November 2009
Posted on November 20, 2009 @ 09:18 am
The Almac Group has completed a 67,000-sq.-ft. expansion to its facility in Durham, NC, which now houses the company’s Clinical Services and Diagnostics Divisions. Staff from Almac Diagnostics’ nearby facility in Durham has relocated to the site.
This expansion increased storage capacity for clinical supplies with an additional 3,000 pallet locations. In recent months, the company also completed a specialist clinical supplies storage facility in Craigavon, U.K. and is developing of a 240,000 sq.-ft. North American headquarters facility in Pennsylvania, which is scheduled for completion in 2010. This new facility will initially house Clinical Services and Clinical Technologies operations with expansion from other divisions in the Almac Group.
Donna Christopher, vice president of operations at Almac Clinical Services, Durham site, said, “This latest investment by Almac will act as a platform for us to serve the increasing demands of our client base who are seeking faster routes to get their products through the clinical development process. We now have 200 employees at our NC operations, which is more than five times the number we had when we first started out in 1998 with a team of 35. With over 20 years’ experience in clinical supply management Almac are recognized as a strategic partner in the clinical supply process by most of the world’s pharma and biotech companies. This increase in capacity is a sign of our commitment to offer market driven solutions to our customers.”
Posted on November 20, 2009 @ 09:16 am
Samir Ghodbane, Ph.D., has been appointed as the new general manager of CMC services and CTM manufacturing at
Frontage. Dr. Ghodbane has extensive experience and expertise in product development and technical operations spanning the complete product development cycle, as well as a comprehensive understanding of branded and generic pharmaceutical environments. He has led drug development and technical services at Actavis, Alpharma, and Wyeth. Most recently, he served as vice president of product development and technical services at Actavis, where he oversaw an organization of 180 people located at three different locations.
Daniel Tang, Ph.D., has been appointed vice president of DMPK and bioassay at the company’s operations in Shanghai. Dr. Tang brings experience from ChemPartner, where he managed DMPK operations and business development. He also served as director of bioanalytical services at Quest Pharmaceutical Services and supervised a bioanalytical group of thirteen scientists conducting GLP bioanalysis.
Ron Connolly has been appointed to a new role as senior vice president of business development.Mr. Connolly will be responsible for sales, marketing, and strategic business initiatives at Frontage. He has held several roles at Frontage, including developing and expanding client relationships, as well as various operational roles as head of U.S. operations.In addition, Ron has 20 years of drug development and FDA inspection experience from Flavine, Wyeth, Sanofi Aventis, and GlaxoSmithkline.
“The strategic hiring of Daniel and Samir will add to the experience of our senior management team, providing management to some of our key service areas of growth opportunities both in the U.S. and China,” stated president and chief executive officer Song Li, Ph.D. “Additionally, transitioning Ron to business development will help the development of our sales organization through his in-depth industry experience, providing Frontage the ability to continue to grow our core service offerings.”
Posted on November 20, 2009 @ 09:15 am
Ligand Pharmaceuticals, Inc. has received $2 million in milestone payments from N. V. Organon, a subsidiary of
Merck, through its research collaboration, which is due to expire at the end of December.
“We have had a long and productive drug discovery relationship with Organon and Schering-Plough (which acquired Organon in November 2007) over the years for a range of research programs,” said John L. Higgins, president and chief executive officer of Ligand. “These activities reflect Ligand’s strong R&D engine and the potential of our partnership portfolio.”
Posted on November 19, 2009 @ 09:37 am
PPD, Inc. has signed an agreement to acquire
BioDuro LLC, a drug discovery outsourcing company. The acquisition will expand PPD's drug development capabilities in China. PPD and BioDuro will perform a range of R&D services from early stage through Phase IV.
BioDuro operates a 110,000-sq.-ft. lab in Beijing. Most of its approximately 660 employees are based in China, where it provides medicinal chemistry, biology, pharmacology, drug metabolism, pharmacokinetic and safety services. The company offers resources and services to synthesize novel compounds and optimize compounds to generate drug candidates.
"Under the leadership of Masood Tayebi and the entire senior management group, BioDuro has built an exceptional team of researchers and scientists whose experience extends across a broad range of drug discovery," said David Grange, chief executive officer of PPD. "This acquisition will strengthen PPD's presence in China and position us to provide services for the growing global discovery outsourcing industry."
Masood Tayebi, founder and chairman of BioDuro said, "PPD shares our commitment for delivering world-class, quality services to clients. Combining our drug discovery expertise with PPD's global drug development resources will allow us to move our clients' programs from drug discovery into late-stage drug development and build upon our strong growth in China."
The acquisition, subject to various closing conditions, is expected to close in 4Q09.
Posted on November 19, 2009 @ 09:35 am
PharmaNet Development Group has been selected to conduct and manage
Scancell Ltd.’s Phase I/II trial with SCIB1 scheduled for 1H10. SCIB1 is a DNA ImmunoBody vaccine for the treatment of melanoma.
David Evans, chairman of Scancell, commented, “We are delighted to have selected PharmaNet to manage Scancell’s Phase I/II trial program with SCIB1. PharmaNet’s extensive experience, particularly in the management of early stage oncology clinical trials, will be of critical importance to Scancell as SCIB1 moves into clinical development.”
Jeffrey McMullen, president and chief executive officer, PharmaNet Development Group, commented, "This is our first project with Scancell. We are thrilled to work on Scancell’s innovative therapeutic cancer vaccine, SCIB1, and are very pleased that they have entrusted PharmaNet with their study.”
Posted on November 19, 2009 @ 09:33 am
Patheon has named
Francisco R. Negron as vice president and general manager of its Puerto Rico operations. Mr. Negron will be based at the company's Manati site.
Mr. Negron has more than 19 years of experience in the pharmaceutical industry. Most recently he served as global vice president for Novartis Consumer Health, OTC and Pharmaceutical Products, with a specific focus on global process improvement initiatives. He also served as vice president of manufacturing and supply for Valeant Pharmaceuticals and as site general manager for McNeil Consumer Healthcare in Piedras, PR.
"Franco is the right person at the right time to manage our organization in Puerto Rico," said Mr. Wes Wheeler, Patheon's chief executive officer and president. "His experience leading complex and highly efficient manufacturing teams for a variety of world class pharmaceutical organizations will help us transform our business in PR and will support our stated goal of creating a strong manufacturing presence in that region. He has my full support and I look forward to his contributions to Patheon in the future."
Posted on November 19, 2009 @ 09:31 am
AstraZeneca has submitted a NDA to the FDA for Brilinta, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).
This submission is based on data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), a Phase III trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin.
Brilinta is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. ADP receptor antagonists work to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.
Posted on November 18, 2009 @ 09:13 am
Asterand has signed an agreement to acquire
BioSeek Inc., a drug discovery services company, for $1.0 million payable in Asterand shares. The acquisition is part of Asterand’s strategy to enhance its position in the global human tissue services market, and according to a company statement, will be Asterand’s first step in its “buy and build” strategy.
A further payment of as much as $13 million will be payable in 2011, pending sales growth achieved by BioSeek by December 31, 2010. If further payment is made, the first $3.0 million will be paid in Asterand shares and additional payments will be either cash or shares.
BioSeek has developed a human primary cell based, high throughput assay system (BioMAP) designed to replicate the intricate cell and pathway interactions present in inflammatory, autoimmune and cardiovascular diseases. The system predicts clinical activities of a potential drug candidate through comparison of results to a database of profiles for known compounds.
BioSeek is located in South San Francisco, CA and has 14 employees. BioSeek’s key managers will join Asterand’s senior management team. Additionally, BioSeek’s chief executive officer, Dr. Mike Venuti, has agreed to act as a consultant to Asterand for a transition period.
Posted on November 18, 2009 @ 09:12 am
Formatech has selected
KAI Pharmaceuticals’ KAI-4169 compound as the second clinical candidate to receive “free” manufacturing services under its Fillanthropy Program. KAI-4169 is being evaluated for the treatment of secondary hyperparathyroidism. Under the program, Formatech will donate the services required to aseptically fill and finish one lot of the drug product for use in KAI’s upcoming trials.
Formatech plans to complete the production run of KAI-4169 in 1Q10. “We’re excited to have the opportunity to work with KAI on this program,” said Jeffrey Bernard, Formatech’s director of business development. “KAI’s technology for developing selective Protein C Kinase inhibitors is very promising and has the potential to be very impactful in the treatment of a number of diseases. We’re pleased to donate our services for this program and we wish KAI success with this candidate.”
“It is an honor to receive this award from Formatech as part of their philanthropic effort,” said Steve James, president and chief executive officer of KAI Pharmaceuticals. “We appreciate Formatech’s commitment to this program. Secondary hyperparathyroidism is leading cause of morbidity and mortality in patients with chronic kidney disease. This fill will help support our program and we look forward to exciting results in the year ahead.”
Posted on November 18, 2009 @ 09:10 am
Genzyme Corp. reported results of a Phase II/III study of its advanced phosphate binder (APB). Although the trial met its primary endpoint, which was to show that the APB lowered phosphate levels compared to placebo, the APB did not show a significant improvement in phosphate lowering compared to Genzyme’s Renvela.
As a result, the company is discontinuing further development of the drug. The company was looking to develop a product with higher potency that would more effectively bind phosphate, while maintaining all the benefits of Renvela.
Posted on November 17, 2009 @ 09:14 am
William B. Gerraughty, Jr. has been promoted to chief operating officer at
Sparta Systems. Mr. Gerraughty will be responsible for overseeing the company’s day-to-day operations, providing strategic planning and resource allocation, and advising the chief executive officer and management team on key planning issues and important business decisions. Mr. Gerraughty will also continue to serve in his current position as chief financial officer and manage the company’s legal and human resource departments.
Prior to joining the company, Mr. Gerraughty served as chief financial officer at NMS Communications and Infinium Software. He also held a number of executive positions, including president, chief operating officer and chief financial officer, at Intellution, a software company serving the industrial automation markets. He began his career at Coopers and Lybrand.
“William Gerraughty’s success in ensuring the financial health of Sparta Systems makes him a natural choice to oversee the company’s daily operation as we head into 2010,” said James E. McGowan, chief executive officer, Sparta Systems.“I’m confident that with his unparalleled record of accomplishment and complete knowledge of the company’s inner workings, his promotion to COO will help position Sparta for continued growth in the coming year and beyond.”
Posted on November 17, 2009 @ 09:11 am
PPD, Inc. has entered an agreement with
Janssen Pharmaceutica to develop and commercialize two Phase II therapeutic compounds, one for diarrhea-predominant irritable bowel syndrome (IBS-d) and one for complicated skin and skin structure and respiratory infections.
PPD in-licensed the two compounds and will advance them through Phase II development. At the completion of Phase II, Janssen will have the option to resume development and commercialization. In exchange, PPD will receive as much as $330 million in clinical and sales milestones, as well as royalties on sales. If Janssen doesn’t chose to take over the program, PPD will have the option to continue development and commercialization and Janssen will receive as much as $250 million in clinical and sales milestones and royalties.
"Our agreements with Janssen diversify and strengthen our compound partnering portfolio and may gain us entry into two large markets," said Fred Eshelman, executive chairman of PPD. "The IBS-d market holds significant drug development potential because of the lack of approved products for this indication, and new antibiotics are needed to address increasing incidences of resistant strain bacterial infections."
The IBS-d compound is a potential locally active mu opioid receptor agonist and delta opioid receptor antagonist. The anti-bacterial compound is a broad-spectrum fluoroquinolone potential antibiotic with activity against gram positive and gram negative bacteria and methicillin-resistant staph aureus (MRSA). It is being developed as both an oral and intravenous therapy to treat skin and respiratory infections.
Posted on November 17, 2009 @ 09:10 am
Genentech has submitted two sBLAs to the FDA for Avastin for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that evaluated Avastin in combination with docetaxel chemotherapy. The other is based on the Phase III study RIBBON 1 that investigated Avastin in combination with a taxane, anthracycline-based or capecitabine chemotherapy. Both studies met the primary endpoints of improving the progression-free survival.
"We look forward to working with the FDA to evaluate the data from more than 2,600 women with advanced breast cancer who participated in these studies that showed Avastin in combination with various chemotherapies helped them live longer without the disease worsening,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer.
Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer.
Posted on November 17, 2009 @ 08:47 am
Azopharma Product Development Group (Booth 1801) has integrated its eight service divisions as part of an effort to streamline its approach to product development for small biotechs and large pharma alike, supporting both full development and specialty stand-alone projects.
The Azophrma Product Development Group — previously made up of Azopharma, APIcross, IQsynthesis, AniClin, Cyanta, ADMEQuant, AvivoClin, and Acromon — has been consolidated into three divisions: Azopharma Contract Pharmaceutical Services, AniClin Preclinical Services, and AvioClin Clinical Services.
At a press event during AAPS, a spokesman for the company said that Azopharma is focusing on its core services and has no acquisition plans for the near future. In the past year, Azopharma expanded despite the down economy, adding to its analytical services in Welwyn Garden City, UK and in Maryland Heights, MO, microdosing and central lab services to its pharmacology research facility in Daytona Beach FL, and more recently, new cytotoxic manufacturing suites for clinical trial materials at its (south Florida) Hollywood location.
Microdosing, a trend among pharmaceutical and regulatory agencies, allows companies to make “kill or carry” decisions with earlier pharmacokinetic and pharmacodynamic data in humans. In microdosing studies, drug substance is dosed sufficiently low not to have observable pharmacological activity, but to screen the ADME properties of several drug candidates. These studies have seen a big push from the FDA through its Critical Path initiative.
Cytotoxic compounds are becoming more prominent in the oncology drug realm. These compounds are difficult and dangerous to work with. With its three new manufacturing suites, equipment, and analytical instrumentation, the company is better positioned to support cytotoxic and highly potent compounds for development. Currently Azopharma is manufacturing two niche commercial products for clients: a cytotoxic product and a highly potent compound. With use of cytotoxics predicted to grow, the spokesman contended that the company is very interested in this smaller volume market.
Azopharma is also tapping into strategic partnerships. The group recently entered ones with Pharmanet to leverage complementary services through business development and co-promotion, and Immunregen, under which Azopharma provides development services in exchange for taking equity in the company.
Posted on November 17, 2009 @ 08:39 am
Although active-only powder in capsule approaches are increasingly popular for Phase I trials, they may result in significantly slower, more erratic and less complete in vitro dissolution for some poorly soluble compounds – with the potential to skew in vivo results and delay or abandon work into promising new drugs. So says Dr. Michael Ruff, CPIP, vice president of pharmaceutical development at
Metrics Inc. (Booth 2133). Dr. Ruff presented his research findings during a poster session on Nov. 9 at AAPS.
In a recent study, Dr. Ruff compared the in vitro dissolution of a non-formulated, active-only powder in capsule to that of a formulated capsule in the case of a poorly soluble drug intended for Phase I trials. He reported that his findings represent a cautionary tale for the pharmaceutical industry, which has increasingly taken an active-only, powder-in-capsule approach towards conducting Phase I first-time-in-man trials. This approach enables companies to skip significant formulation and analytical development activities and put prospective new compounds into patients more quickly.
“Going with a drug-only-in-capsule approach can move up first-time-in-man clinical dosing by two to four months, depending on the complexity of the intended dosage form,” Dr. Ruff said. But in his study examining a typically poorly soluble compound, he found that the powder-in-capsule approach resulted in significantly slower, more erratic and less complete in-vitro dissolution. This situation could potentially yield false negative in vivo results, delaying future trials or causing researchers to abandon studies of potentially beneficial new drugs, he warned.
“I recognize that there’s tremendous pressure to reach that first-in-man milestone – it’s what the industry and shareholders expect,” Dr. Ruff said. “So I’m not suggesting that researchers never do active-only powder in capsule. But this limited data supports the theory that agglomeration of micronized, poorly soluble active ingredients can pose a problem for this approach.”
Headquartered in Greenville, NC, Metrics provides pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.
Posted on November 16, 2009 @ 03:41 pm
Almac Sciences, part of
Almac Group (Booth 2600), has made several appointments.
Denis Geffroy has been named vice president Business Development, with global responsibility. Mr. Geffroy was most recently senior business manager Europe and had been leading Almac Sciences’ rapidd™ early stage development offering.
He joined Almac Sciences in 2004 and has notably developed the European business by adding numerous major pharmaceutical clients to the Almac Sciences portfolio. His new remit includes lab synthesis, PRD chemistry, GMP manufacturing, analytical services, peptide synthesis, radio-labelling, solid state chemistry and biocatalysis. He previously held technology and commercial roles with Chiroscience/ChiroTech and ICI/Synetix Chiral Technologies.
Dr. Charles Shields is joining Almac Sciences as vice president Peptides Operations. Dr. Shields was formerly U.S.-based vice president Global Business Development for Avecia’s oligonucleotides (DNA medicines) business. Prior to 2003 he held a series of senior positions with Avecia, including New Products Development Manager with its Ink Jet Printing Materials business.
Helen McKeever has been named as preclinical program manager, responsible for implementation of rappid™ early stage development programmes. A biochemist with more than 20 years’ CRO experience, Ms. McKeever was most recently senior project manager with Covance.
Almac Sciences president and managing director Stephen Barr remarked, “These appointments bring high levels of proven customer service leadership and delivery in key areas of Sciences’ business, and further increase our emphasis on added value services.”
Posted on November 16, 2009 @ 03:35 pm
Quay Pharma (Booth 2412) is investing nearly $4 million to move to a new purpose-designed factory and headquarters, allowing the company to greatly increase its development and clinical trial manufacturing capacities. The move is expected to create around 52 jobs in the next three years.
The new facility in North Wales, UK, is close to Quay Pharma’s existing premises in the Wirral, and brings together the company’s entire range of services — currently housed in two separate facilities — under one roof.The 40,400-sq.-ft. building, which is four times the size of its existing premises, will feature a variety of state-of-the-art equipment that will enable the company to meet increasing demand for its specialist capabilities, including formulation development, novel drug delivery design, analytical method development and clinical trial manufacture and packaging.
In particular, the expanded operation will provide the opportunity for the further development of Quay Pharma’s expertise in oral dosage form design and development, especially for new chemical entities that exhibit poor solubility and bio-availability, according to the company.
“Our extensive knowledge and experience can play a crucial role in the critical early stages of drug development and in recent years we have seen increasing demand for our services,” said Quay Pharma’s chief executive, Mike Rubinstein. “By creating this new advanced facility to our specific requirements, we will be able to offer an enhanced level of support to our clients.”
The move is planned for January 2010, and will be phased to ensure work on existing client projects is maintained throughout. The new facility is being part funded by a grant from the Welsh Authority Government.
Posted on November 16, 2009 @ 03:29 pm
Avantium (Booth 2061) and Avant-garde Materials Simulations (AMS) have entered into a collaboration for the further development and commercialization of Crystal Structure Prediction (CSP) with AMS’ GRACE software. Pharmaceutical companies can use CSP to predict the crystal structures of their drug compounds. CSP provides an essential approach to significantly reduce the risk of missing a more stable crystal form.
AMS will further develop the software to accelerate the calculations and broaden the range of compounds for which it can be used. AMS will also perform the predictions for third parties. Avantium will develop efficient experimental strategies to physically generate the predicted crystal forms and commercialize Crystal Structure Prediction as a stand-alone service or in combination with experimental programs.
CSP, as developed by AMS, is a breakthrough approach, showing for the first time that the reliable prediction of crystal forms is feasible. AMS in collaboration with the Institute of Pharmaceutical Innovation at the University of Bradford were the first participants ever to score a 4 out of 4 success rate at the 2007 CSP Blind Test.
“The scope of applicability and the accuracy of CSP will continue to improve rapidly,” said Marcus Neumann, managing director of AMS. “The next key challenge is to actually produce predicted but not yet observed forms by rational experiment design. With Avantium Pharma we have found the ideal partner to write the next chapter of the story.”
“The CSP technology is a great extension of our service portfolio,” remarked Guus Scheefhals, chief operating officer of Avantium Pharma. “The predictions will prevent overlooking the most stable crystal form, which will strengthen the IP position of our clients and will help to reduce the risk of crystal form inter-conversions in drug development.”
Posted on November 16, 2009 @ 09:14 am
GlaxoSmithKline and
Nabi Biopharmaceuticals entered an exclusive worldwide option and licensing agreement for nicotine conjugate candidate vaccine NicVAX, an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.
Nabi will receive $40 million upfront and GSK will have an option to exclusively in-license NicVAX on a worldwide basis and a license to develop follow-on next-gen nicotine vaccines using Nabi's intellectual property. Nabi is eligible to receive more than $500 million in option fees and regulatory, development and sales milestones. Nabi will also receive royalties on global sales of NicVAX and next-gen nicotine vaccines, should GSK exercise its option.
NicVAX is currently in Phase III trials. Nabi will be responsible for the Phase III development costs. Upon successful completion of the Phase III studies, GSK can exercise its option to take over further development and commercialization.
"If approved, this smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent, a habit that is well documented to be very hard to stop permanently," said Jean Stephenne, president of GSK Biologicals. "This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio."
"We are very pleased with this deal and proud it is with GSK, one of the world's leading vaccine companies, to further develop and commercialize NicVAX," said Dr. Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. "We look forward to addressing one of the largest unmet medical needs of our time with what we believe will be an effective tool to help people quit smoking and remain smoke-fee for the rest of their lives."
The transaction, subject to approval and customary closing conditions, is expected to close in 1Q10.
Posted on November 16, 2009 @ 09:10 am
Sciele Pharma, Inc., a U.S.-based group of Shionogi & Co., Ltd., has entered an agreement to acquire and
Addrenex Pharmaceuticals, a private, specialty pharmaceutical company, for approximately $29 million in cash.
Addrenex specializes in developing drugs that regulate the adrenergic system. Sciele previously licensed three products from Addrenex: Clonicel for attention deficit hyperactivity disorder (ADHD), Jenloga XR for hypertension, and ADX-415 for the treatment of vasomotor systems and hypertension. The NDA for Clonicel was filed with the FDA in October 2009.
With the acquisition, Sciele will gain two additional mid-stage development products and access to a large library of compounds in various therapeutic areas, including pain management, cardiovascular, and dermatology.
Patrick Fourteau, president and chief executive officer of Sciele Pharma, said, “We are pleased to announce the acquisition of Addrenex, a company we established a partnership with more than two years ago. Addrenex has an exciting development platform and several compounds that have the potential to further expand and diversify our product portfolio.”
Moise Khayrallah, Ph.D., chief executive officer of Addrenex, said, “Sciele Pharma has been a valuable partner and catalyst for the success of Addrenex. The partnership has enabled our team to expand the development pipeline and now gives Sciele access to a large portfolio of products that offer tremendous promise for patients and their families.”
Posted on November 16, 2009 @ 09:07 am
Robert A. Stewart has joined
Watson Pharmaceuticals in the newly created position of senior vice president, Global Operations, effective immediately. Mr. Stewart will be responsible for global manufacturing, supply chain, quality and technical operations. He joins the company from Abbott Laboratories, where he most recently served as divisional vice president, Global Supply Chain.
Also,
Thomas R. Russillo has been named executive vice president, Global Generics and will head the company's newly formed Global Generics commercial function. Mr. Russillo will have overall responsibility for generic sales and marketing for the U.S. and Canada, as well for all international markets once the acquisition of Arrow Group is complete. Previously, he served as executive vice president and president of Watson’s Generics Division since 2006. Both Mr. Stewart and Mr. Russillo report to Paul Bisaro, president and chief executive officer of Watson.
"As we prepare to maximize our global footprint following the acquisition of the Arrow Group, we are refining our management structure in ways that will enhance our ability to aggressively capitalize on expanded opportunities," said Mr. Bisaro. "Bob brings more than 20 years of experience in global pharmaceutical supply chain management. By centralizing all quality and supply chain functions under his leadership, we can ensure that we more effectively continue to pursue additional cost and operational efficiencies under our Global Supply Chain Initiative and Operational Excellence programs. In addition, Bob's extensive international experience will help us maximize the increased international capabilities we gain following the closing of the Arrow acquisition."
Mr. Bisaro continued, "By creating this Global Generics commercial structure, we will look to Tom to develop the strategies that will strengthen and grow Watson's and Arrow's current product portfolios and market positions around the world. He will also have responsibility for ensuring that our commercial needs are appropriately aligned with new product R&D and that Watson efficiently expands its generics position with key product introductions across the 20 countries in which we will operate, including established, expanding and emerging markets."
Posted on November 13, 2009 @ 10:17 am
Steven M. Paul, M.D., executive vice president, science and technology, and president,
Lilly Research Laboratories, will retire, effective February 28, 2010.
Jan M. Lundberg, Ph.D., executive vice president and head of global discovery research, AstraZeneca, will succeed Dr. Paul. Dr. Lundberg plans to join Lilly in Indianapolis as early as January 2010.
"Under Steve's leadership, we now have the most robust pipeline in Lilly's history, including approximately 60 unique potential medicines, both small molecules and biologics, in human testing. Additionally, Steve has helped to recruit many of the top leaders we have in LRL today. Steve has also been actively involved in advancing Lilly's research in the area of Alzheimer's disease, including solanezumab, one of Lilly's two late-stage Alzheimer's molecules," said John Lechleiter, Ph.D., Lilly’s chairman and chief executive officer.
"Advancing our pipeline to patients as quickly and as safely as possible is the biggest challenge Lilly faces in 2010 and beyond. We are confident that Dr. Lundberg will be able to deliver on this challenge," said Lechleiter.
During the last 10 years at AZ, as head of global discovery research, Dr. Lundberg was instrumental in delivering more than 150 drug candidates to the company's pipeline. He had responsibility for discovery research and supported clinical development of therapies for cancer, infection, central nervous system disorders, pain, cardiovascular, metabolic and respiratory diseases, gastrointestinal conditions, and inflammation. Dr. Lundberg was also responsible for discovery-enabling technologies, discovery informatics, drug metabolism and pharmacokinetics, translational science and safety assessment. He has had a leading role in external activities, including in-licensing of projects and technologies, as well as acquisitions of biotech companies.
"I have always had tremendous respect for the quality of people, science and products at Lilly. Therefore, I feel honored to be the successor to Steve Paul. I'm really looking forward to meeting my colleagues at Lilly and together with them conquering the future challenges and advancing innovative medicines that meet the needs of patients, payers and prescribers," said Dr. Lundberg.
Posted on November 13, 2009 @ 10:14 am
Abbott has entered into a definitive agreement to acquire the global rights to PanGenetics BV's PG110 fully humanized antibody to Nerve Growth Factor (NGF). The agreement includes an upfront payment of $170 million plus additional milestone payments, for a total of $190 million, as well as royalties.
PG110 is a biologic in Phase I development for the treatment of chronic pain. NGF is released at sites of tissue damage and inflammation, and plays a significant role in the transmission of pain signals by the central nervous system. PG110 is currently being studied in a Phase I trial in patients with osteoarthritis. If successful, Abbott anticipates evaluating the compound in a number of other pain states, including chronic lower back pain, cancer pain and diabetic neuropathic pain.
"The goal for treatment of chronic pain continues to be potent, long-lasting analgesia that is tolerable for patients without the potential for dependence and abuse," said John Leonard, M.D., senior vice president, global research and development, Abbott. "NGF blockers have demonstrated the potential to address all of these needs, making them a promising treatment for chronic pain patients."
This transaction, subject to customary closing conditions and regulatory approvals, is expected to close in 4Q09.
Posted on November 13, 2009 @ 10:11 am
BioInvent International has entered into a license and discovery agreement with
Daiichi Sankyo Co. for the development of therapeutic antibodies against multiple targets. Daiichi Sankyo will have access to BioInvent's discovery and development technology platform, n-CoDeR library, and in-house antibody expertise. As part of the agreement, BioInvent has secured certain co-promotion rights in Scandinavia and the Baltic countries.
BioInvent will receive an upfront access fee and annual maintenance fees for its antibody library, and success-based milestone payments. Daiichi Sankyo will fund all research work and BioInvent is entitled to royalties on any commercialized products. Financial terms were not disclosed.
As well as working with Daiichi Sankyo in Japan, BioInvent will also work with the company’s German affiliate U3 Pharma GmbH. A joint steering committee will oversee the discovery and development process.
Svein Mathisen, chief executive officer of BioInvent, commented, “We are pleased that our technology platform and expertise continue to attract the attention and long term commitment of big pharma. BioInvent is established as a trusted partner for the discovery and development of therapeutic antibodies, and with this agreement we are continuing to grow our presence and recognition in the Japanese market.”
The n-CoDeR library contains more than 20 billion diverse, fully human antibody fragments that have been created using BioInvent's technology platform.
Posted on November 11, 2009 @ 10:59 am
Sanofi-aventis and
Regeneron Pharmaceuticals, Inc. entered into agreements to expand and extend their existing global collaboration established November 2007, to discover, develop, and commercialize therapeutic monoclonal antibodies.
Sanofi-aventis will increase its annual funding from $100million to $160 million beginning in 2010, and the research funding will extend through 2017. The companies plan to advance an average of four to five antibodies into clinical development each year. Sanofi-aventis has an option to extend the discovery program for an additional three years. Regeneron will contribute its VelocImmune technology to the collaboration and its next generation technologies for antibody generation.
"The first two years of our collaboration with sanofi-aventis have been extremely productive, with five VelocImmune human antibodies in or entering clinical development," commented Leonard S. Schleifer, M.D., Ph.D., president and chief executive officer of Regeneron. "The expansion of our collaboration provides even greater resources over a longer time horizon and will boost our efforts to build a deep pipeline of new human antibody product candidates. Sanofi-aventis is an ideal partner with the expertise and global reach to collaborate with us on our mission to bring important new medicines to patients around the world."
"This collaboration expansion demonstrates sanofi-aventis' commitment to become a key player in the field of monoclonal antibodies and our confidence in our partner Regeneron," declared Marc Cluzel, executive vice president, R&D, sanofi-aventis. "It will further fuel our product pipeline and will allow us to bring multiple antibody product candidates into the clinic, thereby significantly increasing the chance of providing patients access to innovative drugs in various therapeutic areas."
To date, the two companies have advanced four therapeutic antibodies into clinical development and have filed an IND for a fifth additional antibody.
Posted on November 11, 2009 @ 10:57 am
GlaxoSmithKline received approval from the FDA for its sBLA for unadjuvanted influenza A (H1N1) pandemic vaccine. The approval, which was filed as a strain change supplement to GSK’s FluLaval seasonal flu vaccine, allows the company to manufacture a flu vaccine for use in adults to prevent the 2009 pandemic H1N1 influenza A strain.
The United States Department of Health and Human Services has placed an order to fill 7.6 million doses of the vaccine.The vaccine will be produced in multi-dose vials from bulk vaccine manufactured at GSK’s facility in Quebec, Canada.GSK expects to begin shipping vaccine in December and to provide all 7.6 million doses by the end of the year.
Posted on November 11, 2009 @ 10:55 am
Particle Sciences Inc. has acquired additional space bringing its total to approximately 21,000 sq.-ft. The company expects the new space to be operational in 1Q10.
"Our current workload and existing pipeline simply necessitates this addition," said Dr. Mark Mitchnick, chief executive officer. "2009 has been a record year for us and we have pretty good visibility on the next 12 months. The additional space will be used to expand our cGMP warehouse capacity. Also, we will construct a purpose-built sampling and weighing area for highly potent materials.
According to Robert Lee, Ph.D., Particle Sciences vice president of Pharmaceutical Development, "Increasingly, clients are coming to us for clinical trial material manufacturing and to work with a greater number of highly potent compounds. We are fortunate that we are able to expand into both of those needs."
Posted on November 10, 2009 @ 09:39 am
Pfizer has plans to close six R&D sites and cut an unspecified number of jobs in the U.S. and the UK as part of its integration with Wyeth.
According to a company statement, Pfizer will reduce its global R&D square footage by 35%, and will discontinue R&D operations in Princeton, NJ; Chazy, Rouses Point and Plattsburgh, NY; Sanford and Research Triangle Park, NC; and Gosport, Slough/Taplow, UK.
Pfizer will now have five main R&D sites for BioTherapeutics, PharmaTherapeutics and Vaccines. These sites are: Cambridge, MA; Groton, CT; Pearl River, NY; La Jolla, CA; and Sandwich, U.K. These research labs will be supplemented by specialized research capabilities, such as monoclonal antibody discovery in San Francisco, regenerative medicine work in Cambridge, UK, and R&D activities in Shanghai, China.
“By focusing our R&D operations in these centers, we are building the world’s premier biopharmaceutical R&D enterprise,” said Mikael Dolsten, president of BioTherapeutics R&D. “This new structure puts Pfizer in the best position to conduct cutting-edge research within and beyond our own laboratories and to deliver a portfolio of high-impact medicines to patients.”
While these changes are expected to bolster productivity and reduce costs, they will result in staff reductions, according to Martin Mackay, president, PharmaTherapeutics R&D.
Posted on November 10, 2009 @ 09:36 am
Bristol-Myers Squibb and
Alder Biopharmaceuticals, Inc. entered a global agreement for the development and commercialization of ALD518, a biologic that has completed Phase IIa development for the treatment of rheumatoid arthritis.
Under the terms of the collaboration, BMS gains worldwide exclusive rights to develop and commercialize the drug for all potential indications except cancer, for which Alder will retain rights and BMS has an option to co-develop and commercialize outside the U.S. Alder will receive an upfront cash payment of $85 million, development and regulatory-based milestone payments of as much as $764 million, sales milestones which, under certain circumstances, may exceed $200 million, and royalties on sales. Additionally, Alder has an option to require BMS to make an equity investment of as much as $20 million in Alder during an initial public offering.
“With its novel mechanism of action, ALD518 has the potential to offer an exciting new option for patients with rheumatoid arthritis,” said Brian Daniels, M.D., senior vice president, Global Development & Medical Affairs, BMS. “We are pleased to have the opportunity to develop this novel monoclonal antibody. As part of our String of Pearls strategy, this transaction provides Bristol-Myers Squibb with the opportunity to strengthen our immunoscience pipeline, and leverage our company’s experience in developing and delivering novel biologics to help patients prevail over rheumatoid arthritis and, potentially, other autoimmune diseases.”
“Bristol-Myers Squibb and Alder share the vision that ALD518 could become an important part of treating patients with rheumatoid arthritis,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder Biopharmaceuticals. “Bristol-Myers Squibb’s extensive development and commercial experience in immunology translate into an exceptionally good fit for Alder, especially at this stage of our corporate development.”
Posted on November 10, 2009 @ 09:29 am
Novavax, Inc. initiated a Phase IIa study of its trivalent seasonal influenza VLP vaccine candidate in healthy adults 60 years of age or older. This randomized, double-blind, active-controlled study is evaluating the safety, tolerability and immunogenicity of two different doses of Novavax's VLP vaccine compared with a commercially available trivalent inactivated vaccine (TIV, Fluzone). Novavax's vaccine contains VLPs made up of the hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins against the H3N2, H1N1, and B strains recommended for 2009-2010 flu vaccines.
"This is a very important study because it will help establish the safety and immunogenicity of our trivalent seasonal influenza VLP vaccine in older adults and allow us to select a dose for a future Phase IIb confirmatory, non-inferiority clinical trial in this population. Moreover, it will also give us a clear signal of how our seasonal influenza VLP vaccine compares to the current standard of care, TIV (Fluzone)," said Dr. Rahul Singhvi, president and chief executive officer of Novavax. "Recall that in a recent Phase II study in healthy adults ranging in ages from 18-49 years, we showed that our seasonal influenza VLP vaccine was safe and immunogenic at 15 and 60 mcg dose levels. These data give us great confidence as we move forward in this current clinical trial in older adults."
A total of 480 subjects will be enrolled at approximately six sites in the U.S. and one site in India. Preclinical studies have shown that influenza VLP vaccines have stronger T-cell responses than TIV (Fluzone), indicating the potential for better immunologic responses in trials particularly in older adults.
Posted on November 10, 2009 @ 09:06 am
SMI Manufacturing (Booth 1709) has agreed to invest $10 million into HealthSport, Inc., a formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion. The investment is expected to accelerate HealthSport's growth and strengthen its alliances with large pharmaceutical companies.
"The first phase of our relationship with HealthSport was accomplished in July of this year with the signing of the manufacturing agreement between the two companies. This investment represents the next step in that relationship, which is to begin the process of making this breakthrough technology available to the pharmaceutical industry on a worldwide basis," stated Kevin Taheri, SMI's chief executive officer.
"It has been apparent for some time that there is a very strong synergistic relationship between SMI and HealthSport. We are looking to take advantage of that relationship to not only produce dietary supplement and OTC film strip products, but also to begin working with pharmaceutical companies to enter the highly profitable prescription pharmaceutical market," stated Hank Durschlag, chief executive officer of HealthSport. "Our drug delivery platform is ideal for many drugs already used everyday."
SMI and HealthSport signed a stock purchase agreement pursuant to which SMI will invest the $10 million into HealthSport in exchange for a 55% percent stake in HealthSport. Closing of the transaction is anticipated to occur in the next 15 to 20 days. At the time of the closing, SMI will deliver to HealthSport $2 million and a promissory note for $8 million that SMI will pay in five installments through the final scheduled payment on June 30, 2010. Funds from the investment will be used to strengthen HealthSport's working capital position, provide funds for R&D and enhance HealthSport's current manufacturing plant, creating a state-of-the-art, GMP compliant R&D and production facility.
Posted on November 10, 2009 @ 08:52 am
Patheon (Booth 1232) has named William E. Weiser, Ph.D. to the role of group director, Pharmaceutical Development Services (PDS), Analytical Development at the company's Kit Creek laboratory in Research Triangle Park, NC. Also, Anthony Qu, Ph.D. has been named group director of the PDS operation in Cincinnati, OH.
