trials, and will ultimately help move the industry further along the adoption continuum over the next several years," said Bob Weiler, chief executive officer and president, Phase Forward. "Collaboratively, we believe we can help biopharmaceutical and medical device firms realize the full benefits of EDC, and we look forward to working with AAIPharma in pursuing this goal."
Posted on August 29, 2007 @ 08:45 am
Catalent Pharma Solutions, Inc. and
ALK-Abello A/S have signed an agreement that will expand Zydis production capacity dedicated to ALK-Abello's immunotherapy products. Under the agreement, ALK-Abello will fund a new production line for current and future tablet-based allergy products, which will be based at Catalent's Swindon, UK facility. Commercial production on the new line is expected to begin in 2010.
ALK-Abello has launched Grazax, a tablet-based vaccine against grass pollen allergy, using Catalent's Zydis oral dissolving tablet technology, and Catalent is currently producing the Zydis formulation of Grazax in the Swindon facility.
"We are pleased to have reached this next important step in our relationship with ALK-Abello, which began more than four years ago," commented Thomas Stuart, group president of oral technologies for Catalent. "The clinical success of Grazax demonstrates that protein-based products such as allergens can be taken orally by patients rather than via injection, and we believe Zydis provides unique advantages to deliver these and other types of novel compounds. We look forward to supporting the further success of Grazax and additional ALK-Abello immunotherapy products."
"We are pleased to have reached this agreement with Catalent to provide important new production capacity, which we believe will be required to meet the expected future demand for our tablet-based allergy vaccines," said Jens Bager, president and chief executive officer of ALK-Abello. "We appreciate the consistent performance and dedication of the Catalent team in Swindon, and the valuable contribution the team and the Zydis technology is making to our product."
Posted on August 29, 2007 @ 08:42 am
PDL BioPharma, Inc., following a business and portfolio review, has changed its strategic focus to the discovery and development of novel antibodies in oncology and select immunological diseases. According to a company statement, it will realign its organization this fall to support its new strategy.
As a result of this new strategic focus, which does not include cardiovascular disease, PDL plans to sell its commercial assets, including its Cardene, Retavase and IV Busulfex products, as well as the ularitide development-stage cardiovascular product. Also, following a recent Data Monitoring Committee evaluation of data from the ongoing RESTORE 1 trial, the company has decided to terminate the Nuvion (visilizumab) phase III program in ulcerative colitis due to insufficient efficacy and an inferior safety profile.
Posted on August 29, 2007 @ 08:40 am
BioReliance Corp. has launched iNet, an IT system that enables customers to submit test article details via controlled and secure Internet access from any location worldwide. Clients can view the status of current and past studies, view expected completion dates, download reports, and allow colleagues to view testing status—all in one online environment and in real-time, according to the company.
Tim Derrington, president and chief executive officer of BioReliance, stated, “Our customers are now armed with a web-enabled application that offers a precise picture of their project’s current and future status. We look forward to greatly expanding our iNet user base in the upcoming months and continuing to develop and integrate new technologies that will enhance our customers’ service experiences with BioReliance.”
Judith Apshago, senior director of global IT, added, “A lot of effort was placed into making iNet user-friendly, secure and compliant. As a result, preliminary users have navigated through the submission process with little difficulty. In addition, we have implemented multiple layers of security both on the front end and the back end to create an extremely secure online environment that validates users and ensures data integrity.”
iNet is compliant with 21 CFR Part 11 for user authentication, and data exchange over the web is protected by VeriSign. It's compatible with both Windows and Mac operating systems.
Posted on August 28, 2007 @ 09:26 am
Charles River Laboratories International has plans to build a new facility in Sherbrooke, Quebec, to support its preclinical services business. The new facility, which will be located in the company's newly constructed Sherbrooke Biomedical Park, will provide drug discovery and development services to the pharma/biopharma industries.
The new facility will be approximately 300,000 sq. ft., 25% of which will be constructed in a first phase that is scheduled to open in 1Q2009. Construction of the remaining phases will be based on market demand. The Sherbrooke facility will employ 1,000 people who will work with the staff of 1,600 currently located in the company's Montreal facility.
James C. Foster, chairman, president and chief executive officer of Charles River Laboratories said, "We are very pleased to add this new project to our Preclinical Services expansion program. As customers choose strategic outsourcing as a means to improve the drug development process, they are increasingly turning to Charles River for our scientific expertise and the high-quality preclinical services we provide. This new facility will enable us to continue to support that demand from our global customers."
"Our goal was to identify a location similar to Montreal, equally convenient for our customers, where we could situate this new facility. Sherbrooke is ideal for many reasons, including its proximity to world-class educational institutions offering well-educated laboratory and life sciences graduates, as well as opportunities for collaborations and access to cutting-edge technology," said Christopher Perkin, corporate vice president and president, Canadian Preclinical Services. "We greatly appreciate the assistance of the government of Quebec, which is supporting this project, as we support our customers' efforts to bring drugs to market faster and more cost effectively."
Posted on August 28, 2007 @ 09:21 am
Pfizer has licensed non-exclusive, worldwide rights to
Xoma Ltd.'s bacterial cell expression (BCE) technology for phage display and other research, development and manufacturing of antibody products.
Under the terms of the agreement, Xoma will receive an upfront cash payment of $30 million and milestone, royalty and other fees on future sales of all products subject to this license, including products currently in late-stage clinical development.
Steven Engle, chief executive officer and president of Xoma, said, "This agreement provides clear validation of Xoma's antibody research and affirms Xoma's ability to capitalize on the value of our patented technologies. We continue to execute our strategy of using our technologies to generate high-margin revenue in support of our programs, including our proprietary product pipeline. We are very pleased that Pfizer has chosen to incorporate our BCE technology into their global drug development effort, and we look forward to what we anticipate will be a mutually beneficial relationship.
"BCE is an enabling technology for antibody phage display discovery and for the manufacture of bacterially expressed therapeutic antibody products," Mr. Engle continued. "It is a proven technology for commercially significant therapeutic antibodies as demonstrated by the approval of Lucentis for wet age-related macular degeneration. With more than 45 license agreements in place, BCE continues to be a seminal enabling technology in antibody discovery and production."
Posted on August 28, 2007 @ 09:19 am
Schering-Plough/Merck Pharmaceuticals' (SPM) NDA for loratadine/montelukast has been accepted by the FDA for review. The drug is a single tablet that contains the active ingredients of Claritin (loratadine) and Singulair (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.
SPM is seeking marketing approval of loratadine/montelukast for treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion. If approved the medicine would be marketed as a prescription treatment by Schering-Plough/Merck Pharmaceuticals, a joint venture between Schering-Plough and Merck & Co.
Posted on August 27, 2007 @ 08:15 am
NovaQuest, the strategic partnering group of
Quintiles Transnational, has made a strategic investment in
Topigen Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in respiratory disorders. The investment, part of a private placement of $25 million in the Montreal-based company, is intended to helps Topigen accelerate its Phase II lead-product clinical programs. NovaQuest and Quintiles first provided strategic product development advice to the company three years ago, and the relationship has since evolved into an integrated development partnership.
Patricia Lamothe, Topigen's chief financial officer, said, "The ability to access NovaQuest's clinical expertise and Quintiles' development capabilities is a tremendous benefit to our company as we continue to advance our product candidates for significant breakthroughs in the treatment of respiratory diseases."
NovaQuest vice president Ben Cons, Ph.D., added, "Having been very active in 2006, with 16 strategic investments, our focus now is to create fewer but larger partnerships. We're seeking high potential biotechs -- those with excellent pipelines and strong management teams."
In November NovaQuest made a strategic investment in Canadian biotech company BioMS Medical Corp., a developer of treatments for multiple sclerosis. For all of 2006, NovaQuest participated as a minority investor in funding rounds that raised a total of $342 million for 16 emerging biotechnology companies worldwide.
Posted on August 27, 2007 @ 08:11 am
Hani S. Zaki has been appointed vice president and general manager of Periapproval Services for
Covance, Inc. Mr. Zaki will be responsible for managing large research studies on the use of pharmaceuticals in real world clinical practice.
Prior to coming to Covance Mr. Zaki was with PharmaNet for nine years where he served as vice president of business development, leading the company's global efforts to build its Phase IIIb and Phase IV research business. Prior to joining PharmaNet, Mr. Zaki spent more than 16 years working in both clinical research and commercial roles on the client side. After early career experience in data management at Schering-Plough and in clinical operations with Bristol-Myers, Mr. Zaki was with Rhone-Poulenc Rorer (RPR, now sanofi-aventis) where he headed the U.S. anti-infective clinical operations group. While at RPR, he was also a part of Dermik Laboratories' licensing and market development group with sales & marketing responsibilities for several ex-U.S. markets.
"The market for Periapproval Services is likely to accelerate further as manufacturers seek to optimize sales of their in-line products and regulatory changes prompt a heightened need for safety studies," said
Luis Gutierrez, president of Covance Commercialization Services. "Mr. Zaki's depth of experience and track record identifying and developing new business opportunities will help to expand our efforts to maximize the delivery of integrated service offerings to our clients and our overall share of this growing market," he added.
