BMS and Pfizer sign collaboration with Portola Pharmaceuticals to develop and commercialize investigational andexanet alfa in Japan

Andexanet alfa is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis (apixaban).

“We are committed to reducing the risk of stroke in nonvalvular atrial fibrillation patients and treating deep vein thrombosis and pulmonary embolism,” said Douglas Manion, head of Specialty Development, BMS. “BMS and Pfizer’s agreement with Portola is an important step forward toward the goal of delivering the first reversal agent for Factor Xa inhibitors, including Eliquis, to patients in Japan. The ability to reverse the anticoagulation effect of Eliquis and other Factor Xa inhibitors may be helpful for some patients who experience a major bleeding event or require emergency surgery while on Eliquis or another Factor Xa inhibitor.”

“This agreement in Japan is another great example of the alliance’s commitment to the patients we serve. Eliquis has proven to be an important treatment option for patients at risk for stroke and blood clots due to nonvalvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism, but currently there is no approved reversal agent,” said Rory O’Connor, senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc. “With our partner, BMS, we look forward to working with Portola to develop andexanet alfa as a reversal agent for Eliquis in Japan.”

Under the terms of the agreement, Portola will receive an upfront payment of $15 million, potential regulatory milestones of $20 million and sales-based milestones of $70 million as well as compensation based on andexanet alfa net sales. BMS and Pfizer will co-fund with Portola the development and commercialization of andexanet alfa in Japan. Portola will retain rights to andexanet alfa outside of Japan and remain responsible for the manufacturing supply.

This agreement builds on the companies’ existing clinical collaboration to develop andexanet alfa in the US and Europe. In December 2015, Portola announced it had completed the submission of a Biologics License Application to the FDA for andexanet alfa and was awaiting acceptance for filing. The FDA assigned a PDUFA date of 17 August 2016, under an Accelerated Approval pathway. Portola has stated that it plans to submit an EU application in 2017.