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.
For more details, go to: http://www.reuters.com/article/2015/06/04/idUSFWN0YQ01N20150604