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Inspiration Biopharmaceuticals Announces Filing of Biologics License Application (BLA) for IB1001, a Recombinant Factor IX Product for People with Hemophilia B
Date:4/16/2012

possible."

The IB1001 BLA filing includes a comprehensive set of pharmacokinetics safety, and efficacy data from a Phase 3 clinical trial in people affected by hemophilia B.  A surgery substudy was also included.

John Taylor, Co-Founder and Chairman of Inspiration, stated, "With sons affected by hemophilia B, Inspiration co-founder Scott Martin and I are acutely aware of the impact of limited treatment options on families. We believe more choice can help us achieve our mission to broaden access to care—increasing the supply of products, driving healthy competition, and supporting prophylaxis, which is rapidly becoming the standard of care in hemophilia. We believe that the approval of IB1001 will be the first step in our journey to make broader access to care a reality for thousands of individuals with hemophilia."

About IB1001IB1001 is an intravenous rFIX product being developed for the treatment and prevention of bleeding in individuals with hemophilia B.  IB1001 has completed pivotal Phase 3 clinical studies that support the filling of the BLA, conducted at study sites in the U.S., Europe and India.

To date, IB1001 has been well tolerated by patients and pharmacokinetic (PK) analyses have demonstrated non-inferiority to the one approved rFIX product currently marketed for the treatment of hemophilia B.  Confirmatory PK studies reported at the 53rd Annual Meeting of the American Society of Hematology showed no evidence of development of inhibitors during treatment periods ranging from 4 to 18 months.

Results recently presented at the 5th Annual Congress of the European Association for Haemophilia and Allied Disorders demonstrated that IB1001 provided effective surgical hemostasis in study participants with hemophilia B undergoing major surgical procedures.

About Inspiration BiopharmaceuticalsInspiration Biopharmaceuticals is exclusively dedicated to developing treatments for hemophilia, with a
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SOURCE Inspiration Biopharmaceuticals, Inc.
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