CMC Biologics Enters into Commercial Supply Agreement with Portola Pharmaceuticals for Manufacturing of First-In-Class Factor Xa Inhibitor Antidote Andexanet Alfa
SEATTLE, July 2, 2014 /PRNewswire/ -- CMC Biologics, Inc. , a global leader in process development and contract manufacturing, today 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 ANNEXATM (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.
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."
About CMC Biologics CMC Biologics is leading the industry among CMO's in reliability, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com .
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