By Estel Grace Masangkay
Process development and contract manufacturing firm CMC Biologics announced that it has signed into a Commercial Supply Agreement with biopharmaceutical firm Portola Pharmaceuticals for the development of andexanet alfa.
Andexanet alfa is a potential first-in-class Factor Xa inhibitor antidote. The drug is designed to reverse the anticoagulation effect experienced by Factor Xa inhibitor-treated patients who are require emergency surgery or are suffering from a major bleeding episode. Andexanet alfa is currently being investigated in the Phase 3 ANNEXATM (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors) study.
Under the agreement, Portola will extend its manufacturing relationship with CMC Biologics in order to aid its Biologics License Applications (BLA) filing set for next year and initial product launch in the U.S. following approval.
Gustavo Mahler, Global COO of CMC Biologics, said, “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.” Mahler said that the company anticipates advancing andexanet alfa toward regulatory filing and eventually commercialization.
John T. Curnutte, EVP of research and development for Portola Pharmaceuticals, said, “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. 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.”
Last month CMC announced that it has entered a process validation and clinical manufacturing agreement with MacroGenics for the commercialization of an undisclosed next-generation oncology product candidate.