Contract Pharma Breaking News

Lonza Signs Supply Pact with Medarex

Kristin Brooks — Thu, 09 Jul 2009 08:42:00 -0500

Lonza and Medarex, Inc. have signed a collaboration agreement under which Lonza will provide manufacturing services to support the development and commercialization of Medarex’s pipeline of therapeutic proteins and antibody drug conjugates (ADCs). As part of the agreement, Lonza may provide process development services for certain Medarex programs and may reserve manufacturing capacity for antibody and ADC programs at its biopharmaceutical facilities around the world. Further details were not disclosed.

“We are pleased to be working with such a successful mid-size biotech company to advance and strengthen their robust portfolio of innovative therapies,” said Dr. Stephan Kutzer, head of Lonza Biopharmaceuticals. “Supporting Medarex’s immediate and long-term needs with our expertise in mammalian cell culture and antibody drug conjugates is both exciting and rewarding.”

Medarex’s biologics portfolio is focused on treating oncology and immunology therapeutic indications with ten antibody programs in Phase III to Phase I development. Under the terms of the agreement, Lonza may be supporting a portion of the Medarex product pipeline.

ICON Acquires Veeda Labs

Kristin Brooks — Thu, 09 Jul 2009 08:40:00 -0500

ICON has acquired Veeda Laboratories Ltd., a provider of biomarker laboratory services to pharmaceutical and biotechnology companies. The acquisition adds to ICON's bioanalytical and immunoassay capabilities provided at its lab in Manchester, UK, and through Prevalere Life Sciences in the U.S.

“Biomarkers of disease are assuming an ever increasing role in the discovery and development of drugs,” commented Thomas Frey, president, ICON Development Solutions. “In Veeda Laboratories, we have acquired a company that has a very strong reputation for biomarker development and has well-established relationships with top-tier pharmaceutical and biotechnology companies. Veeda’s team of scientists will also greatly enhance ICON’s existing team of biomarker experts.”

“We are excited to be joining ICON,” commented John Allinson, head of Veeda Laboratories, Oxford. “This deal will enable us to enhance and expand our biomarker, pharmacokinetic and immunogenicity services and to offer our clients a broader suite of drug development services. We look forward to working closely with ICON’s global network of laboratories to develop innovative biomarker solutions that improve clients’ drug development and therapeutic decision making.”

Merck, Portola Enter Betrixaban Development Pact

Kristin Brooks — Thu, 09 Jul 2009 08:37:00 -0500

Merck and Portola Pharmaceuticals, Inc. have signed an exclusive global collaboration and license agreement for the development and commercialization of betrixaban, an investigational oral Factor Xa inhibitor anticoagulant currently in Phase II development for the prevention of stroke in patients with atrial fibrillation (SPAF).

Portola will receive an initial payment of $50 million and is eligible to receive additional payments totaling as much as $420 million based on development, regulatory and commercialization milestones, as well as royalties on sales of betrixaban. Merck will assume all development and commercialization costs. Portola has retained an option to co-fund Phase III trials in return for additional royalties and co-promotion of the drug in the U.S.

"Betrixaban represents an important addition to our late-stage portfolio with the potential to be a significant medicine in the Factor Xa inhibitor class," said Luciano Rossetti M.D., senior vice president and franchise head, Atherosclerosis and Cardiovascular, Merck Research Laboratories. "This agreement reinforces Merck's focus on developing an innovative portfolio of products for the treatment and management of multiple aspects of cardiovascular disease."

Charles Homcy, M.D., president and chief executive officer of Portola, commented, “This is the second major collaboration we have announced this year validating the high quality of our drug candidates and the expertise of our R&D team. This represents a significant milestone for the company and we now have over $175 million in cash to further advance the rest of our valuable proprietary pipeline.”

AstraZeneca to Advance NNR Therapeutics

Kristin Brooks — Wed, 08 Jul 2009 08:51:00 -0500

AstraZeneca plans to further develop AZD3480 (TC-1734) for attention deficit/hyperactivity disorder (ADHD) and will make a $10 million milestone payment to Targacept. AZ will also continue development of AZD1446 (TC-6683) in Alzheimer’s disease. The drug is currently in Phase I and was discovered through the parties’ ongoing research collaboration.

Targacept is also eligible to receive a milestone payment for AZD3480 if ADHD is the only target indication for which AZD3480 is developed further. Targacept remains eligible to receive more than $100 million if development, regulatory and commercial sale milestones are achieved for AZD3480 in ADHD, as well as royalties on any future sales of AZD3480 in any indication. Targacept may also receive future success based milestones for AZD1446 and royalties on any future sales.

