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).

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