BMS, Pfizer and Portola team up to bring andexanet alfa to Japan

Bristol-Myers Squibb and Pfizer have entered into a collaboration agreement with Portola to develop and commercialise andexanet alfa in Japan.

Andexanet alfa, which is in Phase 3 clinical development in the U.S. and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis (apixaban).

Commenting on the collaboration, Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb, said: “Bristol-Myers Squibb 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.”

Rory O’Connor, M.D., senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer, added: “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. With our partner, Bristol-Myers Squibb, we look forward to working with Portola to develop andexanet alfa as a reversal agent for Eliquis in Japan.”

Portola plans to submit an EU application for andexanet alfa in 2017

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. Bristol-Myers Squibb and Pfizer will co-fund with Portola the development and commercialisation of andexanet alfa in Japan. Portola will retain rights to andexanet alfa outside of Japan and remain responsible for the manufacturing supply.

William Lis, chief executive officer of Portola, said of the collaboration: “These agreements allow Portola to expand the development and commercialization of andexanet alfa into Japan, which is a new country for us and the third largest market for Factor Xa inhibitors after the United States and EU 5 countries. Bristol-Myers Squibb, Pfizer and Bayer all have extensive infrastructure and experience in Japan. With Bristol-Myers Squibb and Pfizer leading development and commercialization activities and Bayer providing support, the path forward for andexanet alfa as a Factor Xa inhibitor antidote in Japan will be accelerated.”

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