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Biogen Idec’s Commitment To MS Demonstrated Through Significant Scientific Data Being Presented At The 28th ECTRIMS

Biogen Idec (NASDAQ: BIIB) will have extensive data from the company’s leading multiple sclerosis (MS) franchise presented during the 28 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France, October 10 – 13. Fifty-three poster and platform presentations will further showcase Biogen Idec’s commitment to advancing the treatment of MS and improving the lives of people living with the disease around the world.

“For nearly 20 years, Biogen Idec has had a steadfast commitment to the MS community. This began with the approval of AVONEX and then TYSABRI, and continues today with the global regulatory submissions for oral dimethyl fumarate,” said Alfred Sandrock, M.D., Ph.D., senior vice president, development sciences and chief medical officer, Biogen Idec. “Our continued dedication to the advancement of MS treatment is evident in our pipeline, which is the deepest in the industry. Though significant advances have been made, we will not rest while there is so much more we can do to improve the lives of those living with MS.”

Data from the Biogen Idec MS Pipeline Key scientific highlights being presented during ECTRIMS from the company’s pipeline will include analyses of pooled data from the Phase 3 DEFINE and CONFIRM clinical trials of oral dimethyl fumarate (BG-12), primary results from the daclizumab high-yield process (DAC HYP) SELECTION study, and early-stage research showing the results of a study of anti-LINGO 1 (BIIB033) in optic nerve damage in animal models.

Dimethyl FumarateDimethyl fumarate has been studied as an oral agent for MS and is currently under regulatory review in the United States, European Union, Switzerland, Australia and Canada for the treatment of MS. Detailed data from the program’s two Phase 3 clinical trials, DEFINE and CONFIRM, were recently published in The New England Journal of Medicine. There will be 14 posters, one platform presentation and one late breaking news poster presented. Highlights include:

  • Clinical efficacy of BG-12 in relapsing-remitting multiple sclerosis: an integrated analysis of the Phase 3 DEFINE and CONFIRM studies – Platform 151
  • Safety and tolerability of BG-12 in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the placebo-controlled studies – Poster 484
  • Effects of BG-12 on magnetic resonance imaging outcomes in relapsing-remitting multiple sclerosis: an integrated analysis of the Phase 3 DEFINE and CONFIRM studies – Poster 920
  • Long-term safety and tolerability of oral BG-12 (dimethyl fumarate) in relapsing-remitting multiple sclerosis: interim results from ENDORSE – Late Breaker Poster 1103

DAC HYPDAC HYP is an investigational, once-monthly subcutaneous therapy that is in Phase 3 clinical development for the treatment of RRMS. Five DAC HYP posters will be presented, along with one late breaking news platform presentation of the primary results from the SELECTION study, a randomized, double-blind extension study designed to assess sustained efficacy and safety of DAC HYP in the second year of treatment. Highlights include:

  • The effect of daclizumab HYP on sustained disability progression in the SELECT trial – Poster 949
  • Effect of daclizumab HYP treatment in highly active relapsing-remitting multiple sclerosis: results from the SELECT study – Poster 463
  • Primary results of the SELECTION trial of daclizumab HYP in relapsing multiple sclerosis – Late Breaker Presentation 169

Anti-LINGO 1Anti-LINGO 1 is a monoclonal antibody in early stage clinical trials. Previous data from animal models have shown that it promotes remyelination and axon survival. Proof of concept studies in optic neuritis are expected to start in the fourth quarter of this year, and during the second half of 2013 for MS. Two company-sponsored anti-LINGO 1 posters will be presented at the Congress:

  • BIIB033 Anti-LINGO-1 antibody reduces optic nerve axonal degeneration in MOG- EAE rodent models – Poster 785
  • Technical feasibility of implementing multifocal VEP for multicentre clinical trials – Poster 281

Data from the Biogen Idec MS Franchise

TYSABRITYSABRI is approved in the United States for relapsing forms of MS and in the European Union for RRMS. There will be 10 company- and partner-sponsored TYSABRI posters and one platform presentation. Highlights include:

  • Long-term safety and efficacy of natalizumab and assessment of 2-year freedom from clinical disease activity in patients with multiple sclerosis in the TYSABRI Observational Program (TOP) – Poster 519
  • Improvement of MS-related fatigue also significantly improves quality of life in patients treated with natalizumab: results from the TYNERGY trial – Poster 445
  • Relation of disease activity-free status to visual function in the AFFIRM trial – Poster 557
  • Utilization of JC-virus antibody testing in clinical practice – Poster 546

AVONEXAVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. AVONEX PEN, the first intramuscular autoinjector approved for MS, is available in the United States and European Union for those choosing AVONEX to treat their MS. Ten AVONEX posters will be presented. Highlights include:

  • Interim analysis of AMETYST: a Phase 4 observational study of the impact of intramuscular interferon beta-1a on quality of life, disability, and cognition in patients with clinically isolated syndrome/clinically definite multiple sclerosis – Poster 1047
  • Interferon beta‐1a (AVONEX) as treatment option for untreated MS patients (AXIOM) – Poster 1007

FAMPYRAFAMPYRA is a novel MS treatment approved in the European Union to improve walking in adult patients with MS who have walking disability (EDSS between 4.0 and 7.0). There will be seven company- and partner-sponsored posters focusing on FAMPYRA. Highlights include:

  • Dalfampridine extended release tablets: safety profile after 2 years of post-marketing experience in the United States – Poster 1026, sponsored by Acorda Therapeutics
  • An alternative approach to estimate the health economic value of a non-disease modifying therapy for patients with multiple sclerosis: a Swedish application – Poster 1032

About Biogen IdecThrough cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia 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 labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Dimethyl FumarateDimethyl fumarate, also known as BG-12, is an investigational oral therapy in late-stage clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS), the most common form of MS. Dimethyl fumarate is the only currently known investigational compound for the treatment of RRMS that has experimentally demonstrated activation of the Nrf-2 pathway.

Dimethyl fumarate is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.

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