CAMBRIDGE, Mass., April 17, 2012 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of IB1001, an intravenous recombinant factor IX (rFIX) protein for the treatment and prevention of bleeding in individuals with hemophilia B.
Based on the terms of its agreement with Ipsen (Euronext: IPN; ADR: IPSEY), Inspiration will receive a $35 million milestone payment associated with its filing of the BLA. In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen's fully diluted equity ownership position in Inspiration to approximately 43.5%.
Approval of IB1001 would represent a significant advance for the hemophilia community, including the estimated 75% of people living with hemophilia worldwide who do not have adequate access to currently available treatments. IB1001 would be the first recombinant therapy for people with hemophilia B introduced in more than 15 years.
Regulatory review is now pending in both the U.S. and Europe. Inspiration's Marketing Authorization Application for IB1001 was accepted by the European Medicines Agency in September 2011. The company is currently finalizing plans for additional regulatory filings and preparing for the commercial launch of IB1001.
"The introduction of recombinant factor IX was an important step forward in the treatment of hemophilia B, but a single product is not sufficient to meet the needs of all people affected by this disease," said John P. Butler, Inspiration's Chief Executive Officer. "At Inspiration, we are solely focused on the needs of people with hemophilia, and we are proud of the progress we have made towards bringing forward a new choice of treatment for patients. We plan to work closely with regulatory authorities both here in the U.S. and around the world to make IB1001 available as broadly and rapidly as
|SOURCE Inspiration Biopharmaceuticals, Inc.|
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