Inspiration submits IB1001 BLA with FDA for treatment of hemophilia B

Ipsen (Paris:IPN) (Euronext: IPN, ADR: IPSEY) today announced that its partner, Inspiration Biopharmaceuticals, Inc. (Inspiration), has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of IB1001, an intravenous recombinant factor IX (rFIX) for the treatment and prevention of bleeding in individuals with hemophilia B.

The IB1001 BLA filing includes a comprehensive set of pharmacokinetics, safety and efficacy data from a Phase III clinical trial in patients affected by hemophilia B. A surgery substudy was also included.

In January 2010, Inspiration and Ipsen entered into a broad strategic partnership to develop and commercialize a unique portfolio of hemophilia products, which included Inspiration in-licensing OBI-1 from Ipsen, as well as Ipsen providing Inspiration with milestone-based funding to support the development of Inspiration's two lead development programs. Based on the terms of this partnership, Inspiration will receive a $35 million milestone payment from Ipsen associated to the filing of the IB1001 BLA. In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen's fully diluted equity ownership position in Inspiration to approximately 43.5%.

Regulatory review is now pending in both the U.S. and Europe. Inspiration's Marketing Authorization Application for IB1001 was accepted by the European Medicines Agency in September 2011. Inspiration is currently finalizing plans for additional regulatory filings and preparing for the commercial launch of IB1001.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen, said, "The filing of IB1001 in the U.S. is an important step forward in the development of Inspiration. Now filed in Europe and the US, IB1001 paves the way for Inspiration's transformation towards becoming a commercial-stage company. We believe the hemophilia community will positively receive an alternative to the single recombinant FIX currently on the market." Marc de Garidel added, "Ipsen is actively engaged in supporting Inspiration's commercial operations in Europe. Moreover, both companies are looking forward to defining the best roadmap to ensure Inspiration's success in the coming years."