Andexanet alfa is Portola’s investigational Factor Xa inhibitor antidote and edoxaban is Daiichi Sankyo’s Factor Xa inhibitor.
The two firms have signed original collaboration agreement in June 2013 that covered a Phase II proof-of-concept study and its results are expected to be announced later in 2014.
The Phase III edoxaban studies called as ANNEXA- E (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors – Edoxaban) are expected to begin in 2015.
Under the deal, Portola will receive an upfront payment and is eligible to get additional development and regulatory milestone payments, while it also retains full, worldwide commercial rights to andexanet alfa, for which the company is pursuing an Accelerated Approval pathway.
Portola Pharmaceuticals chief executive officer William Lis said the company has now established Phase III clinical 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," Lis said.
"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."
Currently, Portola is evaluating andexanet alfa in Phase III trials with Bristol-Myers Squibb (BMS) and Pfizer’s Eliquis (apixaban), and Bayer HealthCare and Janssen’s Xarelto (rivaroxaban).