"We are so pleased that we have been able to add these two individuals to our organization," said Dr. Colin Minchom, Patheon's vice president PDS North America. "I am confident that our customers and employees will benefit from their broad expertise as leaders and as scientists in research and development."
Dr. Weiser has over 20 years experience in the pharmaceutical industry. Most recently he served as general manager for Liquidia Pharmaceuticals with responsibility for establishing pharmaceutical development operations for nanoparticle therapeutics as well as formulation and analytical development capabilities. He was vice president of analytical chemistry at Cardinal Health/Magellan Laboratories, where he contributed to the growth of their contract pharmaceutical analytical services business. Dr. Weiser also held positions of increasing leadership in Pharmaceutical Development at Burroughs Wellcome Co.
Dr. Qu, with almost 20 years experience in the pharmaceutical industry, is returning to Patheon from his most recent position as vice president of product development at Apotex. His previous Patheon experience included responsibilities as senior director of PDS Global Analytical Operations and director/manager, PDS Analytical Development in Mississauga, ONT, Canada. He has also held positions in R&D and regulatory affairs at Biovail and Taro Pharmaceuticals.
Visit Patheon at Booth 1232!
Posted on November 9, 2009 @ 12:08 pm
AMRI 3Q09
3Q Revenues: $47.7 million (-22%)
3Q Earnings: $0.4 million
YTD Revenues: $153.0 million (-12%)
YTD Earnings: $2.5 million
Comments: Total contract revenues dropped 27% to $39.7 million from 3Q08; Discovery Services was $11.9 million (-27%), Development/Small Scale Manufacturing was $9.7 million (-33%) and Large Scale Manufacturing was $18.2 million (-22%). Contract revenues are down 17% YTD to $121.8 million. Recurring royalties for the quarter were up 39% to $7.9 million.
Posted on November 9, 2009 @ 12:02 pm
Evotec AG and Boehringer Ingelheim have extended their research collabration for four more years. The collaboration was initiated in August 2004 and has been extended on two previous occasions. Based on the success to date in the areas of CNS, inflammation, cardiometabolic and respiratory diseases, the companies have elected to expand the scope of the collaboration to also include oncology targets. Through the term of the extension, Evotec will receive research funding of $22 million, as well as milestones and royalties.
In 2004, Evotec and BI entered into a multiyear drug discovery collaboration to jointly identify and develop preclinical development candidates for the treatment of various diseases. BI has full ownership and global responsibility for clinical development, manufacturing and commercialization of the compounds identified.
In return, Evotec receives ongoing research payments and preclinical milestones. Furthermore, the contract provides substantial long-term upside for Evotec through potential payments for successful milestone achievements during clinical development and royalties when new drugs reach the market.
Dr. Werner Lanthaler, chief executive officer of Evotec, commented, "We are extremely pleased and proud that Boehringer Ingelheim continues to see the value that we bring to their research, by committing to one of the largest and most innovative integrated research projects in the industry. This extension speaks volumes for the excellent scientific results achieved."
Dr. Wolfgang Rettig, corporate senior vice president research of BI, remarked, "Evotec has continually demonstrated exceptional scientific expertise in support of our research. We are very pleased to be able to continue our collaboration with Evotec and expand it into new areas of research and have no doubt that they will continue to assist us in achieving our drug discovery goals."
Posted on November 9, 2009 @ 08:54 am
Enzon Pharmaceuticals (Booth 611) will sell its specialty pharmaceutical business, including its CMO operations, to the sigma-tau Group for $300 million plus an additional amount of up to $27 million based on success milestones. Enzon will also receive royalties of 5 to 10% on incremental net sales above a 2009 baseline amount from Enzon’s four marketed specialty pharmaceutical products through 2014.
Enzon’s specialty pharmaceutical business includes four marketed products: Oncaspar, Adagen, DepoCyt, and Abelcet, as well as the manufacturing facility in Indianapolis, IN which will be purchased by a U.S. subsidiary of Sigma-Tau Pharmaceuticals, Inc., based in MD. Sigma-Tau Pharmaceuticals will distribute the products in the U.S. market.
After the sale of these assets, Enzon’s businesses will consist of its royalties, Peg SN38 and our LNA and PEG technology platforms. “Enzon’s board is evaluating options to return most of the value of this sale to shareholders,” stated Alex Denner, chairman.
“sigma-tau is a great strategic fit for this business, as they have the presence and expertise to effectively market these products in all geographic areas,” said Jeffrey H. Buchalter, Enzon’s president and chief executive officer.
sigma-tau is a global R&D driven, Italian-owned pharmaceutical company dedicated, among other areas, to developing and commercializing medicines for rare diseases. This acquisition will expand sigma-tau’s current presence in the U.S. and in new therapeutic areas.
Marc Tewey, vice president, commercial operations of Sigma-Tau Pharamceuticals, confirmed that the company plans to continue the CMO business.
“sigma-tau is dedicated to providing novel therapeutics to patients suffering from rare diseases and other unmet medical needs,” said Claudio Cavazza, sigma-tau’s president. “Through the acquisition of Enzon’s specialty pharmaceutical business, we will increase our presence in the field of rare diseases with products of great value which are the result of an outstanding research activity. sigma-tau is determined to continue Enzon’s excellent work, especially in the field of rare diseases which is a particularly stimulating one as it aims at tackling life-threatening conditions which all too often affect the very young.”
Posted on November 9, 2009 @ 08:32 am
Win free registration and hotel for 2010 AAPS, courtesy of DPT (Booth 1701)!
Register with DPT for a chance to win FREE registration and hotel stay during the 2010 AAPS Annual Meeting & Expo in New Orleans. Entry tickets are in AAPS registration bags (or you can stop by DPT's booth to pick one up).
Drop off your entry ticket at booth 1701 for your chance to win.One winner will be selected each day of the tradeshow!
(NOTE: must be a pharmaceutical, biotechnology or consumer healthcare employee to enter.)
Posted on November 9, 2009 @ 08:28 am
Catalent Pharma Solutions (Booth 1301) has entered into a strategic alliance with Endotis Pharma for the development of oral formulations of synthetic oligosaccharides.
Using Catalent's drug delivery technologies, the two companies will collaborate exclusively to develop certain oral formulations of small-glycol drugs. Oral formulations of synthetic oligosaccharides will allow full exploitation of the therapeutic potential of small-glycol drugs, which to date are administered only intravenously or subcutaneously.
Catalent and Endotis are initially focusing on the preclinical development of Endotis' EP37151 compound. EP37151 is a first-in-class oral synthetic oligosaccharide anticoagulant which, as an indirect factor Xa inhibitor, acts via antithrombin activation. The companies expect to initiate a Phase I clinical trial program during the second quarter of 2010, and hope to have more oral anticoagulants enter development within the next year.
"This collaboration with Endotis, based upon a unique combination of complementary expertise, has been providing exciting results, proving that the various technical hurdles associated with the oral delivery of small-glycol drugs can be overcome," said Tom Stuart, group president of Catalent's Oral Technologies segment.
Visit Catalent Pharma Solutions at Booth 1301!
Posted on November 9, 2009 @ 08:27 am
DSM Pharmaceutical Products (Booth 1333) has entered a manufacturing alliance with Galenix of Saint Jean D'Illac, France, in which DSM will be the preferred commercial scale manufacturing partner for Galenix commercial products on a global basis.
DSM and Galenix will collaborate on business development opportunities co-marketing Galenix drug delivery technologies, based on the strength of Galenix in drug product development and clinical services and DSM in process development, scale up and commercial scale pharmaceutical manufacturing.
Pieter de Geus, DSM Pharmaceuticals' senior vice president, R&D stated, "These innovative drug delivery technologies enhance our offering in the field of pharmaceutical development services and complement our portfolio of drug delivery technologies. The collaboration with Galenix clearly demonstrates DSM's commitment to bringing improved drug delivery to markets globally."
Hans Engels, president of DSM Pharmaceuticals, added, "The alliance brings out the best of both parties. Combining innovative formulations with flawless transition into commercial products creates an attractive value proposition for any drug company."
Jerome Besse, chief executive officer of Galenix, commented, "This is truly a win-win situation. Galenix is privileged in working with DSM to generate value for our customers. The partnership fits with our strategic intention of expanding service offerings to the North America market, and also with DSM's expansion of sales & marketing focus in Europe."
No financial terms were disclosed.
Posted on November 9, 2009 @ 08:26 am
Analytical Bio-Chemistry Laboratories (ABC, Booth 1119) has expanded its offerings to include comprehensive support for large molecule development.
"This recent investment in biotech development services complements ABC's long history of ELISA, RIA and EIA experience and bioanalytical support. It also leverages ABC's extensive analytical capabilities to provide our clients with more comprehensive support for both large and small molecules," said John Bucksath, general manager and senior vice president of ABC's Pharmaceutical Services division.
To lead the development of a dedicated biotech team and laboratory, ABC recruited industry veteran, John C. Anders, Ph.D., who brings more than 24 years of experience in biopharmaceutical development from both the sponsor and CRO sides of the business. Dr. Anders has held several leadership positions building and leading advanced CGMP biotechnology analytical laboratories, and has expertise in time-tested and new technologies in protein chemistry, analytical methods and analysis of macromolecules by various methods. He played a major role in developing a pipeline of seven genomic expression tests for diagnosis and risk assessment of various types of cancer, including the successful completion of a pre-IND application to the FDA and development of a clinical protocol slated to begin soon.
Dr. Anders has assembled a team of biopharmaceutical experts, each with more than 18 years of experience in protein chemistry and chromatography. To ensure the team is well equipped to meet client demand, ABC has invested in a leading-edge biotech lab housed in ABC’s new, 90,000-sq.-ft. pharmaceutical development facility in Columbia, MO.
“Despite a challenging economic environment, 2009 was a positive year for ABC Laboratories,” said Mr. Bucksath. "Recent investments in people, processes and systems have resulted in 13% growth over 2008 and positioned us well to deliver on our customer’s needs in the years to come.”
Posted on November 9, 2009 @ 08:22 am
ProChon Biotech, Ltd. has selected Lonza (Booth 2800) to manufacture its fibroblast growth factor (FGF2v) variant at its Hopkinton, MA facility. FGF2v is a key regulator of cellular processes involved in blood vessel formation, wound healing and the remodeling of bone and cartilage and is a component of ProChon's BioCart Cartilage Regeneration System.
"With an unparalleled track record in contract manufacturing, Lonza is the ideal partner to manufacture our fibroblast growth factor system," said Patrick O'Donnell, chief executive officer of ProChon. "As we accelerate the BioCart clinical program at medical centers across the country, it is vitally important to have immediate access to our core technology and working with Lonza will make this a reality. We look forward to working with Lonza to develop FGF2v as we move toward our goal of bringing mobility to millions of people who suffer from cartilage injuries."
"We are very pleased to enter this collaboration with ProChon to advance a critical new biotherapy for cartilage regeneration," said Dr. Stephan Kutzer, head of Lonza Custom Manufacturing. "We look forward to supporting ProChon with innovative development services and the latest in biopharmaceutical manufacturing technologies and expect this to be the basis for a successful, long-term relationship."
See Lonza at Booth 2800!
Posted on November 9, 2009 @ 08:20 am
Althea Technologies (Booth 819) has added customized formulation development services to its portfolio. The services will be overseen by newly appointed Dr. James Matsuura, who takes the title director of Formulation Development.
According to a company statement, "This investment in an experienced team of formulation and analytical scientists, along with new laboratory facilities and state-of-the-art equipment, enhances and complements Althea's existing expertise and capabilities in cGMP biologics manufacturing and aseptic filling of injectable products, and completes the full integration of development and manufacturing services available for clients from early-stage development through commercial supply."
The new formulation laboratories are an expansion to the clinical manufacturing facility located on the San Diego campus and are further supported by the analytical expertise of Windrose Analytica, which Althea acquired earlier this year. "The addition of our new formulation development laboratories is the perfect complement to our advanced protein and peptide analytical capabilities, and will allow us to bring our clients' products into the clinic with unmatched speed, efficiency and effectiveness," noted Dr. Alan Herman, vice president of Product Development & chief scientific officer.
"We are delighted to have Dr. James Matsuura join Althea. His many years of experience bring added value to clients in helping them with the complexities of developing protein formulations for both clinical trials and product launch in our new commercial manufacturing facility," commented Dr. Shabbir Anik, Althea's president and chief executive officer.
The expanded facilities include a new development lyophilizer, which allows the group to optimize lyophilization cycles for products requiring enhanced stability. The new formulation laboratory and staff, operating closely with the analytical development group, complete Althea's product development group and enable Althea to support clients with critical development steps, as well as the manufacture of API and finished product.
Posted on November 9, 2009 @ 08:18 am
Surface Measurement Systems Ltd. (Booth 2147) and Particulate Systems, a brand of Micromeritics Instrument Corp. (Booth 2251), have signed a global strategic collaboration. The collaboration will draw on the combined knowledge and experience of both companies in the design and development of advanced analytical equipment for the characterization of particulate, porous, and complex materials. Working together, both companies will strengthen their ability to deliver customer-focused instrumentation solutions globally, according to a joint statement.
In the initial phase of this collaboration, Particulate Systems will have the exclusive distribution rights for key SMS products in selected regions of the U.S. as well as in South America, Central America, and the Middle East. These products include the DVS Dynamic Vapor Sorption systems that utilize dynamic gas flow and the gravimetric technique to produce high-resolution adsorption and desorption isotherms of water and organic vapors on essentially any solid material. In addition, SMS will extend its service and support for customers in the U.S. via the Particulate Systems’ extensive aftercare network. Particulate Systems will also have co-distribution rights to sell Surface Measurement Systems products in China.
Particulate Systems and SMS will begin organizing joint academic meetings, symposia, and other academic training programs to advance the development of particle and sorption technology starting in October 2009.
Preston Hendrix, president of Micromeritics, stated, “Collaboration between the two organizations enhances our ability to offer advanced analytical tools to guide research, resolve problems in production and QC, and to expand the understanding of material structure in general. Joining forces with SMS provides the customers of both companies additional options for solving their analytical needs.”
Dr. Daryl Williams, managing director and founder of SMS, added, “This new relationship builds on both a business and product synergy between our two companies which will allow us to provide total instrumentation solutions for many new research and development sectors.”
Posted on November 6, 2009 @ 09:35 am
Quintiles officially opened its expanded regional headquarters facility in Singapore’s Science Park I. The new facility doubles the size of the company’s previous space in Singapore and provides additional room for future expansion.
Quintiles is leasing a total of 79,000 sq.-ft. of space in the new Cintech IV building, which is capable of accommodating approximately 550 employees when fully occupied.
The new, 13,000-sq.-ft. central lab facility doubles the size of the previous Singapore lab, providing the additional space necessary to accommodate the demand for central lab services in the region. The lab facility provides globally harmonized lab services and plans are underway to expand these capabilities to include an assay development lab (ADL) and an anatomic pathology lab.
“Quintiles’ expansion today, to make Singapore its strategic home-base in Asia to drive regional expansion, represents a strong endorsement of Singapore’s capabilities in regional clinical trial coordination and research. Coupled with our capabilities in translational research, pharmaceutical and biotech companies can leverage Singapore as a one-stop location to carry out through-train drug discovery and development,” said Gan Kim Yong, Minister for Manpower, Singapore.
Posted on November 6, 2009 @ 09:34 am
Gloucester Pharmaceuticals received approval from the FDA for Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
The approval was based on disease response defined as the number of patients with confirmed complete response or partial response. The NDA included efficacy data from two studies involving 167 patients. Istodax is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and is expected to be commercially available in January 2010.
“The approval of Istodax is the result of an extraordinary commitment by our clinical investigators and the patients and their families who volunteered to participate in the Istodax clinical trials,” said Jean Nichols, Ph.D., president and chief operating officer of Gloucester Pharmaceuticals. “Gloucester would also like to recognize the National Cancer Institute which played an invaluable role in the development of Istodax.”
Posted on November 6, 2009 @ 09:30 am
Ziopharm Oncology, Inc. achieved positive data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) in patients with unresectable or metastatic soft tissue sarcoma.
Having achieved the study’s efficacy milestone following safety and efficacy review, it was determined that the data is sufficient to proceed to a pivotal study in support of product registration and to conclude enrollment in the trial.
In the Phase II trial, patients are randomized either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin. As of the October 5th cut-off date, there were 67 patients randomized to the trial, with 65 treated and 61 eligible for analysis. The 61 patients were evaluated for progression-free survival (PFS).
The median (PFS) for doxorubicin is 4.4 months, the median PFS for palifosfamide + doxorubicin has not yet been reached; the 1st PFS was 1.5 months for doxorubicin vs. 3.5 months for palifosfamide + doxorubicin. PFS is a biologically important end point in sarcoma, and has been well demonstrated to be a relevant measurement of the effect of treatment on outcome.
The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin. The company is in the process of finalizing a registration trial plan in soft tissue sarcoma for review by regulatory authorities.
Posted on November 5, 2009 @ 09:12 am
Ligand Pharmaceuticals and
Pfizer have extended their JAK3 research collaboration for another year. Ligand will receive $3.1 million in research payments to continue drug discovery and lead candidate optimization. Under the original agreement, Ligand is entitled to receive as much as $175 million in success-based milestones for the development and commercialization of multiple products. In addition, Ligand will receive royalties on product sales.
“We are very pleased to learn that Pfizer has elected to extend the JAK3 research collaboration with Ligand,” said John L. Higgins, President and chief executive officer of Ligand. “We view JAK3 inhibitors as a very promising market opportunity, and given Pfizer's clinical success with its own internal program we are convinced that they are highly committed to this category. Ligand has an exceptional record of drug discovery while serving major pharmaceutical companies in a number of research collaborations. We are pleased with the team’s progress and look forward to continued success as we drive the program forward for Pfizer.”
Posted on November 5, 2009 @ 09:10 am
Kendle 3Q09
3Q Revenues: $133.8 million (-26%)
3Q Earnings: $8.8 million (-6%)
YTD Revenues: $421.0 million (-19%)
YTD Earnings: $12.9 million (-35%)
Comments: Early Stage revenue was $10.8 million (-4%) and YTD was $27.2 million (+7%). Late Stage revenue was down 17% to $91.5 million in the quarter and down 14% to $284.7 million YTD. New business awards for the quarter totaled $137.2 million, up from $132 million in 2Q09. Contract cancellations for the quarter were $53.8 million or 6% of the company's backlog at June 30, 2009.
Posted on November 5, 2009 @ 09:08 am
Omnicare 3Q09
3Q Revenues: $1.5 billion (-6%)
3Q Earnings: $72.5 million (+35%)
YTD Revenues: $4.6 billion (flat)
YTD Earnings: $132.1 million (+17%)
Comments: CRO business revenues were $36.9 million in the quarter (-28%). Backlog at September 30, 2009 was $235.7 million. The Pharmacy services business generated sales of $1.5 million in the quarter (-1%). Results in 3Q08 include the impact of special items and an accounting change totaling $28.8 million.
Posted on November 5, 2009 @ 08:53 am
Stelmi (Booth 1000) will host a seminar at 9:30 a.m. on Tuesday, Nov. 10, covering the mastery of microbiological and particulate cleanliness in the production RTS and RTU elastomeric closures for pre-filled syringes and vials.
Drawing on Stelmi's experience as a specialist in rubber components for pharmaceutical primary packaging, the seminar will feature targeted presentations on the reduction of microbiological and particulate contamination in the production of rubber closures, with special emphasis on sterile components and visual quality.
This event will also be the cover Stelmi’s newly in-line production concept, PremiumFill. In a globally controlled area, this concept is aimed at optimizing the microbiological and particulate cleanliness levels in the production of sterile (ready-to-use) and cosmetic quality components (visual aspect).
For an invitation, e-mail
contact@stelmi.com or visit Booth 1000.
Posted on November 5, 2009 @ 08:50 am
Addressing the continuing pharmaceutical market trend of manufacturing medication in smaller but more potent doses,
Almac (Booth #2600) has successfully completed the design, manufacture and installation of state-of-the-art containment technology to facilitate the processing of potent compounds in its Product Development facility.
The company says that its in-house engineered containment solutions employ rigid and flexible film Isolator technology around the processing zones of equipment that require containment of airborne particulates. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions; and demonstrate Almac can process compounds with an OEL as low as 30 ng per m3.
Almac has the capability to process batch sizes ranging from 0.1Kg to 100Kg, manufacturing development, clinical & small-scale commercial solid, oral dose products.
Visit Almac at Booth #2600 Posted on November 5, 2009 @ 06:37 am
Phase Forward (Booth 702) has signed a multi-year agreement with Quotient Clinical (Booth 2446) to implement Phase Forward’s InForm Global Trial Management (GTM) electronic data capture (EDC) solution to support data collection, management and analysis for its clinical trials. Quotient Clinical will use Phase Forward’s Central Designer™ module to enhance eCRF design efficiency and improve workflow in the study development process for EDC trials.
“As an innovative provider of early drug development services, we want to ensure that our customers can take advantage of the benefits inherent in using EDC in Phase I trials, including access to high quality data within hours of collection, streamlined process efficiencies and rapid qualification of data,” said David Chalmers, Quotient’s vice president, Biometrics. “We selected InForm because of Phase Forward’s strong position in the marketplace and the company’s experience with Phase I trials.”
By supporting faster accessibility and greater visibility into trial data, the EDC implementation will help Quotient to expand its full-service, in-house Biometrics offering, according to the company. In addition, Quotient plans to offer customers on-line access to trial data, making it easier for them to track progress to date or to review summary reports.
“Quotient’s team is committed to continual expansion of its technical infrastructure to provide advanced services that help customers speed the development process,” said Steve Powell, senior vice president, Phase Forward. “The organization joins the growing number of CROs adopting our InForm product as part of a broader initiative to automate and streamline their Clinical Research Units.”
Posted on November 5, 2009 @ 06:31 am
Vetter (Booth 839) will open Vetter Development Service (VDS), a technologically advanced customer service facility located in Chicago, IL. The site will allow the company to provide greater commitment and support toward the product needs of its North American customers, according to a Vetter statement. Vetter will be capable of aseptically filling very small quantities of products in the new facility, providing faster and more streamlined product delivery and customer service. Headquartered in Ravensburg, Germany, Vetter sees the new facility as a significant investment in Vetter Pharma International GmbH. The 25,000-sq.-ft. facility will open end of 2009.
With its new location in the heart of the U.S., Vetter can now process and test small quantities of materials by bringing the development process closer to key customers, enabling greater cooperation at the earliest stages of development and minimizing the need to transport products, according to the company.
The site is intended to facilitate a shorter time to market for Vetter's North American customers. Peter Soelkner, managing director at Vetter, remarked, “The opening of this new cutting-edge VDS facility shows Vetter’s firm, strategic commitment to the North American market by bringing the state-of-the-art technology to the heart of the U.S.,” said Peter Soelkner. “The support VDS delivers throughout the entire product development cycle can now start earlier, and the proximity to our customers will contribute to streamlining the process and delivering the final product faster.”
Posted on November 5, 2009 @ 06:24 am
Toxikon Corporation (Booth 1161) has expanded the offerings in its immunotoxicology department. To meet increased demand for biologics research, Toxikon has added flow cyctometry to its service offerings, which enables the direct analysis of cells to detect a variety of specifically labeled components.
Christopher Brynczka, Ph.D., head of immunotoxicology, clinical and histology services at Toxikon, remarked, “This is an opportunity for Toxikon to promote the development of our sponsors’ drugs and medical devices,” said Dr. Brynczka. “If there are findings related to immune function in other preclinical studies, a more extensive evaluation of immunotoxicology is often necessary.”
Immunotoxicology study designs examine the physiological functioning of the immune system and the impact treatment with a test article may have in normal function. “The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell,” said Dr. Brynczka.
A study published last fall by the Journal of the American Medical Association stated that almost 25% of biologic drugs approved in the U.S. and Europe since 1995 have been at the forefront of at least one safety-related regulatory action in the decade since initial market approval, while 11% of the biologic therapies within that one-quarter percentile have been issued a black box warning, the study revealed.
While all newly developed drugs carry risks, said a Toxikon statement, biologics are in a special class because they are derived from biological sources, including antibodies, enzymes and hormones.
The new equipment is just one of several additions Toxikon has added to its immunotoxicology department, offering everything from quantitation of splenic B and T cells to a full battery of host resistance models.
Posted on November 5, 2009 @ 06:12 am
Norwich Pharmaceuticals (Booth 2639) has a newly built and commissioned pilot scale development facility. The new area's features state-of-the-art equipment, according to Norwich, and a company statement said the facility "offers greatly expanded contract outsourcing capabilities enabling them to work with customers earlier on in the development cycle, continuing right through scale up and commercial launch."
With the addition of compatible bench scale equipment, the facility has significantly increased its capabilities. The new equipment includes a four, eight, sixteen quart PK Blend Master with intensifier bar, an Aeromatic MP1 Fluid Bed Dryer, a Vector GMX-10 and GMX-25 Hi-Shear Mixer and a Vector FL-M-1 Flo-Coater. These new additions provide a working range of one to 25 Kgs.
Norwich also recently added new commercial large scale facility capabilities, including a Niro precision coater for the Niro MP5 commercial scale fluid bed to support customer product scale up from the development suite. This three-column coater has a volume range of 30 to 245 liters.
Posted on November 4, 2009 @ 09:16 am
Merck has completed its merger with
Schering-Plough Corp. and has outlined its new global strategy. The new Merck will operate as MSD outside the U.S. and Canada, and according to the company, is a global health care leader “aimed at providing innovative, distinctive products and services that save and improve lives, while satisfying customer needs and creating long-term shareholder value,” according to a statement from the new company.
Merck now has approximately 106,000 employees, and operations in more than 140 countries around the world. The company expects to generate more than 50% of its revenue outside the U.S.
Merck will now market more than 530 pharmaceutical, consumer and animal health products, employ approximately 1,800 people, and invest more than $121 million in R&D in Canada, as part of the company's expanded global presence. Merck operations in Canada include research, manufacturing, and sales.
"This is an exciting time for our company as we advance our position as a strong, global health care leader that will make a substantial difference to patients around the world," commented Carlos Dourado, president, Merck Canada. "Thanks to the talent and dedication of our scientists and employees, the company will offer an outstanding clinical development pipeline that will greatly increase our ability to deliver important new medicines to patients. We look forward to continuing to meet and exceed the needs of our customers and providing them with the high-quality products and service they have come to expect."
Posted on November 4, 2009 @ 09:15 am
Pramod Gupta, Ph.D. has been appointed vice president of quality and chief scientific officer,
Coldstream Laboratories, Inc. (CLI). In his new role, Dr. Gupta will focus on strengthening the company’s quality systems, R&D capabilities and overall project execution.
Dr. Gupta has more than 20 years of experience in the pharmaceutical and medical device industries. Most recently, he served as vice president of R&D at Bausch & Lomb with focus on the global development of drugs and devices. Previously, he held leadership positions at Baxter Healthcare Corp., TAP Pharmaceuticals and Abbott Laboratories. He has been involved with the development, approval and commercialization of more than 30 drug and medical products.
Joe Wyse, president and chief executive officer of CLI, said, “I am pleased to have recruited Dr. Gupta at this critical stage of Coldstream’s growth. His extensive industry experience and successful track record will be key to achieving our goal of becoming a leader in research, development and manufacture of clinical and commercial healthcare products.His record of excellence in R&D, technology transfer and regulatory interactions will greatly benefit our organization and our partners.”
Posted on November 4, 2009 @ 08:53 am
Emerson Resources, Inc. has formed a strategic partnership with Bio Research, a CRO specializing in agrichemical and related industries, to extend its business development capabilities. Robert Westbrook, chief executive officer of Bio Research, will spearhead Emerson's business development and sales efforts in an effort to establish a greater footprint in the pharmaceutical and biotech sectors.
Currently, Emerson serves global organizations including branded, generic and OTC pharmaceutical companies, virtual and emerging pharmaceutical research organizations, raw material suppliers, equipment manufacturers, and intellectual property attorneys.
"Our partnership with Bio Research will strengthen our position as the leader in value-added service, ingredients and expertise," said Adolfo Gomez, president of Emerson Resources. "Robert brings a strong combination of business development skills and diverse industry insight to Emerson and I am confident that he and his team will vastly expand our industry presence — particularly on the West Coast, an area that is ripe with opportunity."
Bio Research, based in Fresno, CA, and its subsidiary, Bio Research Services, represents select products and services related to clinical diagnostics, drug discovery, drug development, and agrichemicals.
As Emerson Resources' new business development executive, Mr. Westbrook will focus on creating new sales channels and building client and industry relationships in support of the Emerson's strategic growth objectives.
Posted on November 3, 2009 @ 09:53 am
Johnson & Johnson has announced plans for a global restructuring designed to “prioritize its innovation efforts,” according to a company statement. The plans are expected to increase operational efficiency and generate annual savings of $1.4-$1.7 billion, when fully implemented in 2011, with $800-$900 million expected in 2010. The savings will be allocated to new growth platforms; new product launches; core businesses; as well as provide more flexibility to adapt to the changing market. Along the way, the company will lay off 6-7% of its headcount, which equates to 7,000-8,000 people. The expected restructuring charge will be $1.1-$1.3 billion in 4Q09.
"Johnson & Johnson has long adhered to a broad-based operating model and set of sound management principles that have driven our success," said William C. Weldon, Johnson & Johnson chairman and chief executive officer. "Today, we are announcing a series of actions and plans designed to ensure that our company remains well-positioned and appropriately structured for sustainable, long-term growth in the health care industry."
The company plans to cut layers of management, increase individual spans of control, and simplify business structures and processes across the company's global operations. Mr. Weldon said, “These types of changes are difficult under any circumstances, and will have a very personal impact on people who have been dedicated to the mission of Johnson & Johnson. We recognize their contributions to the achievements of our business, and are committed to treating them fairly and with respect throughout this process.”
Posted on November 3, 2009 @ 09:51 am
Enzon 3Q09
3Q Revenues: $44.6 million (-9%)
3Q Earnings: $0.1 million (loss of $2.0 million in 3Q08)
Comments: Product sales in the quarter were down 1% to $28.6 million.
Contract manufacturing revenue was $2.3 million (-57%), primarily due to cancelled shipments and early discontinuation of processing for a CMO customer scheduled for termination in early 2010. Royalty revenue, for which Pegintron accounts for the majority, was $13.7 million (-6%).
Posted on November 3, 2009 @ 09:49 am
West 3Q09
3Q Revenues: $258.9 million (-1%)
3Q Earnings: $17.2 million (+27%)
YTD Revenues: $762.3 million (-5%)
YTD Earnings: $52.3 million (-24%)
Comments: Pharmaceutical Systems segment sales for the third quarter of were $198.1 million (+4%). Unfavorable foreign exchange accounted for 4%. H1N1 flu vaccination-related sales were $9.7 million in the quarter. Tech Group sales were $62.9 million (-8%).
The company also announced operational restructuring plans for its Tech Group and Pharmaceutical Systems segments. The Tech Group will consolidate manufacturing operations and support functions to better align capacity to contract manufacturing activity. Approximately 65 positions will be eliminated, which is expected to cost between $2 - $3 million. The company expects to generate annual operating cost savings of approximately $2 million in 2010 and $4 million once the restructuring is complete.
Under the Pharmaceutical Systems restructuring, the company will exit certain specialized lab service offerings; retire information technology applications and associated support; and abandon plans to expand its U.S. metals facility. Approximately 35 positions are being eliminated. The costs is expected to be $6 - $7 million, with cost savings in the range of $4.0 million annually.
Posted on November 3, 2009 @ 09:48 am
Kenneth A. Berlin has been appointed president and chief executive officer,
Rosetta Genomics, Ltd., and has been recommended to serve on the company’s board of directors.
Mr. Berlinpreviously served as worldwide general manager at Veridex, LLC, a Johnson & Johnson company. Under his leadership the organization grew to more than 100 employees, and he spearheaded the launch of three cancer diagnostic products. Mr. Berlin joined J&J in 1994 and served as corporate counsel for six years. He led and participated on the legal team that oversaw several mergers, acquisitions, divestitures and commercial transactions. He then held positions of increasing responsibility within J&J and a number of its subsidiary companies.
“Ken is a proven business leader whose background, accomplishments and commercialization experience in the novel diagnostics space are particularly well-suited for Rosetta Genomics at this time,” said Yoav Chelouche, chairman of the board of directors. “We have commercialized three microRNA diagnostic tests and have licensed or formed distribution agreements with six separate parties on five continents for these tests. As we further develop the markets for our paraffin-based microRNA diagnostic tests and pursue avenues to leverage our platform technology, we expect that Rosetta will benefit from Ken’s strong leadership, negotiating and alliance management skills as well as his portfolio management experience.”
Posted on November 2, 2009 @ 09:12 am
Amylin Pharmaceuticals and
Takeda Pharmaceutical have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize compounds for the treatment of obesity and related indications.
The agreement includes Amylin's pramlintide/metreleptin and davalintide, which are currently in Phase II development for treatment of obesity. The agreement also includes additional compounds from both companies' obesity research programs. Amylin will receive a one-time up-front payment of $75 million and is eligible to receive additional payments based on certain development, commercialization and sales milestones that could exceed $1 billion. The agreement also provides for future royalty payments to Amylin based on global product sales.
Amylin will be responsible for development activities through Phase II with the aim of regulatory approval in the U.S. Takeda will then take over further development in the U.S., and all development activities outside the U.S. Amylin will be responsible for 20% of development costs and Takeda will be responsible for 80%. Takeda will cover all development costs associated with obtaining approval for products outside the U.S. Takeda will be responsible for all product commercialization and costs. Amylin will have the option to co-commercialize the first two approved products in the U.S. and any follow-on products containing the identical active ingredients.
"Takeda is excited to realize this partnership with Amylin focused on the treatment of obesity and related indications. By leveraging Takeda's global development and commercial infrastructure we look forward to maximizing the significant potential of the products under this agreement," said Yasuchika Hasegawa, president and chief executive officer, Takeda. "Both Amylin and Takeda have extensive experience in the diabetes and metabolic disease area, and this collaboration should allow us to more quickly bring promising new treatments to patients in need."
"This collaboration will leverage Amylin's experience and expertise with peptide and protein science and Takeda's worldwide development and commercial expertise," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "Amylin recognizes the enormous potential of this collaboration to advance more options in obesity treatment more quickly than either company could do alone. Amylin and Takeda are excited about working together to address the significant unmet need for the millions of patients who need better solutions to manage obesity."
Posted on November 2, 2009 @ 09:10 am
ICON has signed an extension to its strategic agreement with
Lilly to manage the company’s clinical data outside the U.S. ICON will now also oversee Lilly’s needs in Japan in addition to those in Europe, Canada, Latin America, Australia and Asia.
“Today’s announcement is a continuation of a very successful partnership between ICON and Lilly,” commented Peter Gray, chief executive officer at ICON. “Through our existing data management partnership, we have brought significant process efficiencies to Lilly in helping them progress their drug development pipeline. That Lilly has chosen ICON to manage this important business function in such a key region as Japan is a measure of our global data management expertise and our local capabilities in the region.”
"With this transaction, Lilly Data Sciences and Solutions realizes its objective to leverage external, scalable clinical data management capabilities around the globe,” said Jeff Kasher, Lilly’s vice president and chief operating officer of Global Clinical Development. “We’re pleased to extend our relationship with ICON to include Japan, and their proven ability to reliably deliver work within differing cultural climates provided Lilly the opportunity to take another significant step in our ongoing agenda to increase flexibility, reduce fixed cost, and focus internal resources on core capabilities.”
Posted on November 2, 2009 @ 09:06 am
Penn Pharma has completed the first phase of its $19.7 million expansion program with a $.5 million investment extending its facilities by 2,400m
2 and changing the transport and delivery infrastructure at its Tredegar headquarters.
Darren Hassey, chief operating officer at Penn Pharma, said, “The recent developments to the site only add to our established offerings. By altering the externals of the site and moving the delivery and collection points we have in turn altered the internal factory processes, ensuring the smooth flow of people, process and materials.”
Peter George, chief executive officer of Penn Pharma, said, “By heavily investing in our Tredegar site it strengthens our commitment to the local community and as a leading Welsh company we will endeavor to pay back the Assembly Government’s faith in us by driving sustainable growth and employment.”
Additional phases of the expansion will take place during the next five years.
October 2009
Posted on October 30, 2009 @ 10:13 am
Sanofi-Aventis 3Q09
3Q Revenues: $10.8 billion (+8%)
3Q Earnings:$3.3 billion (+16%)
YTD Revenues: $32.0 billion (+7%)
YTD Earnings: $6.7 billion (+20%)
Comments: Pharmaceutical sales were up 6% to $9.3 billion in the quarter and YTD sales rose 4% to $28.5 billion. Exchange rates favorably effected results by 2% and 3%, respectively. Lovenox and Lantus sales reached $1.1 billion, up 14% and 22%, respectively. Plavix sales were $968.9 million (+4%). Apidra sales were up 32% in the quarter to $49.6 million. Sales of Eloxatin were $281.6 million (-44%) due to generic competition. The company launched Multaq, an anti-arrhythmic, in the U.S. with sales of $19.0 million. Human Vaccines revenue rose 5% to $1.5 billion, driven by the performance of Pentacel, Pentaxim and Menactra, as well as the first H1N1 shipments.
Posted on October 30, 2009 @ 10:12 am
Eli Lilly and Co. has opened its new Biotechnology Center in San Diego, as part of its strategy to develop more biopharmaceuticals. The center will focus on discovering, engineering and conducting Phase I and II trials on potential biologic medicines, with an emphasis on cancer, diabetes and autoimmune diseases.
