Date: 2011-09-21
Type of information: Production agreement
Compound: IB1001 (intravenous recombinant factor IX (rFIX) product)
Company: CMC Biologics (Denmark-USA) Inspiration Biopharmaceuticals (USA)
Therapeutic area: Hematological diseases - Genetic diseases - Rare diseases
Type agreement: manufacturing
production
Action mechanism:
Disease: treatment and prevention of bleeding in individuals with hemophilia B
Details: CMC Biologics and Inspiration Biopharmaceuticals have entered into a long-term commercial supply agreement for the manufacture of bulk IB1001, Inspiration's intravenous recombinant factor IX (rFIX) product, for the treatment and prevention of bleeding in individuals with haemophilia B. Under the terms of the agreement, CMC Biologics will be the exclusive manufacturer of bulk IB1001 for at least six years. CMC Biologics expects commercial supply manufacturing to begin this fall. Other terms of the agreement were not disclosed.
IB1001, Inspiration's lead product candidate is close to completing the Phase 3 portion of clinical testing in Europe, the United States, Israel, and India. Pending the outcome from these clinical studies and subsequent regulatory approvals, IB1001 is expected to be the second recombinant FIX product to come to the market for haemophilia B, providing additional product supply and eliminating reliance by the haemophilia community on a single-source supplier of recombinant product. Last Month, Inspiration Biopharmaceuticals has entered into a strategic partnership agreement with Ipsen, to create a European hemophilia commercial organization, to launch Inspiration’s hemophilia product portfolio in Europe, including IB1001.
Financial terms: Financial terms of the agreement were not disclosed.
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