Posted on August 27, 2007 @ 08:08 am
Pfizer and
Bristol-Myers Squibb have finalized their collaboration agreement to research, develop and commercialize DGAT-1 inhibitors. Pfizer's DGAT- 1 discovery program includes advanced preclinical compounds with potential applications for the treatment of metabolic disorders, including obesity and diabetes. The program also includes DGAT-1 inhibitors in-licensed by Pfizer from Bayer Pharmaceuticals in June 2006, including a preclinical compound (known as PF-04415060 or BAY 74-4113) originally discovered by Bayer.
The Pfizer/BMS collaboration was announced in April 2007. Pfizer will be responsible for all research and early-stage development activities for the metabolic disorders program, and the companies will jointly conduct Phase III development and commercialization activities.
"The worldwide incidence of metabolic disorders is increasing rapidly, and complications from diabetes and obesity are leading causes of disability and mortality globally. DGAT-1 inhibitors have shown promise in pre-clinical testing, and this research program has potential to yield several compounds that may improve treatment options for patients," said Elliott Sigal, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. "This collaboration underscores the company's commitment to investing in research and development, and reflects our strategy to identify partnerships that complement our own research efforts to enhance our innovative pipeline."
Posted on August 24, 2007 @ 07:58 am
Gene Logic, Inc. has entered into a drug repositioning and development agreement with
Merck Serono to seek alternative development paths for several Merck Serono drug candidates that were discontinued or de-prioritized in clinical trials for reasons other than safety.
Under the agreement Gene Logic will receive success-based milestones and royalties similar to those paid for development-stage in-licensing deals. Gene Logic also has the option gain exclusive license to any drug candidate it identifies that Merck Serono chooses not to develop. If Gene Logic obtains such a license, Merck Serono would be entitled to receive success-based milestone and royalty payments.
Gene Logic's Drug Repositioning Program offers the potential for pharmaceutical partners to bolster their pipelines with high-quality drug candidates that originated from their own R&D efforts. The program evaluates drug candidates for potential use across a wide range of disease indications by applying a diverse set of drug discovery technologies.
Charles L. Dimmler, III, Gene Logic's chief executive officer and president, said, "Merck Serono is a world leader in reproductive health and has strong market positions in several other therapeutic areas. We look forward to applying our Drug Repositioning Program to complement their internal efforts to determine new uses for their clinical-stage, de-prioritized drug candidates. Our partnership with Merck Serono is our seventh drug development agreement, further substantiating the industry's recognition of our systematic approach to identifying novel therapeutic indications for drug candidates."
Posted on August 24, 2007 @ 07:55 am
MedImmune has opened a new, state-of-the-art pilot lab facility at its Gaithersburg site headquarters. The facility features the latest equipment and process automation systems and will support the company's clinical product pipeline with additional capacity and flexibility.
MedImmune, David M. Mott, president and chief executive officer, stated, "Completing this new facility is an important milestone, signaling our continued growth and success as a world-class biopharmaceuticals company. The opening of this facility, alongside the expansion work underway on our new biologics facility in Frederick, Maryland, reaffirms our leadership role within the state's biotechnology industry and demonstrates our ongoing commitment to the region."
The new pilot lab's 5,000 liters of bioreactor capacity increases production capabilities four-fold. The expanded facility enables the company to produce clinical trial materials at a greater scale and in larger quantities, helping with the testing of potential new products.
"This substantial increase in MedImmune's clinical production infrastructure supports our robust pipeline of product candidates," said Gail Folena-Wasserman, Ph.D., senior vice president, development. "The pilot lab facility is intended to meet our current and future needs, not just through its increased capacity but also through design flexibility, which efficiently allows us to produce multiple clinical products in the same space. We can drive efficiency and meet rigorous quality standards by incorporating the latest technology, including an advanced process control system."
Posted on August 24, 2007 @ 07:53 am
Bengt Danielsson, M.D., Ph.D., has been appointed vice president,
PharmaNet Consulting. He joins the company from the Swedish Medical Product Agency where he served as scientific director/professor in pharmacology and toxicology for the past three years. During that time he also served as a member and the EU Pharmacology and Toxicology representative of the EMEA/CHMP Innovative Medicine Task Force group and a member and Swedish representative of the CHMP/EU Safety and CHMP/EU Cell-based Products working parties. Dr. Danielsson previously worked for Astra AB and AstraZeneca where he served as global director, clinical interface support and global science leader, reproductive toxicology.
"We are extremely pleased to have someone of Dr. Danielsson's stature join PharmaNet Development Group," commented Dr. James Burns, senior vice president, PharmaNet Consulting. "He adds to an already impressive team of experts in our drug development consulting practice, which includes a number of senior former-FDA officials, and will bring significant technical and regulatory experience to assist our clients who are developing products in Europe."
Posted on August 23, 2007 @ 09:22 am
Pro-Pharmaceuticals, Inc. has retained
Camargo Pharmaceutical Services to provide strategic regulatory support for the company’s 505(b)(2) submissions for Davanat with the FDA. Camargo’s regulatory support includes the preparation and submission of NDAs, aNDAs, and 505(b)(2) NDAs to help expedite the regulatory submission and approval process for clients.
"Our goal is to get Davanat to market in a timely manner with multiple chemotherapy drugs," stated David Platt, Ph.D., chief executive officer, Pro-Pharmaceuticals, Inc. "We submitted pre-clinical and clinical data to the FDA that demonstrates Davanat improves 5-FU. In other preclinical studies, Davanat also improved activity of FDA-approved chemotherapeutics, such as Irinotecan, Oxaliplatin, Cisplatin, Avastin, Taxol and Doxorubicin.”
The company has submitted data to begin 505(b)(2) filings for Davanat as a functional excipient to be co-administered intravenously with 5-FU to treat cancer. The functional excipients are important as a drug target delivery to reduce toxicity and/or increase efficacy.
Posted on August 23, 2007 @ 09:20 am
Cephalon, Inc. has signed an agreement to acquire the North American rights to Amrix (cyclobenzaprine hydrochloride extended-release capsules) from
ECR Pharmaceuticals for $100 million cash. ECR is eligible to receive future cash payments based on the achievement of certain milestones.
The FDA approved two dosage strengths of Amrix (15 mg and 30 mg) in February 2007 for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Cephalon expects to launch the product in the U.S. early in the fourth quarter.
"Amrix is an excellent strategic fit with our current sales organization, providing us with a second product that is complementary to many pain relievers used today," said Robert Roche, executive vice president, Worldwide Pharmaceutical Operations. "Cyclobenzaprine HCl is the most widely prescribed muscle relaxant in the U.S., representing 37% of the 45 million prescriptions for muscle relaxants written in 2006, according to IMS. Amrix has convenient once-daily dosing and a side effect profile that includes very low rates of sedation which will provide physicians and patients an attractive alternative to current therapies."
Posted on August 23, 2007 @ 09:17 am
GPC Biotech AG is restructuring and will reduce its U.S. staff by 46 employees (approximately 15%) with reductions in the commercialization, drug development and general and administrative groups. The company also announced that Martine George, M.D. will succeed Marcel Rozencweig, M.D. as senior vice president, drug development and chief medical officer and will assume leadership of the company's drug development team. Dr. Rozencweig will assume the position of senior vice president, clinical science and drug evaluation to focus on new drug development in-licensing opportunities.
Bernd R. Seizinger, M.D., Ph.D., chief executive officer, said, "The decision to reduce staff has been a very difficult one to make, particularly since we have been able to build and grow such stellar teams. However, these decisions were necessary as we focus on moving the company forward and planning for our future."
Dr. Seizinger remarked that GPC will "intensify efforts to in-license promising compounds" and also plans to re-file its NDA for cancer treatment satraplatin.
Dr. George joined the company as senior vice president, clinical development in the spring of 2006 with more than 15 years of experience at major pharmaceutical companies, as well as several years in an academic position as a medical oncologist. Prior to joining the company, Dr. George was senior vice president, head of oncology at Johnson & Johnson Pharmaceutical Research and Development. Previously, she held a number of executive positions in the areas of clinical and medical affairs, including at Rhone-Poulenc Rorer (now part of Sanofi-Aventis), Sandoz Pharmaceuticals (now Novartis) and American Cyanamid (now Wyeth).
The company plans to reduce certain ongoing activities and will halt further financial commitments to its 1D09C3 monoclonal antibody and cell cycle inhibitors programs. The company plans to continue ongoing satraplatin trials, including the SPERA expanded access program.
Posted on August 22, 2007 @ 09:33 am
Frank A. D'Amelio has been named senior vice president and chief financial officer of
Pfizer, effective in mid-September. Mr. D'Amelio is a senior executive with almost three decades of operating and financial experience at AT&T, Lucent Technologies and Alcatel-Lucent, including serving as chief operating officer and chief financial officer at Lucent.
