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BIOGEN IDEC INITIATES PHASE III PROGRAM FOR MS TREATMENT

January 10, 2007

Biogen Idec has begun a Phase III clinical program for BG-12, an oral fumarate in development for relapsing-remitting multiple sclerosis (MS). The DEFINE and CONFIRM studies will include more than 2,000 total patients. These studies have been initiated internationally, and Biogen Idec plans to initiate these studies in the U.S. later this year.

DEFINE and CONFIRM are two-year, randomized, multicenter, double-blind, placebo-controlled, dose-comparison studies to determine the safety and efficacy of BG-12 in subjects with relapsing-remitting MS. CONFIRM will also include a Copaxone (glatiramer acetate) reference comparator arm. Endpoints of both studies include evaluating the effect of BG-12 on measurements of clinical relapse, the progression of disability and various magnetic resonance imaging measures.

Data from a Phase II study designed to evaluate the efficacy and safety of BG-12 were presented at two medical meetings in 2006. The multicenter, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10 countries in Europe. Patients were randomized to receive placebo or BG-12 at 120, 360 or 720 mg per day orally for six months. The patient group treated with 720 mg of BG-12 per day had a 69 percent reduction in the mean number of new gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720-mg dose group also had a 48 percent reduction in new or newly enlarging T2-hyperintense lesions at six months compared with baseline. Although the study was not powered to achieve statistical significance for this endpoint, there was a 32 percent reduction in relapse rate compared with placebo at the 720-mg dose.

Data suggest that BG-12 is an immunomodulator with a novel mechanism of action with a combination of cytoprotective and anti-inflammatory properties. Based on available clinical and scientific information with BG-12 and fumarates, there is strong technical rationale for development of BG-12 in a number of T-cell mediated autoimmune and/or inflammatory diseases, according to Biogen.