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New long-term data to be presented on Elocta(TM) at annual EAHAD meeting


WEBWIRE

Swedish Orphan Biovitrum AB (publ) (Sobi) in collaboration with Biogen Idec will present new data from their haemophilia clinical development programmes at the 8th European Association for Haemophilia and Allied Disorders (EAHAD), taking place in Helsinki, Finland, February 11 - 13, 2015. Six abstracts will be presented, including new, interim results from the ASPIRE long-term extension study. Results from the Kids A-LONG, A-LONG, and B-LONG Phase 3 studies will also be presented.

“We are pleased to continuously share emerging evidence generated from the pivotal clinical programs for the product candidates Elocta and rFIXFc. The new interim results from the ASPIRE study, presented in collaboration with Biogen Idec, discuss the longer term use of Elocta in people with severe haemophilia A, followed in an open label extension from the pivotal A-LONG study, and further establishes the efficacy and safety of Elocta”, says Birgitte Volck, MD, PhD, Senior Vice President, Chief Medical Officer at Sobi.

The titles of the poster presentations are as follows:

Elocta (rFVIIIFc):

  • Long-term safety and efficacy of recombinant factor VIII Fc (rFVIIIFc) in adults and adolescents with severe haemophilia A: an interim analysis of the ASPIRE study; PP066
     
  • Interim analysis of the ASPIRE study evaluating long-term safety and efficacy of recombinant factor VIII Fc (rFVIIIFc) in children with severe haemophilia A; PP076
     
  • Perioperative management of subjects with haemophilia A in the ASPIRE study with long-acting recombinant factor VIII Fc fusion protein (rFVIIIFc); PP116
     
  • Safety, efficacy, and pharmacokinetics of recombinant factor VIII Fc fusion protein (rFVIIIFc) in previously treated paediatric subjects with severe haemophilia A (Kids A-LONG); PP032
  • Subject-reported changes in physical activity during the A-LONG study of recombinant factor VIII Fc fusion protein (rFVIIIFc) for severe haemophilia A; PP035

Alprolix® (rFIXFc):

  • Subject-reported changes in physical activity during the B-LONG study of recombinant factor IX Fc fusion protein (rFIXFc) for severe haemophilia B; PP028

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About Elocta (rFVIIIFc)
Elocta is a long-acting recombinant factor VIII Fc fusion protein product candidate for people with haemophilia A.  Elocta is the trade name in Europe for rFVIIIFc, also known as Eloctate®[Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the US, Canada, Australia, and Japan, where it is approved for the treatment of haemophilia A. A Marketing Authorisation Application for Elocta is currently under review by the European Medicines Agency.

About Alprolix (rFIXFc)
rFIXFc is a long-acting recombinant factor IX Fc fusion protein product candidate for people with haemophilia B. Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is approved for the treatment of haemophilia B in the US, Canada, Australia, and Japan.

About the Sobi and Biogen Idec collaboration
Sobi and Biogen Idec are partners in the development and commercialisation of Elocta/Eloctate/rFVIIIFc for haemophilia A and Alprolix/rFIXFc for haemophilia B. Sobi has final development and commercialisation rights for rFVIIIFc in the Sobi territories (Europe, North Africa, Russia and certain Middle Eastern markets), as well as an opt-in right to take over final development and commercialisation of Alprolix/rFIXFc in the Sobi territories. Biogen Idec leads development for Elocta/Eloctate/rFVIIIFc and Alprolix/rFIXFc, has manufacturing rights, and has commercialisation rights in North America and all other regions in the world excluding the Sobi territories.

About Sobi
Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Inflammation and Genetic diseases, with two late stage biological development projects within Haemophilia. We also market a portfolio of specialty and rare disease products for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2013, Sobi had total revenues of SEK 2.2 billion (€253 M) and about 550 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.



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