Bristol-Myers Squibb and Pfizer join with Portola on development of andexanet alfa

Bristol-Myers Squibb and Pfizer announced this week that the companies have agreed to a cooperative effort with Portola Pharmaceuticals to develop and commercialize andexanet alpha.

Andexanet alpha is an investigational agent produced in Japan that targets Factor Xa and is designed to reverse the anticoagulant actions of its inhibitors. It has reached Phase 3 clinical development in the United States and Europe.

“We are committed to reducing the risk of stroke in nonvalvular atrial fibrillation patients and treating deep vein thrombosis and pulmonary embolism,” Dr. Douglas Manion, head of specialty development, Bristol-Myers Squibb, said.

The terms of the agreement specify that Portola will be paid $15 million by Bristol-Myers Squibb and Pfizer up front and have the opportunity to receive regulatory milestones of $20 million and sales-based milestones of $70 million. Portola will also be compensated based on the net sales of andexanet alfa. The development and commercialization of the product in Japan will be co-funded by all three companies. The rights to andexanet alfa will remain with Portola, as well as the responsibility of manufacturing the product.

The agreement between the companies is an extension of their existing arrangement that has the goal of bringing andexanet alfa to the United States and Europe. The Biologics License Application was submitted to the FDA in December and is currently awaiting acceptance.