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Inspiration Biopharmaceuticals Announces Acceptance of European Marketing Authorization Application for IB1001 for the Treatment of Hemophilia B


10/3/2011 10:40:16 AM

LAGUNA NIGUEL, Calif., Oct. 3, 2011 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced that the European Medicines Agency (EMA) has validated and accepted the filing of the Marketing Authorization Application (MAA) for Inspiration's IB1001, a recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B. In doing so, the EMA has verified that it will begin its regulatory review process of the MAA.

The application includes safety and efficacy data from Inspiration's clinical program for IB1001, which was conducted in the U.S., Europe, Israel and India.

Based on Inspiration's partnership agreement with the Ipsen Group (Euronext: IPN; ADR: IPSEY), which was signed in January 2010, by receiving the IB1001 MAA submission acceptance for review from the EMA, Inspiration will receive a $35 million milestone payment from Ipsen. In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen's fully diluted equity ownership position in Inspiration to approximately 38%.

In late August, 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.

"The MAA submission for our lead program, IB1001, is Inspiration's first product approval regulatory filing, and a key step in the Company's transformation toward becoming a commercial-stage company," stated John Taylor, Co-Founder and Chairman of Inspiration. "We believe the hemophilia community would like to see greater product choice. Currently, individuals with hemophilia B only have one marketed recombinant FIX treatment option. Our IB1001 program is designed to increase product supply, provide patient choice, and help achieve our mission to broaden access to care worldwide."

About IB1001

IB1001, Inspiration's lead product candidate, is an intravenous recombinant FIX product being developed for the treatment and prevention of bleeding in individuals with hemophilia B. IB1001 has completed the pivotal Phase 3 clinical testing for the European regulatory submission, while clinical testing for the U.S. regulatory submission is ongoing. To date, IB1001 has been well-tolerated by patients and pharmacokinetic results have demonstrated non-inferiority to the one approved recombinant FIX product currently available for the treatment of hemophilia B.

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 pre-clinical programs.

Inspiration's lead product candidates are IB1001, an intravenous recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product for the treatment of individuals with congenital hemophilia A who have developed inhibitors against human FVIII and for individuals with acquired hemophilia. Both products are in advanced 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 the Ipsen Group, leveraging the combined expertise and resources of the two companies, to develop a broad portfolio of hemophilia products. As announced in late August 2011, through an extension of the Company's existing partnership with Ipsen, Inspiration will be commercializing its hemophilia product portfolio in Europe, utilizing a hemophilia business unit structure being established within Ipsen's existing European commercial organization. For further information on Inspiration, please visit http://www.inspirationbio.com.

Contacts:




Media

Company

Justin Jackson

Mary Bauman

Maroussia Czarny

Vice President, Global Commercial Strategy

Burns McClellan

Email: mbauman@inspirationbio.com

Tel: +1-212-213-0006


Email: jjackson@burnsmc.com


mczarny@burnsmc.com




SOURCE Inspiration Biopharmaceuticals, Inc.



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