October 2008
Posted on October 7, 2008 @ 09:16 am
Alnylam Pharmaceuticals has earned a $20 million technology transfer milestone from
Takeda Pharmaceutical Co. Ltd. as part of the companies' strategic alliance formed in May 2008. The payment is related to the transfer of Alnylam’s platform technology, including documents, materials, and intellectual property, to Takeda for the development of RNAi therapeutics. Alnylam also received a $100 million upfront payment when the deal was executed. Alnylam is eligible to receive an additional $30 million in technology transfer milestone payments.
“We are excited about the progress we have already made in enabling Takeda with Alnylam RNAi drug discovery capabilities and intellectual property,” said Barry Greene, president and chief operating officer at Alnylam. “We look forward to continuing our efforts in this strategic collaboration which is focused on advancing the development of RNAi therapeutics on a global basis, including Alnylam’s right to co-develop and co-commercialize certain Takeda RNAi therapeutic products in the U.S. market.”
The agreement provides Takeda with worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. It also includes a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi targets. Alnylam has opt-in rights to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S.
Posted on October 7, 2008 @ 09:15 am
Genentech and
Biogen Idec's Phase III study of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL), compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study.
An independent review of the primary endpoint is being conducted for U.S. regulatory purposes. Data from the study, REACH, will be submitted for presentation at a future medical meeting.
"REACH, the largest relapsed CLL trial ever conducted, is the first Phase III study of this treatment combination to show an improvement in progression-free survival for patients," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future.”
"Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy," said Cecil Pickett, Ph.D., Biogen Idec's president of R&D. "The REACH results are promising, and pending confirmation of the results by independent review, we look forward to submitting an application to the FDA for Rituxan’s potential approval in this indication."
Posted on October 7, 2008 @ 09:13 am
Pharmatech Associates has been chosen by Pacific Biopharma Group (PBG) to provide the design for the first FDA- and EMEA-approved biomanufacturing facility to be built in China, which will represent the first reference document reviewed by the FDA as part of any licensure activity in China.
The new 181,000-sq.-ft. facility is a cGMP lab that uses single-use technology throughout the biomanufacturing process. The facility will be located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC). The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects from the California Institute for Quantitative Biosciences (QB3).
“Pharmatech Associates understands every phase of the drug development lifecycle, not just pharmaceutical construction,” said Dr. S. Chang, vice president manufacturing, Pacific Biopharma Group. “Their ability to integrate the critical considerations necessary for international biological market approval is essential to the success of our program in China.”
“We are delighted that PBG chose Pharmatech for this endeavor. The project caters directly to our deep understanding of product development, technology and international compliance,” said Bikash Chatterjee, president and chief technology officer, Pharmatech Associates.
Posted on October 6, 2008 @ 08:48 am
Eli Lilly and Co. and
ImClone Systems have entered a definitive merger agreement under which Lilly will acquire ImClone for approximately $6.5 billion in cash. The acquisition of ImClone supports the Lilly's strategy to increase its focus on biopharmaceuticals and adds oncology therapies Gemzar, Alimta and Erbitux to its biologics pipeline.
The combined companies creates a biopharmaceutical oncology franchise offering targeted therapies and oncolytic agents along with a pipeline spanning all phases of clinical development. The combined oncology portfolio will target various solid tumor types including lung, breast, ovarian, colorectal, head and neck, and pancreatic. The acquisition also expands Lilly's biotechnology capabilities with ImClone's development and commercial manufacturing facility, which will provide flexibility to develop and manufacture complex biomolecules.
"We think very highly of ImClone's ground-breaking work in oncology, particularly its success with Erbitux, a blockbuster targeted cancer therapy, and its ability to advance promising biotech molecules in its pipeline," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "We are excited about the possibilities of improving outcomes for individual patients and building value for shareholders. This transaction will broaden our portfolio of marketed cancer therapies and boost Lilly's oncology pipeline with three promising targeted therapies in Phase III in 2009. By bringing together ImClone's and Lilly's marketed oncology products, pipelines, and biotech capabilities, we are taking a very important step forward in addressing the challenges of patent expirations we will face early in the next decade. We look forward to working with the ImClone team and their partners to ensure a smooth transition."
John H. Johnson, ImClone's chief executive officer, said, "We believe this is an important step forward in ImClone's and Lilly's shared goal of addressing the medical needs of cancer patients around the world. The significant progress ImClone has made over the last few years is a direct result of the important contributions of our employees, and joining forces at this stage of our growth will allow us to leverage Lilly's global capabilities and make even greater advancements in our proprietary pipeline."
Erbitux is marketed by ImClone's two partners, Merck KGaA and Bristol-Myers Squibb. ImClone co-promotes Erbitux in North America with BMS. In 2007, worldwide sales of Erbitux were approximately $1.3 billion.
Posted on October 6, 2008 @ 08:47 am
Perrigo Co. has acquired Laboratorios Diba, S.A. for approximately $25 million in cash. Based in Guadalajara, Mexico, Laboratorios Diba is a store brand manufacturer of OTC and prescription pharmaceuticals, including antibiotics, hormonals and opthalmics. The acquisition is expected to add nearly $15 million of annual sales.
Perrigo's chairman and chief executive officer, Joseph C. Papa stated, "Perrigo has been in the Mexican market for more than 65 years and is the leading supplier of prescription and OTC store brand products there. The acquisition of Laboratorios Diba will enable us to market an additional 150 formulas and 50 trademarks into the rapidly growing Mexican store brand market, saving consumers money on their healthcare options. This further exemplifies Perrigo's commitment to meeting the growing need for quality, affordable healthcare around the world."
Posted on October 6, 2008 @ 08:43 am
Alcan Global Pharmaceutical Packaging has acquired the Chakan flexible packaging plant from Associated Capsules Ltd. in India.
The acquisition expands Alcan's presence in the Indian pharmaceutical market. The Chakan facility has annual sales of $3.6 million and employs approximately 100 people. The integration into the Alcan Packaging group is expected to be completed in early 2009.
"The acquisition of this facility advances our leadership position in pharmaceutical flexibles through growth in emerging markets," said Ilene Gordon, president and chief executive officer, Alcan Packaging.
"Chakan is a well equipped plant with dynamic people and an asset base that will complement our current product portfolio," said Michael Schmitt, president of Alcan Global Pharmaceutical Packaging division. "The expertise with local pharmaceutical companies will be an excellent addition to our organization, increasing our ability to service global and regional customers while maintaining the high quality standards they have come to expect from us."
Posted on October 3, 2008 @ 09:23 am
Genentech, Roche, and
GlycArt (a company wholly-owned by Roche) have entered into a collaboration that includes a license from GlycArt to Genentech for the joint development and commercialization of GlycArt’s GA101 molecule. The companies will develop GA101, a humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death, for the potential treatment of hematological malignancies and other oncology-related B-cell disorders such as non-Hodgkin’s lymphoma.
Under the agreement, the three companies will share certain development costs and Genentech will record $105 million in R&D expenses in 3Q08. Genentech will receive commercialization rights in the U.S. GA101 is currently in Phase I/II trials for CD20-positive B-cell malignancies, such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). GlycArt and Roche plan to provide Phase I data at the American Society of Hematology meeting in December 2008.
Pablo Umaña, chief scientific officer and co-founder of GlycArt, said, “With its unique mode of action, we believe GA101 has the potential to extend the therapeutic benefit over current standards of care, including treatment for patients who do not respond to current therapies.”
“This collaboration with GlycArt and Roche for the GA101 molecule complements our existing research program and our focus on innovative compounds,” said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We are pleased that through this program we may have the potential to offer a new option to treat patients with hematological malignancies.”
“Our early investment in pioneering technologies continues to provide new hope for patients,” said William M. Burns, chief executive officer, Roche Pharmaceuticals. “The exciting work in antibody engineering carried out by our scientists at GlycArt can now be taken to the next stage in developing clinically differentiated treatments.”
Posted on October 3, 2008 @ 09:19 am
A federal court granted
Amgen a permanent injunction prohibiting
Roche Holding AG from selling its Mircera anemia treatment in the U.S., as well as upheld a jury verdict regarding certain patent-infringement claims.
Mircera is currently available in Europe and the FDA has approved the drug, but the legal dispute prevented its sale. The drug, if released in the U.S., would compete directly with Amgen's anemia drugs Aranesp and Epogen, which accounted for more than 40% of its revenue in 2007.
In March, a Massachusetts district county judge pushed back his decision on whether to grant Amgen the permanent injunction, asking a third party to compare dosing and pricing of the companies' products. A jury had found last October that Roche's Mircera infringes 11 of Amgen's patents protecting Epogen.
