Catalyst Biosciences has secured all rights to the manufacturing process for marzeptacog alfa (activated) (formerly known as CB 813d) from Wyeth LLC, a subsidiary of Pfizer. Marzeptacog alfa (activated) is a next-gen Factor VIIa designed to allow effective, long-term, subcutaneous prophylaxis in hemophilia patients with inhibitors. Catalyst has completed a Phase I trial of marzeptacog alfa (activated) in severe hemophilia A and B demonstrating the feasibility of subcutaneous dosing in preclinical models.
 
Catalyst has also signed a drug product fill-finish manufacturing services agreement with Symbiosis Pharmaceutical Services for marzeptacog alfa (activated) for clinical trial applications. This agreement, and the previously announced drug substance manufacturing agreement with CMC Biologics, provides Catalyst with complete manufacturing capabilities to enable cGMP manufacture 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.