U.S. drugmakers Bristol-Myers Squibb (BMS) and Pfizer have announced a worldwide collaboration to develop and commercialize apixaban, an anticoagulant discovered by BMS.
In a separate agreement, the companies will also collaborate on a Pfizer discovery program that includes advanced preclinical compounds with potential applications for the treatment of metabolic disorders, including obesity and diabetes.
Phase III trials are currently under way investigating the potential use of apixaban, a direct factor Xa inhibitor, for the prevention of venous thromboembolism (VTE), which includes deep-vein thrombosis (DVT) and pulmonary embolism, and the prevention of stroke in patients with atrial fibrillation. 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 percent of all planned development costs, and BMS will fund 40 percent. BMS may receive additional payments of up to $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 equally. The companies plan to file for U.S. approval of apixaban for prevention of VTE in the second half of 2009.
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.