"We are moving full speed ahead toward building a biotechnology powerhouse," said John Lechleiter, Ph.D., Lilly chairman and chief executive officer. "The science, technology and talent at our new center in San Diego will help bring novel biotech medicines to patients faster and more efficiently, and reinforces Lilly's commitment and contributions to San Diego's burgeoning bioscience industry."
The facility is located within a life science hub near the University of California, San Diego and other biomedical research institutes. Lilly, as part of its FIPNet strategy, plans to leverage external resources in an effort to advance its pipeline.
Approximately 200 scientists are based at the center, more than half from Applied Molecular Evolution (AME), a wholly-owned Lilly subsidiary that discovers, engineers and develops biotechnology-based therapies from human proteins. The center is also the work base for scientists from discovery chemistry research and technology (DCRT), a division within Lilly that includes scientists from SGX Pharmaceuticals, which Lilly acquired in 2008.
"We are optimizing the synergies between AME and DCRT-San Diego by co-locating them," said Tom Bumol, Ph.D., vice president of biotechnology discovery research at Lilly and head of the new West Coast site. "We in the scientific community have only scratched the surface of what is possible for biologic drug design, and collaborations such as this taking place at our new center will help lead to the next generation of biotechnology-based treatments for patients."
Posted on October 30, 2009 @ 10:10 am
R. Todd Joyce has been named senior vice president and chief financial officer of
Watson Pharmaceuticals, effective immediately. Mr. Joyce succeeds Mark W. Durand, who left the company for personal reasons. Mr. Joyce has served as acting principal financial officer since July 27, 2009, when Mr. Durand took a leave of absence.
"I, the Board of Directors and the senior management team wish to thank Mark for his service to the Company. We appreciate this was a difficult decision for him, and wish him well in the future," said Paul Bisaro, Watson's president and chief executive officer. "We are fortunate that Todd has agreed to become our new CFO. Todd's financial expertise and his history within the organization will enable him to seamlessly perform these duties, and to continue the good work begun by Mark during his tenure. In addition, Todd's international experience will be important as we continue to expand globally, and particularly in the integration of Watson and Arrow Group following the anticipated close of the Arrow acquisition later this year."
Mr. Joyce joined the company in 1997 as corporate controller, and was named vice president, corporate controller and treasurer in 2001. Later, Mr. Joyce served as interim principal financial officer. Previously, he served as vice president of tax, and vice president of tax and finance at ICN Pharmaceuticals. Prior to ICN, Mr. Joyce served as a CPA for Coopers & Lybrand and Price Waterhouse.
Posted on October 29, 2009 @ 10:02 am
AstraZeneca 3Q09
3Q Revenues: $8.2 billion (+5%)
3Q Earnings: $2.1 billion (+27%)
YTD Revenues: $23.9 billion (+2%)
YTD Earnings: $6.0 billion (+27%)
Comments: Sales of Influenza A (H1N1) vaccine totaled $152 million in the quarter. Nexium sales were down 5% to $1.2 billion. Crestor sales were $1.1 billion (+24%). Seloken /Toprol-XL sales were $414 million (+103%). Symbicort sales were $562 million (+12%). Seroquel sales were $1.2 billion (+9%). Casodex sales in the U.S. were down 80% to $14 million following FDA approval of eight generic products. U.S. revenue was up 14%. Revenue in the Rest of World was up 7%. Revenue in Established Markets was up 4% and Emerging Markets was up 15%. In the quarter, diabetes treatment Onglyza was approved in the U.S. and EU.
Posted on October 29, 2009 @ 09:59 am
Novo Nordisk 3Q09
3Q Revenues: $2.5 billion (+11%)
3Q Earnings: $539.7 million (+3%)
YTD Revenues: $7.4 billion (+16%)
YTD Earnings: $1.7 million (+21%)
Comments: In the quarter, Diabetes care sales were $1.8 billion (+12%). Biopharmaceutical sales were $636.3 (+10%). NovoSeven sales were up 8%, Norditropin sales were up 14%, and Hormone replacement therapy sales were up 12%. North America sales were up 20%. Sales in Europe were up 2%. International Operations were up 10% and Japan and Oceania sales were up 20%.
Posted on October 29, 2009 @ 09:57 am
Allergan 3Q09
3Q Revenues: $1.1 billion (+4%)
3Q Earnings: $179.2 million (+8%)
YTD Revenues: $3.3 billion (-2%)
YTD Earnings: $401.1 million (-4%)
Comments: Specialty pharmaceuticals sales were up 8% in the quarter to $940.6 million, while medical devices sales were down 11% to $187.2 million. Botox/Neuromodulator sales were $327.8 million (+3%). Eye Care Pharmaceuticals revenue was $535.1 million (+5%). Skin Care revenue was $62.9 million (+136%). Urologics revenue was $14.8 million (-13%).
Posted on October 28, 2009 @ 09:47 am
PPD plans to spin off its compound partnering business from its core CRO business. The spin-off will result in two capitalized, highly focused, independent public companies, according to a PPD statement.
The CRO business will continue to operate under the PPD name and will be focused solely on its drug discovery and development services. The compound partnering business will focus on developing and commercializing its drug candidates and to access external capital, if needed, without any constraints associated with operating in combination with the CRO business.
Additionally, PPD has entered into an agreement to acquire Excel PharmaStudies, Inc., one of the largest CROs in China, providing PPD additional capacity and expertise in this market. The acquisition adds to PPD’s Phase II–IV clinical, data management, biostatistics, regulatory and quality assurance services. Excel will operate as a wholly owned subsidiary of PPD.
Excel’s 300 employees will join PPD, and Mark Engel, co-founder, will work exclusively with PPD as a strategic consultant. The acquisition, subject to various closing conditions, is expected to close in 4Q09.
Also, PPD has been awarded a contract by the FDA to evaluate the agency's Center for Drug Evaluation and Research (CDER) post-market spontaneous adverse event surveillance system. The company will evaluate the value of the spontaneous adverse event reports to support safety-related regulatory actions and report its findings to the FDA and the public.
The award of $2.7 million for the first year is part of a two-year project of FDA's Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product's Life Cycle (IMPACT). The FDA will use these findings to develop an implementation strategy for ensuring optimal use of the system as part of its pharmacovigilance efforts to protect public health.
Posted on October 28, 2009 @ 09:45 am
PPD 3Q09
3Q Revenue: $341.1 million (-13%)
3Q Earnings: $37.7 million (-25%)
YTD Revenues: $1.1 billion (-11%)
YTD Earnings: $140.3 million (flat)
Comments: Development segment revenue for the quarter was $315.8 million (-12%), and income from operations was $52.2 million (-25%). Discovery sciences segment revenue for the quarter was $1.1 million (-68%). Discovery sciences segment loss from operations was $5.3 million, compared to income of $0.6 million in 3Q08, due to an increase in R&D expenses from the company’s dermatology business, which it acquired in 2Q09. Revenue in the quarter included a $3.0 million milestone payment from Takeda Pharmaceutical Co., triggered by the submission of a new drug application for alogliptin in Japan.
Posted on October 28, 2009 @ 09:44 am
AstraZeneca withdrew its regulatory submissions Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the FDA and the EMEA. The applications were submitted in June 2009.
The decision was based on updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy, as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint might not be sufficient for approval.
The company will complete its ongoing Phase III trial program to assess Zactima’s efficacy in different clinical settings.
Posted on October 28, 2009 @ 09:41 am
Morphotek, Inc. has entered into a license agreement with
Centocor Ortho Biotech for the development and commercialization of an antibody targeting solid tumors. Financial terms were not disclosed.
Morphotek has been granted an exclusive worldwide license for the development, manufacture and sale of the antibody. Preclinical studies conducted by Centocor have shown that the relevant antigen is over-expressed in many solid tumors.
"We are delighted to conclude this license agreement with Centocor Ortho Biotech as we are committed to bringing healthcare solutions to cancer patients, especially for areas of unmet medical need," said Philip Sass, Ph.D., chief operating officer of Morphotek. "Morphotek is well positioned to apply its technologies, knowledge and expertise in monoclonal antibody development for the development and commercialization of this antibody. The preclinical data package for this antibody have shown anti-cancer effects and we look forward to validating these in human trials."
Posted on October 27, 2009 @ 09:24 am
GSK and
Genmab have received approval of Arzerra (ofatumumab) from the FDA for use in patients with chronic lymphocytic leukemia (CLL) that do not respond to fludarabine and alemtuzumab. Arzerra is a monoclonal antibody that causes the body's immune response to fight against normal and cancerous B-cells.
The approval is based on results from a study in which 42% of patients with CLL, who did not respond to both fludarabine and alemtuzumab (two therapies used in treating CLL), responded to treatment with Arzerra. These patients had a median duration of response of 6.5 months. The most common adverse reactions were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions seen were infections (including pneumonia and sepsis), neutropenia, and pyrexia.
"The approval of Arzerra brings an important new treatment option to patients with refractory CLL," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "This approval also marks a key milestone for Genmab as it is our first antibody to reach the market. All of us involved in the development of Arzerra are pleased that we have been able to move the product so quickly through research and development and meet our goal of providing this innovative therapy to patients."
"Arzerra is a significant step forward in helping patients and physicians better manage the challenges of refractory CLL. Patients now have a new choice," said Kathy Rouan, Ph.D., vice president and medicines development leader at GlaxoSmithKline. "The Arzerra approval demonstrates the commitment of the GSK BioPharm and Oncology Units to developing new biopharmaceutical treatment options for cancer patients."
Posted on October 27, 2009 @ 09:22 am
Hospira 3Q09
3Q Revenues: $1.0 billion (+9%)
3Q Earnings: $116.2 million (+42%)
YTD Revenues: $2.8 billion (+4%)
YTD Earnings: $307.2 million (+42%)
Comments: In the quarter, Global Specialty Injectables revenue was $575.7 million (+24%). In the Americas, sales were $449.1 million (+32%). Asia Pacific sales were flat at $57.0 million. Revenue for Other Pharma (including contract manufacturing) was down 2% to $126.0 million in 3Q09. Global Specialty Injectables revenue YTD was $1.5 billion (+10%), with the Americas accounting for $1.2 billion (+17%) and Asia Pacific, $149.0 million (+4%).
Posted on October 27, 2009 @ 09:20 am
Scynexis, Inc. has received a payment from
Merck for achieving a preclinical milestone in the companies’ oncology drug discovery and development collaboration.
“We are pleased to celebrate success in reaching another milestone with our valued partner, Merck,” said Yves Ribeill, Ph.D., president and chief executive officer of Scynexis. “This milestone provides further validation of our long-term relationship with Merck in a number of therapeutic areas through discovery research and innovation.”
Posted on October 26, 2009 @ 09:12 am
HollisterStier Contract Manufacturing and sister organization,
Draxis Pharma, have appointed
Steven Rowan as vice president of business development, Jubilant Organosys Contract Manufacturing North America. Mr. Rowan will oversee a HollisterStier-Draxis corporate business development team.
The two companies have a partnership joining their capabilities and services under the ownership of Jubilant Organosys. Mr. Rowan will be responsible for global business development activities for HollisterStier and Draxis, as well as establishing strategic partnerships to strengthen the companies’ presence throughout Europe and Asia.
Mr. Rowan has more than 20 years of experience in the pharmaceutical and biopharmaceutical industries. His in-depth knowledge, extensive scientific background and experience implementing Six Sigma methodologies will benefit the organizations as they align their manufacturing services.
“I look forward to being a part of this team as we transition into having a more heightened global presence,” said Mr. Rowan. “Together, we offer a level of technical expertise, multiple dosage forms, and understanding of the entire life cycle that proves to be very competitive in the outsourcing industry ─ this is an exciting opportunity for me to help showcase our competitive advantages and strategically position HollisterStier and Draxis Pharma as leading industry players.”
Posted on October 26, 2009 @ 09:08 am
Cephalon, Inc. and
BioAssets Development Corp. (BDC) have signed an agreement that will provide Cephalon with an option to acquire BDC. Cephalon will pay $30 million upfront and an additional payment if it exercises its option. BDC stockholders could also receive additional future payments related to regulatory and sales milestones. The agreement is subject to customary closing conditions.
BDC, a privately held biopharmaceutical company, is currently conducting a Phase II placebo-controlled proof of concept study with the tumor necrosis factor (TNF) inhibitor, etanercept, epidurally administered to patients with sciatica. Sciatica is a neuropathic inflammatory pain condition that occurs when the sciatic nerve is compressed, injured or irritated. Results are expected to be available in 2H10. BDC has secured rights for use of TNF inhibitors for sciatic pain in patients with intervertebral disk herniation, as well as other spinal disorders.
"BioAssets offers an estate of intellectual property and scientific expertise that will allow us to evaluate our own domain antibody tumor necrosis factor inhibitor, CEP-37247 (formerly known as ART-621), for the treatment of sciatica," said Frank Baldino, Jr., Ph.D. chairman and chief executive officer of Cephalon. "Combining these two innovations helps fulfill our strategy to address unmet patient needs, while focusing on specialty physicians."
"Development of an improved non-surgical therapy for sciatica presents a pressing unmet medical need and a potentially significant commercial opportunity," commented James Gorman, M.D., Ph.D., chief executive officer of BioAssets. "Cephalon combines an innovative TNF inhibitor pipeline with a well established pain therapeutic franchise. I believe these capabilities uniquely position Cephalon to develop and commercialize a novel biologic therapy for these patients."
Posted on October 26, 2009 @ 09:05 am
Exelixis and
Bristol-Myers Squibb achieved positive Phase II data showing that XL184 demonstrated activity in patients with glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The study evaluated the safety, tolerability, and clinical activity of XL184 at daily doses of 175 mg or 125 mg in 46 patients with previously treated GBM, including some patients who had received prior antiangiogenic therapy.
The overall rate of confirmed partial response in the patients treated at 175 mg was 17%. Among patients without prior antiangiogenic therapy, 21% achieved confirmed responses. In patients who had received prior antiangiogenic therapy, 8% progressed on vandetinib and achieved a confirmed partial response. Of the 46 patients treated at the 175 mg dose level, 21% attained 6-month progression-free survival (PFS) rate with 35% of patients censored for PFS at the time of analysis. The median duration of response was 5.9 months. The median PFS interval was 3.7 months.
“The updated data from patients treated with the 175 mg dose of XL184 is consistent with what we have reported previously and continue to demonstrate that the compound is clinically active,” said Michael M. Morrissey, Ph.D. president of R&D at Exelixis. “While the data from the 125 mg dose cohort are still early, they are encouraging and we will continue to evaluate the suitability of this dose and potentially others for future clinical studies. This trial in its totality is providing important information that will enable future decision making with respect to designing and implementing trials of XL184 in this patient population.”
Posted on October 23, 2009 @ 08:41 am
Novartis 3Q
3Q Revenues: $11.1 billion (+3%)
3Q Earnings: $2.1 billion (+1%)
YTD Revenues: $31.3 billion (flat)
YTD Earnings: $6.1 billion (-8%)
Comments: Pharmaceutical sales in the quarter were $7.2 billion (+8%). Diovan sales were $4.4 billion (+5% in local currencies), driven by expansion in Japan, which accounts for approximately 20% of sales. Exforge sales were $475 million (+81% lc). Tekturna/Rasilez sales were $202 million (+114% lc). Gleevec/Glivec sales were $2.9 billion (+12% lc). Zometa sales were $1.1 billion(+9% lc). Femara sales were $925 million (+16% lc). Exjade sales were $469 million (+30% lc). Sandoz revenue was $1.9 billion (-3%). Vaccines and Diagnostics sales were down 18% to $543 million, due to lower sales of H5N1 (avian flu) pandemic vaccines in 2009.
Posted on October 23, 2009 @ 08:39 am
BioStorage Technologies, Inc. expanded its European operations with the opening of a new 16,140 sq.-ft., full-service biorepository in Frankfurt, Germany. The new facility will offer worldwide, industry-compliant logistics and supply chain management that meets all international customs and transportation regulations, as well as documentation requirements.
“We are pleased to see such rapid global growth since opening our initial Germany-based facility in 2007,” said F. John Mills, M.D., Ph.D., chief executive officer and chairman of the board at BioStorage Technologies. “Frankfurt has been an ideal location for us to create additional alliances and partnerships with companies conducting pharmaceutical research and development in Europe.”
The company also recently expanded U.S. operations, adding a 40,000 sq.-ft. cold-storage facility and creating 125 new jobs at its global headquarters in Indianapolis.
Posted on October 23, 2009 @ 08:36 am
John L. Workman has been appointed executive vice president and chief financial officer,
Omnicare, Inc., effective November 18th. Mr. Workman will oversee all of the company’s financial operations as well as its information technology function. He will report to Joel F. Gemunder, Omnicare’s president and chief executive officer.
“We are delighted to welcome John to our executive management team,” said Mr. Gemunder. “John has demonstrated strong financial leadership and an operational focus throughout his career, and we believe he will be an invaluable asset in building upon our financial strength and operational efficiency across the organization to support our objective of generating long-term profitable growth.”
Mr. Workman currently serves as executive vice president and chief financial officer of HealthSouth Corp., the nation's largest provider of inpatient rehabilitative healthcare services. At HealthSouth, he was responsible for all financial activities as well as the company’s information technology function. Prior to joining HealthSouth, Mr. Workman was chief executive officer of U.S. Can Corp., where he also served as chief operating officer and chief financial officer during his six-year tenure. Previously, he spent more than 14 years with Montgomery Ward & Co., Inc.
Posted on October 23, 2009 @ 08:33 am
Hovione has acquired an aseptic spray-drying production line, vial filling and back up utilities from
Acusphere, providing access to equipment and knowledge for the production of sterile drug substance and sterile drug product. The equipment includes sterile filtration, aseptic spray drying, secondary drying and vial filling, as well as terminal sterilization systems, lyophilization, WFI and clean steam production utilities.
"This is a very exciting move for Hovione, we are adding aseptic production -a tough new area of pharmaceutical manufacturing- to our offering. We have been considering aseptic production for some time and today we took the first step," said Dave Hoffman, head of Hovione's Exclusives and Particle Design Business Units.
The acquisition adds to Hovione's cGMP spray-drying facilities, which includes lab, pilot and various commercial scale production installations in Portugal, U.S. and in Ireland.
Posted on October 22, 2009 @ 10:02 am
Merck 3Q
3Q Revenues: $6.0 billion (+2%)
3Q Earnings: $3.5 billion (earnings were $1.1 billion in 3Q08)
YTD Revenues: $17.3 billion (-3%)
YTD Earnings: $6.5 billion (+4%)
Comments: Singulair sales were $1.1 billion in the quarter (+5%). Combined global sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough partnership, were $1.0 billion (-7%). Global sales Cozaar and Hyzaar were $861 million in the quarter (-3%). Januvia sales were up 30% to $491 million. Gardasil sales were $311 million (-22%). R&D expenses were $1.3 billion for the quarter (+7). Restructuring costs, primarily related to employee separations, were $42 million for the quarter compared to $757 million in 3Q08.
Posted on October 22, 2009 @ 09:59 am
Bristol-Myers Squibb 3Q
3Q Revenues: $5.5 billion (+4%)
3Q Earnings: $1.3 billion (-54%)
YTD Revenues: $15.9 billion (+4%)
YTD Earnings: $3.5 billion (-26%)
Comments: Biopharmaceutical sales were $4.8 billion (+6%). Plavix sales were $1.6 billion (+8%). Sales of Abilify were $653 million (+16%). Reyataz sales were $360 million (+5%). Sustiva Franchise revenue was $315 million (+7%). Erbitux sales were down 3% to $179 million. Sprycel sales were up 30% to $107 million. R&D expenses were $820 million in the quarter (+5%). BMS’ share of Mead Johnson’s earnings was $127 million in the quarter (-20%).
Posted on October 22, 2009 @ 09:56 am
Schering-Plough 3Q
3Q Revenues: $4.5 billion (-2%)
3Q Earnings: $515 million (-16%)
YTD Revenues: $13.5 billion (-4%)
YTD Earnings: $2.0 billion (+43%)
Comments: Pharmaceutical sales in the quarter were $3.5 billion (+6%). Sales of Remicade were up 8% to $608 million. Sales of Temodar were $278 million (+2%). Nasonex sales were up 3% to $266 million. Pegintron sales were down 16% to $198 million. Global sales of Clarinex were $164 million (-7%). Prescription Claritin sales were $95 million. Net sales of the cholesterol franchise, which include sales of the cholesterol joint venture plus sales recorded by S-P in non-joint venture territories (such as Japan and Latin America), were $1.1 billion (-5%). R&D expenses were $913 million in the quarter (+2%). For the quarter and YTD, results include $160 million gain on sales of certain divested animal health products associated with the OBS acquisition.
Posted on October 22, 2009 @ 09:53 am
Dr. Hui Cai has been appointed as vice president of business development,
WuXi PharmaTech. Dr. Cai will report directly to Dr. Richard Soll, senior vice president of Integrated Services.
Prior to joining the company, Dr. Cai was president of Inflexion BioPartners and vice president of corporate development at HUYA Bioscience. Previously, Dr. Cai spent ten years at Johnson & Johnson Pharmaceutical R&D on multiple small molecule drug discovery programs.
"I am very pleased to welcome Hui on board as we continue to enhance our business development," commented Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech. "Hui brings us a broad portfolio of expertise and experience in strategic planning, business development, and portfolio management, with which we are confident that our discovery business will grow rapidly."
Posted on October 22, 2009 @ 08:02 am
Covance 3Q09
3Q Revenues: $475 million (+8%)
3Q Earnings: $51 million (flat)
YTD Revenues: $1.4 billion (+7%)
YTD Earnings: $134 million (-11%)
Comments: Late-Stage Development accounted for 59% of 3Q revenues and was up 24% to $279 million. Early Development was down 9% to $196 million. For YTD, Late-Stage is up 21% to $794 million and Early is down 7% to $631 million. 3Q09 net income got a $9 million boost from the save of IV/WRSand $2 million from a favorable tax settlement.
Posted on October 22, 2009 @ 07:58 am
Amgen 3Q09
3Q Revenues: $3.8 billion (flat)
3Q Earnings: $1.4 billion (+23%)
YTD Revenues: $10.8 billion (-4%)
YTD Earnings: $3.7 billion (+17%)
Comments: Product sales fell 1% in 3Q09 to $3.7 billion; U.S. sales were flat at $2.9 billion. Enbrel sales climbed 3% to $924 million, with a price increase offsetting a drop in unit sales in dermatology. Aranesp sales fell 19% to $685 million in the quarter, while Epogen rose 5% to $663 million. Neulasta and Neupogen sales grew 2% to $1.2 billion. For YTD, Enbrel sales are -4% at $2.6 billion.
Read Amgen's profile in this year's Top 10 Biopharmas Report!
Posted on October 21, 2009 @ 09:44 am
Laureate Pharma has signed a biopharmaceutical development and manufacturing agreement with an undisclosed client. Laureate will develop the process to manufacture a unique Fc Fusion Protein and produce it under cGMP conditions for use in clinical trials. Terms of the agreement were not disclosed.
"This project is a great fit with the experience that we have developed over the past few years working with fusion proteins," said Robert J. Broeze, Ph. D., president and chief executive officer of Laureate Pharma. "We have had great success working with these unique protein products and are delighted to have the opportunity to help advance this product into the clinic."
"We are seeing a strong trend in the biopharmaceutical industry to develop fusion protein products with unique properties," commented Dan Leone, Laureate's vice president, business development. "Along with monoclonal antibodies, manufacturing fusion proteins has become one of Laureate's core competencies."
Posted on October 21, 2009 @ 07:52 am
ICON 3Q09
3Q Revenues: $220 million (-2%)
3Q Earnings: $24 million (+12%)
YTD Revenues: $660 million (+2%)
YTD Earnings: $63 million (+11%)
Comments: Chief executive officer Peter Gray remarked, "While higher than normal cancellations held back net business awards, the levels of business opportunity continue to be strong and we remain optimistic for the future.”
Posted on October 21, 2009 @ 07:44 am
Lilly 3Q09
3Q Revenues: $5.6 billion (+7%)
3Q Earnings: $942 million (loss of $466 million in 3Q08)
YTD Revenues: $15.9 billion (+5%)
YTD Earnings: $3.4 billion (+119%)
Comments: Earnings comparisons were affected by Lilly's 3Q08 charge of $1.5 billion to settle federal and state investigations into Zyprexa marketing practices. U.S. revenues rose 14% to $3.1 billion, while ex-U.S. figures fell 1% to $2.4 billion. In 3Q09, Zyprexa revenues rose 3% to $1.2 billion, Cymbalta rose 10% to $790 million, Humalog rose 16% to $500 million, and Almita sales grew 47% to $462 million. For the YTD, Zyprexa is flat at $3.5 billion, Cymalta is up 14% to $2.2 billion, Humalog is up 12% to $1.4 billion and Alimta is up 41% to $1.2 billion. Beseiged by generic competition, Gemzar sales fell 25% to $332 million in 3Q09 and 19% to $1.1 billion YTD. The company recognized sales and collaboration revenues of $102 million for Erbitux, which it acquired when it bought ImClone.
Read our Lilly profile in this year's Top Companies Report!
Posted on October 21, 2009 @ 07:34 am
Novavax and
Xcellerex have entered into a strategic collaboration to accelerate the development of Novavax's vaccine manufacturing process to commercial scale and begin immediate production of a novel 2009 H1N1 flu vaccine. The two companies will utilize Novavax's unique virus-like particle (VLP) vaccine technology to produce initial commercial quantities of H1N1 vaccine with Xcellerex's FlexFactory biomanufacturing platform. Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing supply fees from Novavax. Novavax recently launched a two-stage, 4,000-patient trial of its H1N1 flu vaccine in Mexico to support registration in that country.
"Our technology offers Novavax a cost-effective and flexible manufacturing solution for this public health crisis by achieving full commercial-scale production of VLP-based vaccines much more rapidly than traditional vaccine production methods," stated Joseph Zakrzewski, Xcellerex's president and chief executive officer.
"This strategic partnership represents a major step forward for Novavax and will allow us to increase the scale of our VLP vaccine manufacturing process and expand capacity to satisfy potential demand for our H1N1 VLP vaccine in Mexico. This alliance will also enable us to establish commercial-scale production capabilities for our VLP-based seasonal influenza vaccine program and significantly advance our timeline for full scale manufacturing," said Rahul Singhvi, Novavax's President and Chief Executive Officer.
Posted on October 20, 2009 @ 09:06 am
Pfizer 3Q
3Q Revenues: $11.6 billion (-3%)
3Q Earnings: $2.9 billion (+26%)
YTD Revenues: $33.5 billion (-7%)
YTD Earnings: $7.9 billion (flat)
Comments: Total pharmaceutical sales in the quarter were $10.7 billion (-3%). Primary Care sales were down 4% to $5.5 billion. Specialty Care sales were up 3% to $1.6 billion. Oncology revenue was $371 million (-5%). Established Products revenue was $1.6 billion (-12%) and Emerging Markets revenue was $1.6 billion (-4%). U.S. revenues were $4.8 billion (-2%) in the quarter and international revenues were $6.8 billion (-4%). YTD U.S. revenues were $14.3 billion (-6%) and international revenues were $19.2 billion (-8%). Revenues in the quarter and YTD were unfavorably impacted by 5% and 6% respectively, due to foreign exchange. R&D expenses were down 13% to $1.6 billion in the quarter and down 11% to 5.0 billion YTD.
Posted on October 20, 2009 @ 09:03 am
Biogen Idec 3Q
3Q Revenues: $1.1 billion (+3%)
3Q Earnings:$279.6 million (+35%)
YTD Revenues: $3.3 billion (+7%)
YTD Earnings: $671.1 million (+15%)
Comments: Growth in the quarter was driven primarily by Tysabri sales, up 21% to $207 million. Avonex sales were $580 million (+1%). Revenues for the quarter included $284 million from Biogen Idec’s co-promotion arrangement with Genentech for Rituxan. Revenues from other products in the quarter were $15 million, compared to $14 million in 3Q08. Royalty revenues in the quarter were flat at $35 million.
Posted on October 20, 2009 @ 05:31 am
Lonza has withdrawn its offer to acquire
Patheon. Patheon's Special Committee of Independent Directors and Lonza also mutually agreed to terminate discussions regarding other possible strategic transactions between Lonza and Patheon.
When Lonza's proposal was made public in August, JLL Patheon Holdings LLC, which holds 57% of the Patheon's outstanding restricted voting shares, announced that it rejected the proposal and would not support any transaction involving a sale of its shares of Patheon. Lonza offered $3.55 for each share of Patheon, a premium over JLL's earlier $2.00/share bid to take the company private.
Posted on October 19, 2009 @ 09:00 am
Charles River Laboratories has laid off 115 workers from its CTBR Bio-Research unit near Montreal. The company laid off 140 employees from CTBR in May 2006. After this round of layoffs, CTBR will have approximately 1,480 employees.
In an e-mail to
The Montreal Gazette, CRL spokeswoman Amy Cianciaruso remarked, "Like others in our industry, Charles River has been affected by this slowdown and we are taking the difficult but necessary steps to align our workforce with the current demand."
Posted on October 19, 2009 @ 08:37 am
Dr. Robert Garnick has joined
Peregrine Pharmaceuticals as the head of regulatory affairs. Dr. Garnick was formerly the senior vice president of regulatory, quality and compliance at Genentech. During his 24-year career at that company, he was responsible for 17 new product approvals, including most of the company's top selling monoclonal antibody therapeutics such as Rituxan, Herceptin, Avastin and Lucentis. Dr. Garnick will be responsible for overseeing Peregrine's interactions with the FDA and regulatory agencies around the world, and will lead the development of the company's regulatory strategies for advancing its novel MAb-based treatments for cancer and infectious diseases.
"Rob has an unparalleled track record in the biotechnology and pharmaceutical industry, having led the regulatory, quality and compliance strategy for developing many of the most successful monoclonal antibody therapeutics currently on the market representing multiple disease areas," said Steven W. King, president and chief executive officer of Peregrine. "His profound understanding of every aspect of the regulatory process and how it impacts clinical design and drug development is already proving invaluable as we prepare for the next stage of clinical development for our innovative drug candidates bavituximab and Cotara. We have made considerable progress over the past few years in our clinical programs and bringing Rob's expertise and experience on board at this critical time is a significant development for the company."
Dr. Garnick has over 30 years of experience in drug and biologic pharmaceutical development. He joined Genentech in 1984 and after a series of promotions, he became vice president of quality in 1994 and was later promoted to senior vice president of regulatory, quality and compliance in 2001. In this role, Dr. Garnick was responsible for all the regulated aspects of Genentech's business including drug development, commercial production and promotional and labeling compliance. After leaving Genentech in 2008, Dr. Garnick founded Lone Mountain Biotechnology and Medical Devices Inc., a successful company specializing in drug and device consulting where he remains as president and chief executive officer.
Posted on October 19, 2009 @ 08:29 am
Amgen received a Complete Response Letter from the FDA for the BLA for Prolia (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The letter requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program.
The letter did not require additional pre-marketing clinical trials to complete the review of the treatment indication, but the FDA has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication.
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. The agency acknowledged receipt of Amgen's previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia.
Amgen is reviewing the Complete Response Letter and will work with the FDA to determine the appropriate next steps regarding these applications.
Amgen expects to receive a separate response for its application for Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.
"We are confident that we can quickly respond to the FDA's requests for the treatment of postmenopausal osteoporosis indication and plan to do so in the near term," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. "Amgen is fully committed to working with the FDA to make Prolia available to patients in the near future."
Amgen also has submitted Prolia for approval in postmenopausal osteoporosis and bone loss in breast and prostate cancer patients due to hormone ablation therapy in the European Union, Switzerland, Australia and Canada. Amgen is working closely with regulatory agencies in each of these regions to make Prolia available to patients around the world.
Read our Top Companies report on Amgen!
Posted on October 16, 2009 @ 08:38 am
Pfizer has completed its acquisition of Wyeth following the regulatory approval from all government authorities required by the merger agreement and approval by Wyeth shareholders. Under the terms of the transaction, each outstanding share of Wyeth common stock has been converted into the right to receive $33 in cash and 0.985 of a share of Pfizer common stock.
Pfizer and Wyeth will begin joint operations today. The integration of local Pfizer and Wyeth entities is subject to completion of various local legal and regulatory obligations.
Posted on October 16, 2009 @ 08:22 am
GlaxoSmithKline gained approval for Cervarix in Japan, becoming the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare (MHLW).
The vaccine, which is formulated with GSK’s AS04 adjuvant system, has been licensed for the prevention of pre-cancerous lesions (cervical intraepithelial neoplasia – CIN 2 and 3) and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by human papillomavirus (HPV) types 16 and 18, in girls and women aged 10 and above.
The approval was based on data supporting the efficacy and safety profile of the vaccine, which included analysis of the largest efficacy trial of a cervical cancer vaccine, involving nearly 19,000 women. These data demonstrated that the vaccine was highly effective at protecting against the two most common cervical cancer-causing HPV types, 16 and 18. The study also showed that rates of serious adverse events and medically significant conditions in the group vaccinated with Cervarix were similar to the control group.
Marc Dunoyer, president of GSK Japan, commented, “We are extremely pleased with the approval of Cervarix, which is designed to protect women from cervical cancer – a disease that is responsible for the death of 10 Japanese women every day. Experts believe that vaccination in conjunction with regular screening will significantly reduce the burden of cervical cancer, and GSK is committed to working alongside the Japanese government to help ensure that women and girls are educated about the role that vaccination can play in protecting them against it.”
The vaccine is currently approved in the 27 member states of the EU, Australia, Brazil, South Korea, Mexico and Taiwan.
Posted on October 15, 2009 @ 08:51 am
SCHOTT’s Pharmaceutical Packaging business began production of ready-to-fill glass syringes at its manufacturing facility in Lebanon, PA. The company has invested more than $14 million in the new production capability, and will add 40 new jobs during the next year.
Syringe production capability at the 170,000-sq.-ft. plant will be 270,000 units per day. The company will move to 24-hour production within the next two years. With the addition of ready-to-fill syringes, all of SCHOTT’s pharmaceutical packaging products, which include vials, ampoules and cartridges, will now be produced in North America. SCHOTT will be the second company to produce ready-to-fill syringes in the U.S.
“We hope to increase the market share of domestically produced ready-to-fills, once we are fully operational here in Lebanon,” said Renard Jackson, Vice President of SCHOTT North America, Inc. and General Manager of its Pharmaceutical Packaging Division. “We’re delivering the same high quality standards our customers have come to expect.”
The company plans to further invest $30 million in the Lebanon facility in the future, and potentially employ 80 additional people.
Posted on October 15, 2009 @ 08:49 am
Evotec AG has extended its research collaboration with
Ono Pharmaceutical Co., Ltd. and initiated a new discovery alliance. Evotec will provide drug discovery activities, including high throughput screening, medicinal chemistry and in vitro pharmacology to discover small molecular weight compounds against an ion channel target selected by Ono. Ono will use Evotec's ion channel drug discovery platform and expertise and in return, Evotec will receive research funding and milestone payments.
The two companies have been collaborating on novel inhibitors for a protease target since March 2008. Within this collaboration Evotec provides protein crystallography, medicinal chemistry, biology and ADMET services to Ono with the goal of advancing a compound to clinical development.
"Since we have a high regard for Evotec's wide range of drug discovery technologies, and the existing collaboration with Evotec targeting a protease has progressed as planned, we are now pleased to enter into a new drug discovery agreement on an ion channel with Evotec utilizing their proprietary drug discovery platform. We anticipate the collaboration will result in identifying a novel drug candidate with a high potential," said Kazuhito Kawabata, Ph.D., managing director, Research Headquarters at Ono.
Dr. Mario Polywka, chief operating officer of Evotec, commented, "We are delighted to be expanding our collaboration and initiating a new discovery collaboration with Ono, a partner with whom we enjoy a close relationship. This expansion clearly demonstrates the value we bring to our alliance partners in the area of drug discovery. We look forward to continuing working closely with our colleagues at Ono."
Posted on October 15, 2009 @ 08:46 am
Lonza Group and the special committee of independent directors at
Patheon have extended the exclusivity period granted to Lonza, which was scheduled to expire today. The extension allows for continued discussions regarding possible strategic transactions between the two companies. The period of exclusivity will continue until terminated by either party. Other terms of the exclusivity arrangements will remain.
Because JLL Patheon Holdings LLC has announced it’s not prepared to sell its shares of Patheon at this time, discussions between Lonza and the committee include potential transactions that do not require the sale of JLL's shares.
Posted on October 15, 2009 @ 08:10 am
Azopharma Product Development Group and
PharmaNet Development Group have formed a business development and co-promotion alliance to leverage complementary services, develop business opportunities, and jointly manage projects for certain services provided by the two companies.
Phil Meeks, Azopharma's chief executive officer, commented, "This agreement is an exciting opportunity for both of our organizations. Both companies will be introduced to new sets of clients and the clients will be exposed to new compelling solutions for their early phase development."
Jeffrey P. McMullen, PharmaNet's president and chief executive officer, added, "PharmaNet's and Azopharma's services complement each other. Azopharma is an established provider of in vivo services with preclinical and toxicology capabilities and our bioanalytical capabilities are ideally positioned to support these studies."
Posted on October 14, 2009 @ 09:49 am
Lilly has sold its Tippecanoe Laboratories manufacturing facility to
Evonik Industries AG. The manufacturing site, located in Lafayette, IN, will remain in operation with a focus on producing high-quality APIs and specialty chemical and animal health products.
The two companies will also enter into a nine-year supply and services agreement, in which Evonik will manufacture final and intermediate step APIs for certain Lilly human and animal health products. Approximately 700 current Lilly employees, representing all full-time non-contracted workers dedicated to the site, will be offered employment with Evonik. Financial terms of the deal were not disclosed.