Mr. D'Amelio is currently senior executive vice president, integration and chief administrative officer at Alcatel-Lucent. He will join Pfizer's executive leadership team and report to Jeff Kindler, Pfizer's chairman and chief executive officer. He will have responsibility for all aspects of the company's finances, including treasury, tax, the controller's division and investor development. He succeeds Alan Levin, who announced plans to retire from Pfizer in May.
"We are very pleased that an executive with Frank's skills, integrity, global experience and proven leadership is joining our management team," said Mr. Kindler. "Through almost three decades . . . Frank was a senior executive in global companies undergoing the kind of rapid and complex changes we have undertaken at Pfizer in response to our own rapidly changing markets.
Mr. D'Amelio began his career in 1979 at AT&T Bell Labs, where he held various financial, accounting and general management positions. He also served as vice president and chief financial officer of Lucent's Network Systems Business and in 1996, he helped establish the financial structure of the new Lucent company. Prior to being named executive vice president, administration and chief financial officer of Lucent in May 2001, Mr. D'Amelio was group president of Lucent's Switching Solutions Group, where he led the manufacturing, R&D, marketing and product management of Lucent's switching, access and applications software businesses.
In early 2006 Mr. D'Amelio was appointed Lucent's chief operating officer, responsible for leading the operations of the business including sales, the product groups, the services business, the supply chain, IT operations and labor relations. After Lucent merged with Alcatel later in 2006, Mr. D'Amelio was appointed senior executive vice president, integration and chief administrative officer.
Posted on August 22, 2007 @ 09:31 am
Pfizer broke ground on a $50 million expansion at its Chesterfield campus that reflects the company's increased investment in biopharmaceuticals. The expansion doubles the size of a pilot plant that produces protein-based, injectable biologic drugs for clinical trials.
"We're relative novices at this, but we've got some really exciting things early on in the pipeline," said John LaMattina, Pfizer's outgoing head of global R&D. Pfizer currently has four biologics in Phase I trials, eight in Phase II, and a lung cancer treatment that is advancing into Phase III trials.
The expansion includes the addition of fermenters, bioreactors and other equipment used to grow, purify and isolate proteins. The site will enable the company to increase quantities of a single biologic needed for later-stage clinical trials, and to work on more projects simultaneously. The facility is expected to be operational by mid-2010.
Jeff Kindler, Pfizer's president and chief executive, commented that small molecules remain Pfizer's core strength. "But we believe biologics offer significant, promising R&D opportunities that we need to pursue, and we are intent on doing so," he said. "We're looking at various ways to really jump-start our activities in that area."
Posted on August 22, 2007 @ 09:29 am
Hugo Stephenson, M.D. has been appointed president of iGuard, for
Quintiles Transnational Corp., effective immediately. Dr. Stephenson will lead the company's new service that offers personalized safety information and alerts to patients taking prescription drugs. He reports to Stephen DeCherney, M.D., senior vice president and chief innovation officer.
Dr. Stephenson previously served as senior vice president of Quintiles' strategic research and safety services since 2003. Dr. Stephenson was the founder of Health Research Solutions, an Australian strategic research service provider acquired by Quintiles in 2002. He has a particular interest in strategic epidemiology and risk management, and he works closely with senior industry strategists to promote the use of strategic research activities to support advances in pharmaceutical research.
"We're capitalizing on Hugo's expertise in the area of risk management and the demand for consumer involvement in monitoring the safety of drugs that are on the market," said Dr. DeCherney.
Posted on August 21, 2007 @ 08:53 am
ImClone Systems, Inc. received approval from the FDA for a second facility to manufacture Erbitux. This new 250,000-sq.-ft. multi-suite manufacturing facility, referred to as "BB50", more than doubles the company's total production capacity for Erbitux.
"The FDA approval of BB50 represents the culmination of ImClone's efforts over the last several years to establish this state-of-the-art facility. This now provides us with a great deal of strategic and operational flexibility in pursuing additional commercial opportunities going forward," said Richard P. Crowley, senior vice president, biopharmaceutical operations of ImClone Systems. "Together, our two manufacturing facilities provide us with the capacity to produce Erbitux and future products for worldwide development and commercialization, and serve to support our initiatives for the long-term growth and success of ImClone."
Construction of BB50 was completed in 4Q2005. This facility is designed to contain three distinct suites with a total future production capacity of as much as 110,000 liters. The initial validation of one of the suites was completed during 2Q2006 at which point the company began producing Erbitux. The other two suites at this facility will enable the company to produce Erbitux, ImClone products, or third-party products under contract manufacturing agreements, down the road. Both BB50 and BB36 are located on ImClone's Branchburg, N.J. campus.
Posted on August 21, 2007 @ 08:50 am
MPI Research has appointed
David Serota, Ph.D., DABT to the position of vice president, toxicology and pathology, as well as a member of the company's senior management team, and
Tina Rogers, Ph.D., DABT joined the company as the associate director of research.
Dr. Serota will oversee more than 60 study directors and serve as the senior principal study director on several critical ongoing testing programs. He has more than 31 years of experience and previously served as the director of toxicology at Southern Research Institute and as director of laboratory operations at Hazleton Laboratories Vienna (now Covance). Most recently, Dr. Serota was the executive director of toxicology and senior study director at MPI Research.
"Dr. Serota's experience and innovation have set a performance precedent at MPI Research. He has played a key role in our capacity expansion projects, which have allowed us to provide our sponsors with the timely study starts they need to keep their projects moving forward. In fact, our Sponsors often actively seek his expertise," said Jim Laveglia, Ph.D., executive vice president and director of research at MPI Research. "With Dr. Serota leading our toxicology and pathology efforts, our Sponsors can look forward to continued service enhancements and operational excellence."
In her new role, Dr. Rogers will lead initiatives to enhance the targeted discovery research offerings at the company, focusing on biotherapeutics, including viral and other gene vectors as well as cell therapy. She will also concentrate on advancing specialized services and capabilities in other key areas of the company. She has more than 15 years of experience in the CRO industry and has held key leadership positions, including vice president of drug development at Southern Research Institute.
"Dr. Rogers is a knowledgeable leader with proven business acumen," said Dr. Laveglia. "Her unique combination of credentials and experience will only further strengthen our research team and efforts to provide Sponsors with timely, top-quality, and cost-effective preclinical drug development services."
Posted on August 21, 2007 @ 08:48 am
Abraxis BioScience, Inc. and
The Scripps Research Institute (TRSI) have entered an exclusive licensing agreement for the worldwide development and commercialization of an epothilone therapeutic for the treatment of cancer. Epothilones are a new class of microtubule-stabilizing agents, which bind to the tubulin pathway to inhibit the growth and proliferation of cancer cells.
Under the terms of the agreement, Abraxis has rights to eleven potential drug candidates for preclinical evaluation and selection of a lead candidate for clinical development. Financial terms of the agreement were not disclosed.
Abraxis will evaluate TSRI's epothilones using its nab technology platform, which uses the natural properties of the human protein albumin to transport and deliver therapeutic agents to the site of disease. The nab platform eliminates the need for toxic solvents such as Cremophor EL, which allow the administration of the anticancer agent into the bloodstream. Serious side effects have been associated with the use of solvents.
"We are excited to enter into this exclusive agreement with TRSI, which enables Abraxis to expand its rapidly growing oncology pipeline with the addition of a novel epothilone therapy," said Neil P. Desai, Ph.D., vice president of research and development at Abraxis BioScience. "Abraxis is committed to the development of progressive cancer therapeutics and we look forward to initiating studies to evaluate this new class of cancer agents with our nab platform."
"Our preliminary research suggests the epothilones targeted for development by Abraxis BioScience are some of the most potent agents in this new class of drugs," said K.C. Nicolaou, Ph.D., chair, department of chemistry at TRSI. "Abraxis has a strong track record in the development and commercialization of cancer therapeutics. We are excited about our collaboration, which will enable further study of these novel epothilone agents."
Posted on August 20, 2007 @ 02:07 pm
Enzon Pharmaceuticals, Inc. is selling 25% interest in its royalty from PEG-INTRON, marketed by Schering-Plough Corp. for $92.5 million to
Drug Royalty Corp., Inc. (DRC). Enzon is also eligible to receive an additional one-time milestone payment of $15 million in 2012 if certain royalty recognition levels are met for PEG-INTRON. Enzon will retain a 75% interest in the PEG-INTRON royalty, as well as 100% of their other current royalties and any new royalties the company receives. Enzon plans to use a portion of the proceeds for repayment of outstanding debt due in 2008.
"Today's announcement is a result of a thorough and comprehensive evaluation of our options to extinguish our debt due in 2008," said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. "This transaction now fully removes any risk associated with repayment of the 2008 convertible note, and allows Enzon to continue to focus on its goal of building an innovative oncology company."
Enzon currently earns royalties on three marketed products that use its PEGylation platform: PEG-INTRON, Pegasys, and Macugen.
