Wednesday, October 26, 2011

Biogen oral MS drug lands positive trial results

By Julie M. Donnelly, Boston Business Journal

Biogen Idec (Nasdaq: BIIB) stock surged to a new 52-week high this morning on positive top-line data from the second of two Phase 3 trials for its potential oral therapy for multiple sclerosis, BG-12. The Weston-based biotechnology company planned to submit the drug to the U.S. Food and Drug Administration for approval early next year.

If approved, analysts estimate the therapy could be worth up to $3 billion per year.

Biogen shares rose to $117.48, before settling back to $114.99 in late morning trading Wednesday, still up almost 8 percent from $106.87 at the previous close.

The new data shows BG-12 met the study’s primary endpoint by significantly reducing annualized relapse rate by 44 percent for patients taking the experimental drug twice a day and by 51 percent for patients taking the drug three times per day, versus placebo, at two years.

“We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients,” Doug Williams, Biogen Idec’s executive vice president of research and development, said in a statement. “We are gratified by these strong efficacy and safety results, which, when combined with BG-12’s oral route of administration, position it as a potentially important MS therapy. We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible.”

On Oct. 21, Biogen released positive data from the first of the two Phase 3 trials.

On Thursday, the company plans to hold a groundbreaking event for two new buildings in Cambridge at 17 Cambridge Center and 225 Binney Street, which will be completed in 2013. The company plans to move its headquarters back to Cambridge from Weston, and the new buildings will increase the company’s Cambridge footprint to 1.2 million square feet.