The decision to sell the site is based upon a projected decline in utilization of the site due to several factors, including upcoming patent expirations on certain medicines made at the site, Lilly's strategic decision to purchase, rather than manufacture, many late-stage chemical intermediates, and the evolution of the Lilly pipeline toward more biotechnology medicines, according to a Lilly statement.
"Today's announcement represents a positive outcome for employees at the site, the Lafayette community and Lilly," said John Lechleiter, Ph.D., Lilly's chairman and chief executive officer. "We are confident in our decision to sell Tippe Labs to Evonik, as it is a well-established multinational company that will continue to operate the site and more fully utilize its capabilities."
"The acquisition of Tippecanoe Laboratories enables us to meet the growing demand for intermediates and active pharmaceutical ingredients in the pharmaceutical industry and substantially boosts our global exclusive synthesis business," said Dr. Klaus Engel, chief executive officer of Evonik Industries. "The pharmaceutical market is attractive, economically stable, and produces growth rates near the double-digit range every year."
"Tippecanoe Laboratories has maintained a longstanding presence in the Lafayette community and has produced lifesaving medicines for patients and leading animal health products for more than a half-century," commented Frank Deane, Ph.D., president of Lilly manufacturing operations. "We are pleased to reach an attractive outcome that allows the site to remain in operation, maintains employment opportunities for almost 700 affected employees and allows both Lilly and the state of Indiana to continue to benefit from the site's capacity and technical capabilities."
The transaction will close by the end of 2009.
Posted on October 14, 2009 @ 07:43 am
Galapagos NV has expanded its global strategic alliance in metabolic diseases with an affiliate of
Merck to incorporate the development of new therapies for atherosclerosis. Galapagos will be responsible for the discovery and preclinical development of new small molecule candidate drugs based on novel Galapagos targets.
The alliance will make use of Galapagos' proprietary target discovery platform for identification of novel targets in atherosclerosis, as well as in obesity and diabetes. After validation, targets will be selected by a joint steering committee and entered into screening and chemistry by Galapagos. Merck will have an exclusive option to license in each candidate for clinical development and commercialization on a worldwide basis. Upon exercise of such option, Merck will be responsible for the development and commercialization of the candidate drug. Galapagos may execute Phase I clinical studies and will have the right to further develop and commercialize certain compounds for which Merck does not exercise its exclusive option.
In January 2009, Galapagos formed an alliance with Merck in diabetes and obesity. Under the terms of this expanded agreement, Galapagos is eligible to receive research, regulatory and sales milestone payments that may total in excess of $645 million. Galapagos is also eligible to receive royalties upon commercialization of any products covered under the agreement.
This expansion is separate from Galapagos' alliance with Merck in inflammatory diseases, which was formed in April 2009.
Posted on October 14, 2009 @ 07:39 am
Susan Kramer, Dr. P.H., has been named vice president, Project and Alliance Management at
XOMA Ltd. Dr. Kramer has 25 years of industry experience at Genentech and two biotechnology companies and a strong focus on product development and alliance management. She will lead and direct the program management activities for XOMA 052, both strategic and operational, from clinical development through approval. She also will provide leadership to the company's project and alliance management group.
Prior to joining XOMA, Dr. Kramer served as the vice president of development at Anesiva, Inc. where she led the development of Adlea, a non-opioid analgesic. Prior to Anesiva, Susan co-founded Corthera, Inc., and led the development of Relaxin for use in congestive heart failure, orthodontics and preeclampsia. During her 18 years at Genentech, Dr. Kramer served in a number of management positions including senior director of bioanalytical technology, where she supervised a group of more than 100 scientists. She was the project champion and manager of a number of key Genentech projects with partners like Boehringer Ingelheim, Toray Industries, Daiichi Seiyaku and Fujisawa Pharmaceuticals.
Posted on October 14, 2009 @ 07:36 am
Abbott 3Q09
3Q Revenues: $7.8 billion (+4%)
3Q Earnings: $1.5 billion (+37%)
YTD Revenues: $22.0 billion (+2%)
YTD Earnings: $4.2 billion (+26%)
Comments: Pharma revenues for 3Q09 were $4.1 billion, a 2% drop from last year. Currency fluctuation accounted for a 6% shortfall. Pharma sales for YTD were $11.6 billion, down 4% (with a 7% hit from currency). Pharma sales were led by Humira, which posted sales of $1.5 billion (+24%) in 3Q09 and $3.8 billion (+21%) YTD. Depakote sales plummeted due to generic competition, falling 71% to $92 million in 3Q09 and $324 million YTD. Earnings this quarter got a boost from a favorable patent settlement for a stent.
Posted on October 13, 2009 @ 08:32 am
Bruce J. Seeley has been named executive vice president, commercial at
Seattle Genetics. Mr. Seeley brings more than 18 years of experience in oncology drug marketing and sales to the company, most recently from Genentech BioOncology. The company also promoted
Kirk D. Schumacher to vice president, legal affairs and compliance, and general counsel.
“Bruce will lead our efforts to build Seattle Genetics’ marketing and sales functions as we position the company for commercial operations, including the planned 2011 product launch of brentuximab vedotin (SGN-35),” said Clay B. Siegall, Ph.D., president and chief executive officer. “His depth of experience in the commercialization of oncology drugs, including two of the most important therapies for the treatment of cancer, Herceptin and Taxotere, will be a tremendous asset to the company.”
Dr. Siegall added, “Kirk Schumacher has been instrumental at Seattle Genetics, including his contributions to several strategic collaborations and equity financings, and his oversight of our legal affairs. Bruce and Kirk will play key leadership roles as Seattle Genetics continues to execute on its corporate goals.”
Mr. Seeley previously worked at Genentech, most recently as senior director for Herceptin and T-DM1 marketing. His responsibilities included development and implementation of marketing and launch strategies, including product differentiation, pricing, distribution, medical education and promotion. Before that, he spent four years at Aventis Pharma in increasing roles of responsibility, including head of new product commercialization and licensing, global marketing, oncology. While at Aventis, he managed the global marketing activities for Taxotere. Mr. Seeley also held various marketing and sales positions at Rhone-Poulenc Rorer and Bristol-Myers Squibb. He received a Bachelor of Arts in Sociology from the University of California at Los Angeles.
Posted on October 13, 2009 @ 07:12 am
J&J 3Q09
3Q Revenues: $15.1 billion (-5%)
3Q Earnings: $3.3 billion (+1%)
YTD Revenues: $45.3 billion (-7%)
YTD Earnings: $10.0 billion (-2%)
Comments: Worldwide pharmaceutical revenues dropped 14% to $5.2 billion in 3Q09, with currency fluctuation accounting for 2% of that. U.S. pharma revenues dropped 19% to $2.9 billion. For the YTD, worldwide pharma revenues dropped 13% to $16.5 billion (4% from currency), with U.S. drug revenues falling 15% to $9.7 billion. During the quarter, U.S. sales of Topamax fell from $606 million to $72 million. The only major pharmaceutical products to show growth in the quarter were Remicade (+6% to $1.0 billion), Risperdal Consta (+4% to $353 million), and Velcade (+22% to $231 million). New drugs Prezista and Invega were up worldwide 91% to $151 million and 9% to $97 million, respectively.
Posted on October 13, 2009 @ 07:00 am
SAFC Pharma, part of the Sigma-Aldrich Group, has completed an addition to its Carlsbad, CA, facility, expanding its contract manufacturing services for its late phase and commercial clients. The $12 million project includes the addition of two fully segregated state-of-the-art viral product manufacturing suites, built to employ disposable bioreactor technologies, expanding SAFC Pharma's biologics, viral vaccines and gene therapy manufacturing to commercial-scale quantities.
The Carlsbad site specializes in the process development and manufacturing of viral vaccines and viral therapeutics, including support services, from preclinical process and analytical development to final fill/finish and commercial bulk drug supplies. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. Adding 8,000 sq. ft. of manufacturing space to the existing 44,000-sq.-ft. site, the addition enables both 100-liter batch production in stirred tank bioreactors and 1,000-liter batch manufacturing in disposable bioreactors, and is Biosafety Level 2 compliant, allowing manipulation of human pathogens. Designed from the outset as a containment facility, the expansion space allows clients to secure a dedicated suite of cleanrooms for larger scale manufacturing.
"We are delighted to announce this expansion of our capabilities at our Carlsbad facility, particularly when the economic environment has been so challenging," commented David Feldker, Vice President SAFC Pharma. "We expect to see a great deal of value in the biologics and viral manufacturing marketplace in the next three to five years generated by two main customer types - those with late clinical phase opportunities but without any in-house manufacturing capability and those with late clinical phase opportunities that have some manufacturing capabilities but may be seeking an additional 'safety net' or wish to avoid additional capital expansion until their technology and drug has proven itself. By adding and extending our capabilities at Carlsbad, we are providing customers with an attractive, clear pathway that adds value and supports secure, successful product launches."
Facility validation studies are currently underway, with an expected start of cGMP manufacturing operations by the end of December 2009. The site added numerous utility support systems to allow for continuous operation and will now utilize its new Water For Injection (WFI) system. The expansion in Carlsbad follows the acquisition in 2007 of Molecular Medicine BioServices, Inc.
Posted on October 12, 2009 @ 08:41 am
QRxPharma has signed a contract with
Patheon to manufacture clinical supplies of QRxPharma's controlled release Dual-Opioid formulation, MoxDuoCR. MoxDuoCR is designed to provide 12 hours of pain relief in patients suffering from moderate to severe chronic pain (including cancer, lower back, osteoarthritis and neuropathic).
"The Patheon relationship represents a major step forward for QRxPharma that rounds out our platform of MoxDuo products," said Dr. John Holaday, QRxPharma's managing director and chief executive officer. "Our goal is to provide physicians and patients with a variety of complementary Dual Opioids for managing moderate to severe pain. MoxDuoCR is expected to deliver clinical benefits similar to those clinically demonstrated with MoxDuoIR (immediate release formulation) - fewer side effects and superior pain relief."
The new formulation includes tamper resistant features and is designed to provide 12 hours of pain relief. "We are targeting a twice daily dosage with MoxDuoCR, and we anticipate our initial Phase I studies will begin this year to evaluate the pharmacokinetic profile of this patented formulation," said Dr. Holaday. MoxDuoIR is in Phase III trials and scheduled for an NDA in 2010. MoxDuoCR is anticipated to complete clinical trials in 2012.
Posted on October 12, 2009 @ 08:19 am
David Wolton has been named vice president manufacturing at
CMC Biologics. Mr. Wolton has held positions with Elan, Wyeth and Lonza during his 23-year biotech career.
“We are delighted to add David’s tremendous experience to CMC Biologics.He has a proven track record in managing successful manufacturing teams and will bring new opportunities for production efficiencies,” said Peter Vilby, CMC's chief operating officer.
“CMC Biologics continues to attract the highest caliber people in our industry, and David Wolton’s appointment will ensure continued delivery of products to our customers,in the highly demanding regulatory environment of biologicals,” said Mads Laustsen, the company's chief executive officer.
Posted on October 12, 2009 @ 08:17 am
Onyx Pharmaceuticals has signed an agreement to acquire
Proteolix, Inc., a privately held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of hematological malignancies and solid tumors. Proteolix's lead compound, carfilzomib, is a proteasome inhibitor currently in multiple clinical trials, including a Phase IIb trial for patients with relapsed and refractory multiple myeloma.
"Carfilzomib is a next-generation product candidate with a proven and well-validated mechanism of action, strong efficacy signals, demonstrated tolerability and a potential accelerated approval pathway," said N. Anthony Coles, M.D., president and chief executive officer of Onyx. "This acquisition leverages Onyx's proven expertise in developing and commercializing Nexavar and provides strategic expansion into the $16 billion hematological malignancies market. The transaction structure reflects our approach to growing our business in a disciplined fashion, including earnout payments contingent on specific approval-based events. In addition, our development plan is designed to maintain our ability to continue to grow operating cash flow in 2010 and beyond."
Onyx will make a $276 million cash payment upon closing of the transaction. Additional payments include $40 million payable in 2010 based on the achievement of a development milestone and as much as $535 million contingent upon the achievement of certain regulatory approvals for carfilzomib in the U.S. and Europe. A payment of $170 million (of the potential $535 million) is based upon the achievement of accelerated FDA approval. The transaction is expected to close in 4Q09, subject to the receipt of clearance under the Hart-Scott-Rodino Act and customary closing conditions.
Posted on October 9, 2009 @ 09:45 am
Hospira has signed a business cooperation agreement with South Korea-based
Celltrion for future distribution of biogeneric products in the U.S., Europe, Australia, New Zealand and Canada. Celltrion is currently developing eight biogeneric products, five of which relate to Hospira's pipeline.
The companies will collaborate on manufacturing and supply of the products. Following regulatory approval, Hospira and Celltrion will co-market the drugs, with the products independently commercialized under each company's brand name. Financial terms were not disclosed.
"Celltrion brings a history of expertise in the manufacturing of protein-based therapeutics," said Christopher B. Begley, chairman and chief executive officer, Hospira. "This partnership gives Hospira access to Celltrion's large biogenerics portfolio, and is an excellent example of Hospira's commitment to organic and inorganic growth. We're excited to work with Celltrion, and we look forward to expanding Hospira's presence in these significant biogenerics markets."
"Hospira is the world leader in generic injectable pharmaceuticals and has the capabilities and experience to successfully sell biogenerics in these important markets," said Jung-Sin Seo, chief executive officer and chairman, Celltrion. "We believe this partnership will benefit both companies by combining Hospira's broad outreach with Celltrion's advanced biologic manufacturing capabilities."
Posted on October 9, 2009 @ 09:43 am
Paul S. Changelian, Ph.D. and
Peter L. Toogood, Ph.D. have been appointed to
Lycera Corp.'s drug development team. Dr. Changelian, previously director of inflammation biology at Pfizer, will serve as vice president of biology. Dr. Toogood, who was an associate director and research fellow at Parke-Davis and Pfizer, will be Lycera's vice president of chemistry and chemical biology. Both will play important roles in Lycera's efforts to develop novel small molecule treatments for patients with autoimmune diseases including psoriasis, rheumatoid arthritis, lupus erythematosis, inflammatory bowel disease and transplant rejection.
Together Drs. Changelian and Toogood have more than 30 years of drug discovery and development experience. Dr. Changelian's research focuses on autoimmune diseases, organ transplantation and kinase biology. Dr. Toogood's research is in immunology, inflammation, infectious diseases and cancer.
"Paul and Peter bring a wealth of experience in autoimmune drug discovery and development that will be essential to Lycera's success," said Dr. Gary Glick, the company's co-founder and chief scientific officer. "Their track records of successfully developing promising compounds in this area will be crucial as we continue to advance our development initiatives for small-molecule immunomodulators."
Posted on October 8, 2009 @ 09:14 am
3M Drug Delivery Systems is expanding its capabilities with a new lab site at its Singapore facility in Yishun. The Singapore lab will develop products in both the inhalation and transdermal drug delivery categories for pharmaceutical customers in the Asia Pacific region. The facility houses both a feasibility lab and two process development labs.
“Expanding our presence in Singapore will help us provide Asia Pacific customers with a product development service that has both local and global capabilities,” said Jim Vaughan, vice president and general manager, 3M Drug Delivery Systems Division. “Our team in Singapore understands the region’s regulatory requirements, and is able to quickly respond to customer needs. Additionally, our global laboratory network helps us deliver the outstanding quality the 3M brand is known for.”
The lab is 3M Drug Delivery Systems’ first contract R&D facility in the Asia Pacific region dedicated to pharmaceutical product development. Products developed by the Singapore lab will be suitable for manufacture in 3M’s global network of manufacturing sites in St. Paul, MN, and Loughborough, U.K, and will be developed to conform to global standards.
Posted on October 8, 2009 @ 09:11 am
Creapharm Europe has established a U.S. subsidiary, Creapharm-MP5, Inc. Through its subsidiaries Creapharm and MP5, Creapharm Europe manufacturers cytotoxic and other high-potency drugs as well as clinical supply services.
As part of the launch, Matthew Maupin has been appointed vice president of business development, North America. Mr. Maupin’s efforts will focus on promoting MP5’s services in the U.S. and Canada with particular focus on the oncology market. He will also promote Creapharm’s clinical supply offerings.
Most recently, Mr. Maupin was the vice president of business development for a U.S. CMO. Previously held leadership positions in quality and operations in addition to owning a research reagent business focused on RNAi (RNA interference).
Posted on October 8, 2009 @ 09:02 am
NextPharma has expanded its capabilities with the addition of clinical trial services at its San Diego, CA facility. The company’s clinical services include: randomization double-blinding, generation of emergency letters, packaging, kitting, labeling (Phase I – Phase IV studies), cold-chain storage, distribution, return accountability and destruction.
Bill Wedlake, NextPharma’s chief executive officer, added, “We are excited by the addition of this new Clinical Trials Service facility in San Diego. Our Clinical Trials Services personnel have proven expertise in supporting global clinical trials for pharmaceutical, biotechnology academic and research organizations. This new service will leverage our growing presence in pharmaceutical development and contract manufacturing in the U.S.”
NextPharma’s North American operation based in San Diego, CA, serves small to large companies in the biotechnology, pharmaceutical, diagnostic, and medical device markets. Its aseptic area has cleanroom suites offering Class 10,000 (Class 7 or Class C) formulation rooms and Class 100 (Class 5 or Class A) filling hoods or rooms. This facility is FDA licensed for drugs and medical devices and ISO 13485:2003 certified for medical device manufacturing.
NextPharma also has a clinical trials services facility Göttingen, Germany with packaging suites for primary and secondary packaging, a cold storage area, a packaging suite for secondary packaging of high potency drugs, and the capability to perform primary packaging under inert gas conditions, as well as a suite for packaging humidity-sensitive products. The facility operates under cGMP guidelines, meets European compliance regulations and is in the process of being validated to meet FDA regulatory requirements.
Posted on October 7, 2009 @ 09:08 am
Baxter International, Inc. has been granted marketing authorization for Celvapan H1N1 pandemic vaccine from the European Commission. Celvapan H1N1 is the first cell culture-based and non-adjuvanted pandemic flu vaccine to receive marketing authorization in the EU.
Baxter continues to deliver vaccine to national health authorities that have agreements with the company. Initial quantities of vaccine have already been received by a number of countries, including the UK and Ireland.
Baxter is confirming the safety and immunogenicity of Celvapan H1N1 in clinical trials and will supplement the licensure post-approval with data from its ongoing clinical program. Preliminary safety data indicates the vaccine is well tolerated. The current dosing schedule calls for two 7.5 µg doses of vaccine to be given 21 days apart. The company expects the data from the trial of healthy adults to indicate whether a single dose may be possible for Celvapan H1N1. This study will also determine whether a lower dose is sufficient to induce the necessary immune response.
Posted on October 7, 2009 @ 09:06 am
Catalent Pharma Solutions’ dose form development, manufacturing and packaging facility in Schorndorf, Germany, has successfully completed an FDA inspection. The inspection, triggered by pre-approval inspection requirements for two separate products, resulted in three minor observations on FDA Form 483.
Sharon Johnson, Catalent’s executive vice president of Quality, said, “The success of this inspection again demonstrates Catalent’s operational performance, depth of regulatory expertise, track record of quality and commitment to excellence. We are pleased to offer our customers added flexibility in their supply chain options for products coming to the U.S.”
Catalent’s Schorndorf business provides formulation and development services, clinical and commercial manufacturing for oral tablet and capsules, powders and other dose forms. The business also provides clinical and commercial packaging, clinical supply chain management services, and product development and commercial supply chain solutions for products in these dosage forms.
Posted on October 7, 2009 @ 09:04 am
Charles River Laboratories’ new Shanghai facility received accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), the Canadian Council on Animal Care (CCAC) and the Shanghai Laboratory Animal Commission (SLAC). The AAALAC recognizes humane care of research models, CCAC acknowledges veterinary services, and SLAC acknowledges animal welfare policies.
“These three accreditations are a milestone in Charles River’s strategy to create a Center of Excellence in China,” said James C. Foster, president, chairman and chief executive officer of Charles River. “As the leading international CRO with GLP capabilities in China, we are replicating the Company’s high standards of research, safety, humane care and laboratory best practices that globally distinguish Charles River.”
Posted on October 6, 2009 @ 08:58 am
Dr. Ganesh Iyer has been appointed president and chief executive officer,
OctAlgos Therapeutics Inc., effective immediately.
"We were incredibly fortunate to have attracted such a uniquely qualified executive as Dr. Iyer to lead Algos," said Gary Smaby, Algos board chair and managing partner for Quatris Fund, the company's lead investor. "Dr. Iyer possesses the rare combination of scientific expertise and business acumen needed to lead Algos in the deployment of the Company's new service-based CRO model focused on assisting leading pharmaceutical companies in bringing their technological breakthroughs to the marketplace," adds Mr. Smaby.
Dr. Iyer was previously director of strategic analysis and business operations at MDS Pharma Services. Dr. Iyer has more than 16 years of strategic and business development experience with prominent companies, including ZymoGenetics/Novo Nordisk, Xcyte Therapies, SkeleTech, MDS Pharma Services and Microsoft.
"I am very excited about joining Algos and look forward to working with an excellent team to achieving our mission and goal to become the premier preclinical in vivo pain research services company," commented Dr. Iyer.
Posted on October 6, 2009 @ 08:55 am
Bristol-Myers Squibb and
AstraZeneca were granted marketing authorization for Onglyza from the European Commission. Onglyza is indicated as a once-daily 5 mg tablet in adult patients with type 2 diabetes to improve glycaemic control in combination with metformin, sulphonylurea or thiazolidinedione, when these drugs alone, with diet and exercise, do not provide adequate glycaemic control.
The marketing authorization is based on data from six Phase III registrational trials and a Phase IIIb study comparing saxagliptin plus metformin with sitagliptin plus metformin. The trials assessed the safety and efficacy of Onglyza and involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza.
Onglyza is the first drug to be launched in Europe through BMS and AZ’s worldwide R&D collaboration. Onglyza will be launched in 4Q09.
Béatrice Cazala, BMS president, Europe, and president, global commercialization, said, “The European Commission decision marks an important milestone in the alliance between Bristol-Myers Squibb and AstraZeneca. Our legacy in treating type 2 diabetes and cardiovascular disease, together with our knowledge and expertise, enables us to deliver to patients a medicine that will offer further choice for the treatment of this serious condition.”
Ulf Sather, AstraZeneca’s regional vice president for Europe, said, “Diabetes is a growing epidemic currently affecting some 53 million people in Europe with the number of cases expected to increase. Today’s announcement is good news for those affected by type 2 diabetes and further demonstrates the commitment of AstraZeneca and Bristol-Myers Squibb to bring much needed options for the treatment of type 2 diabetes.”
Posted on October 6, 2009 @ 08:51 am
OncoGenex Pharmaceuticals, Inc. received an additional Fast Track Designation from the FDA for OGX-011 (custirsen sodium) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment. OGX-011 previously received Fast Track for second-line docetaxel treatment for progressive metastatic prostate cancer following docetaxel.
Fast Track Designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. It was based on data from a randomized, Phase II study that suggested OGX-011 in combination with first-line docetaxel treatment may improve survival in patients with castrate resistant prostate cancer (CRPC).
"An expansion of the current Fast Track Designation to include OGX-011 in combination with first-line docetaxel treatment is consistent with our current development plans in prostate cancer," said Scott Cormack, chief executive officer of OncoGenex. "We intend to execute Phase III trials, which now have completed Special Protocol Assessments for first-line and second-line chemotherapy treatment, and these Fast Track Designations along with the SPA's should help us move expeditiously toward commercialization of OGX-011 in prostate cancer."
Posted on October 5, 2009 @ 09:36 am
GlaxoSmithKline and
XenoPort, Inc. achieved positive results from a Phase II trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in patients with neuropathic pain associated with post-herpetic neuralgia (PHN), who have had an inadequate response to gabapentin. In this double-blind, two-period cross-over study, 3600 mg/day of GSK1838262 demonstrated a statistically significant improvement over 1200 mg/day of GSK1838262 on the primary endpoint, which was the change from baseline to the end of the treatment period in the 24-hour average pain intensity score.
This study enrolled 138 subjects with PHN who had been experiencing pain for at least three months following healing of the herpes zoster skin rash. Subjects with a history of inadequate response to gabapentin received a dose of 1800 mg/day of gabapentin for two weeks. Subjects who had a 24-hour average pain score of at least four on the 11-point pain intensity rating scale were then randomized to receive either 1200 mg/day of GSK1838262 for the first treatment period followed by 3600 mg/day for the second treatment period, or 3600 mg/day followed by 1200 mg/day. Subjects received 2400 mg/day of GSK1838262 for four days in between the two treatment periods.
“These results from another positive study of GSK1838262 in the treatment of PHN will be important as we evaluate our next steps in the development program for neuropathic pain,” said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicines Development Center.
“Clinical trial experience has shown that there are PHN patients who do not experience adequate pain relief,” said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort. “We are encouraged by these Phase II results and plan to share further details about the study at a future medical meeting.”
Posted on October 5, 2009 @ 09:35 am
Pharmatek Laboratories, Inc. has acquired the Xcelodose 600S system, adding to its preclinical and early phase clinical GMP supply capabilities. The company will install the unit in its solid dose manufacturing facility in San Diego, CA and it’s expected to be validated by mid-October. The company is currently scheduling Xcelodose manufacturing productions for November and December.
"Pharmatek is always looking for ways to move our customers' drug candidates into the clinic more efficiently without compromising quality," said Jeffrey Bibbs, Ph.D., chief scientific officer of Pharmatek. "For powder-in-capsule (PIC) applications, the Xcelodose can drastically decrease time to clinic while also lowering the cost of drug product for first-in-human trials."
The Xcelodose, manufactured by Capsugel, a division of Pfizer, is a precision powder micro-doser and automated encapsulator that has the ability to fill formulations or API directly into capsules. The Xcelodose can measure to levels as low as 100 micrograms and can dispense into capsules from size 00 to 4. According to the company, dosing directly into capsules can reduce the amount of API required and the unit reduces overall development time by simplifying analytical and stability protocols.
Posted on October 5, 2009 @ 09:33 am
OctoPlus N.V. plans to reduce its work force by approximately 25% across all areas of the company. This past year, the company announced a change in strategy to become a drug delivery service-based business in an effort to lead to ongoing short-term revenues and long-term potential royalties.
Simon Sturge, chief executive officer of OctoPlus, said, "These efficiency measures will enable us to operate more competitively and will help to broaden our client base, which will diversify our revenue sources in both drug delivery and pharmaceutical services, aside from our current revenue stream from Locteron. These steps will enhance our ability to build a profitable service organization although these reorganizational changes will prevent us from being operationally cash flow positive in the second half of the year. The measures taken today will streamline the company going forward."
Posted on October 2, 2009 @ 09:19 am
Xcellerex and
Itero Biopharmaceuticals have entered into a strategic collaboration for the production of Itero’s lead product, an undisclosed therapeutic protein. Xcellerex will provide development and product manufacturing for global clinical and commercialization supplies. The two companies anticipate that this will be a multi-product collaboration. For the first product, Xcellerex will manufacture Itero’s Phase III clinical materials in 2010/2011.
“Xcellerex is enabling Itero’s rapid drug development through Phase III utilizing its state-of-the-art PDMax process development platform and its FlexFactory technology, which should provide Itero and its future partners with a cost-effective and flexible manufacturing alternative at full commercial scale,” stated Joseph Zakrzewski, Xcellerex’s president and chief executive officer.
“We believe Xcellerex is the right choice for Itero given their innovative, portable technology and their extensive manufacturing experience, which includes nearly 20 products for clinical trial development,” said Bryan Lawlis, Ph.D., Itero’s president and chief executive officer. “With the equity component of our collaboration, we are confident in their commitment to fully support our manufacturing needs as we make significant strides in building our product portfolio.”
Financial terms were not disclosed. Xcellerex, as part of the payment structure, will become an equity holder in Itero. The collaboration also anticipates Itero’s future purchase of a portable FlexFactory.
Posted on October 2, 2009 @ 09:18 am
The Kansas City District Office of the FDA submitted a recommendation of approval to the Center for Drug Evaluation and Research for
The University of Iowa Pharmaceuticals (UIP) to manufacture an aseptically filled sterile, prescription drug product for a client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into a vial.
The FDA recommendation followed a Pre-Approval Inspection (PAI) of UIP’s facilities and procedures and review of the product’s manufacturing and testing procedures based on the client’s NDA. The inspection covered cGMPs as well as specific information related to the manufacture and analytical testing of the product.
"This accomplishment validates the significant upgrades UIP has made in its sterile products manufacturing area and quality systems to support our goal of providing contract services for new pharmaceutical products from inception through commercial launch and beyond,” said Mickey L. Wells, Ph.D., director of UI Pharmaceuticals.
Posted on October 2, 2009 @ 09:13 am
Haupt Pharma has added a new department and separate area for the production and handling of sex hormone-containing solids, such as oral contraceptives, that will go into operation at its Münster plant.
Haupt Pharma will use the new production facilities to manufacture film- and sugar-coated tablets that will be packed in blisters. The new facility follows the closed and high-containment principle to prevent substances from contaminating machinery and the surrounding area, using a dispensing isolator, one-pot dry mixer and wet-granulating equipment, high-containment tablet presses, as well as a film- and sugar-coater. Critical transfer processes will be carried out using containers that allow dust-free loading of the equipment using special valve systems and lifting columns.
The new production facility complies with FDA requirements. Construction of the separate production area for sex hormone-containing solids began in October 2008 and will be handed over to the production department in November 2009.
Posted on October 1, 2009 @ 09:22 am
Merrimack Pharmaceuticals, Inc. and
Sanofi-Aventis signed an exclusive worldwide licensing agreement for the development and commercialization of MM-121, a fully human monoclonal antibody designed to block signaling of the ErbB3 receptor. MM-121 is currently in Phase I testing as a potential treatment for cancer.
SA will make an upfront payment of $60 million and will be responsible for all development costs. Merrimack is eligible for an additional $470 million in milestone payments as well as royalties on sales. Merrimack will develop MM-121 through Phase II for each indication and SA will be responsible for further development. Merrimack retains the right to co-promote the therapy in the U.S.
The ErbB3 receptor is a novel target known to be a key mediator of a signaling network that impacts a broad array of cancers. By targeting ErbB3, MM-121 is believed to have a broad application across cancer as both a monotherapy and in combination with other therapeutics.
"Merrimack's expertise along with their knowledge of biologics development has allowed them to successfully identify ErbB3 as a promising target and rapidly bring MM-121 into clinical development," said Marc Cluzel, senior vice president R&D, SA. "MM-121 is a pioneering monoclonal antibody which brings a new innovative approach to Sanofi-Aventis' oncology portfolio. We are very excited to collaborate with Merrimack on the development of MM-121, which we believe is a very promising compound that will address a significant gap in treating cancer patients."
Posted on October 1, 2009 @ 09:21 am
Troy W. McCall, Ph.D. has been promoted from chief operating officer to chief executive officer at
Premier Research Group, effective immediately. He replaces Dr. Simon Yaxley, who will transition to an advisory role with the company’s board of directors as deputy chairman.
Michael Barry, non-executive chairman of the board, said, “On behalf of the board, I would like to thank Dr. Yaxley for his efforts, commitment to excellence, and vision as CEO and co-founder of Premier Research. Dr. McCall’s commitment, drive, and deep understanding of the business make him the ideal successor to ensure that Premier Research maintains its outstanding track record of growth and customer service.”
Dr. McCall led the successful integration of four acquisitions, established a global organization, and achieved year-on-year growth in excess of 20%.During Dr. McCall’s tenure, the company also initiated support of medical device trials in the U.S., launched a Functional Sourcing group, expanded clinical research sites, and completed its first NDA submission on behalf a sponsor.
Dr. Yaxley commented, “It is exciting and rewarding to have Troy stepping into the CEO role.This is what we have been working together towards and he deserves the recognition.I can think of no one more suited to continue to grow this successful company we, and many others, have worked hard to create.I also look forward to my continued involvement in the business as we continue to grow both organically as well as through acquisition.”
Posted on October 1, 2009 @ 09:19 am
Dr. John Nash has been named senior director of ADME/PK for
BioFocus. Dr. Nash has 30 years of industrial experience with both service and major pharmaceutical companies. Most recently, he worked for Charles River Laboratories in Quebec, Canada, where he was responsible for strengthening the DMPK service business. John also worked with Anserve and AstraZeneca/Syngenta in the UK in metabolism and pharmacokinetics.
“John Nash’s appointment is a major win for BioFocus in the UK,” commented Dr. Chris Newton, senior vice president, BioFocus.“With this hire, BioFocus continues to elevate its 175-scientist facility at Chesterford Research Park into a leading integrated discovery research center for pharma, biotech and not-for-profit organizations worldwide.”
September 2009
Posted on September 30, 2009 @ 09:47 am
Hospira, Inc. has acquired worldwide rights to a biogeneric version of filgrastim and an affiliated manufacturing facility from PLIVA Hrvatska in Zagreb, Croatia. Financial terms were not disclosed.
Hospira will now have full global rights to the biogeneric filgrastim that had previously been part of a strategic collaboration between Hospira and PLIVA/Barr, now owned by Teva Pharmaceutical Industries Ltd.
As part of the agreement, Hospira has also acquired process development capabilities. The Croatia site has sufficient capacity to meet Hospira's worldwide filgrastim and pegfilgrastim requirements, along with expansion options for additional biogenerics manufacturing.
"With this agreement, Hospira expands its reach to new markets for filgrastim, and its global manufacturing capacity for pegfilgrastim," said Ron Squarer, senior vice president, Global Marketing and Corporate Development, Hospira. "Hospira is already well-positioned in the biogenerics marketplace, given our internal capabilities, our strategic collaborations and our commercialization experience in Europe. The additional vertical integration this deal brings, as well as the access to broader markets for our products, further demonstrates Hospira's robust commitment to the biogenerics space."
Applications for the approval of filgrastim were filed with the EMEA and Australia's Therapeutic Goods Administration (TGA) in 1Q09. Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia.
Hospira's pegfilgrastim would be a biogeneric version of Amgen's Neulasta, also used to treat neutropenia. Hospira is currently working on regulatory submissions in Europe, Asia and the U.S.
Posted on September 30, 2009 @ 08:41 am
Almac has plans for a major expansion at its Craigavon headquarters and has acquired a 5.4-acre site for the first phase of development. The expansion plans were prompted by increased demand for development and manufacturing services to pharmaceutical and biotech companies at its Craigavon site. The expansion could potentially create more than 500 jobs during the next five years.
The initial phase includes the construction of a large three-storey office unit to accommodate 220 existing staff and expected recruits. Additionally, plans are under way for a new research facility, as well as a new distribution unit to expand existing capacity.
Group chairman Sir Allen McClay, said, “This is an exciting time for Almac. Since our foundation in 2001 we have grown at record levels, and we expect this trend to continue over the coming years. With our rapid rate of growth it was important to put proper plans in place and provide the necessary room for Almac to expand.”
Posted on September 30, 2009 @ 08:39 am
Covance, Inc. has added cGMP melamine testing services in North America to meet recent FDA guidance on melamine testing for pharmaceutical and animal health manufacturers.
The company developed the new melamine testing method in food and nutritional chemistry products using LC-MS technology to significantly reduce the risk of melamine contamination in pharmaceutical excipients and products.
The FDA issued Pharmaceutical Industry Guidance on Preventing Melamine Contamination in August 2009, prompted by recent incidents involving food products in China and the U.S. The guidance recommends melamine testing for certain pharmaceutical ingredients used in the manufacture or preparation of drug products.
“Covance is committed to ensuring the quality of every client product in compliance with the latest regulatory requirements,” said John Robson, Ph.D., president, analytical services, Covance. “Our method has demonstrated a significantly better sensitivity than recommended by the guidance, which provides our global clients greater assurance of product safety and an earlier opportunity for process optimization.”
Posted on September 30, 2009 @ 08:35 am
Will Downie has been appointed group president, Sterile Technologies and senior vice president of Global Sales and Marketing,
Catalent Pharma Solutions, effective October 12, 2009. Mr. Downie will have full accountability for the Sterile Technologies segment, which includes the company’s injectable manufacturing businesses in Brussels, Belgium and Limoges, France, as well as its blow-fill-seal business, based in Woodstock, IL. Additionally, Mr. Downie will lead the global sales and marketing functions, including Catalent’s Global Account Sales team. He will report to John Chiminski, president and chief executive officer of Catalent, and will be based in Catalent’s Swindon, UK office.
Mr. Downie most recently served as vice president and global leader of GE Healthcare’s Molecular Imaging business, where he was responsible for leading a global organization of 1,800 people at five manufacturing sites. Prior positions at GE include vice president and general manager of medical diagnostics, Europe, Middle East and Africa; vice president and general manager, Europe; and vice president of sales for medical diagnostics, Europe. Prior to GE, Mr. Downie held senior management positions in operations, sales and marketing at Innovex UK Ltd., and commercial leadership positions with Sanofi-Synthelabo UK, Sanofi-Winthrop Ltd., and Merck.
Mr. Chiminski said, “I am pleased to welcome Will to the Catalent executive team.I’ve worked with him for a number of years, and I believe Will’s unique combination of business management experience and sales and marketing expertise will help us accelerate organic growth for both our Sterile business and the Company overall.”
Posted on September 29, 2009 @ 09:46 am
Catalent Pharma Solutions and
GlaxoSmithKline (GSK) have extended their contract under which Catalent will continue to supply GSK with its trade requirements of Lovaza omega-3 acid ethyl esters in soft gelatin capsules. Lovaza is an omega-3 prescription medication derived from fish oil approved by the FDA to reduce very high triglycerides. The Lovaza softgels are manufactured in Catalent’s St. Petersburg, FL facility, which is part of Catalent’s Oral Technologies segment.
