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."

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.

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 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).

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.

Charles River Laboratories has made changes within its Research Models and Services (RMS) and Preclinical Services (PCS) and Sales organizations. Real H. Renaud, corporate executive vice president and president, Global RMS, announced he will retire by the end of 2010. As part of the transition of Mr. Renaud’s responsibilities, Davide Molho, D.V.M. has been promoted to corporate senior vice president, North American and European RMS.

James C. Foster, chairman, president and chief executive officer, said, “Real Renaud has had a stellar career at Charles River, beginning 45 years ago and rising through the ranks to head our global RMS business. Under his leadership, we have become the premier provider of research models and scientific support services to the drug development industry, recognized worldwide for our quality, biosecurity and scientific expertise. Real has developed a world-class management team, including his successor, Davide Molho, which positions us extremely well to maintain our market leadership.”

Dr. Molho joined Charles River Italy in 1999, and was promoted to director of operations for RMS Italy in 2002. In 2005, his role was expanded to include all French RMS operations and in 2007, he became corporate vice president, European RMS.

Through the restructure of the PCS business, the company created a dual-accountability structure with both global functional teams and site-level management, in an effort to increase harmonization and integration of all services across the PCS organization.

Under the new global operations structure, Brian Bathgate, Ph.D., corporate senior vice president, will assume responsibility for Global Laboratory Sciences in addition to his current responsibility for Global Biopharmaceutical Services. Dr. Bathgate will maintain oversight of PCS, Europe. Christopher J. Perkin, D.A.B.T., corporate senior vice president, will oversee site operations in North America and China. He will have responsibility for harmonizing technical operations and site infrastructure. Stephen K. Durham, D.V.M., Ph.D., D.A.C.V.P., corporate vice president, will assume responsibility for global toxicology and pathology. Dr. Durham will set global standards for and ensure effective delivery of these services across all PCS sites. Joseph C. Siglin, Ph.D., D.A.B.T., divisional vice president, will continue to focus on implementation of the company’s Lean Six Sigma program and other global process improvement initiatives.

Charles River is also realigning its sales organization, switching from a sales approach focused on its portfolio of products and services, to one focused on value-based solutions by customer segment. The company is establishing a three-part sales organization for global biopharmaceutical companies, small and mid-size pharmaceutical and biotechnology companies, and the academic and government sector.

Dr. Christophe Berthoux, corporate executive vice president, Global Sales and Marketing, and chief commercial officer, said, “This is the next step in the evolution of our Sales organization from locally to globally focused. Consistent with the PCS restructuring, we believe the realigned sales force will more effectively address our clients’ needs, and be able to access resources throughout the organization to support each client’s specific requirements.”

Wyeth and Catalyst Biosciences, Inc. have formed an exclusive worldwide collaboration for the discovery, development and commercialization of Factor VIIa products to treat hemophilia and other bleeding conditions. Total payments under the collaboration could exceed $500 million and include an upfront payment of $21 million, research funding and milestone payments.

Wyeth will fund the discovery, research and preclinical development by Catalyst of Factor VIIa products, including Catalyst's CB 813 for the treatment and prophylaxis of acute bleeding in patients with hemophilia. The term of the research agreement is two years, which Wyeth may extend for as many as three additional years. Wyeth will be responsible for the development, manufacturing and worldwide commercialization of products resulting from the collaboration. Wyeth will also have the right of first negotiation for any additional clotting factors discovered by Catalyst.

Catalyst may earn as much as $40 million during the next two years, including the upfront payment, research funding and preclinical and clinical milestone payments. Catalyst will be eligible to receive development and commercialization milestones, plus royalties on sales of products resulting from the collaboration.

"This collaboration serves as an excellent fit with our recombinant Factor VIII and Factor IX hemophilia products and provides us with an opportunity to expand Wyeth's hemophilia franchise," said Mikael Dolsten, president, Wyeth Research. "We have been impressed by the caliber of Catalyst's therapeutic protein engineering skills used in the Factor VIIa program and the lead candidate CB 813. We look forward to a highly productive collaboration."

