Inspiration Biopharmaceuticals Initiates Second Pivotal Clinical Study of Innovative Hemophilia Therapy OBI-1

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 pleased to have enrolled the first patient in this pivotal clinical study."

Inspiration in-licensed OBI-1 from Ipsen as part of their January 2010 partnership agreement, whereby Inspiration is responsible for the clinical development, regulatory approval and commercialization of the product.  Previously, in November 2010, Inspiration initiated the first pivotal study of OBI-1 for the treatment of individuals with acquired hemophilia A, a rare, potentially life-threatening autoimmune bleeding disorder caused by the development of inhibitors against endogenous FVIII.  Results from the first patients in this clinical study were presented in a Scientific Session held in conjunction with the 23rd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in July 2011.  Enrollment in the OBI-1 acquired hemophilia clinical trial is ongoing.

John P. Butler, Chief Executive Officer of Inspiration, commented, "Inspiration is committed exclusively to driving innovation that can bring positive impact to the treatment of people with hemophilia.  We now have OBI-1 in pivotal development for multiple indications.  We also recently announced the filing of a Marketing Authorization Application (MAA) for our other lead program, IB1001, a recombinant factor IX product for the treatment of hemophilia B.  These two late stage products, along with our preclinical programs for factor VIIa and FVIII deficiency, gives Inspiration one of the broadest pipelines for hemophilia treatment in the industry.  As a company, we are committed to developing and commercializing an array of hemophilia products, which will provide value to physicians and to people living with the condition worldwide."

About Hemophilia

Hemophilia is a bleeding disorder caused by low levels or the 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 estimated at $8 billion worldwide.

Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to human FVIII, and can no longer respond to replacement treatment with the coagulation factor.  Current therapies, specifically human factor VIIa (NovoSeven®) and FEIBA, work by bypassing the natural hemostatic pathway.

About OBI-1

OBI-1, a recombinant form of porcine FVIII which may possess low cross reactivity to antihuman FVIII antibodies, is a replacement therapy, facilitating the intrinsic hemostatic pathway.  This should allow clinicians to correlate activity and efficacy with FVIII levels, a surrogate for efficacy in hemophilia, and therefore guide dosing to better monitor and predict treatment outcomes.  OBI-1 presents a unique and alternative approach to address the needs of individuals who have developed inhibitors to FVIII and is highly desired by the medical community.

For more information about enrolling in one of Inspiration's clinical trials, please visit www.hemophiliaregistry.com or call 1-800-361-3227.  For more information on the ongoing clinical studies, please visit http://www.clinicaltrials.gov.

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 products in late-stage clinical development and two preclinical programs.

Inspiration's two lead programs are IB1001, an intravenous recombinant factor IX (FIX) product being developed for the treatment and prevention of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product being developed for the treatment of individuals with congenital hemophilia A who have inhibitors against human FVIII and for individuals with acquired hemophilia A.  Inspiration recently submitted its first marketing application for IB1001 in Europe, with a subsequent regulatory filing planned in the U.S in the first half of 2012.  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 the Ipsen Group (EURONEXT: IPN; ADR: IPSEY), leveraging the combined expertise and resources of the two companies, to develop a broad portfolio of hemophilia products.  As announced in late August 2011, Ipsen and Inspiration extended their partnership to create a hemophilia business unit structure that will act as the exclusive sales organization for all hemophilia products commercialized under the Inspiration brand in Europe.  For further information on Inspiration, please visit http://www.inspirationbio.com.

SOURCE Inspiration Biopharmaceuticals, Inc.

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