“We value our long-term partnership with GSK and look forward to continuing that relationship,” said Dr. Aris Gennadios, Catalent’s vice president and general manager, Pharmaceutical Softgels.
Posted on September 29, 2009 @ 09:45 am
Patheon has opened a new Pharmaceutical Development Services (PDS) manufacturing site for investigational medical products within its existing manufacturing facility in Ferentino, Italy.
The new facility will manufacture sterile products including aseptically filled, terminally sterilized liquids and lyophilization. It also includes development and quality control labs. Three lyophilization units will be available, with two dedicated to development activities for non-human use and one dedicated to the manufacture of clinical trial materials.
The area is designed to accommodate future expansion and is set up specifically for the scale-up of products for clinical use following the completion of development activities on site, and will support mechanisms for the manufacture of biopharmaceutical products. Capabilities will include the manufacture of highly potent drugs, poorly soluble, oxygen and light sensitive compounds, and highly hygroscopic lyo-products. The space is also equipped with a dedicated water and HVAC system.
The expansion doubles PDS manufacturing capabilities for clinical batches and analytical lab capabilities. The new area will be completed for use in November 2009 and will employ an additional 10 process specialists and development scientists.
Patheon’s chief executive officer, Wes Wheeler, stated, "Our new PDS facility will be of strategic importance in order to feed the pipeline of Patheon's two commercial sites located in Italy, offering clients a one-stop shop, from early development all the way through to commercial manufacturing."
Posted on September 29, 2009 @ 09:42 am
Laureate Pharma has entered into a development and manufacturing agreement with ZZ Biotech, LLC, under which Laureate will produce Activated Protein C variant under cGMP conditions. Terms of the agreement were not disclosed.
"We are pleased that ZZ Biotech has chosen Laureate as their manufacturing partner," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. "We will work closely with their team and help them drive their product from development into the clinic."
"Laureate Pharma has a proven track record in biopharmaceutical manufacturing, including capabilities in both clinical and commercial-scale grade materials," said Berislav V. Zlokovic, M.D., Ph.D. founder and chief scientific officer of ZZ Biotech. "This agreement enables us to operationally leverage Laureate's expertise and infrastructure while we seek to establish new treatment for stroke and neurodegenerative disorders."
Posted on September 29, 2009 @ 09:40 am
West Pharmaceutical Services, Inc. has opened its new 129,000-sq.-ft. injection-molding factory in the Shanghai Qingpu Industrial Zone (SQIZ) in China. The company will manufacture TrimTec and InsoCap closures for intravenous solution bottles and will also export the closures to other markets in Asia, Europe and South America. The Qingpu plant currently employs 52 people and is ISO:9001 certified.
“West is experiencing an exciting period of growth in the Asia Pacific region and we are proud to open our first manufacturing operation in China,” said Donald E. Morel, Jr., West’s chairman and chief executive officer. “This facility was established in direct response to client demand, and we are committed to supporting the growth of our pharmaceutical customers in China.
West broke ground for the plant in January 2008. Following completion of systems validation and testing, full commercial production will begin late in 3Q09.
Posted on September 29, 2009 @ 09:37 am
Vetter recently inaugurated its Ravensburg South site with a new 862,000 sq.-ft. area that now includes facilities for the aseptic filling and packaging of injectable drugs. The location features three buildings: a production facility, a final assembly and packaging plant, and a lab for ongoing production-related analyses. The company has invested approximately $220 million in the site and is investing another $73 million to expand pharmaceutical production.
The new location features maximum production automation, the use of RABS (Restricted Access Barrier Systems), central material supply with optimized material flows, and two independent filling lines. The two filling lines were the first segments of the expanded production site to begin operating in early 2007. Currently, final preparations are being made for a third production line, which is scheduled for completion by mid 2011.
The new Vetter Secondary Packaging (VSP) facility, in which the final assembly and packaging of the pre-filled injection systems is handled, is the last step of the company’s complete service offering. The entire VPS process, from hand-packaging and assembly of pens, auto-injectors and safety devices to the fully automated final packaging, takes place in the Ravensburg South plant. It has been operating fully since May 2009.
The final component of the Ravensburg Vetter South Laboratory (RVS-Lab) is the new lab, which includes a microbiological lab and chemical analysis area in new, specially designed spaces.
Posted on September 28, 2009 @ 08:41 am
Abbott has entered a definitive agreement with the Solvay Group to acquire Solvay's pharmaceuticals business for $6.6 billion in cash. The acquisition also includes global rights to the fenofibrate franchise. Currently Abbott has U.S. rights to fenofibrate and pays royalties to Solvay.
Belgium-based Solvay Pharmaceuticals will add more than $3 billion in annual sales; the majority outside the U.S. Solvay also has significant presence and infrastructure in high-growth emerging markets, including Eastern Europe and Asia. The acquisition will also add approximately $500 million to Abbott's annual pharmaceutical R&D investment.
Solvay's portfolio adds to Abbott's presence in specialty markets such as cardiovascular disease, neuroscience and gastroenterology. Solvay has products for Parkinson's disease, Meniere's disease (abnormality of the inner ear), vertigo, and irritable bowel syndrome. Solvay also offers products to treat hormonal health and exocrine pancreatic insufficiency, which is associated with several underlying conditions including cystic fibrosis and chronic pancreatitis.
The acquisition also includes Solvay's vaccines business, which will provide Abbott entry into the global vaccines market. Solvay has a small molecular diagnostics unit that will become part of Abbott's diagnostics organization once the transaction closes.
"The acquisition of Solvay Pharmaceuticals further diversifies our pharmaceutical portfolio, expands our presence in key high-growth emerging markets, enhances our investment in R&D and accelerates our long-term earnings-per-share growth outlook," said Miles D. White, chairman and chief executive officer, Abbott.
"With this transaction Solvay Pharmaceuticals has found a new strong home, within a respected company with a solid and committed position in the industry," said Christian Jourquin, chief executive officer, Solvay.
Posted on September 28, 2009 @ 08:26 am
Johnson & Johnson, through its subsidiary
Ortho-McNeil-Janssen Pharmaceuticals, Inc., and
Crucell have entered into a strategic collaboration for the discovery, development and commercialization of monoclonal antibodies and vaccines for the treatment and prevention of influenza and other infectious and non-infectious diseases.
The collaboration will initially focus on the development and commercialization of a universal monoclonal antibody product (flu-mAb) for the treatment and prevention of influenza. The long-term focus will be on new discovery programs to develop and commercialize a universal flu vaccine as well as monoclonal antibodies and/or vaccines directed against as many as three other infectious and non-infectious disease targets.
J&J, through its affiliate JHC Nederland B.V., has also purchased 14.6 million newly issued ordinary shares of Crucell, representing approximately 18% of Crucell's outstanding shares, for $443.5 million. Additionally, the companies have agreed to development milestones and royalty payments based on the successful development and commercialization of products under the collaboration.
Under the flu-mAb collaboration, Crucell and Ortho-McNeil-Janssen Pharmaceuticals or its affiliates will share responsibilities to develop a universal flu-mAb product targeting all influenza A strains, including H1N1 strains (which cause seasonal flu and the current pandemic) and the H5N1 or avian strain ('bird flu'). Crucell will be responsible for R&D through Phase IIa and Ortho-McNeil-Janssen Pharmaceuticals or its affiliates will be responsible for late-stage development of the flu-mAb product.
Under the long-term collaboration, Ortho-McNeil-Janssen Pharmaceuticals or its affiliates and Crucell will jointly work to discover and develop a universal flu vaccine, as well as antibody and/or vaccine products against three additional infectious or non-infectious disease targets to be selected after exploratory research.
Ortho-McNeil-Janssen Pharmaceuticals will hold commercialization rights for products resulting from both collaborations in all countries throughout the world, except the EU and certain additional European countries, where Crucell will retain commercialization rights. Ortho-McNeil-Janssen Pharmaceuticals' commercialization rights for products resulting from the innovation collaboration may be expanded worldwide if Crucell elects not to contribute toward development.
Posted on September 23, 2009 @ 09:31 am
Opexa Therapeutics has achieved its first technology transfer milestone in connection with its recently announced exclusive stem cell agreement with
Novartis. The milestone was completed on schedule and triggers a payment of $500,000 to Opexa.
Opexa recently entered into an exclusive agreement with Novartis for the further development of its novel stem cell technology. Opexa received an upfront cash payment of $3 million and was entitled to an additional $1 million as a technology transfer fee to be paid over the course of a six-month period. The $500,000 milestone is part of this $1 million fee. Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million, not including royalties. Opexa is eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights.
Opexa is developing Tovaxin, a personalized T-cell immunotherapy for multiple sclerosis (MS).
Read our profile on Novartis in this year's Top Companies Report!
Posted on September 23, 2009 @ 09:27 am
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc., has entered a strategic partnership agreement with
Azopharma Product Development Group. Azopharma will perform research services to further develop ImmuneRegen's lead drug candidate Homspera.
Azopharma will provide full development services to ImmuneRegen, including drug manufacturing, formulation development, and such preclinical services as IND-enabling toxicology and safety pharmacology studies.
Phil Meeks, chief executive officer of Azopharma Product Development Group, commented, "The potential benefits to humankind of ImmuneRegen's lead compound has compelled Azopharma to undertake this strategic partnership. We are excited to undertake the development activities that will enable pre-clinical and clinical evaluation."
The agreement, which is subject to the completion of work scope and budget by both parties and the negotiation and signing of a definitive agreement, is expected to close within 60 days, with work to begin immediately upon closing. ImmuneRegen intends to issue a certain amount of common stock and common stock purchase warrants to Azopharma, subject to the approval of the company's board.
"We believe this partnership will provide the most expedited development of our lead candidate Homspera," said ImmuneRegen chief executive officer Michael Wilhelm. "We feel privileged to be entering this relationship with Azopharma, given their extensive experience in swiftly developing similar products."
Posted on September 22, 2009 @ 08:57 am
Pfizer and
Wyeth have entered into an agreement with
Boehringer Ingelheim to divest certain animal health assets, pending Pfizer’s acquisition of Wyeth. Under the agreement, BI will acquire products, research and manufacturing facilities, located in Fort Dodge, IA, as well as related assets and intellectual property, primarily from Wyeth’s Fort Dodge Animal Health portfolio in the U.S. and Canada. Products include cattle and small animal vaccines and some animal health pharmaceuticals. BI also plans to acquire certain animal health assets in other jurisdictions, including animal vaccines in Australia, and cattle vaccines in the EU and South Africa.
The agreement is subject to approval from the U.S. Federal Trade Commission and the Canadian Competition Bureau, and the satisfaction of other customary closing conditions. Pfizer expects to obtain the necessary approvals shortly and expects to close the transaction in 4Q09.
Financial terms of the agreement were not disclosed.
Posted on September 22, 2009 @ 08:54 am
Avid Bioservices, Inc. and
Boehringer Ingelheim have entered into a global strategic production alliance agreement, under which Avid will become an approved member of BI's global Production Alliance Network (PAN) Biologics.
The Production Alliance is set up to provide customers with a broader range of contract services, offering access to BI’s high expression BI HEX technology, Avid's process development and cGMP manufacturing, along with access to BI’s large-scale commercial manufacturing facilities. The two companies have compatible technology platforms that support a flexible approach in order to facilitate seamless technology transfers throughout the development, scale-up, clinical and commercial scale production phases.
"With its location on the West Coast of the U.S. and a reputation for quality and innovation, Avid Bioservices is well positioned to play an important role as a strategic partner in our global Production Alliance Network," said Professor Dr. Rolf G. Werner, senior vice president of Boehringer Ingelheim's Corporate Division Biopharmaceuticals. "The Network complements our worldwide strategic manufacturing capabilities with strong regional partners providing process development and clinical supply manufacturing capacity and expertise. We believe this partnership benefits both our partners and our customers, and we look forward to working with the Avid team."
"With this agreement, Avid joins an elite group of Boehringer Ingelheim strategic biologics manufacturing partners located in biotech clusters around the world," said Christopher Eso, vice president of business operations of Avid Bioservices. "This agreement represents an important element of Avid's overall growth strategy and is a testament to the quality of services the Avid team provides to its clients. We expect it will extend both companies' customer offerings by capitalizing on the distinctive capabilities of each."
Posted on September 22, 2009 @ 08:52 am
Toxikon Corp. has expanded its immunotoxicology offerings, adding flow cyctometry, which enables the direct analysis of cells to detect a variety of specifically labeled components.
Christopher Brynczka, Ph.D., head of immunotoxicology, clinical and histology services at Toxikon, said, “This is an opportunity for Toxikon to promote the development of our sponsor’s drugs and medical devices. If there are findings related to immune function in other preclinical studies, a more extensive evaluation of immunotoxicology is often necessary. The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell.”
Posted on September 21, 2009 @ 09:30 am
Icagen, Inc. and
Pfizer have extended their worldwide collaboration and licensing agreement aimed at discovering, developing and commercializing compounds as new potential treatments for pain and related disorders.
For the past two years, the two companies have partnered to identify compounds that target three specific ion channels. The ion channel targets are sodium channels, which are important in the generation of electrical signals in nerve fibers that mediate the initiation, transmission and sensation of pain.
Pfizer will continue to fund all aspects of the collaboration including research efforts at both companies. Pfizer retains exclusive worldwide rights to commercialize products resulting from the collaboration. Under the terms of the extended agreement, Pfizer will provide approximately $5 million in committed funding to Icagen through September 30, 2010. Additionally, Icagen remains eligible to receive approximately $359 million in research, development, regulatory and commercialization milestones for each product, as well as royalties on product sales.
Posted on September 21, 2009 @ 09:29 am
DOR BioPharma has been awarded a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). The grant will fund, over a five-year period, the development of formulation and manufacturing processes for vaccines, including RiVax, that are stable at elevated temperatures. The grant will also fund the development of improved thermostable adjuvants expected to result in rapidly acting vaccines that can be given with fewer injections over shorter intervals.
The formulation and process technology funded by the grant will be applied to the further development of RiVax, a subunit vaccine for prevention of ricin toxin lethality and morbidity. The grant will also address the development of manufacturing processes and animal model systems for the preclinical characterization of vaccine formulations. Further, the grant will fund the concurrent development of at least one other protein subunit vaccine. This could lead to new subunit vaccines that would bypass current cold chain requirements for storage and distribution.
"The novel technology supported by this grant will potentially develop new vaccines to address the practical issue of long-term stability in stockpiled vaccines and can subsequently be applied to other vaccine products," said Robert N. Brey, Ph.D., chief scientific officer of DOR. "These new vaccines could be stored for long periods of time at ambient temperature, and avoid the current need for a well-controlled environmental cold chain. This would result in more useful vaccines for both civilian and military purposes."
Posted on September 21, 2009 @ 09:27 am
Anavex Life Sciences Corp. has completed the scale-up manufacturing of Anavex 2-73, its lead compound for the treatment of Alzheimer's disease.
"With sufficient quantities of Anavex 2-73 in hand we are an important step closer to the commencement of Phase I trials, which are scheduled to begin in early 2010," said Dr. Herve de Kergrohen, chief executive officer of Anavex. "This lead drug candidate shows potential to alter the course of Alzheimer's disease by using sigma receptors to correct dysfunction in the mitochondria and ultimately protect cells from oxidative stress, which is believed to be an underlying cause of the disease."
Syntagon AB manufactured the two kilograms of Anavex 2-73 under GMP conditions. Syntagon developed a five-step synthetic procedure that achieved excellent yields in terms of the quantity of the compound that was produced. Syntagon is a provider of synthetic organic chemistry services headquartered in Sodertalje, Sweden.
Anavex plans to announce the selection of the CRO in charge of carrying out its Phase I trials. To date, Anavex 2-73 has demonstrated powerful neuroprotective, anti-amnesic, anti-convulsive and anti-depressive activity in animal models, with an excellent safety profile and therapeutic activity at low doses.
Posted on September 18, 2009 @ 09:46 am
Wyeth and
Ambrx, Inc. have formed a worldwide alliance to discover, develop, and commercialize protein drug candidates for three undisclosed targets. The alliance will utilize Ambrx's recent breakthroughs in applying its protein medicinal chemistry platform to proteins produced in mammalian cells such as antibodies and antibody-toxin conjugates.
Ambrx is eligible for payments from an upfront commitment, target loading fees and research funding, as well as preclinical, clinical, regulatory and commercial milestone payments and royalties on sales of products resulting from the collaboration. Terms were not disclosed.
"This collaboration with Ambrx reinforces Wyeth's commitment to sustaining and growing our already robust capabilities in the field of biologics drug discovery through partnerships with biotech innovators," said Mikael Dolsten, M.D., Ph.D., president, Wyeth Research. "We are enthusiastic about working with Ambrx, a company with the ability to create and advance precisely engineered biologic drug candidates into clinical trials using its proprietary platform."
Stephen Kaldor, Ph.D., president and chief executive officer of Ambrx, said, "Wyeth is a long-standing leader in protein therapeutics with a strong record of successfully developing innovative products. We are pleased that Wyeth recognizes the power of the Ambrx EuCODE platform and look forward to collaborating with Wyeth's talented personnel to produce the next generation of biologic drugs."
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Posted on September 18, 2009 @ 09:39 am
The FDA has approved
Novartis’ Valturna (aliskiren and valsartan) tablets, a medicine targeting two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), a regulator of blood pressure. This is the first approval for Valturna, which is indicated for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
"This unique combination brings together the powerful blood pressure lowering effects of valsartan and aliskiren," said Joe Jimenez, chief executive officer of the Novartis Pharmaceuticals Division. "It offers an important additional treatment option for physicians and hypertension patients, many of whom are not at their blood pressure goal. Valturna builds upon our strong cardiovascular franchise and is consistent with our long-term commitment to developing effective and innovative therapies. It further strengthens our growing portfolio of single-pill combinations to treat high blood pressure."
Valturna combines valsartan, the active ingredient in high blood pressure drug Diovan, and aliskiren, the active ingredient in Tekturna, a direct renin inhibitor (DRI). This approval was based on an eight-week randomized, double-blind, placebo-controlled trial in approximately 1,800 patients, which studied aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination. Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the primary endpoint.
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contractpharma.com/2009conferencePosted on September 18, 2009 @ 09:36 am
Cambridge Regulatory Services (CambReg) has formed a strategic alliance with
SIRO Clinpharm, a global Indian-based CRO, to provide services to pharma companies in both Asia and Europe. The alliance combines CambReg's regulatory expertise with SIRO's clinical trial services.
The alliance will offer full regulatory services for registering human medicines, including new small molecule or biopharmacetical entities, biologics, herbals and generics. Services include preparing clinical trial applications, marketing authorization (MA) applications in eCTD format, pediatric investigation plans and pediatric use MAs, as well as managing decentralized and mutual recognition procedures across the EU.
“Having come highly recommended to CambReg by the Mumbai High Commission, we are extremely pleased to be endorsing this alliance with SIRO,” said Karen James, managing director of Cambridge Regulatory Services. “This partnership will provide European pharma companies with increased confidence in accessing cost effective clinical trial solutions, hence introducing new clients to SIRO. In return, SIRO will have the benefit of offering regulatory expertise through CambReg.”
"Our alliance with CambReg would go a long way in helping small and mid-sized companies cut through the regulatory maze in Europe," said Dr. Chetan Tamhankar, chief operating officer of SIRO Clinpharm. "This alliance builds on the strength of our European clinical trial operations and allows us to offer greater value to our clients."
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Posted on September 18, 2009 @ 09:30 am
Penn Pharma has appointed
Karl Fry as director of quality. Mr. Fry joins the company from a quality management role at sterile pharmaceutical manufacturer, Patheon in Swindon. He has 16 years of pharmaceutical experience, having managed product quality for a range of clinical trial supply, packaging and pharmaceutical contract manufacturing companies. Mr. Fry will manage a QA team of 22 to further develop and grow this area of the business.
Mr. Fry said, “Having started my career with Penn Pharma, I always knew I’d return to this dynamic, forward-thinking company. I have spent the last six years broadening my QA expertise across a variety of pharma companies and sectors, and now seemed an opportune time to employ this expertise in helping to take Penn Pharma to the next stage in its ongoing global expansion plan.”
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Posted on September 17, 2009 @ 09:14 am
ICON has received industry accreditations for three of its laboratories. The company’s bioanalytical lab in Manchester, UK received GCP and GLP accreditation from the MHRA (Medicines and Healthcare products Regulatory Agency), covering bioanalysis of small molecules by mass spectrometry and large molecules by immunoassay techniques. In addition, ICON’s clinical pathology lab in Manchester has received GCP accreditation.
Also, ICON’s Central Lab in Singapore has received NGSP (National Glycohemoglobin Standardisation Program) Level I Certificate of Traceability for successfully completing bias testing using specific methods and instrumentation, reagent lots and calibrator lots. ICON now has NGSP Level I Certified labs in Farmingdale, NY, Dublin, Ireland, Singapore and Bangalore, India.
Peter Gray, ICON’s chief executive officer, said, “We pride ourselves on the strength of our science and the quality and reliability of our lab testing. Having a global network of industry-accredited labs provides clients with the reassurance that their samples will be tested according to the highest industry standards and techniques which in turn will deliver quality results.”
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Posted on September 17, 2009 @ 09:12 am
GlaxoSmithKline and
XenoPort, Inc. achieved positive results from a Phase IIb trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults.
The 14-week, double-blind, placebo-controlled study enrolled 376 subjects with PHN. Subjects were randomized to receive placebo, 1200, 2400 or 3600 mg/day of the drug, dosed twice a day. All doses of GSK1838262 demonstrated statistically significant improvements over placebo on the primary endpoint, which was the change from baseline to the end of maintenance treatment in the 24-hour average pain intensity score.
“We are encouraged by the positive results in this study of GSK1838262 in treating neuropathic pain associated with PHN, which is a debilitating condition for affected patients. We look forward to sharing the full results at a future medical meeting,” said Atul Pande, M.D., senior vice president, GSK Neurosciences Medicines Development Center. “We are currently evaluating the next steps for the development of this compound for the treatment of neuropathic pain.”
The drug was generally well tolerated at all doses in the study. The most common adverse events were dizziness and somnolence; most were mild or moderate in intensity.
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Posted on September 17, 2009 @ 09:09 am
QPS Taiwan has been awarded a GLP lab certification by the Department of Health (DOH), Executive Yuan, R.O.C. (Taiwan). QPS received this certification based on their scientific infrastructure, including global SOPs, understanding of the regulatory agency requirements, and planning for the implementation of systems and processes within the Taiwan facility.
“QPS Taiwan has been awarded the first and only GLP lab certification by DOH, Taiwan for bioanalytical services supporting preclinical and clinical research,” said QPS Taiwan president and chief executive officer, Vincent Yen, M.B.A. “QPS Taiwan shares the same quality criteria, global SOPs, lab procedures, equipment (API 4000 triple quadrupole mass spectrometers, Shimadzu VP-series LCs, Tomtec Quadra), lab operations (Rees Monitors, Watson LIMS systems), and systems and processes as QPS U.S.A. We are excited about this certification, and are looking forward to continuing our partnership with U.S.A. based, E.U. based, and local pharmaceutical sponsors.”
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Posted on September 16, 2009 @ 08:50 am
Bristol-Myers Squibb Co. has reached an agreement for the sale of its OTC assets in Asia Pacific (excluding China and Japan) to
Taisho Pharmaceutical Co., Ltd. for $310 million.
Taisho will acquire certain product registrations, trademarks and related assets of selected pharmaceutical and OTC products sold primarily in Indonesia, Thailand and the Philippines, as well as in other countries in the region. These products include the rights to Tempra, Counterpain, Theragran-M, Engran, Ceetrus and Keri brands. The transaction also includes BMS’ 97.97% stake in PT Bristol-Myers Squibb Indonesia Tbk, and the facilities, product registrations, IP, inventory and other related assets. The transaction is expected to close in 4Q09.
Taisho will continue to supply these products in Indonesia and other countries within Asia Pacific. Additionally, all 126 employees of BMS Indonesia will transfer to Taisho.
“This planned divestiture is a part of BMS’ strategic transformation into a more focused next-generation BioPharma company that develops and commercializes products that address serious unmet medical needs,” said Dieter Weinand, president, Intercontinental, BMS. “The company is looking closely at its geographic and manufacturing footprint to align more closely to the scale and size of a BioPharma company. Today’s announcement is the seventh in a series of transactions Bristol-Myers Squibb has recently executed within this optimization strategy.”
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Posted on September 16, 2009 @ 08:47 am
PPD, Inc. has opened its global central lab facility in Singapore to provide customized lab services in Southeast Asia. PPD also has an office in Singapore that provides clinical development services, including clinical trial management and monitoring, patient recruitment, site identification and regulatory affairs.
"Expanding our global central lab services into Singapore demonstrates our commitment to deliver high quality specimens and laboratory results for our clients in a growing biopharmaceutical market," said Steve Lobel, vice president, global laboratory operations, PPD. "We can expedite delivery of lab data through reduced transportation and shipping time at better logistics costs for our clients."
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Posted on September 16, 2009 @ 08:45 am
Lisa Rojkjaer, M.D. has been appointed vice president and head of clinical development at
MorphoSys. Dr. Rojkjaer joins the company from Novartis Pharma, where she was most recently head of medical affairs, hematology, Europe, responsible for all clinical activities for Novartis's hematology portfolio including Gleevec and Exjade. Prior to Novartis, she spent five years with Novo Nordisk in Copenhagen, Denmark and Princeton, NJ, as the director of global medical affairs biopharmaceuticals and later director, clinical development hematology.
"We are committed to building an excellent development organization by hiring top talent. Thus, I am particularly delighted to welcome Lisa Rojkjaer to occupy a key position in our growing development team," commented Dr. Arndt Schottelius, chief development officer of MorphoSys. "Lisa brings extensive experience of drug development in the pharmaceutical industry, which will support us in our plans to advance and expand our proprietary pipeline and to develop a constant flow of valuable drug candidates."
"I'm looking forward to working with the entire R&D team at MorphoSys to execute the company's strategy and move antibody programs through clinical trials quickly and efficiently. Through both my academic and medical careers as well as my time within the pharmaceutical industry I gained profound scientific and drug development knowledge in hematology and oncology, which I will apply to advance MorphoSys's growing clinical pipeline," said Dr. Rojkjaer.
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Posted on September 15, 2009 @ 10:31 am
In conjunction with
Lilly’s recent restructuring initiative, the company has named the leaders of its Development Center of Excellence (CoE) and its five business units: oncology, diabetes, established markets, emerging markets, and Elanco animal health.
Tim Garnett, M.D., and
Tom Verhoeven, Ph.D., will lead the CoE within Lilly’s Research Laboratories. Dr. Garnett will have responsibility for medical, regulatory, global product safety, translational medicine and global health outcomes. Dr. Verhoeven will have responsibility for the clinical development organization, product R&D, toxicology/ADME and project management.
John H. Johnson will lead the oncology business unit. He currently serves as chief executive officer of ImClone Systems, which Lilly acquired last year.
Enrique A. Conterno will lead the diabetes business unit. He currently serves as president of Lilly USA.
Bryce D. Carmine will lead the established markets business unit. He currently serves as Lilly's executive vice president of global marketing and sales.
Jacques Tapiero, Lilly's president of the intercontinental region, will lead the emerging markets business unit.
Jeffrey N. Simmons will lead Elanco, the animal health business unit, where he currently serves as president. All appointments will become effective on November 1, 2009.
"These are proven leaders who bring a wealth of experience and knowledge to their respective roles," said John C. Lechleiter, Ph.D., Lilly’s chairman, president and chief executive officer. "Each has demonstrated strong leadership and an ability to get results throughout their business careers. Moving forward, these individuals will play a critical role in the success of Lilly's new operating model."
Dr. Lechleiter outlined the details of the CoE, along with the criteria used to establish Lilly's new business units. The CoE, which has more than 60 molecules in clinical development, will be tasked with streamlining the development of pipeline molecules.
In Oncology, Lilly plans to build its presence, aided by the acquisition of ImClone. Currently, one-third of the company's pipeline consists of molecules to treat various forms of cancer.
Diabetes: Lilly has a dedicated portfolio of commercial products as well as pipeline opportunities. The company is also one of only a few global insulin suppliers.
Lilly's other therapeutic areas, including neuroscience, osteoporosis/bone and cardiovascular, are included in the established markets business unit. This unit will have geographic responsibility for these therapeutic areas in the U.S., Japan, EU, Canada, and Australia/New Zealand. The unit will also host Lilly's global marketing organization.
The Emerging Markets unit will include China, Russia, Brazil, Mexico, South Korea and Turkey. The company plans to increase its presence in these countries and others where strong growth rates for pharmaceuticals are projected over the next decade.
The company remains committed to the Elanco Animal Health unit, which is projected to have double-digit earnings growth during the next five years, bolstered by several recent acquisitions and the launch of its companion animal business.
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contractpharma.com/2009conferencePosted on September 15, 2009 @ 10:28 am
Alcon has entered into a definitive agreement to acquire
ESBATech AG for $150 million in cash at closing, plus achievement-based R&D payments of as much as $439 million. ESBATech is a Swiss clinical-stage biotechnology company developing a pipeline of single-chain antibody fragment therapeutics for topical and local delivery.
ESBATech has several stable and soluble single-chain antibody fragments in development, as well as a product candidate that has progressed into Phase I and II studies for the treatment of inflammatory ocular diseases.
"Biotechnology offers significant growth opportunities in ophthalmology because it has the potential to deliver therapies with superior efficacy and safety relative to existing approaches," said Sabri Markabi, M.D., Alcon's senior vice president of R&D and chief medical officer. "Combining ESBATech's proprietary antibody fragment technology with our expertise in ophthalmic formulation and capabilities in global development will strengthen Alcon's leadership position in ophthalmology."
The agreement includes all rights to ESBATech’s technology for therapeutic application to the eye. Also, ESBATech’s employees of will join Alcon following the acquisition. The rights to the technology and products for application outside of ophthalmology will be retained by the previous shareholders of ESBATech and spun off into a separate new company, Delenex Therapeutics AG.
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Posted on September 15, 2009 @ 10:25 am
Marc N. Casper has been appointed president, chief executive officer and a director of
Thermo Fisher Scientific Inc., effective October 15, 2009. Mr. Casper currently serves as executive vice president and chief operating officer and will take over for
Marijn E. Dekkers, who has resigned as president, chief executive officer and a member of the board, to become chief executive officer of Bayer AG.
Chairman Jim Manzi said, “Marc’s strong leadership at Thermo Fisher over the past eight years and his achievements both here and in other companies make him the natural choice to lead the company going forward. We are delighted that he will take on this new role. On behalf of the entire board of directors, we thank Marijn for his dedication to Thermo Fisher over the last nine years. Marijn has led the company through a period of exciting growth and has built a strong foundation for future success.”
Mr. Casper remarked, “I have developed great respect for the knowledge and focus of our employees during my time at Thermo Fisher, and look forward to working with the leadership team and the board in my new role. Thanks to the successful execution of our strategy, demonstrated by our excellent financial track record, we have been able to deliver solid operating performance despite challenging economic conditions. We will work to continue to execute on our strategy for growth and success.”
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Posted on September 14, 2009 @ 08:31 am
Patheon
3Q09 Revenues: $164.4 million (-16%)
3Q09 Loss: $6.0 million (loss of $14.0 million in 3Q08)
YTD Revenues: $479.0 million (-12%)
YTD Loss: $11.5 million (loss of $36.6 million YTD08)
Comments: Revenues were impacted by setbacks in operations in Puerto Rico, where the company "had difficulty releasing a sufficient volume of product lots due to efforts to optimize manufacturing parameters and difficulty meeting stringent release specifications for one product," according to a Patheon statement. Overall, Commercial Manufacturing revenues dropped 16% to $132.9 million. The Pharma Development Services (PDS) unit saw a 17% increase in the number of projects underway in 3Q09, but revenues in that segment dropped 16% to $31.5 million. The company reported, "Unfortunately, the average value of these projects has declined due to a combination of increased price competition and pharmaceutical companies becoming more cautious with their development budgets. Patheon believes that this is a temporary, market driven situation, as sales of new business have recently shown a more encouraging trend." For the year, manufacturing revenues have dropped 13% to $385.8 million and PDS revenues have fallen 9% to $93.2 million.
Posted on September 14, 2009 @ 08:18 am
Lilly has unveiled a new operating model and announced a series of changes with the goal of "speed medicines from its pipeline to patients." The company will establish a Development Center of Excellence (CoE) to streamline and accelerate late-stage development of new medicines, and will reorganize its pharmaceutical business into four business units that will operate alongside the Elanco animal health business unit. In addition, the company has set a goal to reduce its cost structure by $1 billion by the end of 2011. Lilly faces a series of patent expirations for key products beginning in late 2011.
"We remain confident that continued focus on medical innovation is the best way to ensure the long-term growth of our company," said John C. Lechleiter, Ph.D., Lilly's chairman and chief executive officer. "The changes we are announcing today will accelerate the progress of the most exciting pipeline in our history, with more than 60 molecules currently in clinical development. These changes will also ensure that we meet the changing needs of our customers and operate our business in a manner consistent with an increasingly challenging environment. I have great confidence that these changes will have a very positive impact on the company's future."
As part of its restructuring, Lilly will:
- Establish the Development Center of Excellence (COE) "to help address the industry-wide challenge of a drug development process that is increasingly complex, slow and expensive," according to a company statement. The Development COE will distinguish Lilly from its peers by using one common operating system, one common set of priorities and a singular focus to streamline the development of new medicines.
- Organize the company around five global business units: oncology, diabetes, established markets, emerging markets, and Elanco animal health, shifting away from its predominantly functionally-oriented organization to a business-unit structure.
- Streamline the organization and align corporate and general and administrative functions to support the business with a focus on improved quality, strong customer service and reduced costs.
- Reduce the company's cost structure by $1 billion and lower global headcount to 35,000 by the end of 2011, excluding strategic sales additions in high-growth emerging markets and Japan. Lilly had 40,600 employees at the end of 2008.
"While our financial performance during the past few years has been strong, we will soon enter the most challenging period in our company's history. This calls for strong measures to speed our output of new medicines, better meet the changing needs of our customers and reduce our costs," Dr. Lechleiter remarked.
"While our structure and approach served us well in the past, we must take measures now that will make us leaner, more focused, more customer-oriented, and more competitive," he added. "The changes we're making will simplify our organization, clarify accountability and authority, and speed decision making."
Dr. Lechleiter commented that the realigned organization will focus on "speeding delivery of innovative medicines to market; establishing leadership positions in cancer and diabetes therapies; realizing the opportunity for growth in emerging markets and the company's animal health business; and introducing new products in the company's largest base, the established markets."
The new model is expected to be in place by the beginning of 2010. On December 10, 2009, at the company's annual investment community day in New York City, company leaders will present additional details of the changes.
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Posted on September 14, 2009 @ 08:07 am
OctoPlus N.V. has signed a pharmaceutical development and manufacturing contract with a new client,
Axentis Pharma AG. OctoPlus will perform process development and clinical manufacturing of Axentis' lead product, an inhalable liposomal formulation of tobramycin for the treatment of cystic fibrosis. Terms of the contract were not disclosed.
OctoPlus provides formulation development and clinical material manufacturing services to biotech and pharmaceutical companies worldwide, as well as drug delivery technologies for the development of controlled release versions of existing or new drugs.
Posted on September 14, 2009 @ 08:04 am
Elizabeth A. Cermak has been named executive vice president, chief commercial officer of
Pozen, Inc. Ms. Cermak will be responsible for the development and implementation of Pozen's commercialization strategy for all of its future product candidates.
Ms. Cermak was employed for 25 years at Johnson & Johnson, where she held positions of increasing responsibility at Ortho-McNeil Pharmaceuticals, McNeil Consumer and Specialty Pharmaceuticals and other Johnson and Johnson subsidiaries. She most recently held the position of world-wide vice president Personal Products Franchise, Johnson & Johnson Healthcare Products. Her experience spans both prescription and OTC businesses across many therapeutic areas. She specialized in sales and marketing and has managed large and small business units both domestically and outside the U.S.
Pozen previously announced its intention to retain sole ownership of its PA franchise of product candidates while it advances them through Phase III and considers how best to commercialize these assets. Ms. Cermak will be responsible for the development of worldwide commercial strategy for these product candidates. She will also be responsible for the management of all current and future strategic alliances for the Pozen portfolio, as well as business development.
Dr. John R. Plachetka, Pozen's chairman, president and chief executive officer, said, “Hiring an outstanding, multi-talented pharma executive like Liz is a key step in Pozen’s evolution as a company. She has precisely the right experiences and background to help us determine how best we can maximize the value of our PA assets around the world, and all our other products and product candidates, for our shareholders.”
Posted on September 14, 2009 @ 07:58 am
Goodwin Biotechnology Inc. (GBI) has completed the cGMP manufacturing and vialing of Areva Med's monoclonal antibody-chelator conjugate. As part of Areva Med's Lead-212 (212Pb) initiative, the conjugate will be used in Phase I clinical trials to treat several types of deadly forms of cancers.
David Fischer, executive vice president of GBI, said, "We are very pleased to have completed the manufacturing of AREVA Med's conjugate. After some promising preclinical data, we look forward to seeing the outcome of the first-in-man studies."
Posted on September 11, 2009 @ 10:17 am
QPharma, Inc., has opened its Specialized Pharmacy, QPharmaRx. The company currently manages fulfillment programs for clients that engage in Patient Assistance Programs that target both patients and practitioners. With the specialized pharmacy, the company is now able to support and service programs that ship pharmaceutical products directly to their client base. This includes controlled product, non-controlled product, refrigerated, frozen and ambient temperature controlled products.
