Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestones. BMS and Pfizer will continue to provide development and regulatory guidance for the program. Portola retains full, worldwide commercial rights to andexanet alfa, which was designated as a breakthrough therapy by the FDA in November 2013.
"We are pleased to continue our collaboration with Bristol-Myers Squibb and Pfizer, which has been instrumental in accelerating andexanet alfa's development as a potential agent to reverse the anticoagulation effect of Eliquis," said William Lis, chief executive officer of Portola. "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."