Ipsen has received European Commission's orphan drug status for OBI-1 for the treatment of haemophilia. Expected to enter pivotal clinical trials before the end of this year, OBI-1 is designed to treat individuals with haemophilia 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 US 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 haemophilia reinforces Ipsen's commitment to focus its resources and knowhow on its four targeted disease areas (oncology, endocrinology, neurology and haematology), where severe medical conditions remain without appropriate therapeutic response. We are proud that the European authorities have recognized the medical value of treating haemophilia in individuals who have developed inhibitors against human Factor VIII. Our partnership with Inspiration Biopharmaceuticals is a key lever in building a world-leading haemophilia 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.

Approximately one-third of individuals with haemophilia A develop an immune reaction (inhibitors) to hFVIII and can no longer respond to treatment with the coagulation factor. Current therapies, specifically FVIIa and FEIBA, work by bypassing the natural haemostatic pathway and driving coagulation by raising FVIIa and other activated coagulation factors to higher levels than normal.

Ipsen is a global biopharmaceutical group with total sales in excess of 1 billion euros in 2009, and total worldwide staff of more than 4,400.