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Inspiration Biopharmaceuticals Initiates Second Pivotal Clinical Study of Innovative Hemophilia Therapy OBI-1
Date:11/27/2011

LAGUNA NIGUEL, Calif., Nov. 28, 2011 /PRNewswire/ --  Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced the initiation of patient enrollment in the second of two pivotal studies in the Company's OBI-1 Accur8 clinical trial program.  In the newly initiated clinical study, OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, will be evaluated for the treatment of individuals with congenital hemophilia A who have developed inhibitory antibodies (inhibitors) against their human FVIII replacement therapy.  In achieving this milestone, Inspiration has received a $25 million milestone payment from the Ipsen Group (Euronext: IPN; ADR: IPSEY), under a partnership agreement signed with Ipsen in January 2010.  In return, Inspiration has issued Ipsen a convertible note, bringing Ipsen's fully diluted ownership position in Inspiration to 40.7%.

The OBI-1 pivotal clinical study is a prospective, non-randomized, open-label study evaluating the efficacy of OBI-1 for the treatment of serious bleeding episodes, including episodes that are a threat to a patient's life or vital organs. 

Dr. Johnny Mahlangu, MD, Director of the Adult Hemophilia Comprehensive Care Unit at Johannesburg Hospital, and President of the South African Society of Hematology, commented, "There remains a significant unmet medical need when it comes to treating individuals with hemophilia A who have developed inhibitors.  Current therapies do not reach the same level of efficacy as replacement therapy for non-inhibitor patients, leading to potential joint complications, increased risk of bleeding, pain and impact on the patient's quality of life.  Unlike available bypassing agents, OBI-1 facilitates the intrinsic hemostatic pathway, and therefore may allow clinicians to correlate activity and efficacy with FVIII levels (a surrogate for efficacy), enabling them to guide dosing and better predict treatment outcomes.  We are
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SOURCE Inspiration Biopharmaceuticals, Inc.
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