Sobi exercises opt-in right for Elocta(TM)

Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) announced today that the company has decided to exercise its opt-in right to take over final development and commercialisation of Elocta (rFVIIIFc) for the territory composed of Europe, North Africa, Russia and most Middle Eastern markets. Elocta/Eloctate(TM) is a recombinant factor VIII Fc fusion protein product candidate for the treatment of haemophilia A. Sobi will make a payment to Biogen Idec of USD 10 million, which will be held in escrow pending the EU regulatory approval of Elocta. Details about this and other compensation are described in the Collaboration Agreement section below. 

"This is an important milestone for Sobi and the result of a strong collaboration between our two companies," said Geoffrey McDonough, CEO at Sobi. "Sobi's legacy in haemophilia and rare diseases provides a platform for making this innovative treatment available for people with haemophilia A in our territory."

Biogen Idec and Sobi are long-time collaborators in the development and commercialisation of Elocta/Eloctate for haemophilia A. Biogen Idec leads development for Elocta/Eloctate, has manufacturing rights, and has commercialisation rights in North America and all other regions excluding the Sobi territories.

On 31 October 2014 Sobi and Biogen Idec announced that the European Medicines Agency (EMA) validated the Marketing Authorisation Application (MAA) for Elocta. The validation of the MAA initiated the EMA's review process.  Elocta is the European trade name for rFVIIIFc, also known as Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the U.S., Canada, and Australia, where it is approved for the treatment of haemophilia A. Elocta/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.

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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 haemorrhages. The World Federation of Hemophilia global survey conducted in 2012 estimates that approximately 142,000 people worldwide are identified as living with haemophilia A.