21 November 2014 - 21 November 2014 - Swedish Orphan Biovitrum AB (STO:BVT), or Sobi, said Friday that the company had decided to exercise its opt-in right to take over final development and commercialisation of the recombinant clotting factor therapy Elocta (rFVIIIFc) for the territory composed of Europe, North Africa, Russia and most Middle Eastern markets.

Elocta/Eloctate is a recombinant factor VIII Fc fusion protein product candidate for the treatment of haemophilia A.

Sobi will make a payment to US collaboration partner Biogen Idec Inc (NASDAQ:BIIB) in the amount of USD 10 million (EUR 8.038m), which will be held in escrow pending the EU regulatory approval of Elocta. Upon EU regulatory approval of Elocta, Sobi will be liable to repay about half of the development and manufacturing costs for Elocta/Eloctate incurred by Biogen Idec to date (around USD 180 million), as well as for additional investments made until Sobi formally assumes responsibility as the Marketing Authorisation Holder for Elocta. Sobi estimates the total repayment obligation to reach about USD 240 million.

Sobi's CEO, Geoffrey McDonough, called the move a significant milestone for Sobi and the result of a strong collaboration between Sobi and Biogen Idec. Sobi's legacy in haemophilia and rare diseases provides a platform for making this innovative treatment available for people with haemophilia A in the company's territory, McDonough added.

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.

At the end of October the two companies 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 USA, Canada, and Australia, where the therapy is cleared for the treatment of haemophilia A. According to Sobi, 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.  

(USD 1.0 = EUR 0.804)