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DEFINE-ing Boost

More data for BG-12 boosts Biogen Idec $4B; erases $4.5B from Teva in MS race

What a difference more data make. Biogen Idec Inc. (NASDAQ:BIIB) added $4 billion to its market cap last week when it announced detailed results from the Phase III DEFINE trial for oral multiple sclerosis candidate BG-12.

Investors shaved even more value - $4.5 billion - off Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA), whose oral laquinimod also is in Phase III testing. Teva's partner, Active Biotech AB (SSE:ACTI), lost $70.8 million in market cap for the week.

Biogen Idec already had added $2.4 billion in market cap earlier this month when it announced that twice- and thrice-daily BG-12 met the primary endpoint in the DEFINE trial in relapsing-remitting MS. But because BG-12 required more than once-daily dosing and full data were not yet available, clinicians told BioCentury that once-daily laquinimod had the best chance of replacing injectables as SOC for first-line RRMS based on a combination of efficacy, safety and convenience (see BioCentury, April 18).

Last week's detailed results for DEFINE changed the picture.

On the primary endpoint, twice-daily BG-12 significantly reduced the proportion of patients who relapsed at two years by 49% vs. placebo (p<0.0001). On the secondary endpoints, BG-12 significantly reduced annualized relapse rate (ARR) and disability progression by 53% and 38%, respectively.

By comparison, once-daily laquinimod showed a 23% relative reduction in ARR from baseline to two years vs. placebo in the Phase III ALLEGRO trial in RRMS.

ARR was the primary endpoint in the study, which also released

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