PEG-INTRON is a PEG-enhanced version of Schering-Plough's alpha interferon product, INTRON A, which is used both as a monotherapy and in combination with Rebetol (ribavirin) capsules for the treatment of chronic hepatitis C.
Posted on August 20, 2007 @ 09:12 am
Alphora Research, Inc. has invested in a new pilot plant facility in an effort to increase its range of services. The company recently expanded to include a 14,000-sq.-ft. facility. The cGMP pilot plant is currently under construction and is expected to be finished by the end of the year. This facility includes 200L and 400L glass lined reactors, with temperature ranges of cryogenic (-80C) to 200C, as well as support process equipment. Support functions will include warehousing and quality control capabilities.
The company currently operates a cGMP Kilo lab facility, which has completed a number of clinical stage projects, and is currently validating one product for commercial supply. The new pilot plant will allow the company to supply larger quantities of clinical API materials and niche commercial products.
Alphora’s operations include synthetic laboratories, analytical laboratories, cGMP stability studies and cGMP kilo laboratories.
Posted on August 17, 2007 @ 08:32 am
Nexgen Pharma, Inc. has acquired certain assets of
The Chemins Company, Inc. located in Colorado Springs, CO. The acquisition includes 250,000 sq. ft. of manufacturing, laboratory and warehouse/distribution space.
Gary Korngold, Nexgen's executive vice president, stated, "This acquisition represents an exciting opportunity for Nexgen Pharma. We have not only expanded our capacities, but also our dosage form capabilities. The result will be increased offerings to the industry and the ability to meet the increased demands for our products and services."
Nexgen Pharma manufactures pharmaceutical and nutritional products and offers solid dose, powder or liquid pharmaceuticals, medical foods, OTC drugs and dietary supplements. The company has five facilities located in Irvine, CA, Tempe and Phoenix AZ, Colorado Springs, CO and Columbia, MO.
Posted on August 17, 2007 @ 08:28 am
ARTEC, Inc. has made key appointments with the goal of initiating the production and global distribution of Tubercin and related immunostimulant medicines.
"R&D of Tubercin is complete, requiring no further refinement or alteration in terms of its formulation. Our new business associates are joining ARTEC, Inc. in order to stimulate and enforce the production of this potentially promising immunostimulant to combat HIV and Cancer," said Dr. Ronald Shinn, president and chairman of the board of directors of ARTEC. "Our board members will utilize their experience in the areas of product enterprise, contract negotiations and strategic investments to insure that the production and distribution of Tubercin will develop in a way that is internationally accessible while remaining affordable."
George E. Williams, Jr., has been appointed as director. He previously served as vice president of Hana Security Services, a company that provides civilian personnel for the U.S. Department of Defense throughout the U.S. Mr. Williams is also an experienced negotiator in working with governmental contracts throughout the world.
Rodney Watson has been appointed coordinator for ARTEC, South Africa. Mr. Watson was previously business manager for Innovative Investment Holding PPY in Johannesburg, Republic of South Africa. He is a successful business leader in South Africa along with other areas of Africa, responsible for overseeing large acquisitions and activating the funding of state-of-the-art technology projects.
Cecil Thompson will serve as coordinator for ARTEC, Bahamas. He is currently president of Certified Consultants, Inc. Mr. Thompson brings an expertise in property development funding, mining and new business ventures.
Gerry Knight, executive vice president of the company has been appointed as coordinator for the funding of special projects and will focus on the development of the South Africa and Bahamas operations.
Posted on August 17, 2007 @ 08:26 am
Schwarz Pharma, a subsidiary of
UCB, submitted a MAA to the EMEA for Vimpat to treat diabetic neuropathic pain and it has been accepted for review.
Vimpat is an anticonvulsant drug with a novel dual mode of action acting on CRMP-2 (collapsing response mediator protein 2) and sodium channel slow inactivation. Diabetic neuropathic pain is a common chronic pain syndrome from which approximately eleven million people with diabetes suffer. Neuropathic pain is caused by damage to a peripheral or central nerve and can lead to spontaneous sensations of pain.
An application for marketing approval for Vimpat as an adjunctive therapy for adult patients with epilepsy with partial onset seizures was accepted for review by the EMEA in May 2007. The company plans to file for approval in the U.S. in 4Q2007.
Also, clinical studies with lacosamide in additional indications such as fibromyalgia, osteoarthritis and migraine prophylaxis, have been initiated, with first results expected in 2008.
Posted on August 16, 2007 @ 09:20 am
Amgen plans to reduce its headcount by 12-14% or 2,200-2,600 staff in an effort to "create operational efficiencies" and support R&D investments. These initiatives, expected to yield savings of between $1 billion - $1.3 billion in 2008, are in part, due to lower Aranesp sales. Restructuring charges are expected to be $600 - $700 million in 2007 and 2008, which includes $289 million for asset impairment and related costs reported in the second quarter.
With the restructuring, the company plans to improve its cost structure by reducing capital expenditures by approximately $1.9 billion during 2007-2008; closing certain production operations and rationalizing other facilities improve efficiencies; and determining the highest R&D priorities for future growth.
"At Amgen we have always been committed to investing in the future while squarely facing the challenges of today," said Kevin Sharer, Amgen's chairman and chief executive officer. "Recent changes in coverage rules and adjustments to Amgen's FDA approved labels for Epogen and Aranesp have and will adversely affect Amgen's revenue. These initiatives respond to that new reality by taking account of reduced revenues and appropriately lowering costs across the company. We will continue to strongly support our research efforts directed at development of new medicines for grievously ill patients. These changes will also position Amgen for success in 2008 and beyond."
Posted on August 16, 2007 @ 09:17 am
Cell Therapeutics, Inc. will acquire Zevalin, the first FDA-approved radioimmunotherapy, from
Biogen Idec. CTI will be responsible for marketing, sales, and development of the drug in the U.S. The drug will continue to be sold outside the U.S. by Bayer Schering under a previous agreement with Biogen Idec. Zevalin was approved by the FDA in 2002 to treat patients with relapsed indolent non-Hodgkin's lymphoma (NHL). In 2006, Biogen Idec reported $16.4 million in Zevalin sales in the U.S.
Under the terms of the agreement, CTI will pay Biogen Idec $10 million in cash, as much as $20 million more in milestone payments when the product receives approval for a first-line indication in NHL, and royalties on sales. CTI has also agreed to share the cost of certain clinical trials of Zevalin with Bayer Schering. The acquisition is subject to certain closing conditions.
"Zevalin is an effective yet underutilized drug with a favorable tolerability profile, producing high rates of complete response coupled with long-term remissions, all following just a single therapeutic dose," said Jack W. Singer, M.D., chief medical officer of CTI. "We believe the potential cost savings and practice efficiencies compared to standard combination chemotherapy will become increasingly attractive to oncology group practices in the ever-evolving reimbursement environment. We are currently planning to conduct registration-directed trials to expand the label into first-line treatment in both the aggressive and indolent NHL settings," Dr. Singer noted.
"Acquiring Zevalin returns CTI to a select group of biotech companies who market and sell a commercial product in the U.S. We see potential for substantial revenue growth for this product with additional clinical data and increased patient and physician knowledge about its potential in treating patients with NHL," said James A. Bianco, M.D., president and chief executive officer of CTI. "Importantly, in addition to the untapped revenue potential for Zevalin, it is an excellent complement to pixantrone, which is in phase III trials in similar patient populations. Ensuring this important cancer treatment remains available to patients fits into CTI's mission of making cancer more treatable."
Posted on August 16, 2007 @ 09:16 am
Pharmatek Laboratories, Inc. has added cytotoxic and high-potent drug development capabilities to its pharmaceutical chemistry development services. These services include: analytical method development, preformulation testing, formulation development, manufacturing for early phase clinical trials, release testing, and stability testing and storage.
"This expansion was driven by an increase in demand for cytotoxic and high-potent drug development and manufacturing outsourcing among our clients," said Dr. Jeffrey Bibbs, chief executive officer of Pharmatek. "This added capability enables us to provide a broader level of services to our clients with cytotoxic and high-potent candidates."
The company's cytotoxic and high-potent development services will take place in a separate dedicated facility. Manufacturing capability includes two validated and licensed class 100,000 high-containment suites designed with barrier technology for cGMP manufacturing of final form drug products, with dedicated HVAC and HEPA filtration systems to ensure product containment within the suites.
Posted on August 15, 2007 @ 09:27 am
Millipore Corp. expanded its agreement with
Novo Nordisk to provide recombinant human insulin, a key cell culture supplement used to manufacture biologic drugs.
Under the terms of the agreement, Millipore will have exclusive worldwide rights to market and sell Novo Nordisk's recombinant human insulin, branded by Millipore as Incelligent SG and Incelligent AF, for cell culture media applications. Incelligent is an insulin product used in the production of several biologic drugs on the market. The two insulin products are manufactured in separate and independent facilities offering greater supply chain security, according to the company.
