Development and commercialisation of andexanet alfa in Japan fully supported by Daiichi Sankyo


Portola Pharmaceuticals has announced that it has entered into a clinical collaboration agreement with Daiichi Sankyo to develop andexanet alfa as an antidote for edoxaban, Daiichi Sankyo’s Factor Xa inhibitor, in Japan.

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 for life-threatening or uncontrolled bleeding or emergency surgery and urgent procedures.

Under the terms of the agreement with Daiichi Sankyo, Portola will receive an upfront payment and is eligible to receive an additional milestone payment based on Japanese Ministry of Health, Labor and Welfare (MHLW) approval of andexanet alfa as an antidote for edoxaban. Daiichi Sankyo will provide technical support and fund all clinical studies of andexanet alfa with edoxaban in Japan. Daiichi Sankyo will receive no commercial or financial rights under this agreement.

This agreement follows recent agreements with Bristol-Myers Squibb, Pfizer and Bayer Healthcare to develop and commercialise andexanet alfa in Japan. Under those agreements, Bristol-Myers Squibb and Pfizer will be responsible for development, regulatory and commercial activities for andexanet alfa in Japan. Bayer will fund development of andexanet alfa as an antidote for rivaroxaban in Japan. Under this new agreement with Daiichi Sankyo, edoxaban will also be included in the andexanet alfa clinical development programme in Japan.

Portola previously entered into eight separate non-exclusive clinical collaboration agreements with Daiichi Sankyo, Bristol-Myers Squibb, Pfizer, Bayer and Janssen to support Phase 2 and Phase 3 studies of andexanet alfa and edoxaban in the United States, Europe and Japan. Portola may receive additional payments under these agreements. Portola retains all rights, including full commercial and financial rights, for andexanet alfa outside of Japan.