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

Haemophilia is an inherited condition that influences the blood's ability to clot. The most common type of the condition is haemophilia A, where people lack clotting factor FVIII. The symptoms can be mild to severe, depending on the level of clotting factor. People with haemophilia bleed for longer than usual and in severe haemophilia, internal bleeding around joints and muscles are frequent. This causes pain, stiffness and may lead to joint damage. Haemophilia A is a rare disease, occuring in 1 of 5 000 male births.

About Elocta (rFVIIIFc)

Elocta is a long-acting recombinant factor VIII Fc fusion protein product candidate for people with haemophilia A. Elocta is the European trade name for rFVIIIFc, also known as Eloctate[R] [Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the US, Canada, Australia, and Japan, where it is approved for the treatment of haemophilia A. A Marketing Authorisation Application for Elocta is currently under review by the European Medicines Agency.

About the Sobi and Biogen collaboration

Sobi and Biogen are partners in the development and commercialisation of Elocta/Eloctate/rFVIIIFc for haemophilia A. Sobi has final development and commercialisation rights for rFVIIIFc in the Sobi territory (Europe, North Africa, Russia and certain Middle Eastern markets). Biogen leads development for Elocta/Eloctate/rFVIIIFc, has manufacturing rights, and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory.

About Sobi

Sobi is an international pharmaceutical company focused on bringing innovative therapies and services to improve the lives of patients with rare diseases. The product portfolio focuses on haemophilia, inflammation and genetic diseases. On behalf of various partner companies, Sobi also markets a portfolio of speciality and orphan drugs in Europe, the Middle East, Russia and North Africa. In 2014, revenues totaled SEK 2.6 billion ((265 M) and the company had about 600 employess. The share (STO: SOBI) is listed on NASDAQ Stockholm.

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Publication:Worldwide Biotech
Date:Jun 1, 2015

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