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news.Portola Pharmaceutical, Bristol-Myers Squibb Company and Pfizer have signed a clinical collaboration agreement to study a universal Factor Xa inhibitor antidote, PRT4445, and Eliquis (apixaban).
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Bristol-Myers and Pfizer will make an undisclosed payment to Portola for testing the reverse effect of PRT4445 on anticoagulant Factor Xa inhibitor drugs including Eliquis and will provide required development and regulatory guidance.
There are no approved drugs, as of now, with the ability to reverse the activity of Factor Xa inhibitors.
Portola chief executive officer William Lis said oral Factor Xa inhibitors address an important unmet need for patients requiring anticoagulant therapy, but as with all anticoagulants, there is a need for an antidote to help manage the concerns physicians have around infrequent but serious bleeding events.
"This clinical collaboration brings together world-class expertise in the field of thrombosis from Bristol-Myers Squibb, Pfizer and Portola with the goal of accelerating the development of PRT4445 as an antidote to ELIQUIS, while allowing Portola to retain all rights to develop and commercialize the compound in the future," Lis added.
Clinical proof-of-concept study, designed to evaluate the safety and ability of PRT4445, is expected to commence by the end of 2012.
The deal between the companies is effective only during the study. Portola preserves all global development and commercialization rights for PRT4445.
Bristol-Myers global development and medical affairs senior vice president Brian Daniels said, "With our partner Pfizer, we look forward to working with Portola to advance the scientific understanding of the role of PRT4445 as a potential antidote for ELIQUIS."