Portola Pharmaceuticals today announced that it has entered into a second clinical collaboration agreement with Daiichi Sankyo to study Andexanet alfa, Portola's investigational Factor Xa inhibitor antidote, in Phase 3 registration studies with Daiichi Sankyo's Factor Xa inhibitor, edoxaban. (Portola's original collaboration agreement with Daiichi Sankyo, announced in June 2013, covered the conduct of a Phase 2 proof-of-concept study, for which results are anticipated later this year.) The Phase 3 edoxaban studies…are expected to start in 2015.
Under this non-exclusive collaboration agreement, Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestone payments. Portola retains full, worldwide commercial rights to andexanet alfa, for which Portola is pursuing an Accelerated Approval pathway [#msg-99095723].
This deal with Daiichi Sanyo is similar to the non-exclusive clinical collaborations PTLA has with PFE/BMY for Eliquis reversal (#msg-99095723) and with Bayer/JNJ for Xarelto reversal (#msg-97376571).
Inasmuch as the dollar amounts payable to PTLA pursuant to the Edoxaban deal have not been disclosed (as was the case with PTLA’s deals for Eliquis and Xarelto), it’s reasonable to presume that they are minimal.
Despite the regulatory and commercial uncertainty, PTLA has made a hefty commitment to a third party for Andexanet alfa supply (#msg-103956503).