Inspiration Biopharmaceuticals Treats First Patient in Pivotal Study of OBI-1 for Acquired Hemophilia A

LAGUNA NIGUEL, Calif., Nov. 19, 2010 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced the Company has initiated treatment of patients in a pivotal clinical study of OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, for the treatment of acquired hemophilia A, a rare, though potentially life-threatening bleeding disorder.  Based on a partnership agreement signed with Ipsen SA (Euronext: IPN; ADR: IPSEY) in January 2010, Inspiration has received a $50 million milestone payment by Ipsen.  In return, Inspiration has issued to Ipsen a note, which may be converted to Series C preferred stock, bringing Ipsen's fully diluted share ownership position in Inspiration to 34%.

Under the terms of the agreement, Inspiration in-licensed OBI-1 from Ipsen, and is responsible for the clinical development, regulatory approval and commercialization of the product.  Inspiration is developing OBI-1 for the treatment of individuals with acquired hemophilia A and individuals with congenital hemophilia A who have developed inhibitors against human FVIII.

Dr. Anne Greist, at the Indiana Hemophilia and Thrombosis Center, in Indianapolis, Indiana, stated, "Acquired hemophilia is a condition in which patients develop antibodies against their own coagulation factors.  Affecting men and women equally, acquired hemophilia can lead to a life-threatening crisis for patients.  Unfortunately, current therapies are often inadequate to stop these types of acute bleeding episodes, and new innovative therapeutic approaches are needed.  We are pleased to have been the first site in the U.S. to enroll a patient in the pivotal study of OBI-1, a promising and important new product candidate in the treatment of acquired hemophilia."

Michael Griffith, Ph.D., President and CEO of Inspiration, commented, "We are excited to report the initiation of our pivotal clinical trial of OBI-1, one of two product candidates in advanced, clinical stage development at Inspiration.  This is the first development milestone payment we have received from Ipsen, under the terms of our partnership agreement announced earlier this year.  This milestone payment will provide critical funding to advance Inspiration's OBI-1 development program."

The pivotal study is a prospective, non-randomized, open-label study evaluating the efficacy of OBI-1 for the treatment of serious bleeding episodes in individuals with acquired hemophilia with autoimmune inhibitory antibodies to human FVIII.  Serious bleeding episodes include those that are a threat to a patient's life or vital organs, or which require a blood transfusion.  In addition, the study will obtain data about the pharmacokinetic behavior of OBI-1.

For more information on the OBI-1 pivotal study for the treatment of individuals with acquired hemophilia A, please visit http://clinicaltrials.gov/ct2/show/NCT01178294.

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 the congenital form 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 older adults, 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, muscles and soft tissues, as opposed to bleeding into joints, which is more typical in congenital hemophilia.

About OBI-1

Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to human FVIII (hFVIII) and can no longer respond to treatment with the coagulation factor.  Current therapies, specifically human factor VIIa (NovoSeven®) and FEIBA, work by bypassing the natural hemostatic pathway and forcing coagulation with much higher levels of FVIIa than normal.  In contrast, OBI-1, a recombinant form of porcine FVIII that typically possesses low cross reactivity to anti-hFVIII antibodies, is a replacement therapy, activating the natural hemostatic pathway.  This should allow clinicians to correlate activity and efficacy with a biomarker, and therefore guide dosing to better predict treatment outcomes.  OBI-1 presents a unique and alternative approach to address the needs of individuals who have developed inhibitors to hFVIII and is highly desired by the medical community.

OBI-1 has been evaluated in a Phase 2 study in patients with congenital hemophilia A who have developed inhibitors to hFVIII, and who presented with a non-life/non-limb threatening bleed.  The Phase 2 study demonstrated OBI-1 was well-tolerated and can be given over a short infusion time.  In addition to the recently initiated pivotal trial of OBI-1 in individuals with acquired hemophilia A, Inspiration is planning a separate pivotal trial in individuals with congenital hemophilia A who have developed inhibitors against hFVIII.

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.  Both products are in 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 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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