"Amgen is pleased with today's ruling, which recognizes that Amgen is entitled to a permanent injunction against Roche and reaffirms the infringement and validity of our patents," general counsel David Scott said in a statement.
Posted on October 3, 2008 @ 09:17 am
Alba Therapeutics Corp. has made several promotions.
Linda Arterburn, Ph.D., has been promoted to vice president of preclinical development and program management.
Francisco Leon, M.D., Ph.D., has been promoted to vice president, clinical development and medical affairs.
Roberto Allen has been promoted to vice president, legal affairs and intellectual property.
Mark Ginski, Ph.D., has been promoted to senior director of product and analytical development and
Kate Huber has been promoted to director of clinical operations.
Prior to joining the company, Dr. Arterburn was executive director of discovery research at Market Biosciences where she initiated an inflammation research program and was lead inventor on two patents involving novel anti-inflammatory lipids. Previously she led clinical research and scientific affairs at Market Biosciences. Dr. Arterburn also spent seven years at W.R. Grace & Co., where she led an in vitro toxicology research program, and then served as manager of technology and planning.
Dr. Leon is an immunologist with training in basic and clinical immunology and a clinical development in the field of mucosal immunology. Prior to joining the company, Dr. Leon was a director of clinical development, inflammatory and respiratory diseases at MedImmune, where he worked on asthma and mucosal vaccination. He was a director of clinical discovery, oncology / immunology at Bristol-Myers Squibb, where he worked on Crohn's disease, rheumatoid arthritis, and transplantation.
Prior to joining the company, Mr. Allen was president of Respire Medical, Inc., a respiratory and home health care provider serving the Mid-Atlantic region. He was also counsel at Kollman & Saucier, P.A., where he practiced general corporate and labor and employment law. Previously, he was a senior associate in the business department at Saul Ewing LLP.
Dr. Ginski's has experience with lead candidate selection, preformulation and formulation development, development, transfer and validation of analytical and bioanalytical methods, and packaging, labeling and distribution of clinical trial supplies. Prior to joining the company, Dr. Ginski served as associate director of preformulation sciences at Shire, where he played an integral role in developing and implementing Shire's Proscreen and Optiscreen programs designed to facilitate lead candidate selection and product development. Additionally, he worked at Guilford Pharmaceuticals, where he was responsible for leading exploratory pharmaceutics and CMC programs for various development programs. He has published numerous R&D articles and is an inventor for numerous global patents.
Ms. Huber has more than 25 years of experience in the health care industry and has been involved in all aspects of the conduct of Phase I - III clinical trials. She has worked in managing complex projects in the areas of celiac disease, oncology, CNS, vaccines, and diagnostics for HIV, HbsAg, and tuberculosis. Ms. Huber joins the company from Nabi Biopharmaceutical and Guilford Pharmaceuticals, where she had increasing responsibilities in the vaccine, oncology and CNS arenas. She has extensive experience in the diagnostic business and previously worked for Ortho Diagnostic Systems, Inc. and Pharmacia, where she helped develop diagnostic tools for pregnancy, HIV, Hepatitis B, and blood banking reagents.
Posted on October 2, 2008 @ 09:00 am
Merck has decided not to seek regulatory approval for taranabant, an investigational drug to treat obesity, and is discontinuing its Phase III development program for taranabant in obesity. The drug is similar to Acomplia, the Sanofi-Aventis obesity drug that was rejected by the FDA because of adverse events.
"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses. Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity," said John Amatruda, M.D., senior vice president and research head, diabetes and obesity, Merck Research Labs. "We thank the patients and investigators around the world who collaborated with us on the research program for taranabant and look forward to developing new medicines for obesity to address the significant medical need posed by this disease."
Posted on October 2, 2008 @ 08:59 am
Christopher Perley has been named vice president and general manager of
Bristol-Myers Squibb's Devens biologics manufacturing facility. Mr. Perley will be responsible for continuing the supervision of the project to build the Devens facility and will have overall management responsibility for the site when it becomes operational in 2011.
“With an approved capital expenditure of $750 million, the Devens facility represents the largest capital investment in the history of Bristol-Myers Squibb,” said Carlo de Notaristefani, president of technical operations, BMS. “As the company evolves toward a next-generation biopharma model, combining the best of biotech with the best of a traditional pharmaceutical company, biologics will play an increasingly important role in driving our company’s future growth and success, and will be key in helping patients prevail over serious disease. Chris brings extensive biopharmaceutical experience that will support the company in this transition.”
Prior to joining the company, Mr. Perley was vice president of network strategy at Wyeth Biotech, where he gained experience in biopharmaceutical process development, production, supply chain management, and operations. Previously, he held manufacturing and biotechnology process development roles at the Genetics Institute in Andover, MA, and at Hoffmann-La Roche in Nutley, NJ.
Posted on October 2, 2008 @ 08:57 am
Biologic Safety Research, Inc. (BSR) is joining PreLabs, LLC to expand their contract laboratory operations. The existing BSR management team will integrate into the PreLabs organization and continue to guide the expanded group. PreLabs appointed Boris Predovich to serve as president and chief executive officer and Philippe Baneux, DVM to serve as chief scientific officer for the newly expanded company. PreLabs/BSR will provide discovery, preclinical and GLP testing.
“Market demand has created an exciting opportunity for us to expand our business,” said Robert Locke, BSR president. “Transitioning BSR into PreLabs will leverage our existing scientific and operational expertise while adding the CRO and pharmaceutical management expertise that Boris Predovich and Philippe Baneux bring with their 20 plus years at Covance and Pfizer, respectively.”
Posted on October 1, 2008 @ 09:01 am
GlaxoSmithKline plans to eliminate as many as 850 jobs in R&D in the U.S. and Britain, which represents 6% of the company's total R&D staff. According to a company statement, the cuts were necessary "to ensure that we can invest in key areas of future growth and evolve our business to compete effectively in what is a rapidly changing and challenging environment for pharmaceutical companies."
Earlier this year, the company had announced plans to cut 350 R&D positions. According to Claire Brough, a spokeswoman for the Brentford, U.K. office. The exact number of job cuts will be determined after consultations with employees and unions.
Andrew Witty, GSK's chief executive officer has pledged to increase the company's investment in outside research. According to Mr. Witty, half of GSK's drugs in development eventually could come from partnerships with outside firms. To support his plan, Mr. Witty has set up a board that includes venture capitalists to review R&D projects and decide which to fund. He has eliminated some areas of research in order to focus the company on eight disease areas. GSK has Centres of Excellence for Drug Discovery (CEDDs) dedicated to each disease area. These changes impact at least three CEDDs.
Posted on October 1, 2008 @ 09:00 am
Gergely Makara, Ph.D. has been named director of chemistry for European operations,
AMRI. Dr. Makara has responsibility for all European chemistry products and services including custom synthesis, medicinal chemistry, analytical services, library design and production. He will report to Philip Small, Ph.D., managing director of AMRI’s European operations.
Dr. Makara has more than 10 years of industrial experience focused on the development of compound libraries and lead optimization at leading drug discovery companies in the U.S. Most recently, he served as the head of Merck’s Target Validation Chemistry group where he was involved in setting up infrastructure for parallel chemistry synthesis and associated chemoinformatics. Prior to Merck, Dr. Makara was director, hit-to-lead optimization and chemical library development for Neogenesis Pharmaceuticals.
“Dr. Makara brings critical scientific and leadership experience to our European operations. His proven ability to form and lead innovative teams is particularly relevant in helping us to execute against our plan to expand services and operations offered to customers worldwide, and more specifically, to further relationships within the European marketplace,” said Dr. Small.
AMRI chairman, president and chief executive officer Thomas E. D'Ambra said, “The addition of Dr. Makara further demonstrates AMRI’s commitment to the restructuring plan initiated in May to provide a strong foundation for future expansion through realignment of customer offerings, with an emphasis on the expansion of medicinal chemistry and drug discovery services in Europe.”
Posted on October 1, 2008 @ 08:58 am
Tara Webb has been appointed senior director of business development,
Accelerated Community Oncology Research Network (ACORN). Ms. Webb will focus exclusively in the field of oncology, working closely with a select group of sponsors.
“Tara Webb has an exceptional background in the CRO field and is widely respected for her industry knowledge, capabilities and integrity,” said Edward J. Stepanski, Ph.D., chief operations officer of ACORN. “Her responsibilities at ACORN CRO will include presenting ACORN’s capabilities to pharmaceutical companies and emerging biotechs, forging alliances with key accounts and providing customer service oversight on behalf of clients.”
