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Tuesday, April 24, 2012

Biogen Idec sees positive Phase 3 results of MS drug


By Lori Valigra


Biogen Idec Inc. (NasdaqGS: BIIB) shares were up Tuesday morning after the company announced positive data from CONFIRM, the second Phase 3 clinical trial of its oral BG-12 drug candidate for people with relapsing-remitting multiple sclerosis (RRMS).

The stock was up more than 1 percent in early morning trading to $127.49 per share and in a research note April 4, Goldman Sachs analysts upgraded Biogen Idec to a “buy” rating from “neutral,” writing, “Despite the significant outperformance... we see the risk/reward as attractive. We see the success of BG-12 supporting the current valuation.”

The company said in a release that BG-12 demonstrated efficacy across a variety of clinical and radiological outcome measures, as well as favorable safety and tolerability profiles. In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg of BG-12, administered either twice a day or three times a day, for two years. 

The data, along with results from BG-12’s first Phase 3 study, DEFINE, were included in regulatory applications that were submitted to U.S. and European Union regulatory agencies early this year. 
 
“Results from CONFIRM complement the profile we have seen for BG-12 throughout its clinical development program, which now includes robust data sets from two global, placebo-controlled Phase 3 pivotal studies with more than 2,600 multiple sclerosis patients,” Douglas E. Williams, Biogen Idec’s executive vice president of research and development, said in a written statement. “If approved by regulators, we believe BG-12 could be an important new oral therapeutic option for MS patients.”



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