Michael Milunec, operations manager at QPharma, will serve as supervisor for QPharmaRx. Mr. Milunec has more than seven years of experience in the healthcare industry, with specific expertise in implementing and managing Patient Assistance Programs. He will also oversee QPharma’s Call Center and Alternative Sample Management programs.
“With the launch of our Specialized Pharmacy, we open up QPharma to a much larger base of customers — a base that goes far beyond the practitioner. We are looking to assist our clients in creating a more dynamic and efficient environment as they enhance their commitment to Patient Assistance Programs and their associated uninsured/underinsured customer base. The opening of this new facility has positioned QPharma to continue the expansion of our growing fulfillment operation,” commented Jeff Volyn, director of operations at QPharma.
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Posted on September 11, 2009 @ 10:15 am
Amylin Pharmaceuticals and
Biocon, Ltd. have entered into an exclusive agreement to develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes. The two companies will collaborate to develop the compound using Amylin's phybrid technology and will share development costs. A phybrid is a peptide hybrid molecule that combines the pharmacological effects of two peptide hormones into a single molecular entity.
Amylin will provide expertise in peptide hormone development, as well as metabolic disease therapeutics. Biocon will use its recombinant microbial expression expertise to manufacture the compound and will use its experience in preclinical and clinical development of diabetes products.
"This agreement fully leverages the synergistic capabilities of the two companies," said Kiran Mazumdar-Shaw, chairman and managing director, Biocon. "Amylin's knowledge of peptide therapeutics and their leadership in the diabetes market, paired with Biocon's capabilities in process development, manufacturing and clinical development, provides this global program with the potential to effectively bring a novel therapy to patients living with diabetes."
"This program could unleash the potential of cutting-edge peptide science to transform the lives of patients with diabetes," said Daniel M. Bradbury, Amylin’s president and chief executive officer. "We are pleased to work with Biocon, a biologics innovator and world-class manufacturing expert, and look forward to collaborating with them on this exciting program."
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Posted on September 11, 2009 @ 10:13 am
J&J unit
Centocor Ortho Biotech Products received a Complete Response letter from the FDA regarding its sNDA for Doxil (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of metastatic breast cancer. Centocor is evaluating the letter and plans to respond to the agency as quickly as possible. The sNDA for Doxil was submitted in September 2008.
Doxil is currently indicated for the treatment of ovarian cancer that has progressed or recurred after prior platinum-based therapy. Doxil in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously taken bortezomib and have received at least one prior therapy. Doxil is also indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
Doxil is marketed in the U.S. by Centocor Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough has exclusive rights under a licensing agreement to market the drug as Caelyx throughout the rest of the world, excluding Japan and Israel.
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Posted on September 11, 2009 @ 10:00 am
Takeda Pharmaceutical Co. Ltd. and its wholly-owned subsidiary Millennium, The Takeda Oncology Co., initiated a Phase II trial of TAK-700 in patients with advanced prostate cancer. TAK-700 is a non-steroidal androgen synthesis inhibitor that has been shown to bind to and inhibit the enzyme 17, 20 lyase1, suppressing the production of androgen.
The open-label, multiple-dose study will examine the safety and efficacy of TAK-700 in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer. Primary endpoints of the study are safety and tolerability with secondary measures to include efficacy, pharmacokinetic and pharmacodynamic endpoints.
“Our efforts in the development of drugs for prostate cancer represent a high-priority for Millennium,” said Nancy Simonian, M.D., chief medical officer, Millennium. “TAK-700 is the first drug candidate in our prostate program to advance to Phase II clinical trials. We are pleased to see the progress of this compound, and we are striving to develop drugs that will fulfill the unmet medical need for prostate cancer.”
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Posted on September 10, 2009 @ 09:10 am
Lonza Group broke ground at Tuas Biomedical Park in Singapore for the new facility for its Cell Therapy business. The new facility will be adjacent to the company’s large-scale mammalian manufacturing facility.
Stefan Borgas, chief executive officer of Lonza, said, “This new Cell Therapy manufacturing facility is a next step in fulfilling our strategy to expand our capacity globally and our presence in Asia. Cell Therapy is expected to be one of the most important innovation drivers of modern medicine and this new facility reinforces Lonza’s leading position as a custom manufacturer of cellular therapeutics.”
Construction will begin early in 2010 and the facility is expected to begin manufacturing therapies within the first two suites by mid-2011. The facility is designed to accommodate additional suites built to meet customer demand. The total investment for the first phase will be approximately $28.5 million.
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Posted on September 10, 2009 @ 09:09 am
Merck has updated the status of the clinical development programs for MK-0974 (telcagepant) and MK-3207, the company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the treatment of acute migraine.
Merck is discontinuing the clinical development program for MK-3207. While efficacy was demonstrated in a Phase II study with the drug, some subjects in extended Phase I pharmacology studies were found to have experienced delayed, asymptomatic liver test abnormalities, generally following discontinuation of drug administration.
For telcagepant, which is currently in Phase III development, the company is reviewing available clinical data in preparation for discussions with regulatory agencies planned for later this year.
"Merck believes that the blocking of CGRP receptors remains an exciting pathway to address the underlying pathophysiology of migraine," said David Michelson, M.D., vice president of clinical neurosciences, Merck Research Laboratories. "We are continuing our efforts to offer patients a new treatment approach."
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Posted on September 10, 2009 @ 09:03 am
Quintiles has entered a strategic alliance agreement with the University of Pretoria as part of its Prime Site program, an initiative to accelerate the development of new and more effective medicines. Other locations in the Quintiles Prime Site program include Queen Mary's College in London and the Washington Hospital Center in Washington DC.
"Prime Sites are large clinical institutions that collaborate with Quintiles to enhance their infrastructure for conducting clinical trials," said Dr. Christopher Cabell, head of Global Access to Patients. "The University of Pretoria was selected because of its experience in conducting clinical research, its access to substantial patient populations and clinical expertise all across multiple therapeutic areas. Through this new partnership Quintiles will be able to significantly improve its ability to access patients and investigators who are critical to facilitating the increasingly complex therapies under development."
Quintiles plans to set up numerous Prime Sites around the world, moving to include emerging markets in Asia, Latin America, and Central and Eastern Europe in the program.
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Posted on September 9, 2009 @ 08:39 am
Evotec AG has entered into a research agreement with
Biogen Idec, under which Evotec will use its protein production technologies, assay development and high throughput screening to identify hit molecules for Biogen. Evotec will screen a target selected by Biogen with the option to add further targets. Additionally, Biogen will have access to Evotec’s full range of screening technologies and library of compounds, and will use its expertise in protein production and assay development to develop new assays for the target.
Dr. Mark Ashton, Evotec's executive vice president, business development, said, "We believe that the quality of future drug candidates is very much dependent on the identification of high quality starting points. To this end we have established a platform of screening technologies that have been proven to identify high-class hit molecules. We are looking forward to working with Biogen Idec and identifying interesting hit compounds for them."
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Posted on September 9, 2009 @ 08:36 am
Advion BioServices, Inc. has expanded its LC/MS Biomarker Services Group in response to increased interest in the use of biomarkers in drug development. The company will assign an increased commitment of staffing, Thermo Scientific and Applied Biosystems mass spectrometers, liquid chromatography and automated liquid handling systems to this service. Advion launched its LC/MS Biomarker Services Group in 2008.
"Expansion of our LC/MS Biomarker Services Group reflects an increasing demand for biomarker methods as companion assays to other bioanalytical approaches needed for the development of new drugs," says Dr. Stephen Lowes, Advion BioServices' senior vice president, Science. "The FDA has acknowledged that biomarkers can help pharmaceutical companies streamline expensive, later-phase clinical trials by using fewer subjects or patients. Our extensive experience with mass spectrometry, immunoassays, and sample management means that we can meet the need for rapid biomarker assay development, validation, and sample analysis."
Under the direction of Dr. Lowes, the group is led by Dr. Gary Schultz, senior director, biomarkers, who has played a key role in developing new tools and methods for biomarker analysis including the ESI Chip, TriVersa NanoMate, and RePlay proteomics system.
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Posted on September 9, 2009 @ 08:30 am
William Mann, Ph.D., has been appointed chief executive officer for Helsinn Group’s American subsidiary, Helsinn Therapeutics (U.S.) Inc. Dr. Mann previously served as chief operating officer of the recently acquired Helsinn Therapeutics. He has also held leadership positions with a Swiss multinational in business development and research.
Also, William Brown has been named vice president commercial operations to build a direct sales structure for Helsinn Therapeutics in the U.S. Mr. Brown has experience with multinational groups in the management of supportive care. Previously, he managed the product Aloxi at MGI Pharma.
Dr. Riccardo Braglia, the Helsinn group's chief executive officer said, "Helsinn wishes to implement a new group growth strategy in the United States, placing more and more importance on the project development and acquisition of new business expertise. The appointments of William Mann and William Brown will allow us to consolidate Helsinn's U.S. business, the projects currently in development in cancer supportive care and in gastrointestinal areas and will lay the foundations for further development in North America also from a commercial point of view."
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Posted on September 8, 2009 @ 11:41 am
Neoprobe Corp. and
Laureate Pharma have entered into a Biopharmaceutical Development and Manufacturing Agreement under which Laureate will assist in the development and production of Neoprobe’s murine monoclonal antibody CC49. Also called RIGScan CR, CC49 is a tumor-specific targeting agent initially intended for use in treatment of colorectal cancer. Terms of the development and manufacturing agreement were not disclosed.
“We are delighted that Neoprobe has selected Laureate Pharma as their development and manufacturing partner,” said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate Pharma. “We will work closely in partnership with the Neoprobe biotech team and assist them in driving their product from development into the clinic.”
“Laureate Pharma has an established track record in biopharmaceutical manufacturing, including capabilities in both clinical and commercial-grade materials,” said David Bupp, president and chief executive officer of Neoprobe. “This agreement will allow us to leverage Laureate’s expertise and infrastructure while we seek to establish RIGScan CR as an improvement in the treatment for colorectal cancer.”
Posted on September 8, 2009 @ 08:53 am
Bayer Schering Pharma AG has filed to initiate a Phase I trial of MN-IC, an antibody-drug conjugate (ADC) for oncology. The move triggers milestone payments to
MorphoSys AG and
Seattle Genetics. Terms of the payments were not disclosed, but a MorphoSys statement referred to it as "significant."
Bayer Schering licensed Seattle Genetics' ADC technology with antibodies against target molecule MN, also known as carbonic anhydrase, a tumor-associated antigen expressed in many tumor types under hypoxic conditions. The antibody component of the treatment is derived from MorphoSys' HuCal technology.
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Posted on September 8, 2009 @ 08:29 am
Taking effect in 2010,
Pascal Soriot has been named chief operating officer of
Roche's Pharma Division. Mr. Soriot previously served as chief executive officer of Genentech and is a member of the Corporate Executive Committee. He will have global responsibility for Pharma operations, including commercial operations worldwide, global marketing, production, development and registration.
Ian Clark will succeed Mr. Soriot as chief executive officer of Genentech. He previously served as Head Global Product Strategy Pharma.
Jean-Jacques Garaud has been named to the Enlarged Executive Committee and has taken responsibility for Roche Pharma Research and Early Development. He is currently Head Pharma Development.
Daniel O’Day has been named chief operating officer of the Diagnostics Division and Member of the Executive Committee. He previously served as Head Roche Molecular Diagnostics.
Making room for the new appointees,
William M. Burns (chief executive officer Pharma Division),
Juergen Schwiezer (chief executive officer Diagnostics Division), and
Jonathan Knowles (Head Group Research), will resign from the Corporate Executive Committee at the end of 2009. Mr. Schwiezer and Mr. Knowles will retire, while Mr. Burns, as announced previously, will be proposed as a member of the board.
Franz B. Humer, Chairman of the Roche Group, said: "William M. Burns, Jonathan Knowles and Juergen Schwiezer have significantly shaped Roche’s successful development over many years. All three have been instrumental in driving the Group’s overall success. We are deeply grateful for their tremendous contribution throughout their distinguished careers."
Severin Schwan, chief executive offcier of the Roche Group, commented, "Following the conclusion of the Genentech integration we will continue to bring innovative healthcare solutions to patients worldwide through a diversity of research approaches and through efficient global development and commercialization. This broadened and younger Corporate Executive Committee will continue to drive Roche’s long-term vision as the world’s leading biotech company."
Read our profiles of Roche and Genentech in our Top Companies Report!
Posted on September 8, 2009 @ 08:06 am
Tony Engel has been named as head of Analytical Services at
Penn Pharma. Mr. Engel joined Penn from Catalent Pharma Solutions in Swindon. During his 22 years at Catalant Pharma Solutions, he has been involved in analytical development before moving into management of the company’s R&D and commercial testing laboratory.
Mr. Engel will be using his knowledge and operational expertise to manage a team of 45 analytical chemists to provide clients with reputable analytical support across a wide variety of clinical and commercial product development programs.
Posted on September 4, 2009 @ 07:55 am
Bristol-Myers Squibb’s BLA for belatacept has been accepted for filing and review by the FDA. The drug is currently in Phase III development for use in kidney transplantation.
“Belatacept has the potential to address significant unmet medical needs of transplant patients,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, R&D, Bristol-Myers Squibb. “We are pleased the FDA has accepted our submission and we look forward to continuing to work with the agency.”
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Posted on September 4, 2009 @ 07:48 am
Takeda Global Research & Development Center, Inc. received a complete response letter from the FDA regarding its NDA for the fixed-dose combination of alogliptin and Actos (pioglitazone HCl). In June, the FDA said that further review of the NDA would be conditional based on additional data from a cardiovascular safety study that satisfies the requirements of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes."
"This complete response letter from the FDA is consistent with the June 26 complete response letter for alogliptin, a key component of the alogliptin and Actos fixed-dose combination product," said Nancy Joseph-Ridge, M.D., general manager, Pharmaceutical Development Division. "The FDA recently agreed to the study design for a cardiovascular outcomes trial for alogliptin, titled EXAMINE, and patient enrollment is planned to begin this month. We anticipate that the EXAMINE trial will provide the FDA with the information needed to continue the NDA reviews of both the alogliptin monotherapy and the alogliptin and ACTOS fixed-dose combination."
The letter was specific to the FDC of alogliptin and Actos, and did not include any new questions or concerns about either of the drugs.
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Posted on September 3, 2009 @ 09:53 am
Pfizer has agreed to plead guilty to a U.S. criminal charge relating to promotion of Bextra, a pain medicine that is now withdrawn from the market. The company will pay $2.3 billion to settle the allegations that it improperly marketed Bextra and 12 other medicines.
According to the U.S. Department of Justice, Pfizer's marketing team promoted Bextra for acute pain, surgical pain and other unapproved uses, while its salesforce promoted the drug directly to doctors for those unapproved uses and dosages.
The settlement includes a $1.3 billion criminal fine related to methods of selling Bextra, which was withdrawn from the market in 2005 for safety concerns. Pfizer acquired Bextra with the buyout of Pharmacia in 2003. The settlement also includes $1 billion in civil payments related to "off-label" sales of drugs and payments to healthcare professionals. Pfizer denied all of the civil allegations, except for acknowledging improper promotions of the antibiotic Zyvox. The company announced in January that it set aside $2.3 billion to resolve allegations involving Bextra and other drugs, but did not provide further details at the time.
Pfizer said it will pay $503 million to resolve practices involving Bextra, $301 million related to its schizophrenia drug Geodon, $98 million for Zyvox and $50 million for Lyrica used to treat nerve pain and seizures.
"We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls," said Amy Schulman, Pfizer's general counsel. Under the new settlement, Pfizer must adhere to a specified compliance program for five more years.
The settlement is the largest to date for improper marketing of prescription drugs, Earlier this year, Eli Lilly and Co. agreed to pay $1.42 billion for off-label sales of its schizophrenia drug Zyprexa
Six whistleblowers, including John Kopchinski, a former sales representative who exposed Pfizer's Bextra marketing tactics, sparking the government probes, will be rewarded with more than $102 million under the False Claims Act. Mr. Kopchinski's share was expected to be more than $51.5 million.
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Posted on September 3, 2009 @ 09:50 am
Dainippon Sumitomo Pharma Co., Ltd. and
Sepracor Inc. have entered into a definitive agreement under which DSP will acquire Sepracor for approximately $2.6 billion in cash. The boards of directors of both companies approved the transaction. Sepracor will become a wholly owned subsidiary of Dainippon Sumitomo Pharma America Holdings, Inc., a U.S. subsidiary of DSP, and will continue its operations based in Marlborough, MA and in Canada. Sepracor will retain its name, branding and intellectual property rights.
Sepracor, a specialty pharmaceutical company, has a portfolio of pharmaceutical products and candidates with a focus on central nervous system (CNS) and respiratory disorders. Sepracor’s currently marketed products in the U.S. include Lunesta for the treatment of insomnia, Xopenex and Xopenex HFA for the treatment of bronchospasm, Brovana for the treatment of bronchoconstriction, Omnaris Nasal Spray for the treatment of allergic rhinitis, and Alvesco HFA for the maintenance treatment of asthma.
Sepracor’s U.S. commercial organization includes 1,200 sales professionals. The company has a Canadian subsidiary, Sepracor Pharmaceuticals, Inc., that markets several additional products in that region, focused in the cardiovascular, CNS, pain and infectious disease therapeutic areas.
The acquisition provides DSP access to the U.S.- and Canadian-based pharmaceutical platform; expertise to develop and commercialize lurasidone, DSP’s product candidate for the treatment of schizophrenia; and expands the scale of DSP’s portfolio of marketed products.
Masayo Tada, president of DSP, said, “Sepracor has pursued growth through development of its unique pipeline and introduction of innovative pharmaceutical products to the market, a strategy that fits perfectly with our management philosophy. We expect that Sepracor will become a ‘Center of Excellence’ for DSP in the U.S., and will make a significant contribution to DSP both as a commercialization infrastructure for our self-developed products and as a strategically important base for business development.”
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Posted on September 3, 2009 @ 09:49 am
Thomas Laughlin has been named executive vice president of sales and marketing
MPI Research, and will be a member of the company’s corporate management team. Mr. Laughlin has more than 30 years of executive experience in the healthcare industry.
Most recently, he served as president and chief executive officer of SunHealth Solutions, a company he founded that marketed a novel UV ray monitoring skin patch worldwide. Prior to that, he was executive vice president and chief operating officer of Zila Pharmaceuticals, where he led several major healthcare and biotechnology marketing initiatives. He also served as senior vice president for global new business at Bayer. Mr. Laughlin also held key leadership roles at Pharmacia & Upjohn, Procter & Gamble/RVI, and Pfizer.
MPI Research chairman and chief executive officer Bill Parfet said, “With his wealth of knowledge and legacy in key organizations, Tom Laughlin is the right person to take our company to the next level. MPI Research has focused on growing into our current position as the third largest CRO in the world over the past decade; now we look to someone with Tom’s sound business acumen and leadership talent to help us solidify our position as the best CRO worldwide."
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Posted on September 2, 2009 @ 09:56 am
MDS, Inc. has entered into an agreement to sell its Analytical Technologies business to Danaher Corp. for $650 million in cash. The transaction is subject to shareholder and regulatory approval, and other closing conditions. The company also plans to sell its Pharma Services business, which provides drug discovery and early-stage development services for pharmaceutical and biotechnology companies.
Following the sale of these businesses, the company’s strategic goal is to focus on its MDS Nordion business, a provider of medical isotopes for molecular and diagnostic imaging, radiotherapeutics and sterilization technologies.
"The board and executive management team believe the proposed path forward provides the greatest opportunity to unlock the value of MDS businesses in the near-term and enables a substantial return of proceeds from the sale of the MDS Analytical Technologies business to shareholders," said James S. A. MacDonald, chairman of MDS Inc.'s board of directors.
"The economic downturn and the prolonged shutdown of Atomic Energy of Canada Ltd.'s (AECL) National Research Universal (NRU) reactor have created significant challenges for our businesses that contributed to this course of action," said Stephen P. DeFalco, president and chief executive officer of MDS Inc. "During this process, our MDS Pharma Services and MDS Analytical Technologies businesses will remain focused on delivering exceptional service to customers. MDS Nordion will remain focused on innovation and on building its market leadership in the provision of medical isotopes for molecular and diagnostic imaging, radiotherapeutics and sterilization technologies."
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Posted on September 2, 2009 @ 09:54 am
Catherine Michael has joined
BioStorage Technologies as global head of sample management operations. In her new position, Ms. Michael will provide direct leadership of sample management operations, including day-to-day tactical activities associated with receiving, registration and retrievals. Additionally, she will create and implement sample management operations, global policies and procedures, as well as be responsible for identifying and developing strategic opportunities to leverage BioStorage services related to sample storage management.
"Cathy's experience in the world of clinical research and her long list of global leadership roles make her an ideal addition to our team," said Lori Ball, senior vice president. "We are confident that Cathy's skills will help BST's increasing number of international clients, while also advancing the company's growing presence worldwide."
Prior to joining the company, she was executive director of global project and data management at PPD Global Central Labs, where she led two global departments and was responsible for all service and data deliverables to the company's pharmaceutical clients. As part of the executive committee, Ms. Michael defined and led strategic initiatives regarding process and technology, as well as supported financial and operational obligations for all MSAs.
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Posted on September 2, 2009 @ 09:46 am
Tioga Pharmaceuticals and
Ono Pharmaceutical Co., Ltd. have entered an exclusive license agreement under which Ono has licensed rights to develop and commercialize asimadoline in Japan, South Korea and Taiwan. Tioga retains all other rights to asimadoline.
Ono is responsible for developing and commercializing asimadoline in Japan, South Korea and Taiwan. Ono’s initial development of asimadoline will focus on diarrhea predominant irritable bowel syndrome (D-IBS). Tioga will receive an upfront payment and development and commercial milestone payments. Tioga is also eligible to receive royalties on sales of the drug in Japan, South Korea and Taiwan.
“We are pleased to gain rights to develop and commercialize asimadoline in Japan, South Korea and Taiwan from Tioga, a biopharmaceutical company focusing on developing novel treatments for gastrointestinal diseases. The medical needs of D-IBS patients currently are not well satisfied. Asimadoline is expected to provide features that are not offered by existing therapies. We will expeditiously promote the clinical development of asimadoline in Japan, and do our best to make the drug available for the D-IBS patients as quickly as possible," said Gyo Sagara, Ono’s president, representative director and chief executive officer.
Tioga plans to initiate Phase III development of asimadoline for D-IBS in the U.S. in 1Q10, and Ono plans to start Phase I studies in Japan during 1H10.
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Posted on September 1, 2009 @ 10:05 am
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has completed a successful audit of
Cobra Biomanufacturing’s facility in Keele. The authorization followed a three-day inspection and evaluation of the company’s manufacturing, analytical and quality management systems, which demonstrated that the facilities meet cGMP standards.
Simon Saxby, chief executive officer of Cobra Biomanufacturing, said, “This is excellent news and ongoing confirmation of the commitment of the company to meet the needs of worldwide Regulatory agencies. The renewal of our Manufacturers and Importers Authorization for Investigational Medicinal Products MIA (IMP) license acknowledges almost 10 years of cGMP compliance at Cobra and provision of a reliable and responsive biomanufacturing service to over 75 clients worldwide.”
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contractpharma.com/2009conferencePosted on September 1, 2009 @ 10:02 am
Selexis SA and
NKT Therapeutics (NKTT) have entered into a research services agreement under which Selexis will screen antibody variants and generate high performance CHO-based production cell lines using their INTEGRA-D2M platform. The platform enables the rapid isolation of production cell lines associated with the selection of lead compounds from libraries of protein variants expressed in Chinese Hamster Ovary (CHO) cells. The selected CHO-based protein variant expressing clone can then be used directly for cGMP manufacturing, according to the company
"We are excited about the partnership with NKTT, who are recognized as leaders in the biology and therapeutic applications for modulating Natural Killer T cells," said Dr. Igor Fisch, chief executive officer and co-founder of Selexis SA. "Our novel and powerful INTEGRA-D2M platform, is able to support NKTT in rapidly making their final product decision while we also develop and deliver a high-performance production cell line ready for cGMP manufacturing."
"We greatly appreciate working with the team at Selexis and utilizing their powerful technology platform," adds Dr. Alem Truneh, chief scientific officer and co-founder of NKTT.
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Posted on September 1, 2009 @ 10:00 am
Icagen, Inc. achieved positive results from a Phase IIa study of senicapoc in allergic asthma. Senicapoc reduced the late asthmatic response (LAR) to a challenge of inhaled allergen, the primary endpoint of the study, determined by the decline in FEV1, the volume of air that can be forcibly exhaled in one second. The improvement in the average decline in FEV1 was 29%, in the maximum decline 18%, and in the area under the curve 28% of FEV1. Patients receiving senicapoc demonstrated an improvement in all measures of the LAR, while those receiving placebo had no improvements.
A secondary endpoint, the fraction of exhaled nitric oxide, a measure of airway inflammation that is typically elevated in asthmatic patients, was reduced by 24% among patients who received senicapoc, compared to patients who received placebo. An additional secondary endpoint, the early asthmatic response was unchanged. Senicapoc was well tolerated with no serious adverse events in the study. Additional analysis and review of the data are ongoing.
The company has completed enrollment in a randomized, double-blind, placebo-controlled trial of senicapoc in patients with exercise-induced asthma. Results from this second proof-of-concept study are expected during 4Q09.
"We are pleased with the results of this study, and believe that they justify further evaluation of senicapoc as a novel approach to the treatment of asthma," said Seth Hetherington, M.D., Icagen’s senior vice president of Clinical and Regulatory Affairs. "We believe that the combination of the reduction in LAR among the senicapoc-treated patients, along with the improvement in the fraction of exhaled nitric oxide, is consistent with the potential for an anti-inflammatory effect of senicapoc, a selective blocker of the KCa3.1 channel."
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August 2009
Posted on August 31, 2009 @ 08:20 am
Jeffrey Su, Ph.D., has been named vice president of bioanalytical development at
Cytovance Biologics. Dr. Su will head up the bioanalytical development laboratory supporting existing and new client needs. This lab is part of the ongoing strategic expansion of the facilities to add scientific capabilities and the 1,000L Microbial, 1,000L and 5,000L Mammalian process train capacity. “I see this addition as a key placement to meet the needs of our expansion,” said Darren Head, president chief executive officer of Cytovance.
Dr. Su has more than 17 years experience in the pharmaceutical/biotech industry. He has extensive experience in R&D, Process development, cGMP manufacturing, analytical development and quality systems, as well as regulatory affairs. He has successfully managed projects involving partners in the U.S., Asia, Canada and Europe.
Before joining Cytovance, Dr. Su was the vice president of operation and product development at Femta Pharmaceuticals in San Diego, CA. Prior to his tenure at Femta, he served as the deputy director and platform leader for formulation at Sanofi Pasteur, the senior director for manufacturing and control at CancerVax Inc., and other roles at Dow Chemical, Tanox, Pharming Healthcare, Medarex, Human Genome Sciences and Roche.
The bioanalytical development lab will be housed in Cytovance’s multi-product cGMP production facility in Oklahoma City, OK. The 44,000-sq.-ft. facility meets the latest international regulatory standards and is custom-designed for efficient and cost-effective production, according to the company.
Posted on August 31, 2009 @ 08:08 am
Merck released details of the new structure it will implement after completing its merger with
Schering-Plough. The new Merck will have five primary divisions: Global Human Health; Animal Health; Consumer Health Care; Merck Research Laboratories; and Merck Manufacturing. Each division and global support function leader will be a member of the new Merck Executive Committee and will report directly to chief executive officer Richard T. Clark.
Kenneth C. Frazier, currently executive vice president and president of Global Human Health (GHH), will lead the new GHH organization. This group will include the prescription, vaccines and biologics businesses. A new Emerging Markets group will be part of the GHH organization, focusing on regions and markets around the world that represent significant new growth opportunities, including China, Asia Pacific, Latin America, and Middle East/Africa/Eastern Europe, which includes Russia and Turkey.
Raul E. Kohan, currently senior vice president and president of Intervet Schering-Plough Animal Health, will lead the new Merck's Animal Health business. Schering-Plough's Animal Health business has more than 1,000 marketed products and generates approximately $3 billion in revenues from business operations in more than 140 countries, according to a company statement.
Stanley F. Barshay, currently chairman of Consumer Health Care at Schering-Plough, will lead that business unit for the new Merck on an interim basis while the company searches for a permanent leader. Merck plans toincrease emphasis on its consumer business, particularly in markets outside the U.S.
Peter S. Kim, Ph.D., will lead the Merck Research Laboratories (MRL) unit. Dr. Kim is currently executive vice president and president of MRL, which will have a new structure.
A new central franchise structure focused on portfolio management will be aligned with the company's Global Human Health division. A Worldwide Licensing group will continue to look for outside opportunities. According to a company statement, MRL will instill "greater accountability at all stages of the R&D process through two core functions: 1) discovery and pre-clinical development, and, 2) clinical development and regulatory affairs."
MRL will have three new areas of dedicated focus -- emerging markets, vaccines and biologics -- to build on the significant investment that both Merck and Schering-Plough have made in this area.
Four members of Schering-Plough Research Institute (SPRI) will hold leadership positions in the new MRL in senior preclinical, clinical and licensing roles. Most of the basic research heads for SPRI's research sites will remain in their roles following the merger.
Willie A. Deese, currently executive vice president and president of Merck Manufacturing division (MMD), will continue to lead that division. MMD will include new units for consumer health and animal health, and expanded technological capabilities for vaccines and biologics.
Several other appointments to the executive committee were named:
Mirian Graddick-Weir, executive vice president, Human Resources;
Peter N. Kellogg, executive vice president and chief financial officer;
Bruce N. Kuhlik, executive vice president and general counsel; and
J. Chris Scalet, executive vice president, Global Services and chief information officer.
Richard S. Bowles III, Ph.D., currently senior vice president of Global Quality Operations at Schering-Plough, will serve as chief compliance officer at the new Merck.
Mr. Clark remarked, "Today’s announcement is an important step in establishing the new Merck as the leading global health care company — one that will make a difference in the lives of patients around the world. The combined company will draw upon the expertise of the people of both Schering-Plough and Merck. Collectively, the new leadership team has decades of industry experience and proven management track records. To complement our joint talent, we will be adding leaders from outside the two companies with specific experience in key areas. I am confident that the new Merck will have the right team in place to be able to deliver on the promise of this strong combination with Schering-Plough.”
Read our profiles of Merck and Schering-Plough in this year's Top Companies Report!
Posted on August 28, 2009 @ 09:39 am
Orexo has signed an exclusive worldwide licensing agreement with a
Novartis affiliate to develop and commercialize a new product related to Orexo’s OX17 program. OX17, a combination of an H2-receptor blocker and a proton-pump inhibitor, is being studied for gastroesophageal reflux disease (GERD).
Novartis will fund future development of the new product and will receive an exclusive license to all related intellectual property. Orexo will receive development milestone payments and will be eligible for sales milestones. Orexo will also receive royalties on future sales of the product. The financial terms were not disclosed.
Torbjörn Bjerke, president and chief executive officer of Orexo, commented, “Our development collaboration with Novartis, one of the finest healthcare companies in the world, has been outstanding and I am now very pleased to extend this to a full licensing agreement for the new product. This agreement is potentially an important step towards Orexo becoming a sustainable profitable pharmaceutical company. We are convinced that Novartis will make the new product a success.”
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Posted on August 28, 2009 @ 09:34 am
Biotie has reached a milestone in its collaboration with
Wyeth for the development of PDE10 (phosphodiesterase 10) inhibitors for schizophrenia, triggering a $1.0 million milestone payment to Biotie.
Timo Veromaa, president and chief executive officer of Biotie, said, “We are pleased with the progress we have made in collaboration with Wyeth on the PDE10 inhibitor program and look forward to beginning our work together in the clinic. We believe this partnership provides further validation for our PDE platform technology, which has already provided us with one active clinical program and several pre-clinical programs."
PDE10 is a novel CNS drug target that is thought to play an important role in the pathophysiology of schizophrenia. Biotie has demonstrated that inhibitors of PDE10 display antipsychotic activity in experimental models, indicating the potential for a superior efficacy and tolerability profile versus current standard therapies.
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Posted on August 28, 2009 @ 09:32 am
Eurand N.V. received FDA approval for its NDA for Zenpep Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. Zenpep is the only pancreatic enzyme product (PEP) approved for both adults and children, offered in four dosage strengths.
EPI is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. Loss of digestive enzymes leads to maldigestion and malabsorption of nutrients. Zenpep replaces these missing enzymes and improves digestion and absorption. The U.S. commercial launch of Zenpep is planned for 4Q09.
"For years, patients with EPI taking unapproved PEPs have lived with far too much variability in the control of their gastrointestinal symptoms as a result of product instability and dosing inconsistency," said Gearid Faherty, chairman and chief executive officer. "The approval of Zenpep is a major milestone for patients suffering from EPI and for Eurand. In preparation for our U.S. launch we have built and continue to expand a first-rate commercial organization to help Zenpep reach its full market potential."
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Posted on August 28, 2009 @ 09:26 am
Takeda Pharmaceutical Co. Ltd. and
Takeda Global Research & Development Center, Inc., received notification that the FDA has agreed to the study design for the cardiovascular (CV) outcomes trial EXAMINE for alogliptin, a selective DPP-IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.
The trial will be a multicenter, randomized, double-blind, placebo-controlled study to evaluate cardiovascular outcomes following treatment with alogliptin, in addition to standard of care, in Type 2 Diabetes and acute coronary syndrome, and will include approximately 5,400.
"Takeda received FDA agreement to the design of the CV study and we are pleased to move forward with the study and collecting additional safety data so that the FDA can continue the review of the alogliptin NDA," said Nancy Joseph-Ridge, M.D., general manager, Pharmaceutical Development Division. "We are committed to conducting this study to satisfy the CV safety requirements, leading to the enhancement of the product profile of alogliptin. While this trial is dependent on the occurrence of CV events, at this point we anticipate that we will be able to submit interim results to the FDA approximately two years after the study begins that will meet the FDA Guidance criteria for drug approval."
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Posted on August 27, 2009 @ 09:21 am
Biolex Therapeutics has entered into an agreement with
Cook Pharmica under which Cook will manufacture drug substance for use in Biolex's Phase III trials of Locteron. Locteron is a controlled-release interferon alpha 2b, designed to improve patient care with a more convenient dosing schedule and reduced side effects associated with pegylated interferons, the current standard of care.
"We evaluated a number of potential contract manufacturers and were extremely impressed with the personnel and infrastructure assembled by Cook Pharmica, as well as the strong commitment to the Locteron program exhibited by senior management," said Jan Turek, Biolex's president and chief executive officer.
"We are very excited to be the service provider of choice for Biolex in support of their Phase III clinical trial program for Locteron. Our team is looking forward to partnering with Biolex on this project and is committed to supporting Locteron's long-term success," said Tedd Green, Cook Pharmica's president.
Biolex is also conducting a Phase IIb trial of Locteron for the treatment of chronic hepatitis C and expects results in 4Q09. With the completion of GMP manufacturing of Phase IIb clinical supply for Locteron, and the transfer of production capabilities to Cook Pharmica, Biolex will be terminating the majority of its manufacturing operations at its facility in Pittsboro, NC. R&D, manufacturing management, and collaboration support activities, will continue in Pittsboro.
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Posted on August 27, 2009 @ 09:19 am
Genmab achieved positive results from a Phase II study of Arzerra (ofatumumab) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in front line follicular non-Hodgkin's lymphoma (NHL).
The study included a total of 58 patients with previously untreated NHL. The overall response rate (ORR) in patients treated with 500 mg of ofatumumab was 90%, including 24% complete remissions (CR), and 45% complete remissions/unconfirmed (CRu). In patients treated with 1000 mg of ofatumumab, the ORR was 100% including 38% CR, and 17% CRu.
There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse events of grade 3 or 4 (greater than 10%) were leucopenia and neutropenia. No events of sepsis or pneumonia were observed, and no deaths reported in the trial.
"We are pleased with the positive results shown in this study and believe they are indicative of the potential of ofatumumab in the treatment of front line follicular non-Hodgkin's lymphoma," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. Ofatumumab is being developed under a co-development and commercialization agreement with GlaxoSmithKline.
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Posted on August 27, 2009 @ 09:16 am
Schering-Plough’s Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma, has been accepted for review by the EMEA. The EMEA has also validated the company’s MAA for nomegestrol acetate (2.5 mg) / 17 beta-estradiol (1.5mg), a combined oral contraceptive (COC).
Mometasone furoate/formoterol fumarate combines mometasone furoate, the active ingredient of the inhaled corticosteroid, Asmanex, with formoterol fumarate, the active ingredient of the long-acting beta2-agonist, Foradil, administered via a single metered-dose inhaler.
"These two regulatory milestones are important steps toward advancing our late-stage pipeline and meeting patient needs. If approved by the EMEA, the mometasone furoate/formoterol fumarate combination would represent an important additional treatment option for physicians and their patients and further strengthen Schering-Plough's portfolio of respiratory products," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "Schering-Plough is also committed to providing women a variety of birth control options to meet diverse lifestyle needs and choices."
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Posted on August 26, 2009 @ 09:03 am
Cobra Biomanufacturing has signed an agreement with a European biotechnology company to provide development services for an Adenovirus-based product.Cobra will use its virus purification platform, which is based on scalable chromatographic operations that integrates single use technologies. According to the company, the process shows comparable purities to density gradient approaches and yields of as much as 50%.
Simon Saxby, chief executive officer of Cobra Biomanufacturing, said, "We are very pleased to have been selected by this company as this underlines Cobra's extensive experience and expertise in producing virus based products for clinical trials. This agreement also highlights Cobra's continued commitment to be the CMO of choice for virus production."
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Posted on August 26, 2009 @ 08:55 am
Penn Pharma, has launched Solusolve, a specialist formulation development service to increase the bioavailability of ‘difficult’ compounds. Solusolve uses several techniques for increasing water-solubility of lipophilic compounds, including salt selection, particle reduction, use of carriers, such as solution formulations and self-emulsifying drug delivery systems, melt extrusion and granulation and functional ‘bioavailability enhancer’ excipients, such as Gelucire and Vitamin E TPGS.
Paul Wituschek, Penn Pharma’s global sales and marketing director, commented, “The majority of medicines being developed for human use are for oral administration.However, an increasing number — in fact almost half — of all new compounds coming through the development pipelines are BCS Class II drugs.This means that they are highly permeable through biological membranes but are poorly water-soluble.And it is this limited water solubility that poses drug absorption problems in the patient’s gastrointestinal tract.The prime objective of our new formulation service is to improve water-solubility to maximize oral bioavailability of these drugs for our clients.”
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Posted on August 26, 2009 @ 08:49 am
Frank D. Morrow, Ph.D., FACN has been appointed chief operating officer of
LabConnect. Dr. Morrow is a veteran of the central lab business having served as founding executive, president and chief scientific officer at Quintiles Laboratories Worldwide. He was responsible for the division’s growth from inception to $120M in revenue, 1,000 employees, and five central lab facilities worldwide, for more than 10 years. After Quintiles, he served as vice president, Worldwide Operations at Quest Diagnostics Clinical Trials.
“We’re pleased to have one of the industry’s most experienced executives join our team,” noted Eric Hayashi, LabConnect president & chief executive officer. “Frank has the right combination of operational and scientific expertise and the passion to surprise and delight our clients.”
“LabConnect represents the next generation of central labs,” said Dr. Morrow. “Biopharmaceutical sponsors’ increasingly complex testing requirements — both analytically and geographically — necessitate a better operating model for central laboratory services. LabConnect has integrated several of the largest and most experienced global laboratories under a highly advanced information systems platform and has the ability to expertly coordinate multiple specialty labs.”
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Posted on August 25, 2009 @ 09:03 am
Wyeth has agreed to take on all of
Karo Bio’s future R&D activities under the companies’ drug discovery collaboration, beginning September 1, 2009. The collaboration aims to identify and select development candidates for treatment of inflammatory diseases, focusing on the liver X receptor (LXR) as target receptor. The two companies entered the collaboration in 2001.
“We are pleased that this exciting LXR program continues within Wyeth. Since Wyeth will perform all future research and development, Karo Bio will not put any more internal resources into the project and will therefore not receive any further research funding from Wyeth. However, the Collaboration, Research and License Agreement between the companies shall remain in effect,” said Per Olof Wallström, president and chief executive officer of Karo Bio.
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Posted on August 25, 2009 @ 09:00 am
Protalix BioTherapeutics, Inc. received Fast Track Designation from the FDA for prGCD, a plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.
Fast Track designation facilitates the development and expedites the review of drugs to treat serious diseases. It enables the agency to process the NDA on a rolling basis as sections are completed and submitted for review.
The company expects to complete its Phase III trial of prGCD for the treatment of Gaucher’s disease in September, have results by October, and to complete its NDA before the end of the year. Also, the company has initiated a treatment protocol that allows physicians to treat Gaucher disease patients while the drug is still under investigation.
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Posted on August 25, 2009 @ 08:57 am
Myoderm has expanded its portfolio to include distribution management services in an effort to provide clients with an efficient solution for sourcing, managing, and distributing off-the-shelf, commercial drugs used in clinical trials. According to the company, its distribution management service is an alternative to the current approach to site or patient reimbursement of commercially sourced drugs, and is designed to lower costs. The newly constructed distribution facilities features customized technology to support clinical supply planning, management, and sourcing.
Mike Cohen, Myoderm's managing director, foresees significant benefits for their clients, "With Distribution Management Services, our customers will be able to diminish logistical complexities, reduce exposure to waste, greatly improve traceability and control of their drug supplies, and more easily and cost-effectively achieve the time and cost benchmarks of their trials."
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Posted on August 24, 2009 @ 09:25 am
Warner Chilcott has offered $3.1 billion in cash to acquire Procter & Gamble’s global pharmaceuticals business. WC will acquire P&G's portfolio of branded pharmaceutical products, including Asacol HD for ulcerative colitis, Actonel for osteoporosis, and the co-promotion rights to Enablex for overactive bladder, as well as the company's product pipeline and manufacturing facilities in PR and Germany. Also, most of the 2,300 P&G employees are expected to transfer to Warner Chilcott. The transaction is expected to close by the end of the year.
"The acquisition of the P&G pharmaceutical brands and employee talent is a transformational, strategic move for us," said Roger Boissonneault, president and chief executive officer of Warner Chilcott. "The acquisition transforms Warner Chilcott into a global pharmaceutical company, expands our presence in women's healthcare, establishes us in the urology market in advance of the anticipated launch of our erectile dysfunction treatments, and adds gastroenterology therapies to our product portfolio."
The acquisition expands Warner Chilcott’s presence in existing specialty pharmaceutical markets and provides access to new physician offices in 14 countries. Also, P&G's pharmaceutical development capabilities and clinical pipeline, is expected to broaden Warner Chilcott's product portfolio.
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Posted on August 24, 2009 @ 09:19 am
Santhera Pharmaceuticals and
Biovail Corp. have signed a license agreement for Santhera's JP-1730/fipamezole, granting Biovail U.S. and Canadian rights to develop and commercialize the drug for the treatment of dyskinesia in Parkinson's Disease. In a recent Phase IIb study, JP-1730/ fipamezole showed the potential to reduce levodopa-induced dyskinesia.
"Biovail is an emerging key player in the area of neurodegenerative disorders. With its commitment to this therapeutic area and the strong track record it has developed in a short period of time, I am confident that JP-1730/fipamezole will become a key product for the improved management of Parkinson's disease," said Klaus Schollmeier, chief executive officer of Santhera. "Importantly, today's agreement is consistent with our strategy of partnering larger indications whilst retaining co-promotional rights for our commercial operations in the U.S."
Bill Wells, Biovail's chief executive officer said, "This agreement with Santhera is directly on strategy and another important step in our efforts to build a sustainable product-development pipeline in specialty central nervous system disorders."
Santhera will receive an upfront payment of $8 million and a further payment of $4 million upon the successful closing of its acquisition of Oy Juvantia Pharma Ltd. Biovail will pay as much as $35 million in development and regulatory milestones and will make additional sales milestone payments of as much as $145 million. Santhera will also receive royalties on sales of the drug. For a second indication, Santhera is eligible to receive as much as $20 million in success-based milestones.
Biovail will be responsible for the remaining clinical development programs in the U.S. and Canada. Initiation of the first Phase III study is scheduled for 2011. Santhera will retain co-promotion rights in the U.S.
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Posted on August 24, 2009 @ 09:09 am
UCB and
Novartis entered into a license agreement for cardiovascular and diabetes products in Germany. UCB has extended commercial rights for the German market to the cardiovascular drug Provas (valsartan) beyond 2011 and has licensed in commercial rights for two line extensions: Dafiro (valsartan and amlodipine) and Dafiro HCT (valsartan, amlodipine and HCT). In addition, UCB will co-commercialize the two new oral anti-diabetics Jalra and Icandra (vildagliptin and vildagliptin + metformin).
"With this agreement we are building on our strengths in Germany, our excellent position in the Internal Medicine segment," said Willy Cnops, vice president UCB and managing director Germany. "We are extending our cardiovascular and metabolic product portfolio with the most attractive and innovative treatment options to date in line with UCB's ambitions to offer the best medicines to our patients."
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Posted on August 21, 2009 @ 08:20 am
Takeda Canada, Inc. has reacquired Canadian commercial rights to Actos, an oral treatment for type 2 diabetes, from
Eli Lilly Canada Inc. Takeda licensed the drug to Lilly in 1999 as part of a worldwide agreement.
"Reacquiring the commercial rights to Actos is Takeda's first opportunity to establish a commercial presence in Canada," said Daaron Dohler, general manager at Takeda Canada. "It also underscores Takeda's ongoing efforts to reinforce our global operations and build a stronger presence in North America."
Actos was approved by Health Canada as monotherapy to decrease insulin resistance and blood glucose levels in patients with type 2 diabetes mellitus, in September 2000. Takeda took over responsibility for the drug in the Canadian market in mid-June, and currently sells it in other territories, including the U.S., Japan and most of Europe.
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Posted on August 21, 2009 @ 08:18 am
XSpray Microparticles AB has launched its new GMP production facility in Malmo, Sweden. In addition to particle development and characterization services, the company can now provide high quality drug particles and powders for clinical studies.
XSpray's RightSize Particle Manufacturing Technology is based on supercritical fluid technology and is designed for applications, such as inhaled compounds, sparingly soluble compounds and biopharmaceuticals, and is fully scalable.
The new GMP facility was developed in collaboration with Galenica AB, a Swedish CRO focused on pharmaceutical formulation. Galenica will perform manufacturing services at XSpray's GMP suites in Malmo.
XSpray's chief executive officer, Per Andersson, said, "We are extremely pleased to have this facility in place, we can now satisfy our customers' needs for GMP material. This also proves the technology can be scaled-up, an important step towards developing full pharmaceutical manufacturing capabilities." Dr. Andersson continued, "We are very pleased with this collaboration with Galenica.
Ronnie Wallin, Galenica's chief executive officer, added, "Testing the technology went very smoothly and we established a production capacity that meets clinical study requirements. Our facilities comply with both EU and U.S. regulatory standards and we are now able to start manufacturing for XSpray's customers."
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Posted on August 21, 2009 @ 08:13 am
NextPharma has engaged the services of Ron Collins to represent its business development affairs in the eastern part of the U.S. and Canada in order to meet increased demand for its contract outsourcing services.
Sean Marett, managing director NextPharma Technologies, Product Development Services, said, “We are delighted to have Ron working with us. He has a proven track record and extensive knowledge of the North American and Canadian pharmaceutical and biotechnology markets. I am convinced that he will make a significant contribution to NextPharma’s expanding presence in the U.S. and Canada as we continue to enhance our world class product development, contract manufacturing and logistics services globally.”
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations, from tablets and capsules to antibiotics, hormones and controlled release medicines.
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Posted on August 21, 2009 @ 07:22 am
Lonza has submitted a bid of approximately $460 million to acquire
Patheon.
"Our interest in Patheon is consistent with Lonza's stated strategy of expanding our offering across the pharmaceutical manufacturing value chain. An acquisition of Patheon would take us into the complementary activities of finished dosage development and manufacturing for both small molecule and biological active ingredients. With Patheon, Lonza would be in a unique position to offer its customers manufacturing capability across the complete supply chain," said Stefan Borgas, Lonza's chief executive officer.
Reuters reported that Mr. Borgas noted in a conference call, "The next step on the manufacturing side would be to expand our capabilities towards finished-dosage development and production capabilities. Patheon is one great way for us to get into this field." He also remarked that Lonza was negotiating with "two or three other companies," according to the report.
Lonza has signed a confidentiality and standstill agreement with the company, and Patheon has agreed not to negotiate an acquisition transaction with any party other than Lonza for a period ending September 30, 2009, subject to extension in certain circumstances. During this period, Lonza will be perform due diligence. The terms of the exclusivity period permit Patheon to respond to an unsolicited superior acquisition proposal, subject to certain restrictions.
In recent months, Patheon has been involved in an contentious takeover battle with investor JLL Holding. Patheon's Special Committee of independent directors advised shareholders to reject private equity firm JLL's offer for the company's outstanding shares, arguing that the tender offer of $2 per share was too low. The Lonza bid comes in at $3.55 per share. JLL holds 57% of Patheon's shares.
Posted on August 20, 2009 @ 02:30 pm
Catalent Pharma Solutions has launched its Development and Clinical Services unit. A new business segment dedicated to helping customers bring new pharmaceutical and biologic products to market, the unit will bring together Catalent’s analytical and science services and regulatory consulting services — formerly in its Sterile Technologies segment — with its clinical supply services business, formerly in its Packaging Services segment.
The new segment will build upon Catalent’s expertise and experience in supporting the development and testing of drugs and biologics through scientific, regulatory and clinical trial supply chain services, according to a company statement. For small molecule drugs, the company reports, Catalent's services extend from early steps of characterizing a drug molecule, to delivering drugs to the investigator site, on through to final submission of regulatory filings. For biologics, offerings include advanced bioanalytical services, the advanced GPEx technology and cell-line development services, biomanufacturing, and specialized cold chain distribution for clinical trial materials. The new segment provides global regulatory consulting and support, respiratory delivery formulation, development and manufacture and early phase injectables manufacture.
Scott Houlton has been named group president for the new segment, effective August 31. Mr. Houlton most recently served as the chief operating officer of Aptuit, Inc., and before that as president of Aptuit’s clinical packaging business. Prior to Aptuit, he held several leadership roles in the development service business of Quintiles Transnational, with prior experience at Cardinal Health and General Electric.
John Chiminski, president and chief executive officer of Catalent, remarked, “I expect the Development and Clinical Services segment to bring even more value to our customers through a sharpened focus and an integrated approach to solving the challenges our R&D customers face, and believe that this will result in significant new growth for the segment. As we have been involved in more than a third of NDAs and BLAs approved by the FDA in the last seven years, we know what it takes to bring a customer’s drug or biologic to market — each step of the way.”
He added, “I am also very pleased to welcome Scott to Catalent to lead this segment. He is experienced at driving growth, passionate about serving customers, and committed to operational excellence. I expect great things from Scott and the nearly 900 employees of this new segment.”
Posted on August 20, 2009 @ 08:37 am
ChemDiv, Inc. and
Lilly have expanded their drug discovery collaboration through 2010. The two companies will identify and develop leads for an additional therapeutic target using ChemDiv's small molecule resources and Discovery outSource platforms.
The collaboration began in January 2004 to discover and develop leads and research tools across multiple therapeutic areas. With this agreement, Lilly has continued access to ChemDiv's Discovery outSource services for preclinical and clinical development, with expertise in CNS, oncology, inflammation and metabolic disorders. The therapeutic target and financial terms were not disclosed.
"We are pleased to extend our successful collaboration with Lilly with a new therapeutic target," said Ron Demuth, senior vice president of ChemDiv. "We are delighted to have this opportunity to deliver superior value for our partner's R&D portfolio."
Read Lilly's profile in this year's Top 20 Pharma Report!
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Posted on August 20, 2009 @ 08:33 am
Roche and
InterMune have initiated a Phase IIb study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin). The study will be conducted at 45 sites globally and will further evaluate the safety and efficacy profile of the drug. Approximately 300 treatment-naive patients with chronic HCV genotype 1 infection will participate. The initiation of the Phase IIb trial triggered a $20 million payment to InterMune as per the companies' collaboration agreement.
Frank Duff, M.D., head of Roche's Clinical Development for Virology, said, "This trial represents an important step forward in the development of this oral direct-acting antiviral (DAA), and builds on the encouraging clinical safety and efficacy data generated to date."
Dan Welch, chairman, chief executive officer and president of InterMune, added, "We are very pleased to announce with our colleagues, Roche, the start of the global Phase IIb program of RG7227/ ITMN-191 in treatment-naive HCV patients. This study will significantly expand the clinical efficacy and safety database for this treatment, and in the first quarter of next year provide our first look at the rapid virologic response (RVR) rates associated with this triple therapy."
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Posted on August 20, 2009 @ 08:29 am
Brett F. Truitt has been appointed Team Leader, Formulation Development in the Pharmaceutical Development Services division,
Xcelience.
Mr. Truitt has more than 10 years of experience in pharmaceutical research and formulation development. Prior to joining the company, he held various R&D positions at Bilcare Global Clinical Supplies (GCS), Shire Laboratories/Supernus Pharmaceuticals, Pfizer, and Procter and Gamble.
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Posted on August 19, 2009 @ 01:29 pm
Catalent Pharma Solutions' pharmaceutical softgel facility in Buenos Aires, Argentina has successfully completed its first FDA general cGMP audit and pre-approval inspection, with no reported observations on FDA Form 483.
Catalent has been operating in Argentina since 1953 serving local and regional pharmaceutical and consumer health markets, and is completing a substantial expansion of the facility designed to meet FDA and other global regulatory standards. Catalent now has 20 sites approved to produce products registered with the FDA, with two site approvals coming in the last 12 months. In Fiscal 2009 alone, Catalent underwent 10 pre-approval and other inspections by the FDA, along with hundreds of other audits from regulatory authorities and customers, according to a company statement.
“As we celebrate the 75th anniversary of our softgel business, I am very pleased to have reached this important milestone for our global network. This brings our customers an important new supply chain option which further expands Catalent’s global sourcing flexibility. We welcome the opportunity for our experienced team in Buenos Aires to serve new customers, and to build upon their long history of operational performance, quality and compliance,” said Thomas Stuart, the group president of Catalent’s Oral Technologies segment.
Posted on August 19, 2009 @ 09:38 am
Christopher Smith, CQE, RAC has been appointed to vice president of quality and regulatory affairs at AAIPharma Services Corp. This is the company’s first appointment since partnering with private equity firm, Water Street Healthcare Partners, to separate from AAIPharma, Inc. and become an independent company.
Mr. Smith will lead efforts to support customers with their regulatory strategy and submission needs and head the company’s GMP compliance efforts. He has more than 30 years of experience in the pharmaceutical industry and has held management positions in regulatory affairs and quality assurance with the FDA, Abbott Laboratories and Endeavor Pharmaceuticals. Most recently, he built the global quality assurance function for AAIPharma Services’ former parent company, AAIPharma Inc.
“We are very pleased that Chris has agreed to be part of the AAIPharma Services team," said Lee Karras, senior vice president Global Pharmaceutical Services."He brings extensive regulatory and compliance experience to AAIPharma Services and will, no doubt, have a tremendous impact on our company’s future."
Look for our Newsmakers Interview with Lee Karras in the September issue of Contract Pharma!
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Posted on August 19, 2009 @ 09:36 am
CSL Biotherapies, a subsidiary of CSL Limited, received licensure from the FDA for its newest vaccine filling and packaging facility in Kankakee, IL. The facility is part of an investment to expand CSL’s U.S. influenza vaccine production capabilities and includes a high-speed, single-dose vaccine syringe filling line. The company also recently signed an initial contract for at least $180 million to supply the U.S. Department of Health & Human Services (HHS) with Novel Influenza A (H1N1) antigen.
The facility will provide filling and packaging services for CSL Biotherapies’ influenza vaccine supply, which is manufactured in Australia, to the U.S. market. CSL completed production of its seasonal influenza vaccine, Afluria, in early July and will deliver more than eight million doses for the upcoming flu season. The majority of that delivery will be in thimerosal-free, prefilled syringes.
“The licensure of this facility enables CSL Biotherapies to rapidly deliver quality, ready-to-administer, flu vaccines to U.S. healthcare providers,” said Wally Casey, senior vice president and general manager of Kankakee operations. “This milestone demonstrates once more CSL’s expertise and commitment to addressing pressing U.S. public health needs. It also underscores our support to enhance vaccine administration safety through the use of ready-to-use prefilled syringes.”
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Posted on August 19, 2009 @ 09:33 am
Covance has closed its transaction with
Merck to provide genomics analysis services under a five-year contract valued at $145 million. Covance has acquired Merck's gene expression lab in Seattle, WA, and as of August 17th, assumed control of the facility and took on Merck’s Seattle employees.
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Posted on August 19, 2009 @ 07:50 am
After a five-year Phase III study,
Lilly has decided not to submit arzoxifene to regulatory authorities. The osteoporosis treatment met its primary endpoints in the trial, but failed to demonstrate efficacy against placebo in the secondary endpoints. In addition, some adverse events occurred more frequently than in the placebo.
"At Lilly, our goal is to provide innovative therapies that result in better patient outcomes," said M. Johnston Erwin, global brand development leader for the musculoskeletal platform at Lilly. "While arzoxifene met its primary efficacy objectives in this study, we are disappointed that the [trial] data did not convincingly demonstrate that arzoxifene would represent a meaningful advancement in the treatment of osteoporosis."
"The results of arzoxifene's [Phase III] study serve as a reminder of the high risks associated with pharmaceutical innovation," commented John Lechleiter, Ph.D., Lilly's chairman and chief executive officer.
The drug significantly reduced the risk of vertebral fracture and invasive breast cancer in postmenopausal women, but was no better than placebo at such endpoints as non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function. The trial's results will be published in 2010.
Read Lilly's profile in this year's Top 20 Pharma Report!
Posted on August 18, 2009 @ 09:19 am
Wyeth has recognized six suppliers for its Global Recognition for Outstanding Wyeth Suppliers (GROWS) awards program. The company selected recipients based on outstanding performance during 2008 in six categories: Quality, Delivery, Customer Service, Technical Support, Continuous Improvement, and Supplier of the Year. Suppliers to Wyeth’s manufacturing sites in North America and Europe were evaluated by a selection committee made up of procurement, manufacturing and quality and compliance representatives from the company’s Technical Operations and Product Supply (TO&PS) network.
Wyeth’s Supplier of the Year is Drug Plastics & Glass Co., Inc. Other winners include: Klöckner Pentaplast Group (Quality); Colorcon, Inc. (Delivery); H. S. Crocker Co., Inc. (Customer Service); DSM Nutritional Products Ltd. (Technical Support); Schreiner MediPharm (Continuous Improvement). Also, Catalent Pharma Solutions’ softgel manufacturing site in St. Petersburg, Florida recently received a “Preferred Partner Award in Technology” from Wyeth Consumer Healthcare. The award recognizes Catalent’s support in 2008 for technical projects and documents.
“High quality materials and dependable service are critical to providing the exceptional products our customers expect and consumers deserve,” said Paul Addis, Wyeth’s vice president and chief procurement officer. “This year’s winners have distinguished themselves through their strategic alignment with our businesses; their operational performance and outstanding quality; their world class innovation; and their commitment to continuous improvement. We are very appreciative of their strong support and happy to recognize their contributions.”
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Posted on August 18, 2009 @ 09:17 am
Xceleron has signed a second Master Service Agreement with
GlaxoSmithKline, under which Xceleron will provide analytical support to GSK and its affiliated research organizations. Also, Xceleron will increase capacity through the acquisition of an Accelerator Mass Spectrometry (AMS) instrument.
AMS allows for early investigations of the human relevancy of new drugs helping to enhance the drug discovery and development process. This second agreement is focused on the rapid analyses and data turnaround for GSK’s early clinical studies, adding to an existing agreement between the two companies in which a bioanalytical service is provided to support clinical studies for regulatory submission.
Michael Butler, Ph.D., chief executive officer at Xceleron commented, “We’re just pleased that GlaxoSmithKline recognizes the value of AMS, and Xceleron’s expertise with this ultra-sensitive methodology. We’re now well-positioned to strengthen an already productive collaboration.”
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Posted on August 18, 2009 @ 09:15 am
AmerisourceBergen Corp. has made organizational changes, effective September 1, 2009.
Steven H. Collis has been named executive vice president and president of AmerisourceBergen Drug Corporation (ABDC), the company’s largest subsidiary. Mr. Collis was previously executive vice president and president of AmerisourceBergen Specialty Group (ABSG). In his new role, he will lead the ABDC organization and will continue to report to R. David Yost, president and chief executive officer of AmerisourceBergen.
Michael D. DiCandilo continues as executive vice president and chief financial officer of AmerisourceBergen, with responsibility for all corporate financial operations, supply chain management, AmerisourceBergen Packaging Group, and information technology. He continues to report to Mr. Yost.
Michael A. Mullen will lead ABSG as chief operating officer, AmerisourceBergen Specialty Group, also reporting to Mr. Yost. Mr. Mullen previously served as president of distribution services at ABSG, and as the chief financial officer for the subsidiary.
“ABDC has been very successful since we began running it with Mike DiCandilo leading operations and me leading sales and marketing,” said Mr. Yost. “To drive future performance, we are consolidating those functions under one leader, and I am very pleased that Steve Collis will be applying his substantial management talent to lead ABDC. At the same time, Mike DiCandilo will continue his corporate role with ABDC in finance, supply chain management and our very important Business Transformation ERP project. The result will be an even more focused organization.”
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Posted on August 18, 2009 @ 08:17 am
Amcor has offered to acquire parts of
Alcan Packaging for $2.0 billion from Rio Tinto. The Alcan Packaging businesses it has agreed to acquire include: Alcan Packaging Global Pharmaceuticals, Alcan Packaging Food Europe, Alcan Packaging Food Asia and Alcan Packaging Global Tobacco.
The combined company will be one of the world’s leading packaging companies with significant breadth of expertise, products and services, according to an Amcor statement. As of June 2009, Amcor generated $7.8 billion in sales from operations in 34 countries and has 226 sites worldwide, with approximately 21,000 employees. The parts of Alcan Packaging that Amcor has offered to acquire would add approximately $4.1 billion in sales and 14,000 employees across 80 plants in 28 countries.
The proposed acquisition will also support Amcor’s stated objective of growing in its strategic business areas of flexible packaging and folding cartons packaging.
Amcor's managing director and chief executive officer, Ken MacKenzie, remarked, “We believe that this acquisition will bring customers of both Amcor and Alcan Packaging even greater value through broader offerings and enhanced customer service. Critically, beyond the hard assets, the combined company will draw on the best people from both organisations to drive these improvements.”
Mr. MacKenzie added, “This acquisition is a clear fit with our strategic growth plans, building greater shareholder value by expanding our business whilst obtaining the economies of scale that comes with an opportunity such as this. We are committed to becoming a leader in the global packaging industry.”
The acquisition is subject to regulatory approvals as well as consultation with European Works Councils. Closing of the acquisition is not expected to occur for several months. Until this time, both Amcor and Alcan Packaging will continue to operate as separately run companies.
Posted on August 17, 2009 @ 08:42 am
SynCo Bio Partners entered a strategic partnership with
Versartis, Inc. to produce Versartis’ lead drug candidate VRS-859, a GLP-1 analog for monthly dosing to treat type 2 diabetes. SynCo will further develop the existing production process for VRS-859 and optimize the manufacturing process to increase yields for cGMP production.
“Versartis selected SynCo because of its extensive pharmaceutical manufacturing experience and its ability to deliver bulk and final product for clinical trials and ultimately, for commercialization,” said Jeffrey L. Cleland, Ph.D., founder and chief executive officer of Versartis. “We expect SynCo to ensure our goal of initiating Phase 1 clinical trials for VRS-859 in the first half of 2010. SynCo will also become our preferred manufacturing partner for future Versartis products based on the XTEN technology, which have similar production processes.”
Pierre Warffemius, SynCo Bio Partners chief executive officer commented, “We are delighted that SynCo has been chosen to develop and manufacture Versartis’ lead compound VRS-859. As Versartis looks to advance its novel product portfolio through clinical trials, we look forward to a long and successful collaboration with this exciting new company.”
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Posted on August 17, 2009 @ 08:40 am
Cellceutix Corp. has signed an agreement with
Girindus America, Inc. for the manufacture of Kevetrin API. Kevetrin is being developed to treat certain cancers. The company recently reported encouraging results in animal models of drug resistant lung cancers. Terms of the agreement were not disclosed.
“This is a big step toward our short-term goal of filing for an investigational new drug exemption (IND) with the FDA," said George Evans, chief executive officer of Cellceutix. "We will use the material manufactured by Girindus to do the last animal studies needed for the filing of an IND, as well as for Phase I human trials. We think Girindus will be an excellent partner for Cellceutix.”
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Posted on August 17, 2009 @ 08:38 am
Novartis received approval from the FDA for Extavia (interferon beta-1b) for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The drug is also indicated for patients who experience their first clinical episode of MS and have features consistent with the disease based on MRI results.
"Novartis has been a leader in neuroscience for more than 50 years, having pioneered a number of breakthrough therapies which remain important treatments to this day," said Joe Jimenez, chief executive officer of the Novartis Pharmaceuticals Division. "We are committed to providing new approaches to MS care, and the FDA approval of Extavia marks the beginning of our long-term commitment to the MS community in the U.S."
MS is estimated to affect approximately 400,000 patients in the U.S., of whom more than 80% have relapsing-remitting MS. Extavia will be available in the U.S. this fall.
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Posted on August 13, 2009 @ 02:18 pm
Jim Laveglia, Ph.D., has been named executive vice president at
MPI Research.
Tina Rogers, PhD, MBA, DABT, has been named to Dr. Laveglia's former role of director of research.
In his new role, Dr. Laveglia will focus on business development and will continue to serve on the company’s corporate management team and board of directors. Dr. Laveglia joined MPI soon after its inception in the mid-1990’s, and became director of research in February 1997. Prior to MPI, he served as director of toxicology and animal metabolism at Ricerca, Inc. In his numerous leadership positions in the chemical industry and with contract toxicology laboratories, he has directed the activities of toxicologists, pathologists, technical staff, report-preparation staff, and overall corporate operations.
Tina Rogers, PhD, MBA, DABT joined MPI in 2007 as director of the Discovery Center and associate director of research. In her new role as director of research and member of the Corporate Management Team, she will continue to lead major growth initiatives for the company. With more than 20 years of experience in the CRO industry, she has held key leadership positions, most recently as vice president of drug development at Southern Research Institute.
Bill Parfet, MPI's chairman and chief executive officer, remarked, “These are exciting but challenging economic times for the pharmaceutical and biotech customers that we serve. The contract research organizations that partner with them in moving their drug and device candidates forward need to demonstrate sharper business acumen and greater scientific expertise than ever before and Drs. Laveglia and Rogers bring those attributes to the table.”
Posted on August 13, 2009 @ 11:47 am
Catalent Pharma Solutions’ softgel manufacturing site in St. Petersburg, FL recently received a “Preferred Partner Award in Technology” from Wyeth Consumer Healthcare.The award, which recognizes Catalent’s support in 2008 for technical projects and documents, was presented to Janice Bachesais, Senior Client Services Specialist, and Dina Kostakis, General Manager for the site, which is included in Catalent’s Oral Technologies segment.
“We value our long-term partnership with Catalent, and appreciate the consistently high level of performance that this award recognizes,” said Jim Peck, Pharm.D., Technology Scientist IV, Wyeth Consumer Healthcare.
Wyeth Consumer Healthcare’s criteria for its “Preferred Partner Award in Technology” include measures regarding effective project support, consistent follow-through, “right first time” accuracy, and identification of process improvement opportunities. This is the third consecutive year that the St. Petersburg site received this award from Wyeth.
Posted on August 13, 2009 @ 08:11 am
Phase Forward, a provider of data management solutions for clinical trials and drug safety, and
SGS have extended their multi-year, multi-million dollar clinical data management partnership.
The new pact reinforces the companies’ close working relationship and offers SGS’s customers the benefits of Phase Forward’s InForm Global Trial Management, Clarix Interactive Response Technology and Maaguzi Web-based electronic patient reported outcomes (ePRO) and late phase solutions, according to a Phase Forward statement.
The companies have worked together since 2002; SGS manages nearly 100 clinical trials and processes more than one million case report form (CRF) pages each year.
“Our customers are looking for an integrated eClinical solution comprising multiple systems,” said Luc Braeken, global director, Biometrics Services, SGS. “This agreement will allow us to respond to customer demand for this integrated solution with innovative product sets from a market leader. This solution is designed to meet the needs of even the most demanding clinical development professional, offering more effective ways to manage clinical operations, help ensure product safety and reduce time-to-market.”
“SGS has established a reputation as a leading provider of integrated solutions from preclinical activities, to phase one through four trials,” said Mike Davies, vice president, global CRO partnerships, Phase Forward. “We look forward to building on the success of our collaboration to date with the solutions that our acquisitions of Clarix and Maaguzi add to the equation.”
Posted on August 12, 2009 @ 08:43 am
Dr. Sarath Kanekal has been named vice president of Pharmacology and Toxicology at Absorption Systems. Dr. Kanekal has more than 16 years of pharma industry experience in the preclinical field. He will oversee all technical staff at Perry Scientific, the company’s in vivo toxicology and pharmacokinetics facility located in San Diego, CA.
“With extensive industry experience overseeing the full spectrum of preclinical assessment, Sarath is a tremendous asset to Absorption Systems and to our customers,” commented Patrick M. Dentinger, president and chief executive officer of Absorption Systems. “His appointment aligns with our mission to help pharmaceutical and biotechnology companies advance new drug candidates toward clinical testing and regulatory approval as efficiently as possible.”
Dr. Kanekal has led the nonclinical development and safety assessment of numerous drugs through the pre-clinical process all the way to NDA, including Treanda, Accusite, Omacetaxine and IntraDose. For the past year, he has served as a toxicology strategy consultant to Perry Scientific. Prior, he served as executive director of preclinical at Supergen and was responsible for nonclinical IND strategy for two Tyrosine Kinase Inhibitors. Previous to this he was in charge of nonclinical safety assessment at Chiron (Novartis), Salmedix (Cephalon), Corixa (GSK) and Matrix Pharmaceutical (Chiron).
Posted on August 12, 2009 @ 08:39 am
Mark D. Young, Ph.D. has been named senior vice president of Pharmaceutical Operations at
Alder Biopharmaceuticals. Dr. Young brings more than 30 years experience in the process development and manufacturing of biopharmaceuticals produced from yeast, bacterial and mammalian cells. This includes expertise in engineering, technology transfer, manufacturing and clinical development at a number of prominent biotechnology companies including Zymogenetics, Biomira (now Oncothyreon), Protein Design Labs and Synergen (acquired by Amgen).
“Mark’s breadth of bioprocessing experience and leadership will be instrumental to Alder in the continued application of our high throughput antibody selection and yeast production systems to streamline the identification and production of best-in-class biotherapeutics,” said Randall Schatzman, Ph.D., chief executive officer of Alder. “With our recent success of ALD518 in Phase II trials for treatment of RA, Mark’s late-stage manufacturing experience will be key as we gear up to initiate Phase III trials and plan for commercial manufacturing.”
Dr. Young most recently served as a bioprocess consultant, providing technical and strategic consulting on issues of bioprocess development and manufacturing for a variety of biopharmaceutical clients. Prior to that, Young he was senior vice president, Technical Operations for Zymogenetics from 2001 to 2006, where he was responsible for process development, analytical development, formulation development and stability, manufacturing, and quality functions. During his tenure, Young and his group successfully filed chemistry, manufacturing and control (CMC) sections of investigational new drug applications for three products, managed outsourcing for these products and established in-house clinical manufacturing capabilities.
Posted on August 12, 2009 @ 08:32 am
Forest Laboratories and
AstraZeneca have entered into a definitive collaboration agreement to co-develop and commercialize ceftaroline in all markets outside the U.S., Canada and Japan. Ceftaroline is Forest’s late-stage, next generation cephalosporin being investigated for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). Ceftaroline demonstrates bactericidal activity against a broad range of pathogens commonly implicated in cSSSI and CABP, including methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant Streptococcus pneumoniae (MDRSP).
AZ will pay Forest an undisclosed upfront fee, sales-related royalties and payments for reaching certain sales milestones. AZ will assume responsibility for the development, regulatory approval and commercialization of ceftaroline in the licensed territory. The parties will collaborate on future development activities. Financial terms were not disclosed.
David Brennan, chief executive officer of AZ, remarked, “AstraZeneca and Forest Laboratories, through a successful partnership, aim to battle the growing problem of antibiotic resistance. This collaboration complements our existing antibiotic Merrem, and our significant investment in antibiotic research, as well as agents in development such as CytoFab. We are excited to be partnering with Forest and to be part of ceftaroline’s future.”
Forest expects to file an NDA in the U.S. by the end of 2009, while AZ plans to file an MAA in Europe by the end of 2010.
Read AstraZeneca's profile in this year's Top Companies report!
Posted on August 12, 2009 @ 08:26 am
The FDA has extended the action date for its review of Prevnar 13's BLA from September 30, 2009, to December 30, 2009. In response to an FDA request,
Wyeth submitted additional analytical method validation and specification information relating to physical/chemical properties of the product in late July. According to Wyeth, the FDA considered this to be a major amendment and, as a result, has elected to extend the review cycle for the vaccine by 90 days. Prevnar 13 is under review for active immunization of infants and young children for the prevention of invasive disease and otitis media caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes.
"This is a significant application that is under priority review and we are working closely with the FDA on the review, including conduct of the pre-approval inspections," said Emilio Emini, Ph.D., executive vice president, Vaccine R&D, at Wyeth.
Prevnar 13 is based on the scientific foundation of Prevnar (Pneumococcal 7-valent Conjugate Vaccine), the standard in pneumococcal disease prevention for infants and young children. It contains the seven serotypes in Prevnar, as well as six additional serotypes responsible for the greatest remaining burden of invasive disease. Prevnar has been available in the U.S. for more than nine years. It is currently available in 95 countries and more than 235 million doses have been distributed worldwide.
The Prevnar 13 submission is based on a clinical trial program of 13 core Phase III studies involving more than 7,000 infants and young children. To date, the company has submitted regulatory applications for Prevnar 13 in more than 50 countries spanning six continents, with filings in additional countries planned. In July, Prevenar 13*, as it is known outside the U.S., was approved in Chile for use in infants and young children.
Read Wyeth's profile in this year's Top Companies report!
Posted on August 11, 2009 @ 09:27 am
The FDA recently submitted a recommendation of approval to the Center for Drug Evaluation and Research (CDER) for
UPM Pharmaceuticals to manufacture a low-dose tablet product. The recommendation was the culmination of a FDA Pre-Approval Inspection (PAI) of UPM's facility and the manufacturing process for an NDA for one of its clients. The inspection covered general GMPs as well as product specific information.
"This accomplishment represents a significant achievement in UPM's history and supports our goal of successfully developing products for client NDA submissions," said John Gregory, UPM's chief executive officer. "This recent development places UPM in an excellent position to continue to grow our company by providing expanding manufacturing services to our diverse client base."