Ms. Webb brings a successful record of establishing and cultivating CRO relationships. Most recently, she served as senior director, business development for i3 Statprobe, where she was responsible for developing new business opportunities and strengthening current client relationships both nationally and internationally.
September 2008
Posted on September 30, 2008 @ 08:58 am
Pfizer will discontinue development of drugs for heart disease, obesity and bone health as part of its plan to focus research on Alzheimer's disease, diabetes, inflammation/immunology, oncology, pain and psychoses (schizophrenia), according to a company memo. The shift in R&D focus was led by president Martin Mackay, a Pfizer research executive who took over the division in October of last year.
"It's a continuous process to constantly evaluate our pipeline and make decisions based on high priority, unmet medical needs with market growth potential," said Pfizer spokesman, Ray Kerins. The plan is expected to include job and cost cuts, but will not affect products in late stage development or launches scheduled during the next three years, according to Mr. Kerins.
Sales of Pfizer's Lipitor, the world's top selling drug, are slowing as patients have access to generic forms of Merck's Zocor and Lipitor faces generic competition in 2011. Also, the company's second top seller Norvasc lost patent protection in 2007. In December 2006, the company discontinued development of cholesterol-lowering drug Torcetrapib after it was linked to deaths in a large trial, costing the company $800 million.
Posted on September 30, 2008 @ 08:56 am
MedImmune has licensed its reverse genetics technology to Biken, The Research Foundation for Microbial Diseases of Osaka University in Japan, for the development of new vaccine strains to produce non-live human influenza vaccines. Reverse genetics is a method that uses segments of DNA to generate viruses such as influenza. This method helps protect manufacturers from exposure to potentially highly infectious pandemic strains, such as H5N1.
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 technology.
"MedImmune is pleased to license our reverse genetics technology to BIKEN as we have previously to four other influenza vaccine manufacturers," said Sun Park, MedImmune's vice president, corporate development. "Biken is the first Japanese influenza vaccine manufacturer to have entered into licensing agreements with MedImmune for access to the reverse genetics technology, and we are pleased that Biken's pre-pandemic vaccine using this technology is a key part of an ongoing Japanese government public health pilot program to vaccinate about 6,000 first responders and healthcare providers against a potential bird flu outbreak."
MedImmune applied the reverse genetics process to the development of its seasonal live, attenuated nasal spray flu vaccine for the 2008-2009 season.
Posted on September 30, 2008 @ 08:55 am
Enzon Pharmaceuticals, Inc. received approval from the Commission of the European Communities for designation of Oncaspar-IV, the next-gen pegylated L-asparaginase, as an orphan medicinal product.
Orphan drug designation creates favorable conditions for the development of drugs, including potential financial incentives, in addition to market exclusivity for as many as 10 years following approval.
“This announcement is a significant milestone in our overall plan to market the new Oncaspar-IV in new geographic territories.” said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. “We are currently developing the next-generation Oncaspar product to enhance the pharmaceutical properties of the approved version currently marketed in the U.S.”
Posted on September 30, 2008 @ 08:52 am
Analytical Bio-Chemistry Labs (ABC Labs) opened its new 90,000- sq.-ft. pharmaceutical development facility located at the University of Missouri’s Discovery Ridge Research Park, completing the transition of the company’s DMPK, bioanalytical and CGMP Analytical operations to the new facility. The facility more than doubles the company's previous capacity.
“The qualification of the new pharmaceutical facility is complete. All laboratory systems are validated, and scientific teams are quickly settling into their new home," said John Bucksath, senior vice president and general manager of ABC’s Pharmaceutical Division. “We are wrapping up a carefully choreographed project plan—and I’m delighted to report that the transition of pharmaceutical operations went very smoothly." In July, the FDA completed a pre-approval and General Quality Systems audit of the facility, which resulted in no 483s.
"This is an exciting time in ABC's history," says Byron E. Hill, president and chief executive officer. "This expansion provides the ideal platform for a new era of growth, productivity and exceptional client service."
The company will continue operating its chemical services and synthesis operations at its original campus located about five miles east of Columbia. The expansion at Discovery Ridge frees up space for these areas of the business as well. The company plans to renovate existing structures in 2009 to optimize operational efficiency.
Posted on September 29, 2008 @ 09:15 am
Cardinal Health plans to spin-off its clinical and medical products businesses as a separate public company that will be led by current vice chairman David L. Schlotterbeck. The spin-off is expected to be completed by mid-2009. This plan is an effort to enhance management focus and strategic vision, as well as better align management and employee incentives with performance and growth objectives, according to the company.
Chairman and chief executive officer, R. Kerry Clark, will continue to lead Cardinal Health through the spin-off and then will retire from the company. He will be succeeded by George S. Barrett, who has served as vice chairman and chief executive officer of Healthcare Supply Chain Services since joining the company in January. Mr. Barrett has more than 25 years of experience in the health care industry, most recently serving as president and chief executive officer of
North America
for Teva Pharmaceuticals.
"Since 1996, Cardinal Health has built an industry-leading med-tech business that, as an independent company, would have the size and scale to stand on its own," said Mr. Clark. "This business will be well positioned to deliver maximum value to customers and shareholders over the long term. We undertook a very disciplined exploratory process that involved our board, management and outside advisers. The result was a unanimous decision to move forward with the spin-off. This strategic decision will benefit Cardinal Health and the new med-tech company by allowing each business to focus on its unique growth strategies, capital needs and customer requirements, he continued.
In addition, Robert D. Walter will retire from the company’s board of directors when his term expires on November 5th. He will continue to serve as an adviser to the company. "I am fully supportive of our plans to spin off the clinical and medical products businesses and am confident that the two businesses will be well positioned as separate companies," Mr. Walter said. "With strong teams in place to lead these two organizations, my retirement from the board is the next logical step in my leadership transition at Cardinal Health."
Posted on September 29, 2008 @ 09:14 am
SAFC Pharma has commissioned a new suite at its
St. Louis
campus that will produce high-potency active pharmaceutical ingredient (HPAPI) conjugates to support oncology drug development. The 600-sq.-ft. suite will enable the conjugation of HPAPIs to a variety of targeted delivery molecules, including monoclonal antibodies. The new facility can also accommodate early-stage clinical supplies and can handle multi-kilogram quantities, with the capability to expand production up to commercial-scale.
"Bio-conjugates represent the next generation of 'smart munitions' in healthcare's anti-cancer arsenal," said Dave Feldker, SAFC Pharma vice president. "Due to our significant breadth of chemistry, containment engineering and biologics capabilities, SAFC Pharma is well-positioned as the leading player in this exciting niche.
"The HPAPI market has grown at a high double-digit pace; the number of customers we have has more than doubled over the past three years, with particular demand growth for biologic-HPAPI conjugates for oncology drugs," Mr. Feldker continued. "Dozens of products are currently in clinical trials, and this new facility underline's SAFC's intent to support growth in this niche, strengthening our position as the leading pipeline partner for the pharmaceutical and biopharmaceutical industry."
During the past year, the company has announced investments totaling $75 million to expand HPAPI capacity, including a $4.5 million project to add a cGMP pilot plant and kilo-lab capacity at Madison, WI, completed earlier this year; a $29 million investment to expand bacterial and fungal fermentation-derived HPAPI capacity in Jerusalem, due for completion in 2009; and a $30 million investment to build a commercial-scale HPAPI facility at Madison, due to be completed by year-end 2009.
Posted on September 29, 2008 @ 09:13 am
SAFC Pharma’s new reactor at its
Arklow,
manufacturing site has begun operation, expanding the facility's capacity for large-scale active pharmaceutical ingredient (API) manufacturing by approximately 15%.
The $4 million project involved the installation and start-up of a 6,000 liter Hastalloy reactor for large-scale API manufacturing, increasing the total capacity at the site to 96,000 liters, with a reactor range from 250 to 8,000 liters. This adds capacity for both large- and small-scale manufacturing.
SAFC Pharma vice president
Europe
, Dr. Michael Harris, commented, "Our continued investment in capabilities and capacity is a direct reflection of SAFC's long-term commitment to meeting customer requirements for API manufacturing. Our continuing investments in facilities and personnel support the growth of SAFC Pharma and underline our position as an industry leader whose focus includes the responsibility to reduce our environmental footprint."
The 64,000-cubic-meter Arklow complex is cGMP, FDA and IMB inspected and validated. It supports new process evaluation, process development validation and technology transfer. The site's process technologies include carbon coupling reactions, polyamino acids, Suzuki coupling reagents, distillations, salt formations, Grignard chemistry and powder handling, and large-scale simulated moving bed (SMB) chromatography for chiral separations.
