Portola Pharma assigns AndexXa royalties to HealthCare Royalty Partners

Under the terms of the agreement, Portola received $50m at closing and may receive an additional $100m upon US Food and Drug Administration (FDA) approval of AndexXa (andexanet alfa) 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 $150m funded by HCR, at which time the agreement would expire.

Portola CEO Bill Lis said: “We are looking forward to partnering with HCR on this financing, which will provide us with capital to fund our operations in a non-dilutive manner and successfully launch this potentially life-saving agent for the benefit of tens of thousands of patients.

HCR chief medical officer and managing director Dr. Warren Cooper said: “We are very pleased to partner with Portola to help fund the development and commercialization of andexanet alfa.

“Once approved, it will be the first antidote available for the increasing number of patients admitted to the hospital with a major bleeding episode who currently have no options to reverse the effect of anticoagulation.”

HCR Investment Committee managing partner and chairman Clarke Futch said: “This transaction provides capital to Portola to further the development and commercialization of andexanet alfa, which we believe will have a significant impact on the lives of affected patients.”

Portola will use the proceeds for continued clinical and regulatory activities and for planned development and commercialization of andexanet alfa, an FDA-designated Breakthrough Therapy. Andexanet alfa is in development as a potential antidote for 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 EU, the European Medicines Agency is reviewing the Marketing Authorization Application for andexanet alfa.