“We continue to be enthusiastic about neuronal nicotinic receptors as a promising new mechanism in the treatment of multiple cognitive disorders,” said Bob Holland, vice president and head of the Neuroscience Therapy Area, AstraZeneca. “We believe the therapeutic profile of AZD3480, a non-stimulant, may be an important advance for treating patients with ADHD and we also remain positive about the potential of NNR agonists to treat Alzheimer’s disease.”

“We appreciate the efforts and dedication of our colleagues at AstraZeneca as we work together to develop and deliver the promise of NNR Therapeutics to patients affected by cognitive disorders like ADHD and Alzheimer’s disease,” said J. Donald deBethizy, Ph.D., president and chief executive officer of Targacept. “In addition to AZD3480 and AZD1446, we remain enthusiastic about the breadth and pharmacological diversity of our portfolio. With our pipeline, strong alliances and a cash runway that we expect to fund our operations for at least the next two years, we are well positioned to execute our business plan.”

Absorption Systems Acquires Perry Scientific

Kristin Brooks — Wed, 08 Jul 2009 08:49:00 -0500

Absorption Systems has acquired Perry Scientific, Inc., an in vivo toxicology and pharmacokinetics testing company located in San Diego, CA. Perry’s research services include testing for toxicology, medical devices, preclinical models and CNS pharmacology.

In addition to routine preclinical pharmacokinetics testing, Absorption Systems will now conduct GLP studies in the San Diego testing facility, which is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International.

“The acquisition of Perry Scientific furthers our mission to efficiently move clients from the early stages of drug discovery testing for ADME and pharmacokinetics through the definitive safety and toxicology testing necessary for new drug and device submissions,” commented Patrick M. Dentinger, president and chief executive officer of Absorption Systems. “By offering a full range of tests, we will be able to design and perform studies that will get clients to the point of submission to the FDA as quickly as possible.”

“Joining forces with Absorption Systems is a natural step in our growth because our respective businesses are entirely complementary,” said Andrew Perry M.D., Ph.D., founder of Perry Scientific. Now we can offer our customers the convenience and accuracy of having an entire preclinical testing package performed at a single facility—the combined company offers all the services needed to move a new drug from the benchtop to the clinic.”

Biogen's MS Drug Gets Fast Track Designation

Kristin Brooks — Wed, 08 Jul 2009 08:46:00 -0500

Biogen Idec's PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) was granted Fast Track designation by the FDA. Biogen plans to enroll more than 1,200 patients in a Phase III, randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of the drug in patients with RMS.

The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and have the potential to address unmet medical needs.

“Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis,” said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology at Biogen Idec. “We look forward to working closely with the FDA to expedite the compound’s development and review process.”

Norwich, Emerson Form Strategic Alliance

Kristin Brooks — Tue, 07 Jul 2009 11:34:00 -0500

Norwich Pharmaceuticals, Inc. has formed a strategic alliance with Emerson Resources, Inc. focused on bringing together the capabilities of the two companies in order to provide a broader range of services to the industry.

Norwich recently completed an expansion of its capabilities and services focused on full product lifecycle support, with a concentration in the area of new product development. Chris Calhoun, president of Norwich Pharmaceuticals, commented, “This alliance builds on our long-standing relationship with Emerson, and on our new full-service capabilities at Norwich, offering a clear path to commercialization for the clients of both our companies.”

Adolfo Gomez, president of Emerson Resources, said, “Our two companies were formed at about the same time, we’ve grown together, and we’ve been working together for years. Being relatively close to one another, we have been able to quickly access and share each other’s resources. By leveraging our collective experience and combined production capacity, both companies can bring faster, more flexible full-service capabilities to our customers, without the burdens of added bureaucracy that often hamper our competitors.”

Emerson will provide early stage development and clinical trial material manufacturing, as well as analytical services, and support of formulation development, method qualification for pilot clinical trials and analytical method transfer. Phase III and commercial batches will be manufactured exclusively at the Norwich facility, with full regulatory support for compiling INDs/NDA’s/ANDA’s and marketing applications for selected projects.

A joint governance team will oversee the alliance and will be responsible for overall performance management and individual project teams executing separate initiatives. Joint projects will be managed through a single point of contact.

Galapagos Achieves GSK Milestone

Kristin Brooks — Tue, 07 Jul 2009 10:10:00 -0500

Galapagos NV has successfully identified a second preclinical candidate compound in its osteoarthritis alliance with GlaxoSmithKline (GSK) and reached a milestone on another compound, triggering payments to Galapagos totaling $7.3 million.

This small molecule candidate meets all of the chemical and biological criteria set by GSK and is now ready for scale up chemistry and safety studies. Phase I trials are expected to begin in 2010.