Other expansion projects at the Arklow site include the building of a $2.25-million, 15 kg capacity pilot-scale filter dryer designed to double the facility's current capacity for small-scale (10 kg-150 kg) manufacturing of APIs, and a $1.8-million expansion of the site's cGMP warehouse capacity.
Posted on September 29, 2008 @ 09:12 am
Jon Brewer has been named vice president, sales and marketing, BASi. He replaces Emilio Córdova who has resigned to pursue other opportunities. Mr. Brewer has nearly 25 years of experience as a sales and marketing executive in the pharmaceutical industry. Most recently he consulted with companies to develop and implement new business strategies. Previously he served as vice president of Integrity Pharmaceuticals and continued in this role through the merger with Xanodyne, a specialty pharmaceutical company based in
Cincinnati, OH
. He has a background of developing and executing product launches and sales strategies.
Posted on September 25, 2008 @ 05:01 am
Ligand Pharmaceuticals has entered into a merger agreement to acquire
Pharmacopeia, in an all-stock deal valued at $70 million. In addition to the share value, Pharmacopeia stockholders will be entitled to a Contingent Value Right (“CVR”) that entitles a cash payment of $15 million for all Pharmacopeia stockholders, under certain circumstances.
“We are very excited about combining Pharmacopeia with Ligand,” said John L. Higgins, president and chief executive officer of Ligand. “Ligand stockholders will gain access to numerous royalty partnerships, additional pipeline assets, drug discovery resources and cash and NOLs. Pharmacopeia’s shareholders will receive a substantial amount of equity in a well capitalized company with lucrative potential royalties, an expanded pipeline and financial liquidity."
He added, "This is a unique opportunity for Ligand and Pharmacopeia shareholders. Both companies have similar growth strategies, and our respective drug discovery platforms are a great marriage of biology and chemistry resources. The acquisition of Pharmacopeia will complement and accelerate our product development programs, strengthen our research capability and increase our potential royalty streams.”
Joseph A. Mollica, Ph.D., chairman, interim president and chief executive officer of Pharmacopeia, stated, “Pharmacopeia’s portfolio of programs is an excellent complement to Ligand’s pipeline and over the next decade we believe the combined company will have important product introductions. On behalf of our Board, I would like to thank all of our employees for the dedication they have shown in pursuit of our scientific goals and the value they have created for our shareholders. We are excited about this transaction and look forward to sharing in the potential upside of the combined businesses by joining forces with a strong company like Ligand.”
Under the terms of the agreement, Ligand shareholders will own 84% of the combined company and Pharmacopeia stockholders would own approximately 16%. The transaction is expected to close by 1Q09.
Posted on September 25, 2008 @ 04:54 am
Lonza and
Crucell have entered into a co-exclusive manufacturing, sales and distribution agreement related to the Permexcis cell culture medium developed by Crucell for PER.C6 cells. Under this agreement, Lonza will manufacture the medium, and in addition will market and sell it on a global basis. Financial details of the agreement were not disclosed.
The Permexcis medium is a chemically defined cell culture medium that does not contain human- or animal-derived components. Permexcis medium was developed for the cultivation of PER.C6 cells and has been designed for use in the large-scale manufacture of biopharmaceutical products, including vaccines, according to a Crucell statement.
"We are pleased to have entered into this agreement with Lonza. The agreement demonstrates the power and robustness of our PER.C6 technology. Over 60 companies and organizations have already selected our PER.C6 technology to develop their own products across a wide range of therapeutic areas. We are proud that Lonza will manufacture the Permexcis cell culture medium and in addition will market and sell it globally" said Ronald Brus, Crucell's chief executive officer.
Posted on September 25, 2008 @ 04:50 am
Merck and
Japan Tobacco Inc. (JT) have signed a worldwide licensing agreement to develop and commercialize JTT-305, an investigational oral osteoanabolic (bone growth stimulating) agent for the treatment of osteoporosis.
Merck will gain worldwide rights, except for Japan, to develop and commercialize JTT-305. JT will receive an upfront payment and is eligible to receive additional cash payments upon achievement of certain development milestones associated and product royalties.
JTT-305 is an oral calcium sensing receptor (CaSR) antagonist that is currently being evaluated by JT in Phase II clinical trials in Japan for its effect on increasing bone density; it is in Phase I clinical trials outside of Japan.
“Through this agreement with Merck, JT is well positioned to maximize the therapeutic potential for JTT-305 as a possible future option for patients with osteoporosis,” said Noriaki Okubo, president of JT’s pharmaceutical business.
"Partnering with JT to develop this novel compound complements Merck's portfolio of musculoskeletal drug candidates," said Alan B. Ezekowitz, MBChB, D.Phil., senior vice president and franchise head, Bone, Respiratory, Immunology, and Endocrine, Merck Research Laboratories. "In the future, we believe that use of antiresorptive and osteoanabolic agents together may provide an effective way to reduce the risk of fractures in patients with osteoporosis."
Posted on September 24, 2008 @ 07:36 am
Dyax Corp. has completed its BLA for DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). Dyax has requested Priority Review; if granted, this would set a target date of six months from receipt of the completed submission for the FDA to take action on the application. Priority designation is intended for those products that address unmet medical needs. DX-88 was previously granted Orphan Drug designation and Fast Track status by the FDA.
The final portion of the BLA, the clinical section, was based primarily on data from two Phase III clinical studies, EDEMA3 and EDEMA4, which together represent the largest placebo-controlled evaluation of any therapy used in the treatment of HAE, according to a Dyax statement. In these studies, DX-88 demonstrated statistically significant improvements over placebo in both the primary and secondary endpoints.
“The submission of the DX-88 BLA is a major milestone for Dyax,” commented Henry E. Blair, chairman, president and chief executive officer of Dyax. “We believe DX-88, a recombinant, subcutaneously administered therapy, has many characteristics that match well with the needs of HAE patients and physicians for a therapeutic option. We look forward to working with the FDA to make this important product candidate available to HAE patients as soon as possible.”
The recombinant, small protein, DX-88, was discovered utilizing the company’s proprietary phage display technology. DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema.
Posted on September 24, 2008 @ 07:34 am
Takeda's U.S. subsidiary, Takeda Global Research & Development Center, Inc., has submitted an NDA for alogliptin and Actos in a single tablet for the treatment of type 2 diabetes.
Alogliptin is a DPP-4 inhibitor; that class slows the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). The incretins play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. GLP-1 and GIP are produced by the digestive tract in response to food and regulate glucose balance. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness. ACTOS is a thiazolidinedione (TZD) drug that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. Takeda is the originator of the TZD class of oral anti-diabetes medications.
"Alogliptin/ACTOS, if approved, will be the first type 2 diabetes treatment option which includes a DPP-4 inhibitor and a TZD," said Yasuchika Hasegawa, president of Takeda. "Given the increased global incidence of type 2 diabetes and the need for new treatment options, we will strive to provide alogliptin/ACTOS, as a potentially important treatment option, to patients and healthcare providers."
The NDA submission was supported by two phase 3 clinical trials, involving more than 2,000 patients worldwide. The studies assessed the efficacy and safety of this therapy for the treatment of patients with type 2 diabetes not achieving glycemic targets with diet and exercise alone, or for patients uncontrolled on metformin. Study results showed that alogliptin/ACTOS produced significant improvements in glycemic control and measures of insulin resistance and beta-cell function.
Posted on September 24, 2008 @ 07:30 am
inVentiv Clinical Solutions, LLC, a division of
inVentiv Health, has continued its expansion outside North America with a new office in Madrid. The company plans to expand operations to other European countries, including Eastern Europe.
inVentiv Clinical's European operations will be led by Fernando Martinez, Ph.D., MBA, recently appointed as director, Clinical Operations, Europe. Dr. Martinez is responsible for building the unit's European presence and client base. He is also responsible for oversight of all of its European projects.
"We are excited to take this next step along the path to globalization, adding this new European location to our already established operations in India and Latin America," said Mike Hlinak, president and chief executive officer of inVentiv Clinical. "Dr. Martinez has the expertise and skill to help us build our presence in Europe to continue to provide superior quality services to our clients."
Posted on September 23, 2008 @ 09:00 am
Parexel has expanded its early phase drug development capabilities with a dedicated unit to provide biopharmaceutical companies with support for proof-of-concept studies. The new unit integrates capabilities in regulatory strategies, drug development, and clinical pharmacology. Proof-of-concept studies are mainly used in targeted patient populations and are designed to demonstrate early signals of a product's efficacy. The goal of these studies is to help avoid costly late stage clinical development failures.
