Sobi's partner Biogen submits marketing authorisation application for Alprolix® (rFIXFc) in Europe
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that partner Biogen has submitted a Marketing Authorisation Application (MAA) for Alprolix (rFIXFc) to the European Medicines Agency (EMA). Sobi has an opt-in right to assume final development and commercialisation of Alprolix in Europe, Russia, certain countries in the Middle East, and North Africa. The MAA filing with the EMA coupled with the receipt of the opt-in data package, triggers the formal opt-in right, for Sobi to exercise its option in accordance with the collaboration agreement.
Alprolix is a prolonged circulating recombinant factor IX Fc fusion protein product candidate for people with haemophilia B.
About Alprolix (rFIXFc)
rFIXFc is a long-acting recombinant factor IX Fc fusion protein product candidate for people with haemophilia B. Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is approved for the treatment of haemophilia B in the US, Canada, Australia, and Japan.
About the Sobi and Biogen collaboration
Sobi and Biogen are partners in the development and commercialisation of Elocta/Eloctate/rFVIIIFc for haemophilia A and Alprolix/rFIXFc for the treatment of haemophilia B. Sobi has final development and commercialisation rights for rFVIIIFc in the Sobi territories (Europe, North Africa, Russia and certain Middle Eastern markets), as well as the opt-in right to assume final development and commercialisation of Alprolix/rFIXFc in Europe, Russia, certain countries in the Middle East and North Africa. Biogen leads development for Elocta/Eloctate/rFVIIIFc and Alprolix/rFIXFc, has manufacturing rights, and has commercialisation rights in North America and all other regions in the world excluding the Sobi territories.
Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of specialty and rare disease products for partner companies across Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion (USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
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018e_Alprolix filing EMA http://hugin.info/134557/R/1926382/691272.pdf