UPM Pharmaceuticals, Inc. is a Baltimore, MD-based CDMO providing customized formulation development, manufacturing, and analytical services to pharmaceutical, biotechnology, academic, and veterinary clients.
See UPM at Contracting & Outsourcing 2009!Posted on August 11, 2009 @ 08:56 am
Avanir's investigational drug Zenvia met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in a confirmatory Phase III trial. Both Zenvia 30/10 mg and 20/10 mg provided a statistically significant reduction in episode rates over the course of the study when compared to placebo (p<0.0001). In an additional analysis of the primary endpoint, at week 12 (end of study), patients in the 30/10 mg group reported a statistically significant mean reduction of 88% from baseline in PBA episode rates (p=0.01). Zenvia was generally safe and well tolerated in the study.
PBA, also known as emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. PBA is estimated to impact approximately 2 million people in the U.S. with underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, dementias including Alzheimer's disease, stroke, and traumatic brain injury.
"The trial data indicate that the new low-dose Zenvia formulations offer an improved safety and tolerability profile while continuing to deliver statistically significant and clinically meaningful efficacy in the treatment of PBA," said Keith Katkin, Avanir's president and chief executive officer. “We are very encouraged by the top-line results and we believe that the data should be sufficient to address the issues outlined in the FDA approvable letter. We hope to have a full presentation of the trial results at a scientific meeting later this year and plan to submit our complete response to the FDA in the first half of 2010."
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Posted on August 11, 2009 @ 08:26 am
Parexel
4Q Revenues: $247.4 million (-9%)
4Q Earnings: $6.3 million (-75%)
FY Revenues: $1.1 billion (+9%)
FY Earnings: $39.3 million (-39%)
Comments: Clinical Research Services posted revenues of $200.8 million in 4Q09 (-5%) and $804.2 million in FY09 (+8%). Total revenues from the Americas grew 13% to $426,284, revenues from Europe, Middle East and Africa grew 3% and Asia/Pacific revenues were up 35%.
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Posted on August 10, 2009 @ 09:03 am
SGS Life Science Services (LSS) is expanding its R&D / QC operations in North America by doubling its facilities in Chicago and tripling those in Toronto. The moves are in response to 10-15% annual growth in the market for pharmaceutical contract testing.
SGS has been operating its LSS division in Canada since 1984, and has been in its existing facility located in the Toronto suburbs of Mississauga since 1987. The new facility, also located in Mississauga, will triple the space from 15,000 sq. ft. to 46,000 sq. ft. The company anticipates doubling its technical resources to handle new business opportunities.
Concurrent with the move to the new Mississauga facility, the R&D / QC group will expand its capabilities in Canada by offering testing services for the analysis and characterization of biopharmaceuticals. The move is currently underway in phases and is expected to be completed by September.
In the U.S., SGS LSS’ sites include a 35,000-sq.-ft. facility in northern NJ, in close proximity to top pharmaceutical companies. In 2006, SGS expanded its U.S. market presence by acquiring Northview Laboratories, adding an existing facility in the Chicago suburb of Northbrook, IL. SGS LSS will move from the Northbrook facility to a new site in Lincolnshire, IL, doubling the facility size from 21,500 sq. ft. to almost 40,000 sq. ft.
As part of the move, SGS will increase its offerings in Stability Studies and Stability Program Management. SGS LSS plans to double its technical staffing by the end of 1Q10,. Modifications to the building are currently in progress, with move-in by the end of 2009.
“For SGS’ Life Science Services, the expansion at these two sites demonstrates our continued commitment to delivering excellent quality and service.” said Sohil Mana, Sr., vice president and regional business manager, North America. “The move also involves the implementation of Lean Projects to increase efficiencies in our laboratories. These projects will strengthen our performance by developing innovative solutions to lead the industry in on-time delivery. Given that outsourcing is a continuing trend within the pharmaceutical market, these recent expansions will contribute to positioning SGS Life Science Services as the preferred partner to the pharmaceutical and biotechnology industries.”
SGS Life Science Services' R&D / QC division performs method development and quality control testing for the pharmaceutical, biopharmaceutical, medical device, chemicals and cosmetics markets.
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Posted on August 10, 2009 @ 08:18 am
Millipore has acquired
BioAnaLab, a European-based services provider that specializes in the analysis of biologic drugs and vaccines. The transaction enables Millipore to expand its biopharma services business into Europe
"Our acquisition of BioAnaLab will allow us to build on our reputation as a trusted outsource partner in North America by establishing a presence in the fast-growing European biotech market," said Jonathan DiVincenzo, president of Millipore's Bioscience Division. "BioAnaLab will add cGMP support testing capabilities to our portfolio, a solid customer base, and a team of highly talented services professionals with expertise in emerging scientific disciplines."
Based in Oxford, UK, BioAnaLab was spun out of the University of Oxford in 2002 to meet the unique requirements of the biopharmaceutical industry by helping its customers better understand the safety and efficacy of biologic drugs and vaccines, using "a broad range of services to assist with evaluating and advancing these therapeutics from the drug development pipeline to the market," according to a Millipore statement. BioAnaLab's services include assay transfer/development, validation and sample analysis, pharmacokinetics/toxicokinetics, immunogenicity, biological potency, and vaccine services.
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Posted on August 10, 2009 @ 08:10 am
Nycomed and
Forest Laboratories have entered into a collaboration and distribution agreement for Daxas in the U.S. Daxas is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD (chronic obstructive pulmonary disease) and for which Nycomed submitted an NDA with the FDA in July.
Forest will make an upfront payment to Nycomed of $100 million and will pay undisclosed milestone payments. In addition, Nycomed will receive royalties based on Daxas sales. Forest will assume responsibility for the U.S. regulatory approval and commercialization of Daxas in the U.S. and the companies will collaborate on future development programs.
Hakan Bjorklund, chief executive officer of Nycomed, said: "We have received considerable interest in the marketing rights to Daxas and we believe Forest Laboratories is the best possible partner for Nycomed in the US. Forest Laboratories has a significant US sales force, an increasing focus on respiratory products and an unrivalled track record of partnering with European companies to build hugely successful franchises. We believe their absolute commitment to Daxas will help to bring this innovative new therapy to as many patients in the United Sates as possible who suffer from COPD, a disease which is predicted to become the third-leading cause of death worldwide by 2030."
Howard Solomon, chairman and chief executive officer of Forest, said, "Daxas represents the first in a new class of agents to treat COPD and would be the first oral agent to be approved for this debilitating disease. If approved, Daxas will give physicians and patients a much needed new treatment option in a unique oral dosage form that can augment the existing armamentarium of inhaled therapies."
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Posted on August 10, 2009 @ 08:06 am
Patheon's solid dose manufacturing facility in Manati, Puerto Rico received regulatory approval from the EMEA following the completion of a successful inspection in May by the Medical Products Agency of Sweden. The inspection of the facility marks 19 successful regulatory inspections at nine manufacturing sites for the company in 2009, including eight FDA inspections and two European inspections.
"Patheon's track record of regulatory compliance underscores our commitment to quality and reliability for our customers," said Terry Novak, President, Patheon North America. "The approval of our Manati facility allows us to ship solid dosage product into Europe from Puerto Rico, which provides additional benefit and flexibility for our clients."
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Posted on August 7, 2009 @ 08:25 am
Nabi Biopharmaceuticals has signed a definitive agreement to sell PentaStaph (Pentavalent S. aureus Vaccine) and related assets to
GlaxoSmithKline for as much as $46 million. Nabi will receive an initial cash payment of $20 million upon closing and an additional $26 million based on four milestones.
It is believed that the successful development of a vaccine against S. aureus is critical in the fight against Methicillin-resistant S. aureus (MRSA), an increasingly prevalent strain of the bacterium.
"We are very pleased that GSK is acquiring the PentaStaph program and undertaking its further development and commercialization in this area of high unmet medical need. This transaction is the next step in the execution of our strategic alternatives process and we are pleased to be able to generate near-term value from this program for our shareholders," said Dr. Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. "We believe in the potential of PentaStaph and are confident that GSK will continue to develop this vaccine into a successful weapon against the growing threat from Staphylococcus infection."
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Posted on August 7, 2009 @ 08:23 am
Sanofi Pasteur, the vaccine division of Sanofi-Aventis, has submitted a supplemental application to the FDA to license its influenza A/H1N1 2009 monovalent vaccine. The application requests the FDA's evaluation of the influenza A/H1N1 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.
"Filing this application is consistent with our commitment to work collaboratively with public health officials in producing a vaccine against the influenza A/H1N1 2009 virus," said Wayne Pisano, president and chief executive officer of Sanofi Pasteur. "It is essential that we pursue the vaccine licensure pathway made available to us, while at the same time, continue the important clinical studies of our vaccine."
The supplemental application follows recent recommendations by the FDA to evaluate the influenza A/H1N1 2009 monovalent vaccines using the same regulatory process used for new viral strains contained in annual seasonal flu vaccines. The company’s supplemental application specifies the evaluation of a non-adjuvanted vaccine.
These strain change supplements are not required to be supported by new clinical data, but immunogenicity and safety data will be made available through clinical studies. The company will conduct clinical trials testing the immunogenicity and safety of the vaccine. Trials in the U.S., which began August 6, will consist of approximately 2,000 subjects.
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Posted on August 7, 2009 @ 08:19 am
Sigma-Aldrich has acquired
ChemNavigator, Inc., a provider of discovery research informatics software tools used for design, selection and procurement of chemical compound libraries. The acquisition combines ChemNavigator's suite of virtual screening and selection tools and searchable database of compounds, with Sigma-Aldrich's chemical compound management expertise, procurement and global distribution.
ChemNavigator’s sourcing database, iResearch Library, contains millions of chemical products available for selection and purchase. The acquisition aligns the global procurement and distribution capabilities of Sigma-Aldrich's Discovery(CPR) service with ChemNavigator's front-end cheminformatics research tools. These combined capabilities are part an effort to provide customers with complete chemical discovery, from compound selection to delivery of custom packaged chemical building blocks and screening libraries ready for testing.
"ChemNavigator is well-recognized for its fast and efficient virtual discovery tools and for its extensive database of chemical compounds," said Dr. Ilya Koltover, manager, business development, for Sigma-Aldrich. "This acquisition enables Sigma-Aldrich to provide the research community with an efficient, seamless discovery offer that extends from virtual selection to compound delivery."
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Posted on August 6, 2009 @ 09:36 am
Formatech has introduced a “Fillanthropy” Program, under which the company will donate an aseptic fill and finish manufacturing service each month for selected therapeutic candidates entering human trials.
“At Formatech, we envision a world where all companies with promising new drug therapies have the opportunity to conduct a full clinical development program,” said Jeffrey Bernard, director of business development. “We have observed that the current economic climate has hindered the progress of many companies that are trying to get new therapies into the clinic. While many within our industry are now forced to cut back, we are fortunate to be in a position where we can provide support and give back during these challenging times. Formatech feels that it is our social responsibility to contribute to our industry and ultimately to the patients that will benefit from these new medicines.”
The company is accepting applications for the program. To qualify, companies must be developing a clinical candidate that is delivered via sterile injectable. To participate, contact
jbernard@formatech.com.
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Posted on August 6, 2009 @ 09:29 am
Baxter International has completed production of its first commercial batches of Celvapan A/H1N1 pandemic vaccine and is discussing distribution plans with national health authorities, subject to obtaining authorizations. Celvapan is made using the company’s Vero cell culture technology. The company was able to produce the vaccine within 12 weeks of receiving the A/H1N1 virus strain.
Baxter plans to deliver initial quantities of the vaccine to national health authorities that have placed orders for the vaccine after the World Health Organization (WHO) declared a Phase 6 pandemic.
“We are pleased with our company’s ability to meet its expected timelines in developing and producing Celvapan,” said Joy Amundson, corporate vice president and president of Baxter BioScience. “This is an encouraging validation of our science, our Vero cell vaccine technology and the teamwork at Baxter in meeting this important milestone to help address an urgent public health issue.”
“To make Celvapan A/H1N1 vaccine, we applied the same development, qualification and manufacturing processes used in gaining EMEA licensure of a mock-up pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. “The mock-up vaccine made with a different pandemic strain was tested in five clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated during an ongoing Phase III study.”
Confirmatory trials — to evaluate safety and immunogenicity of the vaccine in adults, the elderly and children — are scheduled to begin this month.
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Posted on August 6, 2009 @ 09:23 am
Galapagos NV has successfully completed a Phase I trial of its drug candidate GLPG0259 for rheumatoid arthritis (RA). The drug showed good safety in healthy volunteers and an excellent pharmacokinetic profile, which supports once-daily oral dosing, according to the company. GLPG0259 is a new mechanism-of-action inhibitor of the protein kinase MAPKAPK5, which represents a new approach for the treatment of RA.
The double-blind, single-ascending and multiple dose study was conducted in 34 healthy volunteers. The compound was administered as many as five consecutive days and showed good safety, with no cardiovascular side effects. The desired PK profile obtained thus far supports once-daily oral dosing.
"We are encouraged by the positive outcome of the first human trial for a candidate drug derived from Galapagos' target discovery platform," said Onno van de Stolpe, chief executive officer of Galapagos. "We are on track to complete the Phase I trials for GLPG0259 by the end of 2009. Furthermore, preparations are underway to start a Phase IIa study in 2010, where we will assess the efficacy of this novel mechanism of action candidate drug in treating RA patients."
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Posted on August 5, 2009 @ 03:54 pm
Kendle Int'l.
2Q Revenues: $107.4 million (-15%)
2Q Earnings: $3.2 million (-48%)
YTD Revenues: $215.5 million (-11%)
YTD Earnings: $4.1 million (-61%)
Comments: New business awards were $132 million, while there were $48 million in contract cancellations, comprising 5% of the company's backlog. Early-stage revenues dropped 15% to $7.3 million in 2Q09, but rose 15% for YTD09. Late-stage revenues fell 17% to $96.6 million for 2Q09 and 13% in YTD09 to $193.2 million. During this quarter, the company took a $6.0 million pretax charge for severance and other restructuring costs.
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Posted on August 5, 2009 @ 08:59 am
Charles River Laboratories
2Q Revenues: $308.2 million (-13%)
2Q Earnings: $34.2 million (-30%)
FY Revenues: $609.7 million (-12%)
FY Earnings: $59.6 million (-36%)
Comments: Sales declined in both the Research Models and Services (RMS) and Preclinical Services (PCS) segments, reflecting the negative impact of foreign exchange, as well as softer market demand. RMS sales were $165.7 million in the quarter (-4%) and PCS segment sales were $142.5 million (-21%).
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Posted on August 5, 2009 @ 08:57 am
DSM Pharmaceutical Products’ Greenville, NC facility has received Potent Compound Safety Certification from
SafeBridge Consultants, Inc. The certification is for competency and proficiency in the safe handling of potent APIs and potent drug products, as well as the site's potent sterile fill/finish production area, high containment fill/finish facility, and quality control labs.
SafeBridge conducted a 60-element review of programs, verifying performance with established criteria in management, evaluation, containment, control and communication elements of production operations. The program includes on-site assessment of the potent compound manufacturing and lab areas and the associated equipment, training, and toxicology and industrial hygiene support.
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Posted on August 5, 2009 @ 05:48 am
AMRI
2Q Revenues: $51.3 million (-11%)
2Q Earnings: $179,000 (net income of $5.7 million in 2Q08)
YTD Revenues: $105.3 million (-6%)
YTD Earnings: $2.1 million (-80%)
Comments: Total contract services revenue dropped 16% to $38.8 million in 2Q09, driven by Discovery Service (-22% to $11.5 million) and Development/Small Scale Manufacturing (-47% to $15.3 million). Large Scale Manufaturing revenues grew 18% to $19.2 million in the quarter. For YTD, Discovery Services are down 18% to $23.1 million, Development/Small Scale Manufacturing is down 33% to $19.0 million and Large Scale Manufacturing is up 14% to $39.9 million. AMRI chairman, president and CEO Thomas E. D'Ambra remarked, "We continue to believe that long term prospects for outsourcing remain strong and that AMRI is uniquely and well positioned in our space." AMRI's recurring royalties were $8.5 million (+13%) and the company gained a $4 million milestone payment from Bristol-Myers Squibb related to a license and research agreement. It marked the second AMRI compound from this agreement to be selected by BMS for Phase I testing.
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Posted on August 4, 2009 @ 08:08 am
Amgen announced positive top-line results from a pivotal Phase III head-to-head trial evaluating denosumab administered subcutaneously versus Zometa administered as an intravenous (IV) infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma.
Here's what Amgen had to say: "For the primary endpoint, patients treated with denosumab experienced a similar time to first skeletal-related event (SRE) (fracture, radiation to bone, surgery to bone, or spinal cord compression) compared with those receiving Zometa (hazard ratio 0.84, 95 percent CI: 0.71-0.98), which is statistically significant for non-inferiority (p<0.0007). Although numerically greater, the delay in the time to first SRE associated with denosumab treatment was not statistically superior compared to Zometa (adjusted p=0.06) (secondary endpoint). The time to first-and-subsequent SRE was also numerically greater but not statistically superior compared to Zometa (hazard ratio 0.90, 95 percent CI: 0.77-1.04) (secondary endpoint)." Incidence of adverse events and serious adverse events was consistent with what was previously reported for these two agents.
"We are extremely pleased with these results, which continue to demonstrate that inhibiting RANK Ligand with denosumab provides a clinically meaningful benefit for advanced cancer patients with solid tumors that have metastasized to the bone, and to patients with multiple myeloma, both groups who routinely suffer SREs," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. "We are very encouraged by the overall strength of the data, which we will present in a scientific forum later this year. We are also looking forward to reviewing the results of a final SRE study, in patients with advanced prostate cancer, next year."
Full safety and efficacy data will be submitted for presentation at an upcoming medical meeting in the second half of this year.
Read this year's Top 10 Biopharma profile of Amgen!
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Posted on August 4, 2009 @ 08:04 am
Gregg H. Alton has been named executive vice president, Corporate and Medical Affairs at
Gilead Sciences. He was previously senior vice president and general counsel, responsible for legal, government and public affairs and international access operations, and recently assumed the additional responsibility of management for Gilead’s global medical affairs activities and personnel. Mr. Alton will continue to report to
John C. Martin, Ph.D., Gilead’s chairman and chief executive officer.
“Gregg has established and built a number of critical functions at Gilead, and in doing so has demonstrated his leadership and his understanding of how every part of our organization contributes to delivering therapies to patients,” said Dr. Martin. “Gregg’s knowledge of public health and health policy will be instrumental to our medical affairs efforts across therapeutic categories. This promotion is recognition of his many contributions to our company and the importance of his continued leadership and vision.”
Mr. Alton joined Gilead Sciences in 1999. From 2000 to 2009 he served as general counsel. Prior to joining Gilead, Mr. Alton was an attorney at the law firm of Cooley Godward, LLP, where he specialized in mergers and acquisitions, corporate partnerships and corporate finance transactions for healthcare and information technology companies.
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Posted on August 4, 2009 @ 08:00 am
Diana Hausman, M.D. has been named vice president, Clinical Development at
Oncothyreon. Dr. Hausman will be responsible for planning and implementing the clinical development program for the company's pipeline of oncology product candidates.
"Dr. Hausman is an experienced oncologist who brings an extensive background in drug development to her new role at Oncothyreon," said Robert L. Kirkman, M.D, the company's president and chief executive officer. "Her leadership and knowledge of all aspects of cancer drug development will be very important as we prepare to move both PX-866, our inhibitor of PI-3 kinase, and PX-478, our inhibitor of hypoxia inducible factor 1-alpha, into Phase 2 trials. We are delighted to have her join our team."
Dr. Hausman was previously at Zymogenetics, Inc., where she held a number of clinical research positions from 2005 to 2009, most recently as senior director of Clinical Research with responsibility for all therapeutic areas, including oncology, autoimmune disease and virology. Prior to Zymogenetics, Dr. Hausman led a global drug development team at Berlexfrom 2002 until 2005. Dr. Hausman will assume her new role at Oncothyreon on September 1, 2009.
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Posted on August 4, 2009 @ 07:57 am
The FDA has approved Livalo, a statin developed by Kowa Research Institute (KRI) and
Kowa Pharmaceuticals America, Inc. (KPA). According to a KPA statement, Livalo is a fully synthetic and highly potent statin engineered in Japan, with a unique cyclopropyl group on the base structure that "contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol."
"The approval of LIVALO is a testament to the commitment and skill of Kowa's clinical development and regulatory groups in successfully bringing a new therapeutic option to a large, competitive market for cardiometabolic disorders," said Ben Stakely, chief executive officer and president, KPA. "KPA is very pleased with the approval of LIVALO and is excited about the opportunity to introduce this new therapeutic option to physicians and patients."
Kowa plans to launch Livalo in the U.S. during 1Q10, and is seeking a co-promotion partner.
Sign up today for Contracting&Outsourcing 2009!Posted on August 3, 2009 @ 09:13 am
Margie McGlynn, president of
Merck Vaccines and Infectious Diseases, has resigned effective November 1st. Amy Rose, a spokeswoman for the company, commented, "She has professional and personal aspirations she'd like to pursue." A replacement has not yet been named.
Ms. McGlynn oversaw the launch of Gardasil cervical cancer vaccine, Rotateq rotavirus vaccine and Zostavax shingles vaccine, among other products. She spent 26 years with the company and previously helped run U.S. commercial operations.
Merck is expected to complete its $41 billion acquisition of Schering-Plough by the end of the year. According to Ms. Rose, the company will announce the members of the executive committee of the combined Merck/Schering-Plough, and senior management, as the close of the merger nears.
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Posted on August 3, 2009 @ 09:11 am
Bristol-Myers Squibb and
AstraZeneca received FDA approval for Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Onglyza is a once-daily dipeptidyl peptidase-4 (DPP4) inhibitor that can be used in combination with commonly prescribed anti-diabetic medications or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels.
“The FDA approval of Onglyza is an important development for adult patients with type 2 diabetes struggling every day to control their blood sugar levels. Nearly half of adult patients remain uncontrolled on their current treatment regimen and may thus require additional medications,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer, and president, R&D, BMS. “Our ongoing clinical trial program has demonstrated that Onglyza showed improved A1C control both in combination and monotherapy settings.”
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Posted on August 3, 2009 @ 09:08 am
Genentech has received approval from the FDA for Avastin plus interferon-alfa for metastatic renal cell carcinoma, the most common type of kidney cancer. According to the American Cancer Society, kidney cancer is the eighth most commonly diagnosed cancer in the U.S.; nine out of ten people with kidney cancer have renal cell carcinoma.
“During the last five years, Avastin has been approved by the FDA to treat five different types of cancer,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “We aim to help more people facing difficult-to-treat cancers and will continue studying Avastin in more than 30 other tumor types.”
Avastin is designed to block the vascular endothelial growth factor (VEGF) protein, an underlying cause of cancer growth. Avastin works differently than other approved kidney cancer drugs because it specifically binds to the VEGF protein, which is produced in elevated amounts in most kidney cancers.
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Posted on August 3, 2009 @ 08:23 am
Despite a 14-1 advisory panel recommendation, the FDA has issued a Complete Response letter to
Savient Pharmaceuticals for its gout treatment Krystexxa. The letter cites deficiencies with the CMC section of Krystexxa's BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS).
Savient plans to immediately request a meeting with the FDA to discuss and clarify the issues raised in the letter. The company contends that, under FDA guidelines, this meeting is deemed a "Type A" meeting, meaning that the FDA would meet with Savient within 30 days of its receipt of the meeting request. The company plans to resubmit the BLA in early 2010.
One of the issues raised by the FDA in the complete response letter addressed a change made by the company in the proposed process for manufacturing Krystexxa for commercial use. The FDA concluded that "the comparability data submitted for the material manufactured using the proposed commercial manufacturing process was not adequate to demonstrate that it was representative of the material used to establish the safety and efficacy of KRYSTEXXA in its Phase III clinical trials," according to a Savient statement. The agency stated that Savient has the option of either reverting to and validating the manufacturing process used to produce Krystexxa for the Phase III trials or conducting additional comparability clinical trials to support the use of Krystexxa manufactured using the proposed commercial manufacturing process. Savient currently expects to revert to and revalidate the earlier manufacturing process.
The letter included additional CMC comments focused on tightening manufacturing parameters and narrowing analytical specifications associated with commercial production. Savient will also have to include an update of safety data from all ongoing studies when it resubmits its BLA.
Savient's drug substance manufacturer, BTG-Israel, has provided a work plan to remediate observations arising from the FDA pre-approval inspection of its manufacturing facility. A satisfactory inspection report is required prior to the approval of Krystexxa.
"While our timeline for resubmission to the FDA is subject to a number of uncertainties, we currently believe that we can target completion of our resubmission for early 2010. We hope to have more clarity on the expected timeline after we meet with the FDA to discuss the complete response letter," stated Paul Hamelin, president of Savient Pharmaceuticals. "While we believe we have made substantial progress toward the potential final approval of Krystexxa, we also have more work to do with the FDA to resolve these open issues. We are committed to work diligently to address these issues with a goal of obtaining final approval for Krystexxa so we can provide this therapy to those chronic gout patients who are suffering from this crippling, debilitating disease and have no other treatment options."
Sign up today for Contracting &Outsourcing 2009!Posted on August 3, 2009 @ 08:13 am
Cherokee Pharmaceuticals has signed a new five-and-a-half-year commercial supply agreement with DuPont Applied BioSciences, a division of DuPont. Cherokee will manufacture a new product for DuPont using a DuPont proprietary fermentation process at its Riverside, PA facility.
Initial production is scheduled to begin in late 2009. Over the term of the contract, production is expected to employ a significant proportion of Cherokee's fermentation capacity. The manufacturing of this product will create more job opportunities, although the number of additional employees that will be needed is not yet available, according to a company statement. Facility development work has already begun at the Cherokee facility in order to meet the requirements of the proprietary process. The value of the contract was not disclosed.
"We are excited to have this opportunity to work with DuPont, a leader in the biosciences field," says John Elliot, president of Cherokee Pharmaceuticals. "This agreement is a strong testament to our ability to compete successfully in the global marketplace, even in this tighter economic climate.”
The DuPont contract is consistent with Cherokee Pharmaceuticals' strategy to diversify its customer base. Since acquiring the facility from Merck in January 2008, Cherokee Pharmaceuticals has initiated the three-fold expansion of its multipurpose manufacturing facility to increase its API manufacturing capacity.
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Posted on August 3, 2009 @ 08:09 am
URL Pharma, a specialty pharma company, has acquired the manufacturing assets of PharmPro, a division of Fluid Air, Inc. The acquisition expands the capacity and capabilities of URL Pharma's product development and manufacturing operations.
The 19,000 sq. ft. facility, located in Aurora, IL, includes fluid bed technology, enabling water and solvent coating processes critical to the development and manufacture of a wide array of modified release products. The acquisition also includes DuraGran, a proprietary platform technology that enables the efficient production of uniform, small granules in the development and manufacture of modified release dosage forms. The site is FDA inspected and DEA licensed.
"This acquisition brings fluid bed technology in-house, enabling us to develop and manufacture a broad range of products for our pharmaceutical technology and brand pipelines," commented Richard H. Roberts, M.D., Ph.D., URL's president and chief executive officer. "As part of this transaction, 17 former Fluid-Air employees, many with critical engineering expertise, will join URL Pharma and help integrate the new technology into our product development and manufacturing operations."
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July 2009
Posted on July 31, 2009 @ 10:58 am
The FDA informed
Genzyme that it will re-inspect the company’s Allston Landing, MA manufacturing facility. The re-inspection is a follow-up to an inspection the agency conducted in May 2009 and is intended to verify that all CAPA identified in a February warning letter have been implemented.
In a letter to Genzyme, the agency indicated that all promised actions had not been either fully or adequately implemented at the time of the May inspection.During the re-inspection, the FDA will also review Genzyme’s remediation efforts related to the recent identification of a virus at the Allston plant that required the company to temporarily halt production. The sanitization of the facility is complete and production of Fabrazyme and Cerezyme has resumed. Genzyme will schedule the re-inspection as soon as possible.
Sign up today for Contracting &Outsourcing 2009!Posted on July 31, 2009 @ 08:13 am
Craig C. Phillips has been appointed as vice president and general manager of the Oncology Business Unit of
Cephalon. In this role, Mr. Phillips will have responsibility for managing all aspects of the U.S. oncology business including sales, marketing and medical affairs.
"Since joining Cephalon two years ago, Craig has clearly demonstrated an ability to exceed expectations and bring value to our organization through his leadership," said Robert Roche, Cephalon's executive vice president, Worldwide Pharmaceutical Operations. "I am confident that Craig's leadership and vision will support the dynamic growth of the Cephalon Oncology business and allow us to continue to bring medicines that matter to the healthcare professionals and patients battling cancer."
Mr. Phillips joined Cephalon in 2007 as senior group director of sales, national accounts and sales training for the Oncology Business Unit. Under his leadership, the sales team was instrumental in 2008 for the successful U.S. introduction of two indications for Treanda for Injection, the most recent addition to the company's Oncology portfolio. Prior to joining Cephalon, he spent 15 years at Johnson & Johnson and has more than 22 years of pharmaceutical industry experience.
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Posted on July 31, 2009 @ 07:30 am
Jeffrey Davidson, Ph.D. has been named senior director, Clinical Statistics. In this new position, Dr. Davidson will oversee all statistical activities and staff, as well as provide strategic direction and leadership for all statistical functions.
Dr. Davidson comes to Octagon with extensive experience in statistics and biometrics, totaling more than 20 years in industry. Prior to joining the company, he worked as senior vice president, Statistical Consulting at a global CRO, where he developed and led the business unit responsible for providing statistical consultancy to clients in the life sciences industry. Previously, he served as senior vice president, Biometrics at the same company, where he directed all Biometrics and Medical Writing.During his career, Dr. Davidson also served as vice president, Global Biometrics at Shire Development.
Dr. Davidson also led statistical efforts at Purdue Pharma, led Medical Affairs Statistics at Hoffmann-La Roche, and held a leadership role at Knoll. He further served as Therapeutic Area Statistical Lead at Wyeth.
"Dr. Davidson's extensive experience in the industry will be an asset to Octagon," commented Matt Stroschien, vice president, Operations, Octagon. "We're looking forward to the positive and innovative impact he will have on Octagon's Clinical Statistics initiatives."
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Posted on July 31, 2009 @ 07:20 am
Covance will acquire
Merck's Seattle-based Gene Expression Laboratory in exchange for a $145 million, five-year supply agreement with Merck for genomic analysis services. The lab performs genomics services such as genotyping, gene sequencing and gene expression profiling.
"The acquisition of this laboratory brings world-class talent and technologies to Covance and further expands our capabilities in genomics testing and personalized medicine," said Joe Herring, chairman and chief executive officer of Covance. "We recognized the need to expand our footprint in the important and growing genomics testing market and this transaction provided both a superior and quicker entry point than the build or buy options we considered. The overall size of the genomics market is estimated at several hundred million dollars per year, including services for discovery/preclinical and clinical trials support."
"We believe this acquisition establishes Covance as the largest genomics service provider in the world," said Deborah Tanner, corporate senior vice president, and president, Central Laboratory Services at Covance. "This agreement will broaden our participation in projects and partnerships with clients in the drug discovery process."
Covance expects to offer employment to the majority of current employees and is scheduled to assume occupancy of the site and operation of the Gene Expression Laboratory on August 17, 2009.
"The Gene Expression Laboratory has established a strong reputation for consistent delivery of high quality experimental data in support of Merck's external collaborations and internal research projects," said Dr. Rupert Vessey, vice president, Merck Research Laboratories. "This agreement assures continued access to these services for our researchers while securing a future for the facility as an integral part of a world leading drug development service provider."
See Merck's profile in this year's Top 20 Pharma Report!
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Posted on July 31, 2009 @ 07:18 am
AstraZeneca has submitted an NDA to the FDA for vandetanib 100 mg for use in combination with chemotherapy for the treatment of advanced non-small cell lung cancer in patients previously treated with one prior anti-cancer therapy. The company also submitted an MAA to the EMEA for the drug. If approved, the treatment will be marketed as Zactima.
Evaluation of vandetanib is ongoing as a monotherapy or in combination with other anti-cancer therapies in a range of tumor types, including thyroid cancer. Results from the ZEPHYR (300mg monotherapy study in EGFR failures in advanced NSCLC, Phase III) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer, Phase III) studies will be presented in the first half of 2010.
According to AZ, Vandetanib has a unique profile that fights cancer through two clinically proven mechanisms: by blocking the development of tumor blood supply (anti-angiogenesis or anti-VEGFR), and by blocking the growth and survival of the tumour itself (anti-EGFR). Vandetanib also inhibits RET-tyrosine kinase activity, an important growth driver in certain types of thyroid cancer.
Howard Hutchinson, M.D., AZ's chief medical officer, commented, "Lung cancer is an area of high unmet need and these submissions are an important step toward potentially broadening the treatment options available for patients."
See AZ's profile in this year's Top 20 Pharma Report!
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Posted on July 30, 2009 @ 08:36 am
Covance 2Q09
2Q Revenues: $466 million (+7%)
2Q Earnings: $43 million (-16%)
YTD Revenues: $907 million (+7%)
YTD Earnings: $83 million (-17%)
Comments: Early Development revenues dropped 6% in the quarter to $200 million, reflecting lower demand in toxicology services. Demand grew for clinical pharmacology, analytical chemistry and research services. Late-Stage Development revenues grew 19% to $266 million, driven by increases in demand for central lab services, as well as clinical development and commercialization services.
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Posted on July 30, 2009 @ 08:28 am
Sanofi-Aventis will buy
Merck's 50% interest in the companies' animal health joint venture, Merial Limited, for $4 billion in cash. The price values Merial at 3 times its 2008 sales and 10.2 times itsearnings before interest and taxes (EBIT).
In addition to the Merial agreement, Merck, SA and
Schering-Plough announced the signing of a call option agreement. Following the closing of the Merck/Schering-Plough merger, SA will have the option to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be owned equally by the new Merck and SA.
"These agreements should enable us to proceed expeditiously with the closing of our merger with Schering-Plough in the fourth quarter as planned, and also gain an outstanding animal health business through Intervet/Schering-Plough Animal Health," said Richard T. Clark, Merck's chairman, president and chief executive officer. "We are pleased that our long-time partner Sanofi-Aventis will purchase Merck's interest in Merial, the successful joint venture we built together," he added. "We look forward to the potential opportunity to bring together the strong animal health businesses of sanofi-aventis and the new Merck."
Christopher A. Viehbacher, chief executive officer of SA, remarked, “We are pleased with the acquisition of Merial, a major global player in animal heath, and the possibility of combining Merial and Intervet/Schering-Plough's complementary businesses. The combination would create a new leader in this $19 billion global animal health market, supporting our vision of a global diversified healthcare leader. In an environment of increasing complexity, I am convinced that alliances have an important place and I look forward to the prospect of further partnering with the new Merck in animal health to build on our longstanding relationship."
The sale of Merck's interest in the Merial joint venture is subject to clearance by the European antitrust authorities.
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Posted on July 30, 2009 @ 08:20 am
AstraZeneca 2Q09
2Q Revenues: $8.0 billion (flat)
2Q Earnings: $2.4 billion (+70%)
YTD Revenues: $15.7 billion (flat)
YTD Earnings: $4.0 billion (+21%)
Comments: Two generic marketers of Toprol-XL withdrew from the U.S. market,and the introduction of generic Casodex was delayed, giving AZ a boost. Nexium posted a 6% drop in sales in 2Q09 to $1.2 billion, while Crestor posted a 23% rise to $1.1 billion. Nexium sales rose 12% to $1.2 billion. Seloken/Toprol-XL sales doubled to $417 million. Symbicort sales were up 6% to $551 million.
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Posted on July 29, 2009 @ 04:05 pm
Valeant Pharmaceuticals International will acquire
Tecnofarma S.A. de C.V., a privately held company located in Mexico for approximately $33 million. Tecnofarma is a producer of generic pharmaceuticals, with $33 million in annual sales primarily to the government and private label markets. Valeant's subsidiary in Mexico works in the branded generics field and does not currently serve either of those two markets.
The deal will allow Valeant Latin America to reduce its dependence upon third party manufacturers, since Tecnofarma has several manufacturing sites, including a new 160,000 sq. ft. manufacturing plant. Technofarma has 80 registered products that Valeant can bring into its branded generics marketing efforts.
"The acquisition of Tecnofarma is consistent with our business plan strategy," stated J. Michael Pearson, Valeant's chairman and chief executive officer. "The government and private label markets in Mexico are large and growing components of the overall pharmaceutical industry in the region and are complementary to Valeant Mexico's current market focus on the commercial branded generic market. Adding two well-established businesses to our current branded generic portfolio mix, a new pipeline of products for our branded generic business, as well as a manufacturing infrastructure capable of expanding to meet future demand, we believe we are well positioned to reach our growth objectives in Latin America."
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Posted on July 29, 2009 @ 09:54 am
Sanofi-Aventis 2Q
2Q Revenues: $10.4 billion (+11%)
2Q Earnings: $3.2 billion (+29%)
YTD Revenues: $20.4 billion (+7%)
YTD Earnings: $6.2 billion (+22%)
Comments: Pharmaceutical sales were up 7% to $9.4 billion. Lantus sales were up 26% to $1.1 billion. Lovenox sales were up 13% to $1.1 billion. Taxotere sales were $820 million (+11%). Plavix sales were up 5% to $989 million. Eloxatin sales were down 4% to $496 million. Sales in the U.S. and Europe were up 5%, and 20% in emerging markets. Human vaccine sales were down 1% to $1.0 billion. This includes $32.5 million of H5N1 vaccine sales in the U.S., compared to $192.5 million in 2Q
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