Portola Pharmaceuticals, a South San Francisco, California-based biopharmaceutical company focused on the field of thrombosis and other hematologic diseases, has signed a $150-million royalty agreement with HealthCare Royalty Partners (HCR), a private investment firm, for Portola’s blood coagulant drug, AndexXa (andexanet alfa).

Under the agreement, Portola received $50 million and may receive an additional $100 million upon approval by the US Food and Drug Administration (FDA) for AndexXa in exchange for a tiered, mid-single-digit royalty based on worldwide sales of the agent. The agreement is subject to a maximum total royalty payment of 195% of the $150 million funded by HCR, at which time the agreement would expire.

Portola will use the proceeds for continued clinical and regulatory activities and for planned development and commercialization of andexanet alfa, which has been designated a breakthrough therapy by the FDA. Andexanet alfa is in development for reversing the anticoagulant effects of Factor Xa inhibitors.

Portola received a Complete Response Letter from the FDA regarding its biologics license application for andexanet alfa in August 2016 and expects to resubmit the application in the first half of 2017. In the European Union, the European Medicines Agency is reviewing the marketing authorization application for andexanet alfa.

Source: Portola Pharmaceuticals