"We are thrilled to join forces with Wyeth, a biopharmaceutical company at the forefront of both hemophilia treatment and the development and commercialization of biologic therapies," said Nassim Usman, Ph.D., chief executive officer of Catalyst Biosciences. "This collaboration highlights the value Catalyst has created in our Factor VIIa portfolio of products. Revenues generated from research collaborations such as this one allow us to continually expand and support existing discovery efforts around bleeding disorder product candidates and the engineering of new Alterase therapeutic products."

Sanofi-Aventis is restructuring its R&D operation and plans to close eight of its 27 R&D sites. The new R&D model, which is expected to be in place by 2013, aims to group researchers in more productive structures, working more closely with academics and hospitals to help drive innovation. The company will focus on diabetes, cancer and age-related diseases as well as anti-inflammatory and anti-infectious diseases, according to Christian Lajoux, head of Sanofi-Aventis France.

Under the reorganization, four sites in France and sites in Britain, Japan, Spain and the U.S. will close. According to the company, there will be no layoffs at this time but a plan for voluntary departures is being considered. The company employs 13,000 people in R&D and administrative positions.

“The objective of this new R&D model is to propose innovative solutions that respond to specific, unmet needs of patients and continue our success in a very competitive international environment,” said Christopher A. Viehbacher, chief executive officer of Sanofi-Aventis. “It is centered on the real needs of patients, the development of scientific networks and openness toward outside entities to strengthen creativity, and a flexible and entrepreneurial approach to research.”

Covance, Inc. is expanding its analytical and stability services facility in Madison, WI, doubling capacity for large-scale, long-term stability and release programs for preclinical, clinical, and chemistry, manufacturing, and control (CMC) development of pharmaceutical and animal health products.

The expanded facility includes upgraded stability chambers equipped with high-density tracked shelving to help increase pharmaceutical analysis service capacity and utilization, and will have as many as ten walk-in chambers and several reach-in chambers. The facility will also provide space for further expansion.

"Covance is committed to providing world-class CMC analytical services for our clients to provide the highest quality data and reduce developments timelines," said Henry Hummel, vice president and general manager, Madison sites, Covance. "Together with our integrated discovery, preclinical, and clinical service offerings and dedicated program management team, we can now offer CMC analytical services as part of an entire molecule development program."

Pharmaceutical Development Services Ltd. (PDS) has opened an office in South Carolina to support expansion efforts in the U.S. Dr. Jeff Rudolph will guide U.S. pharmaceutical companies with drug development in Europe, covering regulation, quality management, European legal framework and the sourcing of local contractors.

Dr. Michael Gamlen, managing director of PDS, said, "Having established expert knowledge in European pharmaceutical development, we have built up a bank of expertise in our team that can considerably shorten the timescales and reduce the costs for American companies of introducing pharmaceutical products into Europe. Our business from U.S. companies has steadily increased and by opening a U.S. office with Dr. Rudolph as our main contact point, we are ensuring that we can effectively manage our expansion in the U.S."

Dr. Rudolph is an experienced pharmaceutical scientist with more than 30 years of experience with domestic and international development and management of branded, generic and OTC products. He held senior pharmaceutical development positions at McNeil Laboratories (J&J) and spent 23 years at AstraZeneca and its predecessor companies, where his responsibilities included vice president, international pharmaceutical development/R&D operations. Dr. Rudolph most recently provided consulting services to the healthcare industry in the areas of CMC, process optimization, production troubleshooting, device design, organizational and business development as well as serving as an expert witness on formulation/drug delivery patent cases.

MorphoSys AG will receive a milestone payment from Centocor Ortho Biotech, Inc. for the initiation of a Phase I trial using a HuCAL-derived, fully human antibody in the therapeutic area of inflammation.

"The advancement of a new HuCAL antibody into human clinical trials is an important step forward for MorphoSys," commented Dr. Simon Moroney, chief executive officer of MorphoSys. "Progress in the development of innovative biopharmaceutical agents by our partners is a key driver of our company's growth."

This is the second HuCAL antibody program derived from the companies' collaboration to enter clinical trials. With the new study, Centocor Ortho Biotech will be running three clinical trials of HuCAL antibodies.

Mylan Inc. and Biocon Ltd. have entered a definitive agreement to collaborate on the development, manufacture, supply and commercialization of multiple, generic biologic compounds.