Cell culture supplements are products that help engineered cells to efficiently produce the proteins that are the basis of biologic drugs. Incelligent is available in a standard grade as well as an animal-free version that uses no animal-derived products in its manufacturing process, which helps to ease regulatory concerns for biopharmaceutical manufacturers.
The current long-term supply agreement between the two companies was extended for several years, ensuring that biopharmaceutical manufacturers will have a guaranteed, secure supply of insulin to use in the production of biologic drugs and the development of new cell lines.
Posted on August 15, 2007 @ 09:26 am
Michael Troullis has been named chief financial officer,
Quintiles Transnational Corp., effective immediately. Mr. Troullis had been acting chief financial officer for the past year. He will report to Dennis Gillings, CBE, chairman and chief executive officer of Quintiles Transnational.
Mr. Troullis joined the company in 1992 as director of finance, Europe. Prior to his appointment as acting chief financial officer, he was senior vice president and worldwide controller. Prior to joining the company, Mr. Troullis had a 10-year career with CooperVision, where he held several positions of increasing responsibility, finally as European finance director; and six years with KPMG in the UK.
"Mike's financial expertise and deep knowledge of Quintiles and our markets make him the best person to be the fourth CFO in Quintiles' 25-year history," said Mr. Gillings. "He has helped put in place the financial systems and controls needed to support Quintiles' growth from a small CRO to being the global leader in helping companies bring medicines to market faster and more efficiently."
Posted on August 15, 2007 @ 09:24 am
The FDA has accepted for review
GlaxoSmithKline's BLA for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age. The rotavirus candidate vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain.
The BLA for the rotavirus candidate vaccine includes data from clinical trials conducted in the Americas, Europe, Asia and Africa in nearly 75,000 infants.
The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination against rotavirus to prevent rotavirus gastroenteritis with the vaccine currently licensed by the FDA at two, four, and six months of age.
Posted on August 15, 2007 @ 09:23 am
Sancilio & Company, Inc. is expanding the analytical services offered through its FDA and DEA registered cGMP analytical chemistry lab at SCI's Riviera Beach, FL location.
Dr. Nealie Newberger, formerly of the Analytical Services Lab at SCI, is heading up business development efforts. Dr. Newberger has worked for such groups as Wyeth Ayerst Research and Vital Pharma, Inc. She obtained her Ph.D. in chemistry while working with the Marine Natural Products Group at Florida Atlantic University.
"Our team is known as the 'fire fighters' of the industry, and are ready to help pharmaceutical researchers and developers deal with the most challenging situations," said Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of Sancilio & Co. "We specialize in stability testing, shelf-life determination and trending, method development, verification and method validation. Our organization offers expert laboratory analysis using modern equipment, highly sophisticated SOPs, and a professional staff second to none. Data interpretation is performed by veterans of the industry with over 30 years of experience at executive levels. Our automated lab will report data back to the SCI client in less than 72 hours of receipt of samples using HPLC, GC, Dissolution, FTIR or TOC analysis," concluded Dr. Sancilio.
Posted on August 14, 2007 @ 08:41 am
Icagen, Inc. has entered into a worldwide collaboration and licensing agreement with
Pfizer for the discovery, development and commercialization of ion channel-focused therapeutics for pain and related disorders. The two companies will combine resources to identify compounds that target three ion channels. Pfizer will fund all aspects of the collaboration including the research and preclinical development efforts at Icagen and will have exclusive worldwide rights to commercialize products that result from the collaboration. Also, in connection with the collaboration Pfizer will make an equity investment in Icagen.
The ion channel targets included in the collaboration are important in the generation of electrical signals in nerve fibers that cause pain. In preclinical studies, compounds identified by Icagen have demonstrated efficacy in pain models.
"We are enthusiastic about entering into this collaboration with Pfizer," said P. Kay Wagoner, Ph.D., president and chief executive officer of Icagen. "By combining one of our multi-target ion channel pain programs with similar programs at Pfizer, we believe that together our scientific teams will be well positioned to capitalize upon this exciting therapeutic opportunity. Given that there are three different ion channel targets in the collaboration, we believe that there is a possibility for at least three unique products to emerge from this joint effort."
Under the terms of the agreement, Pfizer will provide $38 million to Icagen during the first two years of the collaboration, including an upfront license fee of $12 million, as much as $15 million through an equity commitment, and R&D funding. Icagen is also eligible to receive $359 million in research, development, regulatory and commercialization milestones for each product, as well as royalties.
Posted on August 14, 2007 @ 08:37 am
EPIX Pharmaceuticals, Inc. has earned a $3 million milestone payment under its collaboration with
GlaxoSmithKline related to the first of three discovery stage programs. EPIX has identified three lead candidates that will move forward into lead optimization in this first G-protein coupled receptor (GPCR) discovery program.
The two companies entered the multi-target collaboration in December 2006 to discover, develop and market medicines targeting four G-protein coupled receptors (GPCRs) for the treatment of a variety of diseases. The alliance includes EPIX's 5-HT4 partial agonist program and PRX-03140, which is in early-stage clinical development for the treatment of Alzheimer's disease. As part of the collaboration, EPIX received total initial payments of $35 million, including $17.5 million through the purchase of its common stock, and may be eligible to earn as much as $1.2 billion in milestones across the four GPCR programs. EPIX is also entitled to receive royalties on all product sales resulting from the collaboration. The alliance is conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).
"We are extremely pleased with the progress of our collaboration with GSK," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "In addition to our joint focus on developing PRX-03140, our proprietary 5-HT4 agonist, for the treatment of Alzheimer's disease, EPIX and GSK have agreed upon the three discovery program targets and are making significant progress on each program. We are on-schedule and expect to continue moving forward to achieve key milestones across all of our collaborative programs."
"We have been impressed by the quality and efficiency of the lead identification process for this collaborative effort between EPIX and GSK," said Hugh Cowley, M.D., head of GSK's CEEDD. "In addition to the PRX-03140 program in Alzheimer's disease, we are moving forward with EPIX to discover and develop GPCR candidates for the treatment of a variety of diseases. This marks an initial milestone in what we expect will be a long and productive collaboration."
Posted on August 14, 2007 @ 08:34 am
Dr. Hans Van Bronswijk has been appointed to the position of principal consultant for
Parexel Consulting in its European Drug Development Practice. In this role, Dr. Van Bronswijk will advise clients on all aspects of clinical development and regulatory affairs with his in-depth knowledge of drug development and European Union (EU) regulatory procedures.
Dr. Van Bronswijk served on the Dutch Medicines Evaluation Board (MEB) for nine years as head of clinical assessment and was the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) member representing The Netherlands for six years. Dr. Van Bronswijk's experience also includes various positions within Novartis, most recently as global head of regulatory affairs for the transplantation and immunology business unit.
"We expect that Parexel clients will benefit from Dr. Van Bronswijk's internationally recognized drug development expertise and his unique combination of pan-European regulatory, medical, scientific, and pharmaceutical industry experience," said Dr. Alberto Grignolo, corporate vice president, Parexel Consulting. "This appointment reinforces our leadership in helping clients achieve successful international product registrations, clinical and manufacturing performance excellence, and product safety."
Posted on August 13, 2007 @ 10:55 am
Patrick P. DeLuca, Ph.D., professor in the faculty of Pharmaceutical Sciences at the University of Kentucky College of Pharmacy, has been elected to serve as president-elect of the American Association of Pharmaceutical Scientists (AAPS), based in Arlington, VA. He will begin his term in November of 2007 at the AAPS Annual Meeting in San Diego, CA.
AAPS executive director, John Lisack, Jr., commented, “Dr. DeLuca has been deeply involved in the association and there is no doubt in my mind that his presidential term will more than live up to the standard of excellence that has been established by his predecessors.”
As president-elect, Dr. DeLuca will join 2008 president Karen Habucky, Ph.D.; Former president Gene Fiese, Ph.D.; Treasurer, Phil Mayer, Ph.D.; and John Lisack, Jr. on the executive committee of the AAPS executive council.
Also, Peter A. Crooks, Ph.D. and David Y. Mitchell, Ph.D., have been elected to three-year terms as AAPS members-at-large. They join Robert G. Bell, Ph.D., Patrick J. McNamara, Ph.D., and Janet C. Walkow, Ph.D. as the remaining members on the 2008 AAPS executive council.
Posted on August 13, 2007 @ 08:51 am
Roche has filed an IND with the FDA for a
Genmab antibody developed under the companies' collaboration. Genmab will receive a milestone payment from Roche.
Under the agreement with Roche, Genmab uses its antibody expertise and development capabilities to create human antibodies to a range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products. Genmab may also obtain rights to develop products based on disease targets identified by Roche. Genmab stands to receive as much as $100 million plus royalties if all goals are reached.
"This will be the second antibody produced under our collaboration with Roche to enter the clinic and Genmab's seventh antibody to enter clinical development overall," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "Our partnership with Roche continues to bear fruit and add value to Genmab's expanding product pipeline."
