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Sobi's partner Biogen Idec to present phase 3 data on prolonged half-life of Haemophilia candidates in young children at annual ASH meeting

Press Release   •   Dec 03, 2013 10:18 GMT

Swedish Orphan Biovitrum AB's (publ ) (Sobi) partner Biogen Idec today announced that new data from their haemophilia clinical development and research programs will be presented at the 55th Annual Meeting of the American Society of Hematology (ASH), taking place in New Orleans, December 7-10. Researchers will discuss 10 abstracts covering the breadth of the company's comprehensive basic and clinical research programs. This includes new interim data from Phase 3 studies in paediatric populations evaluating the company's investigational long-lasting recombinant factor VIII Fc fusion protein candidate for haemophilia A and factor IX Fc fusion protein candidate for haemophilia B.

The titles of the key presentations are as follows:

Factor VIII Fc fusion protein candidate (ELOCTATE(TM)):

  • Pharmacokinetics of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Pediatric Subjects with Hemophilia A: An Interim Analysis of the Kids A-LONG Study - Poster #3609 - Monday, December 9 - 6:00-8:00 PM (CST) 
  • Dosing Long-Lasting Recombinant Factor VIII Fc Fusion Protein: Experience in the A-LONG Study - Poster #3598 - Monday, December 9 - 6:00-8:00 PM (CST) 
  • The Bleeding Tendency In Relation To Predicted FVIII Activity Levels In Severe Hemophilia A Patients Treated With Recombinant Factor VIII Fc Fusion Protein - Poster #3590 - Monday, December 9 - 6:00-8:00 PM (CST) 

Factor IX Fc fusion protein candidate (ALPROLIX(TM)):

  • Association of Bleeding Tendency with Time Under Target FIX Activity Levels in Severe Hemophilia B Patients Treated with Recombinant Factor IX Fc Fusion Protein - Poster #2349 - Sunday, December 8 - 6:30-8:30 PM (CST) 
  • Pharmacokinetics, Safety and Efficacy of Long-lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Adolescent Subjects with Hemophilia B: A Subgroup Analysis of the B-LONG Study - Poster #2350 - Sunday, December 8 - 6:30-8:30 PM (CST) 
  • Pharmacokinetics of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Pediatric Subjects with Hemophilia B: An Interim Analysis of the Kids B-LONG Study - Poster #3599 - Monday, December 9 - 6:00-8:00 PM (CST)

Hemophilia Health Outcomes Research

  • Psychometric Evaluation of Health-Related Quality of Life Data from the A-LONG and B-LONG Hemophilia Clinical Trials - Oral Presentation/Abstract #423 - Monday, December 9 - 11:00 AM (CST) 

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About the Fc Fusion Technology Platform
ELOCTATE and ALPROLIX were developed using Fc fusion technology, which takes advantage of a naturally occurring pathway that delays the breakdown of IgG1 (protein commonly found in the body) by recycling it back into the bloodstream. This technology is thought to be responsible for the prolonged time that ALPROLIX and ELOCTATE circulate in the body. While Fc fusion is an established technology that has been used for more than 15 years, Biogen Idec is the only company to apply it in haemophilia.

About Haemophilia
Haemophilia is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. There are different types of haemophilia depending on which clotting protein, or factor, is missing or reduced, including haemophilia A (factor VIII deficiency) and haemophilia B (factor IX deficiency). Haemophilia A occurs in about one in 5,000 male births annually. Haemophilia B is less common, accounting for about one in 25,000 male births annually. Both forms of haemophilia occur more rarely in females.

People with haemophilia can experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages. Prophylactic infusions of factor VIII or IX can restore the coagulation process, as well as reduce or prevent new bleeding episodes. The Medical and Scientific Advisory Council of the National Haemophilia Foundation recommends prophylaxis as the optimal therapy for people with severe haemophilia.

About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development and commercialization of ELOCTATE for haemophilia A and ALPROLIX for haemophilia B. Biogen Idec leads development, has manufacturing rights, and has commercialization rights in North America and all other regions excluding the Sobi territory. Sobi has the right to opt in to assume final development and commercialization in Europe (including Russia), the Middle East and Northern Africa.

About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, haemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labelling, press releases and additional information about the company, please visit www.biogenidec.com.

For more information - not for publication
Sobi:

Media relationsInvestor relations
Oskar Bosson, Head of CommunicationsJörgen Winroth, Vice President, Head of Investor Relations
T: +46 70 410 71 80T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
E: oskar.bosson@sobi.comE: jorgen.winroth@sobi.com

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 Inflamma-tion and Genetic diseases, with three late stage biological development projects within Haemophilia and Neonatology. 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 infor-mation is available at www.sobi.com.

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