"As the biopharmaceutical industry explores new development paradigms to bring safe and effective treatments to market more efficiently, companies are conducting a growing number of complex and rigorous proof-of-concept studies. Providing clients with integrated, early phase development strategies and expertise gives them the ability to support early identification and selection of the most promising compounds," said Herman Scholtz, M.D., corporate vice president, Early Drug Development, Parexel.
A dedicated team will provide clients with the required scientific, therapeutic, and regulatory services to design and implement these studies for new drug entities across a range of therapeutic indications. This team offers solutions including the use of biomarkers and adaptive trial designs, which are supported by biostatistical and eClinical technology capabilities. Relevant technologies include Interactive Voice and Web Response Systems (IVRS/IWRS) to randomize patients and track drug inventory, as well as EDC to provide rapid access to study data.
The proof-of-concept service offering provides the company's SuperSites capabilities together with a global network of investigator and academic sites to help accelerate patient recruitment. The SuperSites solutions use the company's hospital-based Clinical Pharmacology Research Units, drawing on recruitment specialists and relationships with local, hospital-based physicians as well as on-site call centers and database capabilities.
Posted on September 23, 2008 @ 08:59 am
Tris Pharma has completed the expansion of its research and manufacturing facility in South Brunswick, NJ. The expansion provides 15,000 sq. ft. of additional space to the facility and is FDA-compliant with cGMP. It allows for additional commercial-scale equipment and a new, larger warehouse with a high-speed packaging area.
"These recent events show that the company is on a steady and stable path as charted," says Ketan Mehta, chief executive officer and founder of Tris Pharma. "FDA's assurance of our facilities and the recent investment in our capabilities mean we have ample infrastructure with which to leverage our pipeline of drug delivery technologies and services."
Posted on September 23, 2008 @ 08:56 am
Ronald Shoup has been named executive director of Pharma Services,
AIT Laboratories. Mr. Shoup was the former co-founder and chief scientific officer of West Lafayette, IN-based Bioanalytical Systems, Inc. (BASi).
"Ron brings 30 years of leadership, entrepreneurship, and scientific expertise to AIT as we look to expand our facility to meet the growing needs of the Pharma industry," said AIT president and chief executive officer, Michael A. Evans, Ph.D.
AIT supports clinical trials through its current drug analysis services and plans to offer regulated bioanalytical services for preclinical development in the future. AIT develops, validates, and performs mass spectrometry analysis in support of new drug development.
Posted on September 22, 2008 @ 09:51 am
Schering-Plough plans to cut 20% of its U.S. sales force by October 1 as part of a previously announced restructuring plan aimed at saving $1.5 billion by late 2012. The company said it will eliminate 1,000 sales positions from its U.S. Primary Care field force, which markets prescription drugs to physicians, and make organizational changes within the operation. According to the company, 4,000 positions will remain.
The restructuring program, announced in April, was designed in part to eliminate costs associated with the company's $14.5 billion acquisition of Organon BioSciences.
Posted on September 22, 2008 @ 09:50 am
Genzyme Corp. opened its new Science Center in Framingham, MA. The facility serves as a central site for early stage research to discover new treatments for diseases such as Parkinson's, cancer, and heart disease. The Science Center has received a Gold certification under the U.S. Green Building Council's LEED (Leadership in Energy and Environmental Design) Green Building Rating System. It's one of 10 labs to receive this rating.
"Genzyme exists to innovate, and the Science Center reflects this purpose," stated Henri A. Termeer, Genzyme's chairman and chief executive officer. "The work done at this facility will ensure that we can continue to bring forward therapies to significantly improve patients' lives and will help support the company's long-term growth. I am so proud of our scientists who discover and make possible life-saving medicines."
Researchers at the Science Center focus on areas including genetic diseases, cancer, immune diseases, kidney disease, cardiovascular disease, endocrinology and neurological disorders, and utilize a range of technologies, such as proteins, antibodies, cell therapy and gene therapy.
Posted on September 22, 2008 @ 09:49 am
John J. Dupree has joined
Girindus as senior director, business development. Mr. Dupree has more than 34 years of sales, business management, and corporate accounts management experience. He spent his entire career with Eastman Chemical Co. as a senior corporate account executive until joining Girindus.
“John Dupree is a known leader in the custom chemistry market and has had an impressive career with Eastman Chemical. He brings with him significant knowledge and experience in numerous areas of the chemical business. We look forward to the expertise and passion John brings to Girindus,” commented Mark Laskovics, president and chief operating officer of Girindus America, Inc. “I am excited to join the impressive Girindus Team and working with Girindus’ customers, developing the growing Oligonucleotide medicines market,” said Mr. Dupree.
Posted on September 19, 2008 @ 09:31 am
Laureate Pharma, Inc. is increasing its manufacturing capacity with the addition of two Single-Use Bioreactors (S.U.B.), a 250L and a 1000L S.U.B. The S.U.B. is a single-use alternative to stirred tank bioreactors. The S.U.B. consists of a permanent stainless steel outer support container and a Bioprocess Container (BPC), integrated with an existing bioreactor control system. According to the company, this provides a flexible, rapid and economic option to update or increase the bioreactor capacity. The S.U.B. will supplement the company’s current single-use bioreactors, Wave Bioreactors and hollow-fiber systems, as well as the conventional stainless steel stirred-tank bioreactors.
“We are excited about adding the S.U.B. to increase our bioreactor capacity. It is a scalable technology that will support the demand from our growing client base and meet their needs and manufacturing objectives,” said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. “The HyClone S.U.B. provides us with all the advantages of single-use bioprocessing, while maintaining aspect ratios and agitation mechanisms comparable to traditional stainless steel stirred-tank bioreactors.”
Posted on September 19, 2008 @ 09:29 am
MethylGene, Inc. has exercised its right to convert to a royalty and milestone arrangement with
Celgene Corp. for MGCD0103 under the 2006 license and collaboration agreement between the companies.
MethylGene will no longer be responsible for development costs for the drug. Celgene will assume all program costs for its licensed territories. MethylGene will receive royalties in lieu of profit sharing in North America and is eligible to receive milestone payments of as much as $141 million. Celgene will also pay royalties to MethylGene on annual sales in its territories. MethylGene retains its rights under the original terms of the agreement to co-develop and co-promote subsequent compounds, including second-generation histone deacetylase (HDAC) inhibitors and sirtuin inhibitors for cancer.
"We believe that MGCD0103 presents a promising opportunity for the treatment of cancer. After thoughtful and careful analysis conducted with outside consultants, we have concluded that converting to a royalty at this time is financially advantageous," said Donald F. Corcoran, president and chief executive officer of MethylGene. "Moving forward, while participating in the upside and potential of MGCD0103, we will be focusing on developing the two compounds of which we own 100%, MGCD290 and MGCD265, which are expected to enter Phase I trials by the end of this year."
Posted on September 19, 2008 @ 09:28 am
A new study of
Novartis' MF59-adjuvanted vaccine showed that it rapidly induced protective antibody levels against diverse strains of avian flu. In the study, individuals immunized six years earlier with an MF59 adjuvanted H5N3 (clade 0) vaccine mounted a protective immune response seven days after a single immunization with an H5N1 (clade 1) vaccine containing Novartis' adjuvant MF59. The immune response was broadly cross reactive and covered all H5N1 clades known to date.
In addition, these study results suggest individuals primed with an MF59-adjuvanted H5 vaccine, would only need one dose of an MF59-adjuvanted vaccine in a pandemic situation to elicit initial protection reducing overall response time, and potentially the spread of the virus.
Posted on September 18, 2008 @ 09:15 am
Bilcare Global Clinical Supplies has completed the expansion of its warehouse and distribution facility in Phoenixville, PA. The facility now provides 300% more ambient storage capacity, as well as a 50% larger distribution pack-out area, and a second distribution dock for increased output.
"The increase in storage capacity is the latest in a series of global upgrades designed to demonstrate to customers that Bilcare is a company focused on providing high quality service and cutting edge technology for its customers to ensure on time project completion," said Bilcare GCS, Americas president Vincent Santa Maria.
In addition to this facility expansion, the company has expanded its facility in Rajgurunagar, near Pune, India and plans a $21 million expansion for a new clinical supplies facility in South Wales.
Bilcare GCS chief executive officer, Vito Mangiardi stated, "These capital improvements combined with our experienced project managers and global footprint in the Americas, Europe and Asia signifies that Bilcare GCS is a growing company committed to providing world-class service."
