Daiichi Sankyo has expanded its existing clinical collaboration agreement with Portola Pharmaceuticals, a South San Francisco-based biopharmaceutical company, to develop AndexXa (andexanet alfa) as an antidote for edoxaban, Daiichi Sankyo’s US Food and Drug Administration (FDA)-approved factor Xa inhibitor used to reduce the risk of stroke and systemic embolism. AndexXa is currently under European Medicines Agency (EMA) review for reversal of factor Xa inhibition in patients experiencing a life-threatening or uncontrolled bleed and for patients requiring urgent or emergency surgery. As part of the updated agreement, Portola will expand an ongoing study of AndexXA in bleeding patients in Germany.

Under the terms of the updated agreement, Portola will receive a $15 million upfront payment and is eligible to receive up to an additional $10 million upon meeting site initiation and enrollment targets. Upon AndexXa’s approval, Daiichi Sankyo will be eligible to receive a low single-digit royalty on AndexXa sales up to a total of $8 million.

Portola previously entered into nine separate non-exclusive clinical collaboration agreements with Daiichi Sankyo, Bristol-Myers Squibb, Pfizer, Bayer, and Janssen to support Phase II and registrational studies of AndexXa in the United States, Europe, and Japan. Portola retains all rights, including full commercial and financial rights, for AndexXa outside of Japan.

AndexXa is a modified human factor Xa molecule that acts as a decoy to target and sequester both oral and injectable factor Xa inhibitors in the blood, according to the company. The EMA completed the validation period of Portola’s marketing authorization application in August 2016, and a decision is expected in 2017.

Source: Portola Pharmaceuticals