Bristol-Myers Squibb, Pfizer collaborate with Portola to develop 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, includingEliquis (apixaban).

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

"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 onEliquis or another Factor Xa inhibitor."

Pfizer senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business Rory O’Connor said: "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."

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 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 U.S. and Europe. In December 2015, Portola announced it had completed the submission of a Biologics License Application to the U.S. 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.

About Andexanet Alfa

Andexanet alfa, an investigational drug, is a modified human Factor Xa molecule that acts as a decoy to target and sequester with high specificity both oral and injectable Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus allowing for the restoration of normal hemostatic processes.

Andexanet alfa is the only compound being studied as a reversal agent for Factor Xa inhibitors that directly and specifically corrects anti-Factor Xa activity – the anticoagulant mechanism of these agents.

About Eliquis

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and thus blood clot formation. Eliquis is a prescription medicine approved for multiple indications in the United States, the European Union (which includes 28 member states plus Iceland and Norway) and Japan, as well as a number of other countries around the world based on efficacy and safety data, including results from seven Phase 3 clinical trials.

In Japan, Eliquis is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Eliquis is also approved in Japan for the treatment of venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE following initial therapy.