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Establishes Phase III agreements for Factor Xa inhibitors
July 8, 2014
By: Kristin Brooks
Managing Editor, Contract Pharma
Portola Pharmaceuticals has entered a second clinical collaboration with Daiichi Sankyo to study andexanet alfa, Portola’s investigational Factor Xa inhibitor in Phase III studies with Daiichi’s Factor Xa inhibitor edoxaban. Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestones. Portola retains full commercial rights to andexanet alfa. Financial details were not disclosed. The original alliance, dating back to June 2013, covered the conduct of a Phase II proof-of-concept study, for which results are expected later this year. “We have now established Phase III collaboration agreements with all of the manufacturers of Factor Xa inhibitors. This, combined with the FDA’s designation of andexanet alfa as a breakthrough therapy, underscores the significant need for an antidote for the millions of patients currently being treated with these novel anticoagulants,” said William Lis, chief executive officer. “We are pursuing an accelerated approval pathway for andexanet alfa in order to bring this novel therapy to market as quickly as possible for the benefit of patients.”
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