BMS, Pfizer Sign Pacts on Apixaban, Metabolic Program

Bristol-Myers Squibb and Pfizer have announced a worldwide collaboration to develop and commercialize apixaban, an anticoagulant discovered by BMS being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. In a separate agreement, the companies will also collaborate on the R&D and commercialization of a Pfizer discovery program that includes advanced preclinical compounds with “potential applications for the treatment of metabolic disorders, including obesity and diabetes,” according to a Pfizer statement.

Apixaban is currently in Phase III trials investigating its potential in the prevention of venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of stroke in patients with atrial fibrillation (AF). Phase II trials are studying apixaban in the treatment of acute symptomatic DVT and for the secondary prevention of cardiovascular events in patients with acute coronary syndrome.

Terms of the apixaban agreement include an upfront payment of $250 million by Pfizer to BMS. Pfizer will fund 60% of all planned development costs effective January 1, 2007, and BMS will fund the remainder. BMS may also receive additional payments of as much as $750 million based on development and regulatory milestones. The companies will jointly develop the clinical and marketing strategy of apixaban, and will share commercialization expenses and profits/losses equally on a global basis.

In the other program, Pfizer will be responsible for all research and early-stage development activities for the metabolic disorders program, and the companies will jointly conduct Phase III development and commercialization activities. BMS will make an upfront payment of $50 million to Pfizer as part of this agreement. The companies will share all development and commercialization expenses along with profits/losses on a 60%-40% basis, with Pfizer assuming the larger share of both expenses and profit/losses.

“By combining our company’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field, we can maximize the potential benefits of apixaban for patients. In addition, the metabolic disorders program complements existing research efforts in another area of significant unmet medical need where BMS is quite active,” said Jim Cornelius, interim chief executive officer, BMS. “This collaboration supports our strategy to focus on serious diseases, maintain commercial emphasis on specialists and high-prescribing primary care physicians, and work with partners to offset the risks inherent with developing certain medicines.”

“We’re very pleased to collaborate with Bristol-Myers Squibb on the worldwide commercialization of apixaban, which has the potential to be a best-in-class product and would represent an excellent strategic fit with our global cardiovascular franchise,” said Jeffrey B. Kindler, chairman and chief executive officer, Pfizer. “We see significant opportunities for an orally active anticoagulant with the clinical profile apixaban has demonstrated to date, particularly because of the clear need for new treatments to combat thrombosis and stroke. This agreement demonstrates our commitment to pursue revenue opportunities both through our business development and external alliances as well as our internal research and development pipeline.”