Mylan's chairman and chief executive officer Robert J. Coury commented, "This unique collaboration combines Biocon's scientific expertise, excellent product development track record, appreciation of complex regulatory requirements, and state-of-the-art, cost-efficient and scalable biologics manufacturing with Mylan's one-of-a-kind global commercial footprint and our regulatory expertise around the world. Biocon also has a unique corporate culture that is very similar to Mylan's. All of these attributes will provide a critical synergy and create a strong and effective long-term partnership."

Biocon chairman and managing director Dr. Kiran Mazumdar-Shaw commented, "Biocon is extremely pleased to have found a partner as strong as Mylan to accelerate our work in generic biologics, especially with monoclonal antibodies, and take it to the next level around the world, especially in regulated markets. Monoclonal antibodies are emerging as the most dominant class in biologics. Through this partnership we hope to deliver high quality, affordable biogeneric antibodies and biologics, thereby addressing a critical need to lower spiraling healthcare costs in both the developed and emerging economies."

The two companies will share development, capital and certain other costs. Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand and in the EU through a profit sharing arrangement with Biocon. Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world. Financial terms and product details were not disclosed.

Icon Central Laboratories has moved its Singapore central laboratory to a new, larger facility located at Loyang Way, Eastern Singapore. The new laboratory meets the growth in demand for Icon's services in Singapore, which has increased by 149% over the past six months. The larger facility also enables the company to expand its test menu offerings in the region to include increased esoteric testing as well as flow cytometry, molecular diagnostics and biomarkers, to complement the services of Icon's other wholly-owned central laboratories in Europe, India and the U.S.

"As ICON celebrates its 10th year of operation in Singapore, our move to a larger laboratory signals our continued commitment to the region," commented Bob Scott-Edwards, president, Icon Central Laboratories. "Singapore has become a regional hub for drug development in Asia-Pacific and we now have the capacity, the range of testing services and, above all, a highly experienced team of lab professionals to support the growth of clinical trials in the region."

Icon Central Laboratories Singapore supports all major therapeutic areas, including cardiovascular, oncology, endocrinology and metabolism, and virology. The laboratory serves as a regional hub for test samples from Australia, New Zealand, South Korea, Malaysia, Singapore, Taiwan, Japan, Thailand, Hong Kong, China and Indonesia. The unit received CAP (College of American Pathologists) accreditation in March 2009.

Teva Pharmaceutical Industries and Active Biotech have completed patient enrollment for the second pivotal Phase III clinical trial, BRAVO, evaluating the novel, oral once-daily immunomodulating compound, laquinimod, for the treatment of relapsing-remitting multiple sclerosis (RRMS). BRAVO is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex.

“Teva and Active Biotech are encouraged by the potential of laquinimod to address patients' unmet need for an oral immunomodulating MS therapy that provides efficacy while maintaining safety,” said Moshe Manor, Teva’s group vice president, Global Branded Products. “We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for RRMS patients.”

The companies recruited more than 1,200 patients at 156 sites in the U.S., Europe, Israel and South Africa for this trial. The first global Phase III trial of laquinimod completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites. The trial is currently ongoing. In February 2009, laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Pfizer released results from a Phase III trial of Sutent in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors, which is a different type of cancer than the more common pancreatic adenocarcinoma. Study findings demonstrated that median progression-free survival (PFS) was 11.1 months in patients treated with Sutent compared to 5.5 months in patients treated with placebo. Researcherspresented the data at the 11th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The independent Data Monitoring Committee (DMC) recommended halting the trial earlier this year because Sutent showed significant benefit and the study had met its primary endpoint. Full analysis of the data is ongoing.

“In this study, Sutent demonstrated an impressive improvement in progression-free survival for patients with pancreatic islet cell tumors,” said Dr. Eric Raymond, M.D., Ph.D., professor of Medical Oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France, and lead investigator on this study. “This is encouraging news for patients, especially given that there are limited treatment options for this type of advanced cancer.”

“The observation of substantial improvement in progression-free survival in Sutent-treated patients was the basis for the independent Data Monitoring Committee’s recommendation to halt accrual to the study early,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “This is welcome news, as there is currently no standard of care for patients with pancreatic islet cell tumors who progress on prior therapy.”