Posted on September 18, 2008 @ 09:14 am
Crucell has signed an exclusive, commercial license agreement with NC-based
Talecris Biotherapeutics for an undisclosed protein to be produced using the PER.C6 cell line. Crucell will receive an upfront payment of $2.5 million and will be eligible for milestone payments of approximately $30 million across multiple indications. Further details were not disclosed.
Posted on September 18, 2008 @ 09:11 am
Roger Rush, Ph.D. has been named vice president of preclinical development,
Wolfe Laboratories. Dr. Rush has more than 25 years of international experience in pharmaceutical R&D with a focus on preclinical research, development, and program management, particularly in the transition of discovery research candidates to clinical development.
"We're delighted to have Dr. Rush as part of our team," said Janet Wolfe, Ph.D, president of WLI. “His wealth of experience will be a tremendous asset to the company. He will play a critical role in the company as we expand our services and continue to provide clients with the highest quality preclinical services in a timely manner."
Prior to joining the company, Dr. Rush held a number of positions of increasing responsibility with pharmaceutical and biotechnology companies, including department head of drug metabolism at Syntex Research in Europe, and vice president of preclinical sciences at Roche Pharmaceuticals, which involved responsibility for the functions of drug metabolism and pharmacokinetics, toxicology and pathology, and pharmaceutical development. Throughout his career he has contributed to the approval of numerous INDs, CTAs, NDAs and MAA drug registration dossiers.
Dr. Rush participated in the transition of the Syntex Research Centre in Edinburgh into Quintiles Transnational and established that facility as a provider of pharmaceutical R&D services. In his role as business development director he was responsible for the sales and marketing of Quintiles’ preclinical services.
Posted on September 17, 2008 @ 09:20 am
Valeant Pharmaceuticals has signed a definitive agreement to acquire
Coria Laboratories, Ltd., a specialty pharmaceutical company focused on dermatology products in the U.S., for $95 million. This acquisition expands Valeant’s U.S. business and adds to its dermatology franchise with the acquisition of several products, for which annual sales are approximately $40 million. Coria was owned by DFB Laboratories, which also owns DPT Laboratories, a contract development and manufacturing organization (CDMO).
“Valeant is committed to growing our dermatology franchise and this acquisition is a key step in transforming this business in the U.S. and gaining the critical mass and profitability we need,” said J. Michael Pearson, chairman and chief executive officer of Valeant. “The acquisition of Coria provides Valeant with access to a unique product portfolio, which includes both prescription and OTC products, additional pipeline opportunities for the future and a talented dermatology workforce. With the identified synergies between the two companies, we expect this transaction will be accretive to our earnings in 2009.”
The Coria transaction will add the following marketed dermatology products: CeraVe Skin Care Line, Cloderm Cream for the treatment of dermatoses, Akne-Mycin and Atralin for the treatment of acne, and Salex for the treatment of hyperkeratotic skin disorders, as well as Tetrix Cream for the treatment of hand dermatitis, which is expected to launch later this year. Coria also has several products under development, including line extensions for the CeraVe brand product line.
Posted on September 17, 2008 @ 09:17 am
Pharmatek has opened its highly-potent and cytotoxic facility in San Diego, CA. The 18,000-sq.-ft. facility includes newly constructed analytical and formulation development labs and cGMP manufacturing suites for the development of highly-potent and cytotoxic drug product for early phase clinical trials.
The facility holds a State of California Food and Drug Branch (FDB) Drug Manufacturers License and is currently working on several highly-potent development projects. The FDB license authorizes Pharmatek to manufacture and ship clinical material from its manufacturing and development site.
"Highly-potent and cytotoxic compounds are among the most sensitive drugs to handle and produce," said Kevin Rosenthal, director of manufacturing of Pharmatek. "Our primary goal when designing the facility was to optimize product quality while ensuring operator safety to guarantee our clients' drug candidates move smoothly from discovery to clinical trials."
Posted on September 17, 2008 @ 09:15 am
Millennium (a.k.a. The Takeda Oncology Co.) has added
Claire Thom, Pharm.D. as senior vice president, portfolio management and
Isabelle Mercier as vice president, marketing for Millennium's commercial organization.
"We are very excited to have these two, highly-successful pharmaceutical executives join the Millennium team to help lead the organization towards becoming a top three global oncology company," said Deborah Dunsire, M.D., president and chief executive officer, Millennium. "Claire and Isabelle will offer insight and perspective to effectively develop and market the molecules in our expanding oncology pipeline as well as bring a proven level of entrepreneurship and innovative thinking."
Dr. Thom joins Millennium with nearly 20 years of experience in drug development, new product planning and marketing. She will be responsible for the oncology portfolio management process. Previously, Ms. Thom was responsible for the oversight and implementation of the global therapeutic area strategies for oncology, urology and gynecology franchises of Takeda Pharmaceutical Co. in Japan. She also held several senior R&D and product planning positions at Takeda Global R&D and Takeda Pharmaceuticals North America. Prior to Takeda, she held positions of increasing responsibility at G.D. Searle and Co. in the areas of global new product planning and U.S. oncology marketing.
Ms. Mercier brings more than 16 years of global pharmaceutical marketing experience. She will lead and develop U.S. and global marketing strategy for the commercialization of late phase development products as well as marketed oncology products, including Velcade for Injection for patients with multiple myeloma. She joins the company from Sanofi-Aventis and most recently served as vice president of Taxotere Marketing. She also has global experience in sales, clinical research and oncology product launches from Sanofi-Synthelab and SangStat Medical Corp.
Posted on September 16, 2008 @ 09:00 am
GlaxoSmithKline and
XenoPort, Inc. have submitted a NDA to the FDA requesting approval of Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the U.S. and can result in symptoms that disrupt sleep and impact daily activities.
The NDA submission is based on a Phase III clinical development program for Solzira in RLS patients, including data from two randomized, double-blind, placebo-controlled trials evaluating the safety and efficacy of Solzira over 12 weeks. The submission also included results from a third trial evaluating the ability of the drug to maintain efficacy in treating RLS symptoms over a nine-month period. The most common side effects of Solzira were dizziness and somnolence.
"GSK is committed to bringing innovative products to patients where there is unmet medical need," said Atul Pande, M.D., senior vice president, GSK Neurosciences Medicine Development Center. "We believe that Solzira may offer a new therapeutic option to treat primary Restless Legs Syndrome, a condition that includes both sensory and motor symptoms."
"We are very encouraged by the results that we have seen in the clinical development program for Solzira," said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort. "Solzira is the first non-dopaminergic compound to demonstrate efficacy in large, controlled clinical trials for the treatment of primary RLS, and we believe it will offer patients a beneficial alternative to currently approved therapies."
Posted on September 16, 2008 @ 08:59 am
Charles River Labs has acquired
Molecular Imaging Research, Inc. (MIR Preclinical Services) for approximately $12.5 million in cash. MIR, based in Ann Arbor, MI, provides discovery services using extensive in vivo imaging capabilities to pharmaceutical and biotechnology clients.
MIR offers non-GLP preclinical efficacy testing services with expertise in the therapeutic areas of oncology and inflammation, employing a variety of in vivo imaging techniques. MIR applies a wide array of high-throughput and efficient imaging technologies, including preclinical positron emission tomography (PET), preclinical micro-computed tomography (CT), anatomical and functional magnetic resonance imaging (MRI), and bioluminescence and fluorescence biophotonic imaging. These imaging services allow for noninvasive and quantitative analysis of both efficacy and mechanism of action, with the goal of accelerating the drug discovery process. The company also offers other in vivo, in vitro and analytical services. MIR will join Charles River Discovery Services to evaluate the efficacy of compounds.
James C. Foster, Chairman, president and chief executive officer of Charles River, said, "As pharmaceutical and biotechnology companies increasingly seek the means to accelerate their drug development efforts, in vivo imaging is becoming a key tool in making more effective and informed 'go/no-go' decisions early in the drug development process. The addition of MIR’s oncology and inflammation therapeutic expertise and state-of-the-art in vivo imaging capabilities allows Charles River Discovery Services to offer a broader portfolio of efficacy testing services to better support our clients’ needs. We welcome MIR Preclinical Services to the Charles River family."
Dr. W.R. “Dick” Leopold, president and chief executive officer of MIR, commented, “At MIR, we have dedicated ourselves to improving the drug development process by building a leading preclinical imaging business with drug discovery expertise in key therapeutic areas. By joining with Charles River, we will be able to extend our joint reach and aide our clients in finding treatments for cancer and other devastating diseases.”
