USA-based Portola Pharmaceuticals (Nasdaq: PTLA) has entered into a second clinical collaboration agreement with Japanese drug major Daiichi Sankyo (TYO: 4568) to study andexanet alfa, Portola's investigational Factor Xa inhibitor antidote, in Phase III registration studies with Daiichi Sankyo's Factor Xa inhibitor edoxaban (proposed trade name Savaysa).
Portola's original collaboration agreement with Daiichi Sankyo, announced in June 2013, covered the conduct of a Phase II proof-of-concept study, for which results are anticipated later this year. The Phase III edoxaban studies, known as ANNEXA- E (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors - Edoxaban), are expected to start in 2015.
Under this non-exclusive collaboration agreement, Portola will get an upfront payment and is eligible to receive additional development and regulatory milestones. Portola retains full, worldwide commercial rights to andexanet alfa, for which Portola is pursuing an Accelerated Approval pathway.
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