Posted on August 13, 2007 @ 08:50 am
Timothy Forsey, Ph.D. has been appointed principal regulatory affairs consultant at
Kendle, specializing in providing regulatory affairs guidance to biotechnology customers. He will be based in the Ely, Cambridgeshire office in England and will work with customers to gain regulatory approval for marketing authorizations. Dr. Forsey will provide customers with advice on strategy and regulatory approaches to development and assist them with dossier preparation.
"As biotechnology's overall contribution to the healthcare arena continues to grow, so will the demand for outsourcing services, as new therapies move from preclinical to the clinical phases of drug development," said Melanie Bruno, Ph.D., vice president global regulatory affairs and quality. "Tim Forsey's experience with this customer group and in the regulatory environment will be a tremendous asset to our biotech and pharmaceutical customers seeking to move their new compounds from discovery to market approval," she added.
Dr. Forsey previously served as head of biologicals and the biotechnology unit for The Medicines and Healthcare products Regulatory Agency (MHRA), where he represented the UK on the Biologics Working Party of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA). He also worked as senior director, head of European regulatory affairs for Shire Human Genetic Therapies, Ltd. Prior to that, he worked for Pharmacia, Amgen, the National Institute for Biological Standards and Control and the University of London. He brings more than 30 years of pharmaceutical, governmental and research experience to his new role at Kendle.
Posted on August 10, 2007 @ 08:36 am
John H. Johnson, formerly of Johnson & Johnson, has been named chief executive officer,
ImClone Systems, effective August 27th. Mr. Johnson has more than two decades of executive and operational management experience in the biopharmaceutical and healthcare industries. He has held senior management positions of increasing responsibility at J&J and most recently served as company group chairman of its worldwide biopharmaceuticals unit, where he was responsible for the biotechnology, immunology and oncology commercial businesses, including Centocor, Ortho Biotech Products and the Worldwide Strategic Marketing Group.
"John has a strong track record in the biopharmaceutical industry and we are happy to have him serving as chief executive officer during this new era for ImClone," said Alexander J. Denner, Ph.D., chairman of the executive committee of ImClone Systems.
Posted on August 10, 2007 @ 08:30 am
Paul Clancy has been appointed executive vice president and chief financial officer,
Biogen Idec. He reports to James C. Mullen, the company's chief executive officer, and most recently served as senior vice president of finance, responsible for leading the treasury, tax, investor relations and business planning groups.
"Paul brings more than 20 years of experience in financial management and strategic business planning," Mr. Mullen said. "In his six years at Biogen Idec, he has repeatedly proven himself to be an effective and valued leader. With Paul's help, we will continue to optimize shareholder value by driving our strategic and operational plans."
Mr. Clancy has held several senior executive positions since joining the company in 2001, including vice president of business planning, portfolio management and U.S. marketing. Prior to joining the company, he spent 13 years at PepsiCo, serving in a range of financial and general management positions.
Posted on August 10, 2007 @ 08:29 am
Bilcare has begun a capital investment project in an effort to enhance its global footprint and increase capacity and capabilities. The company is upgrading its packaging, storage and distribution facilities at its U.S. headquarters in Phoenixville, PA. The initial phase of the project includes an overhaul of each of the company's eight primary and 12 secondary packaging rooms.
The second phase involves the expansion of the company's nearby storage and distribution facility to 72,000 sq.-ft. and the construction of four new secondary packaging rooms. The secondary packaging rooms will be completed this month and the primary packaging rooms are scheduled for completion early in 4Q2007.
"With the sophisticated systems required to manage the production and logistics of clinical trial supplies on a global basis, our expanded and upgraded U.S. facilities combined with our strong foothold in India, UK and Singapore, leave Bilcare well-positioned to take advantage of the trend toward global clinical trials," said Vincent Santa Maria, Bilcare's global clinical services president. "These facility improvements further enhance our distribution, storage and packaging capability, and allow Bilcare to provide a higher level of quality and service to our customers as they conduct clinical trials in the U.S. and throughout Europe and Asia."
Posted on August 10, 2007 @ 08:26 am
Wyeth and
Solvay Pharmaceuticals received a "not approvable" letter from the FDA in response to the NDA for bifeprunox, an atypical antipsychotic for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients.
The FDA stated in the letter that bifeprunox demonstrated effectiveness in its long-term maintenance study and indicated that a second positive maintenance study could be sufficient to support a maintenance claim for bifeprunox. The companies will meet with the FDA to discuss study design and to assess how this additional study, combined with ongoing and planned studies, might support a maintenance indication. The Agency also requested further information regarding human metabolism of bifeprunox, and additional information regarding a patient who died while participating in one of the trials.
"We believe that bifeprunox is a promising drug for the treatment of schizophrenia and that there is a need for new treatment options to help people with schizophrenia manage their disease," says Laurence Downey, M.D., president and chief executive officer of Solvay Pharmaceuticals, Inc. "We will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible."
"The development of bifeprunox offers the possibility of a new treatment approach for patients where maintaining stability is challenged by the metabolic consequences frequently encountered with long-term therapy. We continue to support the development of the compound and the approach," adds Gary L. Stiles, M.D., executive vice president and chief medical officer, Wyeth Pharmaceuticals.
Posted on August 9, 2007 @ 09:54 am
The FDA has issued a "not approvable" letter for
GlaxoSmithKline's sNDA for the 500/50 strength of Advair Diskus for the treatment of chronic obstructive pulmonary disease (COPD). Specifically, the agency questioned how the new dose compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK will be meeting with FDA to discuss this request and determine next steps, including discussion of GSK's recent data on the reduction of exacerbations with the Advair 250/50 strength.
"We are very surprised and disappointed by this FDA decision, particularly given the outcome of the FDA advisory committee meeting earlier this year," said Katharine Knobil, M.D., vice president of respiratory clinical development for COPD at GSK. "The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward."
Posted on August 9, 2007 @ 09:52 am
BASi
3Q Revenues: $12.6 million (26%)
3Q Earnings: $449,000 (loss of $1.8 million 3Q2006)
YTD Revenues: $34.8 million (+8%)
YTD Earnings: $1.1 million (loss of $1.9 million YTD2006)
Comments: Revenue growth was driven by a $2.7 million, or 34%, increase in service revenues, led by improvements in toxicology and clinical research operations. YTD growth was the result of a 10% increase in service revenues. Operating expenses in the quarter were $3 million, a decrease of $1.9 million, and were $8.4 million YTD, down $4.4 million. Expenses in 2006 included $1.3 million in write-downs of asset values at the company’s Baltimore clinic. The remainder of the decrease is the result of job cuts at the beginning of the 2007 fiscal year.
Posted on August 9, 2007 @ 09:44 am
Abraxis BioScience, Inc.
2Q Revenue: $242.5 million (+51%)
2Q Earnings: $23.1 (loss of $90.8 million 2Q2006)
YTD Revenues: $454.7 million (+49%)
YTD Earnings: $34.2 (loss of $88.9 million YTD2006)
Comments: In the quarter, Abraxane revenue was up 116.7% to $78.7 million. The company recently announced plans to separate its proprietary business, Abraxis Oncology and Abraxis Research (ABI), from its hospital-based business, Abraxis Pharmaceutical Products (APP). Until the separation is complete, the company will continue to report in two segments: the ABI segment and the APP segment. ABI segment gross margin for the quarter was 92.2% compared to 86.5% in 2Q2006. R&D expenses were $15.5 million in the quarter up 5% but are expected to be to be in the range of $120 million to $130 million in 2007 as a result of acquisitions, licensing, and collaborations. Hospital-based product revenue for the APP segment in the quarter increased 32.6% to $159.3 million. This includes sales of $36.1 million from the anesthetic/analgesic products acquired from AstraZeneca in June 2006. R&D expenses were $12.9 million for the quarter up from $6 million due to the expense associated with its Puerto Rico manufacturing facility.
Posted on August 8, 2007 @ 09:23 am
Merck and
Neuromed Pharmaceuticals have discontinued development of NMED-160 (also known as MK-6721), a Phase II compound for the treatment of chronic pain. Their joint research collaboration will continue to evaluate other therapeutic candidates.
While no serious adverse events with the drug were observed in clinical trials, it was determined that MK-6721 does not demonstrate the "ideal pharmaceutical characteristics considered necessary to advance the compound further in development," according to a press statement.
"We are encouraged by what we've learned from MK-6721 and are continuing our productive collaboration with Merck with a focus on improving the pharmaceutical properties of our compounds to produce a best-in-class pain treatment," said Dr. Christopher Gallen, president and chief executive officer of Neuromed.
"Merck and Neuromed are committed to the further research and development of oral N-type calcium channel blockers for pain," said Dr. Darryle Schoepp, senior vice president, franchise head, Neuroscience at Merck. "Neuromed is a leader in the field of oral N-type calcium channel blockers and we are pleased with the results of our ongoing collaboration."
