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Biogen Idec Showcases Commitment To Advancing Hemophilia Treatment And Care At ISTH Congress

Stocks in this article: BIIB

Biogen Idec (NASDAQ: BIIB) will showcase new data from a number of development and early-stage research programs at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress. Researchers will present 33 abstracts on clinical and pre-clinical research in hemophilia, the breadth of which reflects the company’s commitment to innovation and the scientific advancement of hemophilia treatment and care. The ISTH Congress will be held June 29 through July 4 in Amsterdam, The Netherlands.

“There are significant unmet needs in hemophilia A and B, rare chronic diseases that have a tremendous impact on the lives of patients and their families,” said Glenn Piece, M.D., Ph.D., senior vice president, Global Medical Affairs and chief medical officer at Biogen Idec. “The robust research being showcased at ISTH reflects our commitment to the community to address these unmet needs through innovative research and science. This includes striving to bring the first major advances in hemophilia treatment in more than fifteen years.”

Biogen Idec and Swedish Orphan Biovitrum (Sobi) will present new analyses of the phase 3 A-LONG study of ELOCTATE* and B-LONG study of ALPROLIX**, results of which add to the growing body of evidence supporting the potential efficacy and safety of these long-lasting clotting factor candidates for the treatment of hemophilia A and B.

The company will also share pre-clinical findings from new factor VIII molecules that achieved a circulating half-life of 30 hours in mice, representing a four-fold improvement over factor VIII. Additionally, new data will be presented from the company’s long-lasting factor VIIa program targeting development of a potential new option for patients with hemophilia who have inhibitory antibodies that make factor replacement ineffective.

Notable data from Biogen Idec at ISTH 2013 include:

ELOCTATE

  • Population Pharmacokinetic Analysis of Long-Lasting Recombinant Factor VIII Fc fusion Protein (rFVIIIFc) in Patients with Severe Haemophilia A – e-Poster PA 2.06-3 – Tuesday, July 2 – 17:00-18:30 (CEST)
  • Evaluation of the Thrombin Generation Potential of a Recombinant Factor VIII Fc Fusion Protein in a Phase III Multi-National Clinical Trial – Oral Platform OC 64.3 – Wednesday, July 3 – 08:30-08:45 (CEST)
  • Evaluation of Whole Blood Clotting Activity of Recombinant Factor VIII Fc Fusion Protein by ROTEM Analysis in a Multi-Center Phase 3 Clinical Trial – Oral Platform AS 26.1 – Wednesday, July 3 – 13:30-13:45 (CEST)
  • Treatment of Bleeding Episodes in Subjects with Haemophilia A with Long-Lasting Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Phase 3 A-LONG Study – e-Poster PB 4.37-3 – Thursday, July 4 – 13:30-15:00 (CEST)
  • Long-Lasting Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) for Perioperative Management of Subjects with Haemophilia A in the Phase 3 A-LONG Study

– e-Poster PA 4.07-2 – Thursday, July 4 – 13:30-15:00 (CEST)

ALPROLIX

  • Long-Lasting Recombinant Factor FIX Fc Fusion (rFIXFc) for Perioperative Management of Subjects with Haemophilia B in the Phase 3 B-LONG Study – e-Poster PA 2.07-4 – Tuesday, July 2 – 17:00-18:30 (CEST)
  • Clinical Implications of Population Pharmacokinetics of rFIXFc in Routine Prophylaxis, Control of Bleeding and Perioperative Management for Haemophilia B Patients – e-Poster PA 2.07-5 – Tuesday, July 2 – 17:00-18:30 (CEST)
  • Treatment of Bleeding Episodes in Subjects with Haemophilia B with the Long-Lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the Phase 3 B-LONG Study – e-Poster PA 2.07-6 – Tuesday, July 2 – 17:00-18:30 (CEST)

Pre-Clinical Research

  • A Platelet-Targeted Factor VIIa – XTEN Fusion Protein with Increased Circulating Half-Life and Improved Clotting Activity – e-Poster PB 1.58-1 – Monday, July 1 – 17:00-18:30 (CEST)
  • Engineering A Novel rFVIII-VWF D’D3 Fusion Protein to Enhance Stability and Improve Pharmacokinetic Properties of FVIII – Oral Platform OC 37.5 – Tuesday – July 2, 09:00-09:15 (CEST)
  • A New Class of Coagulation Factor VIII Molecules that Achieved Four-Fold Longer Half-Life than Recombinant FVIII in Hemophilia A Mice – Oral Platform AS 45.1 – Thursday, July 4 – 16:00-16:15 (CEST)
  • VWF Affects the Clearance and Biodistribution of Recombinant Factor VIII Fc Fusion (rFVIIIFc) – e-Poster PA 4.13-6 – Thursday, July 4 – 13:30-15:00 (CEST)

Hemophilia Health Outcomes and Resource Utilization Research

  • Adherence to clotting factor treatment among patients with haemophilia A or B – e-Poster PB 1.37-4 – Monday, July 1 – 17:00-18:30 (CEST)
  • Comparing projected prophylactic consumption and effects of recombinant factor VIII Fc Fusion (rFVIIIFc) and shorter half-life FVIII products in haemophilia – e-Poster PB 3.55-5 – Wednesday, July 3 – 17:00-18:30 (CEST)

Biogen Idec and SOBI-Sponsored Educational Symposia

  • Microphysiology of Joint Damage: Surrogate Measures of Joint Damage and Inflammation – Co-Chair Glenn Pierce, MD, PhD, senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec’s hemophilia therapeutic area; Monday, July 1, 18:30-20:00 (CEST)
  • Novel Therapy Development in Hemophilia – Co-Chair George Scangos, PhD, chief executive officer of Biogen Idec; Tuesday, July 2, 18:30-20:00 (CEST)

Full session details and data presentation listings for the 2013 Congress can be found on the ISTH website at http://www.isth2013.org/.

ELOCTATE and ALPROLIX Global Regulatory Status

Biologics License Applications (BLAs) for Biogen Idec’s long-lasting hemophilia product candidates ELOCTATE and ALPROLIX are currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia A and B, respectively.

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