Portola signs $120 million-worth licensing deals with Japanese pharma majors

02 February 2016 | News | By BioSpectrum Bureau

Portola signs $120 million-worth licensing deals with Japanese pharma majors

California-based Portola Pharmaceuticals has announced today that it has licensed lead development and commercial rights to its investigational agent in Japan to Bristol-Myers Squibb Company and Inc. to be developed as an antidote for and other Factor Xa inhibitors.

Separately, Portola has entered into a clinical collaboration agreement with HealthCare to include its Factor Xa inhibitor 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 '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 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).

With the Bayer Clinical Collaboration agreement, Portola will receive an upfront payment of $5 million and is eligible to receive an additional milestone payment based on Japanese MHLW approval of andexanet alfa as an antidote for rivaroxaban. Bayer will provide technical support as well as fund clinical studies of andexanet alfa with rivaroxaban in Japan. Bayer will receive no commercial rights under this agreement.

Portola previously entered into two separate non-exclusive clinical collaboration agreements with Bayer HealthCare and its development partner, Janssen Pharmaceuticals to support phase 2 and phase 3 studies of andexanet alfa and rivaroxaban in the United States and Europe. Portola may receive additional milestone payments under these agreements based on developments in the United States and EU.