Catalyst Biosciences Completes Manufacturing Agreements for its Novel Factor VIIa Product, Marzeptacog alpha (activated)

Catalyst Biosciences has secured all rights to the manufacturing process for marzeptacog alfa (activated) (formerly known as CB 813d) from Wyeth LLC, a wholly-owned subsidiary of Pfizer. Marzeptacog alfa (activated) is a next-generation Factor VIIa product that was designed to allow for the effective, long-term, subcutaneous prophylaxis in hemophilia patients with inhibitors. Catalyst has successfully completed an intravenous Phase 1 clinical trial of marzeptacog alfa (activated) in patients with severe hemophilia A and B with and without inhibitors and has demonstrated the feasibility of subcutaneous dosing in preclinical models.

In addition, the Company announced that it has signed a drug product fill-finish manufacturing services agreement with Symbiosis Pharmaceutical Services Limited for marzeptacog alfa (activated) for clinical trial applications. This agreement, and the previously announced drug substance manufacturing agreement with CMC Biologics, provides Catalyst Biosciences with complete manufacturing capabilities to enable cGMP manufacturing of marzeptacog alfa (activated).

“We are delighted to have successfully concluded our agreement with Wyeth LLC that gives us full rights to use Wyeth’s commercial scale manufacturing processes, materials, know-how and intellectual property for marzeptacog alfa (activated).  With the Wyeth, CMC Biologics and Symbiosis Pharmaceutical Services agreements in place we are now prepared to initiate an efficacy study in 2017 and have a commercial scale manufacturing process in place,” said Nassim Usman, Ph.D., President and Chief Executive Officer of Catalyst.

Catalyst is focused on the prevention of spontaneous bleeding in hemophilia through the development of clotting factors that may be injected subcutaneously, including marzeptacog alfa (activated). The Company is also developing CB 2679d/ISU304, a next-generation coagulation Factor IX variant that Catalyst, with its collaboration partner, ISU Abxis, plan to initiate a Phase 1/2 proof-of-concept study in individuals with hemophilia B in the first quarter of 2017.