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CMC Biologics Enters Commercial Supply Agreement with Inspiration Biopharmaceuticals for IB1001
Date:9/20/2011

SEATTLE, COPENHAGEN, Denmark and LAGUNA NIGUEL, Calif., Sept. 20, 2011 /PRNewswire/ -- CMC Biologics and Inspiration Biopharmaceuticals ("Inspiration") today announced that the two companies 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 hemophilia 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.

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"We are extremely excited to be the commercial manufacturer of IB1001 – an important new therapy option for people with hemophilia B," stated Gustavo F. Mahler, Ph.D., Global Chief Operations Officer at CMC Biologics. "This contract represents a key milestone in our commercial manufacturing strategy."

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 hemophilia B, providing additional product supply and eliminating reliance by the hemophilia community on a single-source supplier of recombinant product.

"We have worked with CMC Biologics on the process development and manufacture of clinical product supply of bulk IB1001 over the past five years, and we have great confidence in their development and manufacturing capabi
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SOURCE CMC Biologics
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