Posted on September 16, 2008 @ 08:57 am
Perrigo Co. has acquired
JB Laboratories for approximately $44 million in cash. JB Labs is a contract manufacturer of OTC and nutrition products for healthcare suppliers in the U.S. The acquisition is expected to add more than $70 million in annual sales.
Perrigo's chairman and chief executive officer, Joseph C. Papa, stated, "The acquisition of JB Laboratories will further expand our high-quality manufacturing base and provide additional FDA-approved production capacity to help us service our current and future customer needs. And in addition to the immediate top line sales contribution, this investment will be accretive to earnings this year and beyond. This acquisition further exemplifies Perrigo's commitment to meeting the world's growing need for quality, affordable healthcare."
Posted on September 15, 2008 @ 09:45 am
Talecris Biotherapeutics, Inc. received approval from the FDA for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue and can cause severe impairment of motor skills. Gamunex is the first therapy approved for the treatment of CIDP as well as the first IVIG therapy approved in the U.S. to treat a neurological disorder.
The FDA’s ruling provides Orphan Drug Designation for Gamunex, which grants Talecris marketing exclusivity for the treatment of CIDP for seven years. This approval was based on results from the first and only large-scale trial for the treatment of CIDP. The study validates the long-term safety and efficacy of Gamunex as the first line and maintenance treatment for CIDP, according to a Talecris statement.
“We are proud to be the first company to prove the efficacy of an IGIV product for CIDP,” said Lawrence Stern, president and chief executive officer for Talecris Biotherapeutics. “For people with this neurological disorder, Gamunex provides a safe and effective method of treatment. To help provide patients access to this important therapy, we are working to substantially increase supplies of Gamunex in 2009.”
Posted on September 15, 2008 @ 09:45 am
Pfizer updated safety and efficacy results for its investigational compound CP-751,871 in patients with non-small cell lung cancer (NSCLC). Results from a Phase II, randomized, non-comparative study showed 54% of patients with Stage III/IV treatment-naïve NSCLC receiving the combination CP-751,871 plus carboplatin and paclitaxel experienced objective responses. The response rate was 41% in patients treated with carboplatin and paclitaxel alone.
Also, 78% of a subset of patients with squamous cell carcinoma and 57% of a subset of patients with adenocarcinoma receiving 20 mg/kg of CP-751,871 plus carboplatin and paclitaxel experienced objective responses. Response rates were 46% and 25%, respectively, for squamous cell and adenocarcinoma patients receiving carboplatin and paclitaxel alone. No response advantage with CP-751,871 was seen in a subset of patients with undifferentiated tumors.
Patients receiving CP-751,871 20 mg/kg showed the greatest improvement in progression-free survival (PFS). PFS was defined as either the length of time before the cancer progressed or death. Of the 53 patients in the carboplatin and paclitaxel arm, 20 crossed over to receive CP-751,871.
The side effects of CP-751,871 were generally manageable. The most common side effects reported in this study were fatigue (10%), hyperglycemia (20%) and neutropenia (30%).
Posted on September 15, 2008 @ 09:43 am
ProStrakan Group received approval from the FDA for Sancuso (Granisetron Transdermal System), the first patch to provide five days of control of nausea and vomiting for patients undergoing chemotherapy.
Chemotherapy-induced nausea and vomiting (CINV) is common among patients undergoing chemotherapy and can lead to dehydration, malnutrition, treatment delay, or even discontinuation of treatment.
Sancuso is a transdermal patch that delivers granisetron through a thin layer of adhesive that attaches to the skin. The medicine is then released slowly and continuously into the bloodstream for as many as five consecutive days.
The approval is based on the results from a multicenter Phase III randomized, double-blind, study comparing the efficacy, tolerability and safety of Sancuso with once-daily oral granisetron. The trial enrolled 641 patients undergoing chemotherapy, and met its primary endpoint of achieving complete control of CINV, working as well as oral granisetron. Complete control was defined as no vomiting and/or retching, no more than mild nausea and no rescue medication from first administration of Sancuso until 24 hours after the last day of chemotherapy. Sancuso was generally well-tolerated.
Posted on September 12, 2008 @ 09:17 am
MedImmune, the global biologics unit of AstraZeneca, and
SBI Biotech Co., Ltd, have entered into a licensing and collaboration agreement to develop and commercialize SBI Biotech's anti-ILT7 protein for the potential treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases. MedImmune will have global rights to any resulting product candidates and will be responsible for preclinical and clinical development, as well as all future development, manufacturing, sales and marketing activities.
Under the terms of the agreement, SBI Biotech will receive an undisclosed upfront payment, milestone payments and royalties on future marketed products. MedImmune has an exclusive license to research, develop and commercialize products that target the ILT7 protein. MedImmune will also have the option to license additional targets resulting from SBI Biotech's research activities.
"It's an honor to work with Ken-ichi Arai, founder of SBI Biotech and one of Japan's leading scientists. We look forward to collaborating with him and his organization as we develop potential new treatments for autoimmune diseases such as SLE," said Anthony J. Coyle, Ph.D., vice president, research, respiratory, inflammation and autoimmunity. "As an innovative company dedicated to making a difference for patients, MedImmune will continue to seek out research and development initiatives that may address some of society's critical unmet medical needs."
Posted on September 12, 2008 @ 09:16 am
GlaxoSmithKline has formed GSK Oncology, a newly integrated Oncology R&D Organization. GSK Oncology unites small discovery units (DPUs) within the existing Centre of Excellence for Drug Discovery (CEDD), and a highly specialized drug development group to create a dedicated oncology R&D organization, led by Paolo Paoletti, M.D., senior vice president Oncology R&D.
“GSK has designed this new organization to help us increase the breadth and depth of our core oncology knowledge, in order to ultimately deliver more innovative medicines that enhance cancer patients’ lives,” said Dr. Paoletti. “By creating an end-to-end R&D unit we are able to capture the many synergies that exist between discovery and development in oncology. The application of translational medicine will bring about significant enhancements to the R&D group via the ‘bench to bed’ connection — the constant loop and flow of information from early to late stage development, and vice-versa.”
“The newly formed GSK R&D Oncology Unit is directly aligned with our R&D strategy to deliver more products of value, and will help us increase our efforts towards personalized medicine in oncology,” said Moncef Slaoui, chairman, R&D. “This dedicated unit will have the primary goals of identifying new targets and pathways, conducting innovative clinical research and cost-effectively increasing development capacity in order to deliver the unit’s large portfolio of medicines.”
Posted on September 12, 2008 @ 09:14 am
TestPak has launched its latest child-resistant and senior-friendly compliance packaging system,
Stora Enso’s Pharma DDS. Pharma DDS is a flexible and reclosable system with the capacity to contain a 30 count supply of most solid dose products and can be tailored to fit various blister designs. Its opening lock feature is designed to require minimal dexterity and provide ease of use. DDS has been tested successfully in the U.S. and in Europe for child-resistance and senior-friendliness, meeting F=1 child-resistant performance.
“We are very pleased to introduce DDS to our line-up because it adds another outstanding compliance packaging option for our customers. We have high expectations for DDS because of its ease of use and cost-effectiveness,” said Bill Eveleth, vice president sales and marketing at TestPak. Based on initial customer inquiries, the company already has a number of design applications on the drawing board.
“Stora Enso appreciates the dedication of TestPak towards the pharmaceutical compliance packaging market. The adoption of Pharma DDS further strengthens our cooperation with TestPak and provides a great avenue to the market,” stated Ralph Mendoza, sales manager of Stora Enso Pharmaceutical Solutions.
Posted on September 11, 2008 @ 09:31 am
Norwich Pharmaceuticals, Inc., a provider of contract manufacturing and packaging services, will implement
SupplyScape Corp.’s Nexus solution to drive visibility, control and efficiency within its business operations and among its trading partners. Norwich will utilize Nexus to offer its client base a full suite of serialization services to monitor and optimize product movement, security and supply chain performance, according to a company statement.
SupplyScape Nexus is a business collaboration environment designed to help companies and their partners connect and share rich product information across business processes. By combining serialization and electronic pedigree information with operational and transaction data, organizations can dramatically improve supply chain visibility and business responsiveness to changing supply chain conditions, said SupplyScape.
As one of the first outsourcing providers to implement the Nexus solution, Norwich Pharmaceuticals president, Chris Calhoun, contends the initiative is part of the company’s mission. “Norwich is committed to providing our customers with uncommon value and everyday excellence – and SupplyScape helps us achieve that,” he remarked, adding, “In addition to innovative technology, deep domain expertise and strong partnerships with technology leaders such as SAP, SupplyScape’s value chain network-based approach enables us to offer our customers a comprehensive set of serialization packaging and patient safety services to meet all their customers’ needs.”