“Six months after announcing our first pre-clinical candidate in this alliance, we are pleased to announce the delivery of a second candidate drug,” said Onno van de Stolpe, chief executive officer of Galapagos. “This achievement illustrates that Galapagos is successfully progressing multiple programs across each alliance, thereby increasing the likelihood of producing novel, disease-modifying therapeutics.”

The two companies entered the alliance  in June 2006 to discover and develop disease-modifying medicines for GSK’s global R&D organization. To date, Galapagos has earned approximately $42 million in payments from GSK under this alliance.

Novo Nordisk Diabetes Drug Approved in EU

Gil Roth — Mon, 06 Jul 2009 07:09:00 -0500

The European Commission has granted marketing authorization for Novo Nordisk's Victoza for the treatment of type 2 diabetes in adults. The authorization covers all 27 European Union member states.

Victoza is the brand name approved in Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. The authorization covers:

combination treatment with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, and
combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

"This is an important milestone for Novo Nordisk and for the treatment of type 2 diabetes," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "In clinical studies involving more than 6,500 people with type 2 diabetes, Victoza has been shown to have a significant blood glucose-lowering effect and lead to weight loss, while having a low risk of hypoglycaemia. On this background, we are convinced that Victoza is a valuable new treatment option for people with type 2 diabetes."

Novo Nordisk will launch Victoza in the UK, Germany and Denmark during the summer and in other European markets during the second half of 2009 and throughout 2010.

Novartis, MorphoSys Extend Pact

Gil Roth — Mon, 06 Jul 2009 06:12:00 -0500

Novartis has committed to a 10-year term of the strategic alliance with MorphoSys. The companies began their alliance in December 2007. The decision to extend to the full term of the agreement was based on the successful achievement by MorphoSys of certain predefined improvements in its proprietary technologies, according to a MorphoSys statement. The collaboration will now run until 2017 and may be extended by Novartis for an additional two years beyond that time under the same financial terms and conditions. The option for Novartis to terminate the alliance after seven years has been removed.

"Our alliance with Novartis is developing well and we are therefore delighted to be able to exploit its full potential", commented Dr. Simon Moroney, chief executive officer of MorphoSys. "The latest technological advances in our core antibody platform contributed significantly to achieving this extension."

In December 2007, MorphoSys and Novartis forged a comprehensive strategic alliance in the discovery and development of biopharmaceuticals. Financial terms include committed payments in excess of $600 million over the 10-year lifetime of the agreement. Within the collaboration, two antibody programs are currently in clinical development.

J&J Buys Into Elan's Alzheimer's Program

Kristin Brooks — Thu, 02 Jul 2009 08:43:00 -0500

Johnson & Johnson and Elan Corp. entered a definitive agreement under which J&J will acquire all of the assets and rights to Elan's Alzheimer's Immunotherapy Program (AIP), through a newly formed company. J&J, through its affiliate, will invest $1 billion in Elan in exchange for newly issued American Depositary Receipts (ADRs) of Elan, which represents 18% of the company's outstanding shares.

The AIP Program is the result of Elan's collaboration with Wyeth to research, develop and commercialize selective products for the treatment and/or prevention of neurodegenerative conditions, including Alzheimer's disease.

Elan will receive a 49.9% equity interest in the newly formed J&J company and will be entitled to a 49.9% share of the profits and certain royalty payments upon the commercialization of products under the collaboration with Wyeth.

J&J will assume and continue Elan's activities with Wyeth under the AIP Program and will initially commit as much as $500 million for the development and commercialization of bapineuzumab, currently in Phase III trials evaluating slowing the progression of Alzheimer's disease, as well as other compounds. The agreement provides for additional funding as needed.

"Alzheimer's disease is a significant unmet need in aging populations globally," said Sheri McCoy, J&J’s worldwide chairman, Pharmaceuticals. "Johnson & Johnson's development capabilities, commercial experience and global reach will provide the foundation to accelerate the AIP Program development, and increase its potential availability for patients globally."

Elan chief executive officer Kelly Martin contends that this transaction positively impacts Elan and patients globally, remarking, "This transaction will leverage Elan's unique scientific and clinical work and leadership in bringing treatments to market that potentially slow the progression of Alzheimer's disease. The Elan commitment to scientific innovation and patients remains absolute and we will continue to build upon and expand our leadership in the fields of neuroscience and immunology."

Pfizer's Chantix Label Gets Black Box Warning

Kristin Brooks — Thu, 02 Jul 2009 08:42:00 -0500

The FDA has mandated that Pfizer update the U.S. product labeling for Chantix, a smoking cessation treatment, with safety information in a black box warning as well as revised warnings and precautions.

The updated label, based on post-marketing reports, highlights safety information about reports of neuropsychiatric events and updates the warning about reports of neuropsychiatric symptoms and suicidality. It also adds warnings about reports of allergic reactions and serious skin reactions, and updates precautionary information about driving or operating machinery to include details about reports of accidental injury.

