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Bristol-Myers Squibb and Pfizer Sign Collaboration with Portola Pharmaceuticals to Develop and Commercialize Investigational Andexanet Alfa in Japan
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Under the terms of the agreement, Portola will receive an upfront payment of $15 million, potential regulatory milestones of $20 million and sales-based milestones of $70 million as well as compensation based on andexanet alfa net sales. Bristol-Myers Squibb and Pfizer will co-fund with Portola the development and commercialization of andexanet alfa in Japan. Portola will retain rights to andexanet alfa outside of Japan and remain responsible for the manufacturing supply.This agreement builds on the companies’ existing clinical collaboration to develop andexanet alfa in the U.S. and Europe. In December 2015, Portola announced it had completed the submission of a Biologics License Application to the U.S. Food and Drug Administration (FDA) for andexanet alfa and was awaiting acceptance for filing. The FDA assigned a PDUFA date of August 17, 2016, under an Accelerated Approval pathway. Portola has stated that it plans to submit an EU application in 2017.
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Strategic Initiative Date
Announcement Date: Feb 02, 2016 Projected Implementation: Q1, 2016 Relevance Tracked Until: Q4, 2016
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Related Keywords Collaboration, Andexanet Alfa, Apixaban, Eliquis, Factor Xa Inhibitor, Anticoaulant Activity