Pfizer and Bristol-Myers Squibb announced that the companies have entered into a collaboration agreement
with Portola Pharmaceuticals Inc. to develop and
commercialize the investigational agent andexanet alfa in Japan.
Andexanet alfa, which is in Phase 3 clinical development in the U.S. and
Europe, is designed to reverse the anticoagulant activity of Factor Xa
inhibitors, includingEliquis (apixaban).
Under
the terms of the agreement, Portola will receive an upfront payment of
$15 million, potential regulatory milestones of $20 million and
sales-based milestones of $70 million as well as compensation based on
andexanet alfa net sales. Bristol-Myers Squibb and Pfizer will co-fund
with Portola the development and commercialization of andexanet alfa in
Japan. Portola will retain rights to andexanet alfa outside of Japan and
remain responsible for the manufacturing supply.
This
agreement builds on the companies’ existing clinical collaboration to
develop andexanet alfa in the U.S. and Europe. In December 2015, Portola
announced it had completed the submission of a Biologics License
Application to the U.S. Food and Drug Administration (FDA) for andexanet
alfa and was awaiting acceptance for filing. The FDA assigned a PDUFA
date of August 17, 2016, under an Accelerated Approval pathway. Portola
has stated that it plans to submit an EU application in 2017.
Andexanet alfa, an investigational drug, is a modified human Factor Xa
molecule that acts as a decoy to target and sequester with high
specificity both oral and injectable Factor Xa inhibitors in the blood.
Once bound, the Factor Xa inhibitors are unable to bind to and inhibit
native Factor Xa, thus allowing for the restoration of normal hemostatic
processes. Andexanet alfa is the only compound being studied as a
reversal agent for Factor Xa inhibitors that directly and specifically
corrects anti-Factor Xa activity – the anticoagulant mechanism of these
agents.