N-type calcium channel blockers represent a class of analgesics that are selective for calcium channels involved in pain signal transmission.
Posted on August 8, 2007 @ 09:21 am
Galapagos NV's service division,
BioFocus DPI, has entered into a new drug discovery collaboration with
AstraZeneca, under which BioFocus will perform medicinal chemistry, computational chemistry and support biology and ADMET services for AZ's infection discovery program based in Boston. Total contract value for Galapagos will be $938,000.
This is the third collaboration between the two companies since August 2006. BioFocus DPI is also providing chemistry and supporting biology and ADME services for an AZ hit-to-lead program.
"We now have a global relationship with AstraZeneca, working with several sites based in Europe and the U.S.," said Galapagos' chief executive officer, Onno van de Stolpe. "This type of expansion fits very well with our strategy for growth of the BioFocus DPI service division."
"Our European colleagues have been pleased with the progress of the drug discovery programs ongoing with BioFocus DPI. The decision for our U.S.-based R&D to enter into this collaboration with BioFocus DPI is based on this productivity and the good working relationship between the two companies thus far," added Trevor Trust, vice president - Infection Discovery at AstraZeneca U.S.
Posted on August 8, 2007 @ 09:12 am
Hospira
2Q Revenues: $869.4 million (+29.5)
2Q Earnings: $30.7 million (-43%)
YTD Revenues: $1.7 billion (+24%)
YTD Earnings: $1.3 million (-99%)
Comments: Pharmaceutical contract manufacturing revenues were $36.9 million in the quarter, down 26%, and $78 million YTD, down 23%. 2Q and YTD results include Mayne Pharma integration charges, and charges related to Hospira's manufacturing initiatives. R&D expenses were $52.5 million, up 35% in the quarter and $96 million YTD, up 37%, impacted by acquired in-process R&D related to the acquisition of Mayne Pharma.
Posted on August 7, 2007 @ 10:30 am
Following yesterday's approval of HIV drug Selzentry,
Pfizer chose to issue a statement regarding its clinical pipeline. The company announced that it has 47 active programs in its Phase II R&D pipeline—the largest in its history—and contends this will triple the company's Phase III portfolio by 2009.
"The growth of our Phase II cohort is encouraging progress toward meeting our target for our Phase III portfolio by 2009," said Pfizer's chairman and chief executive officer Jeff Kindler. "With the progress we are seeing in our pipeline, we are also continuing to target having a steady stream of new medicines from our internal R&D, four a year, starting in 2011. Our portfolio is very promising and focused on markets where we see substantial opportunities to meet unmet medical needs with innovative science and technology. We will continue to sharpen the focus and simplify the structure of our R&D organization so that we bring our pipeline forward to commercialization as rapidly as possible and enhance our productivity in all aspects of our clinical work."
According to the company, there are 99 total programs in development: 38 in Phase I, 47 in Phase II, 11 in Phase III and three in registration, awaiting regulatory action. Three compounds have entered Phase III, 14 have entered Phase II, and seven have entered Phase I.
Among the 47 programs in Phase II, 14 compounds were added and four were discontinued in recent months. The Phase II group covers a wide range of therapeutic areas including 20 treatments for cancer; 16 for cardiovascular, metabolic and endocrine diseases; 17 for pain and inflammation; 17 for neurological disorders and 10 for infectious diseases; as well as gastrointestinal, genitourinary, ophthalmology, dermatology and allergy/respiratory. Overall a total of 13 programs were discontinued.
The development pipeline has 14 biologic compounds, including vaccines and antibodies designed to treat cancer, rheumatoid arthritis, influenza and other serious medical conditions. The company is investing to further expand its presence in biologics and hopes to benefit from "certain development opportunities."
The number of Phase I compounds, which recently declined, now stands at 38, reflecting both transfers to Phase II and some attrition. The majority of Pfizer's Phase I compounds are targeted for trials the second half of 2007. New Molecular Entities comprise 85 of the 99 programs, with the remaining 14 covering new indications or enhancements for Lyrica, Geodon, Selzentry, Eraxis and Vfend, among others.
"In the last eight months, we have advanced 27 programs, with the loss of just 13. Our progress is especially gratifying since we are continuing to make major structural and organizational changes while we pursue all of these opportunities. We are revising the allocation of our capital so that we target the areas of greatest medical and commercial promise, and I am confident that you will see Pfizer bring forward significant new therapies to fight cancer, cardiovascular disease, neurological disorders, infections and many other conditions," said John LaMattina, president of Pfizer Global R&D, who announced his plans to retire from the company earlier this year.
Posted on August 7, 2007 @ 10:27 am
Althea Technologies, Inc. has been selected by
GeoVax Labs, Inc., an Atlanta-based biotechnology company, to manufacture its HIV-1 DNA (AIDS) vaccine for GeoVax’s Phase II trials, expected to begin in early 2008.
GeoVax AIDS vaccines are designed to prevent development of Acquired Immunodeficiency Disease (AIDS) caused by the HIV-1 virus by vaccinating individuals prior to the AIDS virus infection. The GeoVax vaccine regimen uses a “prime-boost strategy,” where participants receive the GeoVax HIV-1 DNA vaccine, which “primes” the immune system followed by the GeoVax HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines deliver more than 50% of the AIDS virus components but cannot cause AIDS.
Ongoing trials with GeoVax's preventive HIV/AIDS vaccine have indicated an acceptable safety profile and anti-HIV immune responses in as many as 100% of vaccine recipients.
Don Hildebrand, chief executive officer and president of GeoVax Labs, commented, “We are very pleased with our decision to use Althea as the contract manufacturer for our DNA-AIDS vaccines due to their long and well known expertise in this arena. The manufacturing of these vaccines for GeoVax’s Phase II trials is a very important step forward in our development plan and demonstrates our confidence in the future success of our AIDS vaccine program.”
Posted on August 7, 2007 @ 10:18 am
Integrated Project Services (IPS) broke ground for
RxElite Holdings, Inc.'s new Greenfield headquarters, distribution center and future manufacturing facility located in Nampa, ID. RxElite is engaged in the formulation and manufacture of specialty generic drug products.
The initial six-acre site includes the construction of a 76,000- sq.-ft. building designed to accommodate initial warehousing, new headquarters and distribution. Near and long-term plans allow the growth of the facility to include manufacturing at the new Nampa site, for a total of 230,000 sq.-ft. on 17 acres of land.
"IPS is the ideal partner to help execute RxElite's strategy to develop into a full-service manufacturer of a select group of GMP compliant ANDA drug products," stated Earl Sullivan, executive vice president, RxElite. "The systems we will create will set the platform for a flexible, cost-effective operation that enables both the growth of our top-line while maintaining the highest levels of service to our customers."
"We are very excited about the opportunity to support this major stepping-stone in the life cycle of RxElite," said Dave Goswami, president of IPS. "IPS is providing the technical know-how and expertise to support RxElite's aggressive goals for the design, construction, commissioning and validation of this new facility. We are committed to delivering high performance, technically complex facilities for all of our clients on time and on budget."
Posted on August 6, 2007 @ 01:10 pm
The FDA has approved
Pfizer's Selzentry tablets, the first in a new class of oral HIV medicines in more than 10 years, according to the marketer. Selzentry blocks viral entry into white blood cells, significantly reducing viral load and increasing T-cell counts in treatment-experienced patients infected with a specific type of HIV. Selzentry is expected to be available in the U.S. by the middle of September.
The FDA granted accelerated approval to Selzentry for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. A diagnostic test confirms whether a patient is infected with CCR5-tropic HIV-1, which is also known as "R5 virus."
An accelerated approval allows for earlier approval of drugs that provide a meaningful therapeutic advantage over existing treatment for serious or life-threatening diseases. This approval is based on 24-week data. Longer-term data will be required before the FDA can consider traditional approval for Selzentry.
Selzentry is the first in a class of drugs known as CCR5 antagonists, which block the CCR5 co-receptor, the virus' predominant entry route into T-cells. Selzentry stops the R5 virus on the outside surface of the cells before it enters, rather than fighting the virus inside as do all other classes of oral HIV medicines.
Posted on August 6, 2007 @ 08:54 am
Steven B. Engle has been named president, chief executive officer and a member of the board of directors of
Xoma Ltd. Mr. Engle succeeds
Jack Castello, the company's former president and chief executive officer, who announced his retirement plans earlier this year. Mr. Castello will remain with the company as non-executive chairman of the board during a transition period, expected to run through October of 2007.
"On behalf of the Xoma Board, I couldn't be more pleased that Steve has joined Xoma to serve as the company's next president and chief executive officer," said
Denny Van Ness, a member of Xoma's board of directors who led the succession search. "His leadership experience in our industry, together with his expertise in therapeutic products, operations and corporate development, make him the right person to lead Xoma forward. I am confident in Steve's ability to enhance and execute the company's strategic plan to create value for Xoma shareholders."
