CMC Biologics, Portola Pharma partner to develop andexanet alfa

Currently, andexanet alfa is in Phase III ANNEXA (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors) studies.

The antidote is designed to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are experiencing a major bleeding episode or who require emergency surgery.

As part of the deal, Portola will expand its manufacturing commitment at CMC Biologics to include commercial supply for a Biologics License Applications (BLA) filing, which is expected at the end of 2015, and initial product launch in the US.

CMC Biologics global chief operations officer Gustavo Mahler said Portola’s decision to extend its partnership with the company to produce material through commercial launch of its FDA-designated breakthrough therapy is a true testament to the successful and long-standing relationship between its two companies.

"We deliver on our promises to our customers, and are committed to providing solutions to help Portola advance andexanet alfa toward a BLA filing and commercialization," Mahler said.

"We look forward to working with Portola to bring this valuable new class of drug into the market."

Portola Pharmaceuticals executive vice president of research and development John Curnutte said extending the collaboration with CMC as a contract manufacturing partner through commercial launch will help the company meet its accelerated development timelines for andexanet alfa, with the goal of going from IND to BLA in under four years.

"We are developing this FDA-designated breakthrough therapy under an Accelerated Approval Pathway to address the urgent unmet need for an antidote for the millions of patients who are being treated with Factor Xa inhibitors," Curnutte said.