“The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely,” said Dr. Briggs W. Morrison, senior vice president, Primary Care Development Group at Pfizer. “Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex.”

GlaxoSmithKline’s smoking cessation drug, Zyban, will also put a black box warning on its label.

Sanofi-Aventis' Multaq Approved by FDA

Gil Roth — Thu, 02 Jul 2009 04:45:00 -0500

The FDA has approved Sanofi-Aventis's Multaq (dronedarone) 400 mg tablets. Multaq, an anti-arrhythmic, is the first drug approved in the U.S. to show a clinical benefit to reduce cardiovascular hospitalization in patients with atrial fibrillation (AF) or atrial flutter (AFL), according to SA. The FDA's approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients.

“The FDA approval of Multaq is an important milestone in the management of atrial fibrillation or atrial flutter that demonstrates the commitment of Sanofi-Aventis to provide patients and physicians with important new medicines in therapeutic areas with significant healthcare needs,” said Christopher A. Viehbacher, chief executive officer of SA. “Sanofi-Aventis is proud of its ability to bring innovative therapies to market and contribute to reducing the public health burden of atrial fibrillation.”

To ensure the use of Multaq in the appropriate patient population, Sanofi-Aventis U.S. LLC has launched mPACT — Multaq Partnership for Appropriate Care and Treatment — the Risk Evaluation and Mitigation Strategy (REMS) developed by sanofi-aventis U.S. LLC. The mPACT Partnership was developed to assist healthcare professionals (HCPs) with the identification of appropriate patients and to ensure the safe use of Multaq while minimizing risk. The risk mitigation program consists of a Communication Plan for HCPs, a medication guide for patients and post-marketing surveillance.

“We are pleased that the FDA has granted approval of Multaq for patients in a therapeutic area that has seen few new treatment options in the last 20 years,” said Marc Cluzel, M.D., SA's senior vice president, R&D.

The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern and affects about 2.5 million people in the U.S. and 4.5 million people in the EU. Atrial fibrillation is a potentially life-threatening condition, with significant burden on patients, health care providers and payers.

Multaq® is under regulatory review by the European Medicines Agency (EMEA).

Pfizer’s Sutent Fails Colorectal Cancer Trial

Kristin Brooks — Wed, 01 Jul 2009 09:54:00 -0500

Pfizer is discontinuing the SUN 1122 Phase III trial evaluating Sutent plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer (CRC). An independent Data Monitoring Committee found that the addition of Sutent to the chemotherapy regimen would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to FOLFIRI alone. No new safety issues were identified.

“We are disappointed with this result, but trial successes and failures are an integral part of cancer drug development and contribute to a growing body of knowledge on improving patient care,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “Pfizer remains committed to developing new agents for colorectal and other GI cancers with ongoing clinical studies evaluating other agents in its pipeline. Investigators will be consulted about the status of sunitinib colorectal studies other than the SUN 1122 trial. Pfizer also continues to study sunitinib in late-stage trials as a potential treatment for various other types of cancer.”

Sutent is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma (RCC).

Maxygen, Astellas Form Protein JV

Kristin Brooks — Wed, 01 Jul 2009 09:53:00 -0500

Astellas Pharma and Maxygen will establish a joint venture focused on the discovery, research and development of multiple protein pharmaceutical programs, including Maxygen’s MAXY-4 program and other early stage programs. As part of the arrangement, Astellas will have an option to acquire all of Maxygen’s ownership interest in the joint venture within three years of the joint venture. The arrangement expands the two companies existing MAXY-4 collaboration in autoimmune diseases and transplant rejection.

Maxygen will contribute all of its programs and technology assets in protein pharmaceuticals, as well as $10 million in cash for the new JV. Maxygen's ownership interest will be approximately 83%. Astellas will also invest $10 million and will have a 17% ownership interest. Should Astellas acquire Maxygen’s ownership interest at specified exercise prices, the increase each quarter will go from $53 million to $123 million during the three-year term of the option. Grant Yonehiro, Maxygen’s chief business officer, is expected to serve as chief executive officer of the venture.

Under a separate collaboration agreement, Astellas will fund all of the costs, as much as $30 million over the three-year option term, for the discovery, research and development of multiple protein therapeutics (other than MAXY-4) by the JV. Astellas will be granted an option to obtain a license to one product developed by the venture under this collaboration, if Astellas does not exercise its buy-out option during the option term. Development costs for the MAXY-4 program will be shared by the JV under the terms of the existing MAXY-4 collaboration agreement.

In the event Astellas does not exercise its buy-out option, all rights to the protein therapeutics developed through the JV will be retained by the JV, and Astellas will provide as much as 18 months of transition funding to it.