Date: 2016-12-19
Type of information: Production agreement
Compound: marzeptacog alfa activated (CB 813d)
Company: Catalyst Biosciences (USA - CA) Pfizer (USA - NY)
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Type agreement: manufacturing - bioproduction
Action mechanism: coagulation factor/protein. 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.
Disease: hemophilia A with inhibitors, hemophilia B with inhibitors
Details:
- • On December 19, 2016, Catalyst Biosciences announced it has secured all rights to the manufacturing process for marzeptacog alfa (activated) (formerly known as CB 813d) from Wyeth, a wholly-owned subsidiary of Pfizer.
- 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 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).
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Is general: Yes
