Biogen Idec Demonstrates Commitment to Advancing Hemophilia Research and Care at Annual ASH Meeting

Biogen Idec will present new data from its hemophilia clinical development and research programmes at the 55th Annual Meeting of the American Society of Hematology (ASH), taking place in New Orleans, 7–10 December.

Reflecting Biogen Idec’s commitment to transform hemophilia care, researchers will discuss 10 abstracts covering the breadth of the company’s comprehensive basic and clinical research programmes. This includes new, interim data from Phase III studies in pediatric populations evaluating the company’s investigational long-lasting recombinant factor VIII Fc fusion protein candidate, ELOCTATE, for hemophilia A and factor IX Fc fusion protein candidate, ALPROLIX, for hemophilia B.

“These new data from our groundbreaking research and development programmes demonstrate our commitment to improving hemophilia treatment,” said Glenn Pierce, MD, PhD, senior vice president of Global Medical Affairs and chief medical officer at Biogen Idec’s hemophilia therapeutic area. “We are excited to share our findings with physicians on the front lines of hemophilia management to further the understanding of the disorder.”

The titles of key Biogen Idec presentations are as follows:

ELOCTATE

• 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 9 December — 6:00–8:00 PM (CST)

• Dosing Long-Lasting Recombinant Factor VIII Fc Fusion Protein: Experience in the A-LONG Study, Poster #3598 — Monday 9 December — 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 9 December — 6:00–8:00 PM (CST)

ALPROLIX

• 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 8 December — 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 8 December — 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 9 December — 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 9 December — 11:00 AM (CST)

Nonclinical Research

• Evidence for Flexible Tethering of Fc to FVIII in Recombinant FVIII-Fc Fusion Protein rFVIIIFc, Poster #1102 — Saturday 7 December — 5:30–7:30 PM (CST)

• Immunohistochemical Staining of rFVIIIFc and rFVIII in Liver Cells Differentiates between a VWF-Dependent and Independent Clearance Pathway in Mice, Poster #2331 — Sunday 8 December — 6:30–8:30 PM (CST)

• An Immunodeficient Mice Model with Circulating Human Platelets to Evaluate the Platelet Clearance and Pharmacokinetics of Platelet-targeted Coagulator Factor VIIa, Abstract #2345 — Sunday 8 December — 6:30–8:30 PM (CST)

Full session details and data abstracts for the 2013 Annual Meeting can be found on the ASH website. Full-text abstracts will be published in the 6 December issue of Blood, the journal of ASH.

Regulatory applications for ELOCTATE and ALPROLIX are currently under review in several countries including the US, Canada and Australia.