Catalyst picks up manufacturing rights to hemophilia drug
- Catalyst Biosciences has picked up all the manufacturing rights for marzeptacog alfa (activated), a Factor VIIa product for subcutaneous prophylaxis in hemophilia, from Pfizer's subsidiary, Wyeth.
- The small South San Francisco biotech has also inked a deal with Symbiosis Pharmaceutical Services for drug product fill-finish manufacturing for clinical trials of the agent; along with an earlier deal with CMC Biologics, Catalyst now has access to full cGMP manufacturing.
- Marzeptacog alfa (activated) has completed a Phase 1 study as an intravenous dose and preclinical studies as a subcutaneous dose; an efficacy study of the subcutaneous dose is planned for 2017.
"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)," said Nassim Usman, president and CEO of Catalyst.
"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," he added.
Catalyst and its partner ISU Abxis are is also working on CB 2679d/ISU304, which is a next-generation coagulation Factor IX variant. A Phase 1/2 proof-of-concept study is planned for 2017 in people with hemophilia B.
Earlier this year, Catalyst cut its staff by half, halting research into programs other than hemophilia and seeking purchasers for its discontinued programs.
Hemophilia, a rare but serious inherited or acquired bleeding disorder, affects around 20,0000 people in the U.S. and 400,000 worldwide. Catalyst Biosciences' focus is on hemostasis, and marzeptacog alfa (activated) is its lead product, in Phase 1 studies for both hemophilia A and B.
- Catalyst Biosciences Statement
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