Updated on 2 February 2016
California-based Portola Pharmaceuticals has announced today that it has licensed lead development and commercial rights to its investigational agent andexanet alfa in Japan to Bristol-Myers Squibb Company and Pfizer Inc. to be developed as an antidote for apixaban and other Factor Xa inhibitors.
Separately, Portola has entered into a clinical collaboration agreement with Bayer HealthCare to include its Factor Xa inhibitor rivaroxaban in this clinical development program in Japan.
Three oral Factor Xa inhibitors are currently on the market in Japan - Bristol-Myers Squibb and Pfizer's apixaban, Bayer HealthCare's rivaroxaban, and Daiichi Sankyo's edoxaban - but an antidote is not yet approved. A universal antidote for Factor Xa inhibitors is needed for certain patients in Japan, as the clinical use of these novel oral anticoagulants is growing.
Portola is developing andexanet alfa, a US Food and Drug Administration (FDA)-designated breakthrough therapy, for patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as in life-threatening or uncontrolled bleeding or for emergency surgery/urgent procedures. Portola retains full, worldwide commercial rights to andexanet alfa outside of Japan.
Under the terms of the agreement with Bristol-Myers Squibb and Pfizer, Portola will receive an upfront payment of $15 million and is eligible to receive potential regulatory and sales-based milestone payments totaling $90 million, as well as double-digit royalties based on andexanet alfa net sales in Japan. Bristol-Myers Squibb and Pfizer will be responsible for all development and regulatory activities for andexanet alfa in Japan and for commercializing the drug in Japan, assuming it receives regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW).