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New Data From Phase 3 Studies Provide Additional Evidence Supporting Treatment Effect For Oral BG-12 (Dimethyl Fumarate) In Multiple Sclerosis

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About DEFINE

DEFINE ( Determination of the  Efficacy and safety of oral  Fumarate  IN r Elapsing-remitting MS) was a global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of dimethyl fumarate (240 mg, BID or TID) and enrolled 1,237 people with RRMS. The primary objective was to determine if dimethyl fumarate was effective in reducing the proportion of relapsing patients at two years. Secondary endpoints included reduction in the number of new or newly enlarging T2-hyperintense lesions and Gd+ lesions as measured by MRI, reduction in ARR, and reduction of disability progression as measured by EDSS. Additional endpoints included the safety and tolerability of dimethyl fumarate. Detailed results from DEFINE were presented at the 5 th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in October 2011.

About CONFIRM

CONFIRM ( COmparator and a N oral Fumarate In Relapsing-remitting MS) was a global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of dimethyl fumarate and enrolled 1,430 people with RRMS. The study evaluated two dose regimens of dimethyl fumarate, 240 mg BID and 240 mg TID, as well as a reference comparator of GA (20 mg subcutaneous daily injection). Both dimethyl fumarate and GA groups were evaluated versus placebo. The primary objective was to determine whether dimethyl fumarate was effective in reducing the rate of clinical relapses at two years. Secondary endpoints at two years included reduction in: the number of new or newly enlarging T2-hyperintense lesions and the number of new non-enhancing T1-hypointense lesions (MRI scans were obtained at a cohort of sites); the proportion of patients who relapsed; and in progression of disability as measured by EDSS. Safety and tolerability of dimethyl fumarate were also assessed. Detailed results from CONFIRM were presented at the 64 th Annual Meeting of the American Academy of Neurology (AAN) in April 2012.

About ENDORSE

ENDORSE is an ongoing global, dose-blind extension study to determine the long-term safety and efficacy of dimethyl fumarate (240 mg, BID or TID). The study has enrolled 1,738 patients with RRMS who completed the DEFINE study or the CONFIRM study. Patients participating in ENDORSE will be followed for up to five years. The primary objective is to evaluate the long-term safety profile of dimethyl fumarate. Secondary objectives include: long-term efficacy of dimethyl fumarate on clinical outcomes and MS brain lesions on MRI scans; and effects of dimethyl fumarate on quality of life measurements. It is estimated that the ENDORSE study will be completed in 2016.

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