European Commission grants Ipsen's OBI-1 orphan drug status for treatment of hemophilia

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Product Candidate to Treat Hemophilia patients who have developed Inhibitors to Human Factor VIII

Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) announced today that the European Commission has granted orphan drug status for OBI-1 for the treatment of hemophilia. Expected to enter pivotal clinical trials before the end of this year, OBI-1 is designed to treat individuals with hemophilia who have developed inhibitory antibodies (inhibitors) against human Factor VIII (hFVIII). The orphan drug status would trigger a 10-year market exclusivity for OBI-1 in the European Union after its marketing approval. The U.S. Food & Drug Administration (FDA) issued an Orphan Drug Designation for OBI-1 in March 2004.

Stéphane Thiroloix, Ipsen's Executive Vice-President, Corporate Development, commented : "The European Commission's decision to grant OBI-1 orphan drug status for the treatment of hemophilia reinforces Ipsen's commitment to focus its resources and know-how on its four targeted disease areas (oncology, endocrinology, neurology and hematology), where severe medical conditions remain without appropriate therapeutic response. We are proud that the European authorities have recognized the medical value of treating hemophilia in individuals who have developed inhibitors against human Factor VIII. Our partnership with Inspiration Biopharmaceuticals is a key lever in building a world-leading hemophilia franchise covering a wide range of bleeding disorders."

According to the partnership agreement signed in January 2010, Ipsen has granted a licence to Inspiration Biopharmaceuticals (Inspiration) for OBI-1. Inspiration is responsible for the clinical trial development and commercialization of OBI-1.



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