Mr. Van Ness added, "I also want to thank Jack Castello for his strong leadership and years of service at Xoma. It is due to his efforts that Xoma is so well-positioned today. We appreciate his many contributions to the company and wish him all the best in retirement."
Mr. Engle has more than 25 years of executive leadership and biotechnology and pharmaceutical industry experience. He previously served as chairman of the board and chief executive officer of La Jolla Pharmaceutical Co. Prior to joining La Jolla, he held executive-level positions at Cygnus Therapeutic Systems and Micro Power Systems, Inc. He began his professional career with the Strategic Decisions Group and the Stanford Research Institute.
Posted on August 6, 2007 @ 08:48 am
Bayer HealthCare and
Nektar Therapeutics have agreed to develop and commercialize NKTR-061 (inhaled amikacin). NKTR-061 is under development for adjunctive treatment of Gram-negative pneumonias that often lead to significant morbidity and mortality. Nektar's proprietary pulmonary technology would be employed to deliver a specially-formulated amikacin, an aminoglycoside antibiotic, for inhalation deep into the lung.
As part of this agreement, Nektar will receive milestone payments of up to $175 million associated with the successful development and commercialization of NKTR-061. This includes an upfront payment of $50 million. Folowing successful clinical and regulatory development of the product, the companies have agreed to co-promote the product in the U.S. and to share profits. For ex-U.S. sales, Nektar will receive tiered performance royalties up to a maximum of 30%.
Under the terms of the agreement, Bayer is responsible for the global clinical development, regulatory strategy, manufacturing and marketing of the product, with Nektar participating in all aspects of decision-making and governance.
"This new development agreement reinforces our commitment to fight infectious and respiratory diseases and is a natural fit with Bayer HealthCare's strategy of developing and marketing specialty pharmaceutical products," said Dr. Ulrich Kostlin, a member of the Bayer's executive committee.
Currently, NKTR-061 is being studied in Phase II trials for the adjunctive therapy of ventilated patients with hospital-acquired, Gram-negative pneumonias. These pneumonias are a serious problem afflicting patients even in the world's most advanced clinical settings and are responsible for a significant number of deaths. Increasingly, multi-drug resistant, Gram-negative bacteria have magnified the problem of hospital-acquired infection. Some 20-50 percent of patients intubated and on ventilators who acquire Gram-negative pneumonia will die. NKTR-061 (inhaled amikacin), if approved, would be administered while the patient is on the ventilator and also would allow for ongoing dosing (transition therapy) after the patient no longer requires ventilatory support.
This is the second collaboration between Bayer and Nektar. In 2005, they agreed to collaborate on the joint development of inhaled ciprofloxacin as a potential dry powder therapy for treating pseudomonal infections in patients suffering from cystic fibrosis.
Posted on August 3, 2007 @ 08:41 am
Thomas B. Smith, M.D. has been named vice president, medical affairs,
Kendle. Dr. Smith will develop and lead the company's new global medical affairs organization, aimed at enhancing delivery of Phase II-IV services worldwide. This team of medical directors will serve as medical and therapeutic advisors to customers in areas such as protocol design, endpoint selection and inclusion/exclusion criteria, providing a resource across the clinical development process in an effort to create efficiencies and maximize opportunities as a compound progresses through study and its lifecycle.
Dr. Smith most recently served as global medical director for Kendle, responsible for providing strategic medical and therapeutic leadership to clinical development projects with a particular emphasis in the Central Nervous System (CNS) therapeutic area.
Dr. Smith joined the company with 20 years of experience in clinical practice and the pharmaceutical industry, including positions as senior director, clinical R&D, at Akros Pharma, medical director, global R&D at Genzyme Corp., and associate medical director, neuroscience global pharmaceuticals R&D, at Abbott Laboratories.
"This move further positions Kendle as a strategic partner for our customers across the clinical development process as they focus on maximizing the therapeutic potential for their compounds," said Candace Kendle, Pharm.D., chairman and chief executive officer. "With an increasing focus on novel drugs like TNF blockers and the multiple therapeutic possibilities these proteins bring, Kendle's Medical Affairs organization will provide a competitive advantage by offering expertise across the full therapeutic spectrum. We are thrilled to have someone of Dr. Smith’s caliber to lead the growth of this valuable resource within Kendle."
Posted on August 3, 2007 @ 08:37 am
Regeneron Pharmaceuticals and
Bayer HealthCare AG initiated a Phase III study of the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD). The study will compare the VEGF Trap-Eye and ranibizumab, Genentech's Lucentis, an anti-angiogenic agent approved for wet AMD. The study will be conducted for the FDA's Special Protocol Assessment (SPA).
The VIEW 1 trial is expected to enroll approximately 1,200 patients in more than 200 centers throughout the U.S. and Canada. The study will evaluate the safety and efficacy of the VEGF Trap-Eye at doses of 0.5 mg and 2.0 mg administered at four-week dosing intervals and 2.0 mg at an eight-week dosing interval, compared to 0.5 mg of Lucentis administered every four weeks.
The primary endpoint of the study is the proportion of patients treated with the VEGF Trap-Eye who maintain or improve vision at the end of one year, compared to Lucentis patients. After the first year of treatment, patients will continue to be treated and followed for another year.
Interim data from the ongoing Phase II trial in wet AMD demonstrated a statistically significant reduction in retinal thickness and improvement in visual acuity after 12 weeks, compared to baseline. There were no drug-related serious adverse events, and treatment with the VEGF Trap-Eye was generally well tolerated.
The two companies are collaborating on the global development of the wet AMD treatment, diabetic eye diseases, and other eye diseases and disorders. Bayer HealthCare will market the VEGF Trap-Eye outside the U.S. and Regeneron maintains exclusive rights to the VEGF Trap-Eye in the U.S.
Posted on August 3, 2007 @ 08:35 am
Dr. Jur Strobos has been appointed chief medical officer of
InNexus Biotechnology, Inc. Dr. Strobos has extensive experience as director of policy research in the office of the Commissioner of the FDA and has a background in drug law, medical product development, and health care. Most recently, he was vice president of clinical research and regulatory affairs for Medicis Pharmaceutical Corp.
His areas of expertise include food and drug law, clinical study design and good manufacturing practices. He has been involved in the success of multiple drugs and devices through the FDA and will be working closely with Dr. Thomas Kindt, InNexus' chief scientific officer and previous director of Intramural Research at the National Institute of Health.
Dr. Kindt said, "Dr. Strobos joins InNexus as we prepare to launch our first pre-clinical development project. His experience is invaluable and his ability to develop our programs and articulate them to the FDA will be a critical aspect of our success."
Posted on August 2, 2007 @ 09:09 am
Genzyme Corp. met its primary and secondary endpoints in a second Phase III trial of Mozobil in multiple myeloma (MM) similar to the recent trial in non-Hodgkin's lymphoma. The combined results of these two trials—in which patients with two types of cancer achieved more rapid and effective mobilization of stem cells in preparation for transplant than patients treated with current therapies—will support the drug's regulatory approval.
The randomized, double-blind, placebo-controlled trial included 302 patients undergoing a hematopoietic stem cell transplant (HSCT) for MM and examined the effectiveness of Mozobil in increasing the number of stem cells collected for a transplant. The trial then compared the stem cell yield from patients treated with Mozobil following G-CSF to patients treated with placebo following G-CSF.
In the primary efficacy endpoint, 72% of patients treated with Mozobil and G-CSF achieved the target threshold for collection, compared with 34% of patients in the G-CSF/placebo group. Like the previous trial, these results exceed the 20% absolute difference prospectively defined through the FDA's SPA as a successful result.
More than half of the patients treated with Mozobil and G-CSF reached the target cells in the first day of apheresis. By comparison, it took four days for a similar percentage of the G-CSF/placebo group to reach this threshold.
Secondary outcomes were consistent with the primary endpoint, showing a statistically significant result in favor of Mozobil. The drug was well tolerated in the trial, with the most common adverse events being mild gastrointestinal effects and redness at the site of injection.
Posted on August 2, 2007 @ 08:49 am
AMRI
2Q Revenues: $49.4 million (+8%)
2Q Earnings: $4.6 million (loss of $353,000 in 2Q2006)*
YTD Revenues: $97.7 million (+10%)
YTD Earnings: $7.8 million (earnings were $1.5 million YTD2006)
Comments: Contract revenue in the quarter was $39.9 million, up 4%. Contract revenue from development and small-scale manufacturing was $10.6 million, up 25%, while large-scale manufacturing revenue was down 5% to $19.6 million. Revenue from discovery services in the quarter was $9.7 million, up 6%. YTD development and small-scale manufacturing revenues were $20.9 million, up 21% and YTD large-scale manufacturing revenues were $40.7 million, up 2%.
*2Q2006 earnings included charges of $2.2 million to reduce the carrying value of the company's former Mount Prospect Research Center.
Posted on August 1, 2007 @ 09:42 am
Johnson & Johnson is restructuring and plans to reduce its global work force by 4% or approximately 4,820
Magazine
