Inspiration Biopharma earns $35 million milestone from Ipsen on acceptance of hemophilia drug MAA

3 October 2011

French drugmaker Ipsen (Euronext: IPN) and its partner, privately-held Inspiration Biopharmaceuticals say that the European Medicines Agency 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 USA, Europe, Israel and India.

Early last year, Inspiration and Ipsen entered into a broad strategic partnership worth a potential $1 billion to the US firm 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, including FIX IB1001 (The Pharma Letter January 21, 2010).

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