AGC Biologics Cleared for Commercial Manufacture of Portola's FDA-Approved Andexxa®
May 24, 2018
AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today that it will supply bulk drug substance for the launch of Portola Pharmaceuticals' Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Andexxa® received both U.S. Orphan Drug and FDA Breakthrough Therapy designations, and was recently approved under the FDA's Accelerated Approval pathway based on the change from baseline in anti-Factor Xa activity in healthy volunteers. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients.
AGC Biologics is presently manufacturing bulk drug substance for Portola's planned launch of Andexxa®.
"We are extremely pleased to have had the opportunity to help Portola provide this unique antidote for rivaroxaban- and apixaban-treated patients with life threatening or uncontrolled bleeding," said Gustavo Mahler, Ph.D., President & Chief Executive Officer of AGC Biologics. "Our facilities in the United States, Denmark and Japan enable us to provide unique and robust manufacturing solutions to bring products to market globally. As with Portola, our commitment to deliver marketed products is prioritized across our entire organization."
About AGC Biologics
AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), with a strong commitment to deliver the highest standard of service to our clients and partners. AGC Biologics is the product of the convergence and integration of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH, and CMC Biologics. The company currently employs more than 850 employees worldwide. Our extensive network spans three continents, with cGMP-compliant facilities in Seattle, WA; Berkeley, CA; Copenhagen, Denmark; Heidelberg, Germany; Yokohama, Japan; and Chiba, Japan.
AGC Biologics offers deep industry expertise and unique customized services for the scale-up and cGMP manufacture of protein-based therapeutics; from pre-clinical to commercial production, for mammalian and microbial. Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage, and protein expression — including our proprietary CHEF1® Expression System for mammalian production. Further information can be found at www.agcbio.com.