Biogen Idec and Sobi announce European Medicines Agency validates Elocta(TM) (rFVIIIFc) Marketing Authorisation Application for review

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) of Elocta^(TM) (rFVIIIFc), a recombinant factor VIII Fc fusion protein product candidate for the treatment of haemophilia A. The validation of the MAA initiates the EMA's review process.

Elocta is the European trade name for rFVIIIFc, also known as Eloctate^(TM) [Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the U.S., Canada, and Australia, where it is approved for the treatment of hemophilia A. Eloctate is the first recombinant clotting factor VIII therapy with prolonged circulation to provide protection from bleeding episodes with the potential for an extended interval between prophylactic injections.

"The validation of Elocta's application by the EMA is an important step toward bringing this innovative treatment to people with haemophilia A in Europe," said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen Idec. "Elocta has the potential to protect against bleeding episodes while helping to address the challenge of frequent injections."

The regulatory application included results from the pivotal, Phase 3 clinical study, A-LONG that examined the efficacy, safety and pharmacokinetics of rFVIIIFc in males 12 years of age and older with severe haemophilia A and from the Phase 3 clinical study, Kids A-LONG that evaluated the efficacy and safety of rFVIIIFc in children with haemophilia A under 12 years of age. 

Biogen Idec and Sobi are collaborators in the development and commercialization of Eloctate/Elocta for haemophilia A. Sobi has an opt-in right to take over final development and commercialisation of Elocta for the Sobi territories (Europe, North Africa, Russia and most Middle Eastern markets). Biogen Idec leads development for Eloctate/Elocta, has manufacturing rights, and has commercialisation rights in North America and all other regions in the world excluding the Sobi territories.

"Sobi and Biogen Idec are committed to addressing significant medical needs in the global haemophilia community," said Birgitte Volck, M.D., Ph.D., senior vice president of Development and Chief Medical Officer of Sobi. "We're working collaboratively to deliver innovative medicines that have the potential to change the way haemophilia A is treated."

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About Haemophilia A
Haemophilia A is a rare, chronic, genetic disorder in which the ability of a person's blood to clot is impaired, due to missing or reduced levels of a protein known as factor VIII. People with haemophilia A experience bleeding episodes that may cause pain, irreversible joint damage and life-threatening hemorrhages. The World Federation of Hemophilia global survey conducted in 2012 estimates that approximately 142,000 people worldwide are identified as living with haemophilia A.