Biogen Idec rises on strong Ph III data with oral MS drug BG-12

US drugmaker Biogen Idec (Nasdaq: BIIB) shares closed up 7.2% at $78.55 6.4% in heavy trading yesterday, after announcing positive top-line results from DEFINE, the first of two pivotal Phase III clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis (RRMS).

Results showed that 240mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a highly statistically-significant reduction (p<0.0001) in the proportion of patients with RRMS who relapsed at two years compared with placebo. Both doses of BG-12 also met all of the secondary study endpoints, providing a statistically-significant reduction in annualized relapse rate, in the number of new or newly enlarging T2 hyperintense lesions, in new gadolinium-enhancing (Gd+) lesions, and in the rate of disability progression as measured by the Expanded Disability Severity Scale (EDSS) at two years.

Late comer to oral MS drug sector