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

Thu, 11/18/2010 - 10:35pm
Bio-Medicine.Org

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 candi

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