Inspiration Biopharmaceuticals Awarded Two Grants Under the Qualifying Therapeutic Discovery Projects Grant Program (QTDP)

LAGUNA NIGUEL, Calif., Nov. 5, 2010 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced the Company was awarded two grants, totaling $488,958, under the Qualifying Therapeutic Discovery Projects Grant Program (QTDP).  The grants are being provided under section 48D of the Internal Revenue Code, enacted as part of the Patient Protection and Affordable Care Act of 2010.  The grants will be used to advance the clinical development of Inspiration's lead product candidates, IB1001 and OBI-1.  Inspiration is developing IB1001, an intravenous human recombinant factor IX product, for the acute and preventative treatment of bleeding in individuals with hemophilia B.  OBI-1 is Inspiration's intravenous recombinant porcine factor VIII product for the treatment of individuals who have developed inhibitors against human factor VIII and for individuals with acquired hemophilia A.  Inspiration in-licensed OBI-1 from Ipsen SA earlier this year.

Michael Griffith, Ph.D., President and CEO of Inspiration, commented, "We are very pleased to receive these federal grants.  The QTDP grant will further enable Inspiration to continue the development of IB1001 and OBI-1, and address the significant unmet needs of individuals with hemophilia."

Under the QTDP program, tax credits or grants were made available to companies with 250 or less employees to encourage therapeutic discovery projects that showed a reasonable potential to result in new therapies to treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions; reduce the long-term growth of health care costs in the United States; or significantly advance the goal of curing cancer within 30 years.  For additional information on the QTDP program, please visit http://grants.nih.gov/grants/funding/QTDP_PIM.

About Hemophilia and Acquired Hemophilia

Hemophilia is a bleeding disorder caused by low levels or absence of a protein called a coagulation factor, essential for blood clotting.  The two most common forms of hemophilia are types A and B.  Hemophilia A is caused by a factor VIII deficiency and occurs in ~1 out of every 5,000 male births.  Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of every 30,000 male births.  Approximately 60% of persons with hemophilia have a severe condition, which results in frequent spontaneous bleeding episodes, in addition to serious bleeding after injuries. The annual market for hemophilia treatments is $7.5 billion worldwide.

Acquired hemophilia is a rare though potentially life-threatening bleeding disorder caused by the development of autoantibodies (inhibitors) against coagulation factors.  Unlike congenital hemophilia, acquired hemophilia is typically a disorder of middle age and occurs equally in both males and females.  Also, the pattern of bleeding seen in acquired hemophilia is different from that observed in the more common congenital form.  In acquired hemophilia, individuals typically bleed into the skin and soft tissues, as opposed to bleeding into joints, which is more typical in congenital hemophilia.

About Inspiration Biopharmaceuticals

Inspiration 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 late-stage products in clinical development and two pre-clinical programs.

Inspiration's lead product candidates are IB1001, an intravenous recombinant factor IX (FIX) for the acute and preventative treatment of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) for the treatment of individuals who have developed inhibitors against human FVIII and for individuals with acquired hemophilia A.  IB1001 is currently in Phase 3 clinical development, and OBI-1 is expected to begin the first of two pivotal trials later this year.  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 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 senior leadership was directly responsible for the development and commercialization of the majority of hemophilia products currently on the market.  In addition, in January 2010, Inspiration entered into a strategic partnership with Ipsen SA, leveraging the combined expertise and resources of the two companies.  For further information on Inspiration, please visit http://www.inspirationbio.com.

SOURCE Inspiration Biopharmaceuticals, Inc.

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