EMA accepts Inspiration's IB1001 MAA for treatment of hemophilia B

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."