Portola Pharmaceuticals Gives The Green Light On Second Clinical Collaboration Agreement With Pfizer And Bristol-Myers Squibb

Portola Pharmaceuticals has announced its second clinical collaboration with Bristol-Myers Squibb Co., and Pfizer Inc. to further study Portola’s andexanet alfa (PRT4445) with Eliquis (apixaban). Andexanet alfa, Portola’s investigational Factor Xa reversal agent, has shown immediate reversal of anti-Factor Xa activity induced by Eliquis, an oral Factor Xa inhibitor. The collaboration originally covered Phase II proof-of-concept of the study and will continue Phase III stage with Eliquis, including possible U.S. and/or EU regulatory approval of andexanet alfa.

Portola CEO William Lis says his company is pleased to continue its alliance with Pfizer and Bristol-Myers Squibb.  He says the collaboration has been instrumental in further development of andexanet alfa regarding its role as a potential agent in reversing Eliquis’ anticoagulation effect. "The FDA's recent designation of andexanet alfa as a breakthrough therapy recognizes the medical need for this antidote as well as its attributes, which distinguish it from general procoagulant approaches. Andexanet alfa is the only agent that has been shown to reverse the anticoagulation effect of Factor Xa inhibitors in humans," Lis shares in Portola’s press release.

Bristol-Myers Squibb recently announced that Eliquis received a Supplemental New Drug Application (sNDA) from FDA last year for potential deep vein thrombosis (DVT) and pulmonary embolism (PE) treatment, as well as reduction of recurrence risk. An estimated 900,000 patients are diagnosed with DVT and PE every year in the US alone. Nearly one million are diagnosed with venous thromboembolism (VTE) every year in the EU. Eliquis prevents thrombin generation and the formation of blood clots by inhibiting a key blood clotting protein, Factor Xa. Andexanet alfa, a first-in-class recombinant and modified molecule, acts as a Factor Xa decoy to target both direct and indirect Factor Xa inhibitors present in the blood.

Pfizer began collaboration with Bristol-Myers Squibb in 2007 to develop and commercialize Eliquis. With the non-exclusive collaboration agreement with Portola, Pfizer retains the right to provide regulatory and development guidance for the andexanet alfa-Eliquis study. Portola is currently pursuing an Accelerated Approval pathway for andexanet alfa with the FDA.

Phase III studies of andexanet alfa with Eliquis are set to begin in the first half of the year.