SOBI opts to extend its marketing territories for Alprolix (rFIXFc) to treat haemophilia B

Swedish Orphan Biovitrum AB (Sobi) announced that the company has decided to exercise its opt-in right to take over final development and commercialisation of Alprolix (rFIXFc) for the territory composed of Europe, North Africa, Russia and certain Middle Eastern markets. Alprolix is a recombinant factor IX Fc fusion protein product candidate for the treatment of haemophilia B. Sobi will make a payment to Biogen of $10 million, which will be held in escrow pending the EU regulatory approval of Alprolix.

Comment: Alprolix is approved in the US, Canada, Australia and Japan for the control and prevention of bleeding episodes and routine prophylaxis, in adults and children aged >12 with haemophilia B. Alprolix is the first approved long-acting haemophilia B therapy and is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic injections scheduled once weekly or once every 10-14 days. On 26 June 2015 Sobi and Biogen announced that the European Medicines Agency (EMA) had validated the Marketing Authorisation Application (MAA) for Alprolix. The validation of the MAA initiates the EMA's review process.