Posted on September 11, 2008 @ 09:30 am
Quintiles Transnational Corp. will expand its Singapore operations to meet the growing demand in the Asia-Pacific region. The new regional headquarters will be double the size of its existing presence in Singapore. The company has also expanded seven local offices in the region and the added a new location in Indonesia.
"Our growth in Singapore has been bolstered by the expanding base of companies and research institutes in Singapore's larger biomedical sciences research community," said Anand Tharmaratnam, M.D., head of clinical development, Quintiles Asia Pacific. "We are projecting continued strong growth in the future, and this new facility gives us the room we will need. The new location also will allow us to work more efficiently, share best practices and deliver truly turnkey solutions to our customers."
Quintiles' Central Lab and its Clinical Development Services (CDS) offices will occupy 80,000 sq. ft. of space in the Cintech IV building now under construction in Singapore's Science Park One. The move is planned for 3Q09. The company has also opened an office in Jakarta and has recently expanded offices in Manila, Taipei, Seoul, Kuala Lumpur, Bangkok, Sydney and Hong Kong. In Singapore, Quintiles has about 225 employees, occupying 40,000 sq. ft. of space in three locations. The new location has a capacity of about 400.
Posted on September 11, 2008 @ 09:29 am
BioReliance Corp. has expanded its Rockville facilities and staff to accommodate the growing demand for its genetic toxicology testing services. BioReliance provides biologics safety testing, toxicology, viral manufacturing and laboratory animal diagnostic services to the pharmaceutical and biopharmaceutical industries.
The expanded gene tox facilities features new labs and additional scientific staff for these services. In March 2008, the company restructured its toxicology and LADS services, forming a new business unit — Toxicology and LADS — headed by Darryl L. Goss, vice president.
Government regulations require gene tox testing to identify the potential of drugs, chemicals and other products to damage DNA. With pharmaceuticals, these tests are used throughout the drug development process, including discovery, lead optimization, preclinical safety testing and to further investigate mechanism of action to help characterize human risk.
“Expanding the facility is in response to the growing needs of the industry. Our dedicated staff works closely with regulatory agencies and customers to ensure faster and safer drug development. The additional capacity will allow us to serve our client’s screening and regulatory required testing needs faster and more efficiently with the highest degree of precision,” said Mr. Goss.
Posted on September 11, 2008 @ 09:27 am
Akorn, Inc. has entered into a 10-year exclusive contract manufacturing supply agreement with an undisclosed ophthalmic company. Under the terms of the agreement, Akorn will be responsible for the development, manufacturing and supply of two new ophthalmic products. The estimated manufacturing revenue from this agreement is $2–$3 million. The two products are targeted for launch in mid-2009.
Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “This agreement reflects Akorn’s commitment to expanding our contract pharmaceutical manufacturing business unit.”
Posted on September 10, 2008 @ 10:31 am
Sanofi-Aventis has named
Chris Viehbacher chief executive officer of the Group, effective December 1st, 2008. He succeeds Gerard Fur, who will continue to provide general management of the Group in the scientific area.
Mr. Viehbacher has spent 20 years of his career within the GlaxoSmithKline Group, where he has held a variety of senior positions, including general manager of France and later of Europe. He most recently served as president Pharmaceutical Operations, North America and as a member of the board.
Posted on September 10, 2008 @ 09:28 am
Cellzome, Inc. and
GlaxoSmithKline entered a worldwide strategic alliance to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases. The alliance gives GSK access to Cellzome's expertise in identifying and developing selective kinase inhibitors and its Kinobeads technology, which screens compounds in a physiological setting and is designed to improve the predictability of these drug candidates in clinical testing. Kinases are key molecular switches in cellular signaling events with a central role in many inflammatory responses. Selective inhibitors offer a different therapeutic approach to diseases such as rheumatoid arthritis or multiple sclerosis.
Under the agreement GSK has exclusive options to license drug candidates from Cellzome's kinase programs directed against four identified targets, and three additional targets to be identified by both parties. Cellzome will use its Kinobeads technology to discover small molecule inhibitors of these targets, and then will develop the most promising candidates through a clinical proof of concept trial, unless GSK elects to exercise its option earlier. In this case GSK would have an exclusive option to license all product candidates from that program. GSK would then assume full responsibility for further clinical development and commercialization on a worldwide basis. Cellzome is eligible to receive success-based milestones as product candidates are advanced and retains the right to continue the development and commercialization of candidates GSK chooses not to develop.
Cellzome will receive upfront payments of $25.3 million comprised of both cash and equity and is eligible for as much as $208 million per program in potential development, regulatory and commercial milestones, in addition to sales-based royalties.
Jose Carlos Gutierrez-Ramos, Ph.D, senior vice president and head of the Immuno-Inflammation Centre of Excellence for Drug Discovery of GSK said, "GSK is committed to becoming a world leader in immuno-inflammation drug discovery by finding transformative medicines through internal efforts and external collaborations. We are excited to be working with Cellzome to discover and develop improved approaches to existing biologic therapies, which cannot access intracellular signaling mechanisms. Cellzome's Kinobeads technology will provide a distinct advantage because it uses native kinases directly isolated from human cells and tissues."
Posted on September 10, 2008 @ 09:26 am
Azopharma Product Development Group announced the successful FDA audit of its
Cyanta Analytical Laboratories facility in Maryland Heights, MO. The audit occurred from Aug 19-20 and produced no 483s or other major observations.
Mr. Phil Meeks, chief executive officer of Azopharma, commented, “We are very pleased with the results of the recent FDA audit. It demonstrates our commitment to quality systems and personnel.”
Cyanta Analytical Laboratories is a member of the Azopharma Product Development Group and provides analytical testing to the pharmaceutical, biotechnology and medical device industries. The Cyanta facility was previously audited in 2006 which also produced no 483s or major observations.
Posted on September 10, 2008 @ 09:24 am
Charles River Laboratories has completed the acquisition of privately held
NewLab BioQuality AG, a Dusseldorf, Germany-based provider of safety and quality control services to biopharmaceutical clients. NewLab joins Charles River Biopharmaceutical Services, which provides services to support the development and manufacture of biologics.
James C. Foster, chairman, president and chief executive officer of Charles River, said, "The acquisition of NewLab further strengthens our portfolio of essential products and services to help our clients accelerate drug development. NewLab enhances the scientific depth, geographic scope and client base of Charles River’s global biopharmaceutical services offering to support the rapidly growing market for biologic drug compounds. We are pleased to welcome NewLab BioQuality to the Charles River family."
Posted on September 9, 2008 @ 09:01 am
Pfizer will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. NDA and the European MAA.
Following feedback from regulatory authorities, the company plans to conduct an additional Phase III trial with dalbavancin for the treatment of adults with complicated skin and skin structure infections caused by Gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus), a virulent and potentially deadly bacterium. The global study will generate additional data to support planned future regulatory submissions. A pediatric program with the drug is also planned.
“After careful consideration of feedback and ongoing dialogue with regulatory authorities, Pfizer has decided to study dalbavancin further in patients with complicated skin and skin structure infections,” said Dr. Mark Kunkel, Pfizer’s global medical therapeutic area leader for anti-infectives and HIV. “Dalbavancin represents a potential important treatment advance and Pfizer is committed to ongoing research of its use in patients who suffer from serious skin infections, including those caused by MRSA.”
Pfizer acquired the drug in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.
Posted on September 9, 2008 @ 08:59 am
Bilcare Global Clinical Supplies has enhanced its global Phase III capabilities. The company has upgraded its Kalish large-scale bottling line at its U.S. facility and invested in new Pentapack blistering technology for expanded packaging capabilities in America and Europe.
The Pentapack CT1200L system allows the company to package high-volume runs for large-scale clinical trials and stability tests. This technology provides additional flexibility in trial design and execution to meet individual client needs. The Pentapack system enables the design of blister packaging configurations online using Trialpack Designer II packaging design software, which can be implemented immediately for production. According to the company, the system’s automation significantly reduces manufacturing times and creates a 21 CFR Part 11-compliant electronic paper trail that documents changes from design to production through quality control.
“Bilcare GCS has built its reputation on providing customers with the highest quality research services and clinical supplies delivered on time, every time,” said Vince Santa Maria, president of Bilcare GCS, Americas. “The Pentapack and the expanded Kalish lines are key components to taking Bilcare’s Phase III clinical trial services to the next level by leveraging state-of-the art packaging technologies to deliver superior quality products in a highly flexible and efficient manner. These latest investments are further proof of Bilcare’s long-term commitment to serving the industry with exceptional
