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CMC Biologics Enters into Commercial Supply Agreement with Portola Pharmaceuticals for Manufacturing of First-In-Class Factor Xa Inhibitor Antidote...

July 16, 2014



CMC Biologics Enters into Commercial Supply Agreement with Portola Pharmaceuticals for Manufacturing of First-In-Class Factor Xa Inhibitor Antidote Andexanet Alfa

By a News Reporter-Staff News Editor at Biotech Week -- CMC Biologics, Inc., a global leader in process development and contract manufacturing, announced that it has entered in to a Commercial Supply Agreement with Portola Pharmaceuticals, a biopharmaceutical company for the development of andexanet alfa, a potential first-in class Factor Xa inhibitor antidote in Phase 3 ANNEXA™ (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors) studies. Andexanet alfa 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 (see also CMC Biologics).

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Under this agreement, 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 United States.

"Portola's decision to extend its partnership with CMC Biologics to produce material through commercial launch of its FDA-designated breakthrough therapy is a true testament to the successful and long-standing relationship between our two companies," said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics. "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. We look forward to working with Portola to bring this valuable new class of drug into the market."

"We have been working with CMC Biologics to manufacture clinical supply of andexanet alfa, and we have been impressed by the quality of their infrastructure and demonstrated expertise in manufacturing complex proteins and coagulation factors. Extending our collaboration with CMC as a contract manufacturing partner through commercial launch will help us meet our accelerated development timelines for andexanet alfa, with the goal of going from IND to BLA in under four years," said John T. Curnutte, M.D., Ph.D., executive vice president of research and development for Portola Pharmaceuticals. "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."

Keywords for this news article include: CMC Biologics.

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Source: Biotech Week


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