Swedish firm Orphan Biovitrum (Sobi) has obtained orphan drug designation in Switzerland for its long-acting haemophilia drug candidate Elocta (rFVIIIFc) to treat patients with haemophilia A.
Haemophilia is an inherited condition that regulates the blood’s ability to clot and the most common type of the condition is haemophilia A, where people lack clotting factor FVIII.
Elocta is a long-acting recombinant factor VIII Fc fusion protein product candidate for patients with haemophilia A.
Elocta is the European trade name for rFVIIIFc and is also called Eloctate (Antihemophilic Factor [Recombinant], Fc Fusion Protein) in the US, Canada, Australia, and Japan, where it received approval to treat haemophilia A. Marketing authorisation application for Elocta is currently under review by the European Medicines Agency.
Sobi and Biogen collaborated on the development and commercialisation of Elocta or Eloctate or rFVIIIFc for haemophilia A.
Under the deal, Sobi will have final development and commercialisation rights for rFVIIIFc in its territory, including Europe, North Africa, Russia and certain Middle Eastern markets.
Biogen will take responsibility for the development of Elocta, and will hold manufacturing and commercialisation rights in North America and all other regions across the globe except Sobi territory.
Sobi produces products for haemophilia, inflammation and genetic diseases.
The company, along with various partner companies, markets a portfolio of speciality and orphan drugs in Europe, the Middle East, Russia and North Africa.