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news.The European Commission (EC) has granted orphan drug status to Ipsen OBI-1 to treat individuals with hemophilia who have developed inhibitory antibodies (inhibitors) against human Factor VIII (hFVIII).
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The orphan drug status would trigger a 10-year market exclusivity for OBI-1 in the European Union after its marketing approval.
Ipsen licensed OBI-1 to Inspiration Biopharmaceuticals under an agreement signed in January 2010.
As per the agreement, Inspiration is responsible for the clinical trial development and commercialisation of OBI-1.
Ipsen Corporate Development executive vice-president Stephane Thiroloix said that 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 recognised the medical value of treating hemophilia in individuals who have developed inhibitors against human Factor VIII," Thiroloix said.