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Elocta Gets Orphan Status

Swedish Orphan Biovitrum AB has received orphan drug designation in Switzerland for its long acting hemophilia drug candidate Elocta (rFVIIIFc), developed for the treatment of hemophilia A. An orphan drug designation encourages the development of medicines for rare diseases and provides orphan status to drugs and biologics under development.

 Elocta is a long-acting recombinant factor VIII Fc fusion protein product candidate for people with hemophilia A. Sobi and Biogen are partners in the development and commercialization of Elocta/Eloctate/rFVIIIFc for hemophilia A. Sobi has final development and commercialization rights for rFVIIIFc in the Sobi territory, which includes Europe, North Africa, Russia and certain Middle Eastern markets. Biogen leads development for Elocta/Eloctate/rFVIIIFc, has manufacturing rights and has commercialization rights in North America and all other regions in the world excluding the Sobi territory.

Hemophilia A is a rare disease, occuring in 1 out of about 5,000 male births. People with hemophilia bleed for longer than usual if they are cut or scraped and in severe hemophilia cases, internal bleeding around joints and muscles is common.