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Inspiration Biopharmaceuticals Announces Acceptance of European Marketing Authorization Application for IB1001 for the Treatment of Hemophilia B
Date:10/2/2011

's lead product candidate, is an intravenous recombinant FIX product being developed for the treatment and prevention of bleeding in individuals with hemophilia B.  IB1001 has completed the pivotal Phase 3 clinical testing for the European regulatory submission, while clinical testing for the U.S. regulatory submission is ongoing.  To date, IB1001 has been well-tolerated by patients and pharmacokinetic results have demonstrated non-inferiority to the one approved recombinant FIX product currently available for the treatment of hemophilia B.

About Inspiration BiopharmaceuticalsInspiration Biopharmaceuticals is dedicated exclusively to developing treatments for hemophilia, with a primary mission to broaden access to care, including prophylactic therapy, and to improve the treatment of individuals with inhibitor complications.  Inspiration has a broad portfolio of recombinant hemophilia products, which includes two products in late-stage clinical development and two pre-clinical programs.

Inspiration's lead product candidates are IB1001, an intravenous recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product for the treatment of individuals with congenital hemophilia A who have developed inhibitors against human FVIII and for individuals with acquired hemophilia.  Both products are in advanced clinical development.  Earlier-stage preclinical programs at Inspiration are focused on human recombinant factor VIIa (FVIIa), for individuals with either hemophilia A or hemophilia B who have developed inhibitors, and for individuals with factor VII deficiency; and human recombinant FVIII, to treat individuals with hemophilia A.

Inspiration has extensive expertise and experience in hemophilia product development, biologics manufacturing, regulatory approval and global commercialization. The Company's
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SOURCE Inspiration Biopharmaceuticals, Inc.
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