Biogen to present late-stage clinical therapies for MS at ECTRIMS Congress

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Oct 6 2010Biogen Idec

Biogen Idec (NASDAQ: BIIB) today announced that more than 45 company- and partner-sponsored platform and poster presentations will be presented during the 26^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden, October 13 - 16, 2010. ECTRIMS is the world's largest medical meeting dedicated to research and advances in multiple sclerosis (MS). Data being presented will include Biogen Idec's currently marketed products, TYSABRI^® (natalizumab) and AVONEX^® (interferon beta-1a), as well as four late-stage programs: prolonged-release fampridine tablets, the oral compound BG-12 (dimethyl fumarate), PEGylated interferon beta-1a and daclizumab.

“With three compounds in late-stage clinical studies Biogen Idec has one of the deepest late-stage pipelines in the industry. We are not resting on our laurels and will continue to work tirelessly until we find a cure for this disease.”

"We are fully committed to the MS community with our leading MS therapies, AVONEX and TYSABRI, both of which have been used in a broad range of patients worldwide. We are also working diligently towards moving prolonged-release fampridine tablets, a treatment with the potential to improve walking ability in MS patients, through the regulatory process in markets outside of the United States," said John R. Richert, M.D., Vice President and Senior Fellow, Neurology Research and Development at Biogen Idec. "With three compounds in late-stage clinical studies Biogen Idec has one of the deepest late-stage pipelines in the industry. We are not resting on our laurels and will continue to work tirelessly until we find a cure for this disease."

Data from one of the industry's most extensive MS pipelines

Prolonged-release fampridine tablets

There will be six posters featuring prolonged-release fampridine tablets, which is being developed for its potential to improve walking in adult patients with MS. Biogen Idec has licensed the rights to develop and commercialize prolonged-release fampridine tablets outside the United States (U.S.) from Acorda Therapeutics, Inc. Acorda is developing and commercializing this compound in the U.S., where it is approved for use under the trade name AMPYRA^® (dalfampridine) Extended Release Tablets, 10 mg.

Highlights include the following posters:

Walking speed improvements in a pooled analysis of prolonged-release fampridine in patients with multiple sclerosis - Poster P922
Analysis of open-label extension studies of prolonged-release fampridine tablets in multiple sclerosis - Poster P518

BG-12 (dimethyl fumarate)

There will be four BG-12 posters and presentations. BG-12 showed positive safety and efficacy data in a Phase IIb study, which supported its further clinical investigation. Results from this study also stimulated further evaluation of BG-12's potential for neuroprotection. Two Phase III clinical trials, DEFINE and CONFIRM, have completed enrollment and full data readouts are expected in 2011.

Feasibility of magnetization transfer ratio imaging in multicentre trials of patients with multiple sclerosis - Poster P764
BG-12 exhibits anti-inflammatory and prometabolic effects in brain astrocytes - Poster P879
Oral BG-12 in combination with interferon beta-1a or glatiramer acetate: pharmacokinetics, safety and tolerability - Poster P478
Neuroprotective effects of dimethyl fumarate and monomethyl fumarate on primary cultures of human spinal cord astrocytes after oxidative challenge - Poster P887

PEGylated interferon beta-1a

There are three PEGylated interferon beta-1a posters being presented. PEGylated interferon beta-1a is being evaluated for its ability to last longer in a patient's system, potentially leading to an MS treatment that would require fewer injections. Data presented at ECTRIMS supports the continued evaluation of the compound in the ongoing Phase III ADVANCE clinical study, which is currently enrolling patients.

The ADVANCE Phase 3 study of PEGylated interferon beta-1a in relapsing multiple sclerosis: rationale and design - Poster P904
Development of a high-throughput whole-blood expression profiling method to identify genes induced by IFN beta-1a or PEGylated IFN beta-1a in healthy control subjects - Poster P971
Pharmacological changes related to the Th17 regulatory network induced by interferon beta-1a and PEGylated interferon beta-1a in healthy volunteers - Poster P968

Daclizumab

Two daclizumab posters are being presented. Daclizumab is currently in late-stage clinical trials for the treatment of relapsing-remitting MS, the most common form of MS. Both posters being presented at ECTRIMS support the evaluation of daclizumab in the ongoing, Phase III DECIDE trial. Biogen Idec is developing daclizumab in collaboration with Abbott.

Daclizumab treatment and CD56^bright NK cell counts independently predict being lesion free on brain MRI scans: Results from the Phase II CHOICE trial - Poster P557
CD56^brightNK cell counts correlate with therapeutic response to daclizumab independently of other pharmacodynamic response markers - Poster P561

Biogen Idec is also sponsoring two symposia during the Congress. Both will feature presentations from world-renowned experts in MS: