Biogen Idec's oral BG-12 handily outstripped Teva's Copaxone in a Phase III study for multiple sclerosis, setting up a direct march to the FDA with positive late-stage data covering 2,600 patients. In its release this morning the Boston biotech posted reduced annualized relapse rates of 44% and 51% for groups taking a 240 mg pill either twice or three times a day over two years. The Copaxone crowd registered a 29% drop in the rate compared to a placebo.
Biogen Idec ($BIIB) has a big stake in the success of BG-12. A drug like this could earn $3 billion a year, according to some analysts, which is enough money to make up for multiple R&D sins of the past. It also makes George Scangos, the new CEO, look good at a time he and his new executive team are shaking up the pipeline and executing an ambitious strategy on partnering and development. While they may not have been around when the original deal for BG-12 was struck, they are in place to reap its rewards.
Teva ($TEVA) is also feeling the heat. Piper Jaffray analyst David Amsellem downgraded Teva specifically because of the prospect of stiff competition from BG-12. And this morning Teva's shares slid by 6%.
"We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients," said Doug Williams, Biogen Idec's R&D chief. "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 the secondary endpoint side BG-12 reduced the number of new or newly enlarging T2-hyperintense lesions by 71% and 73%; Copaxone registered a 54% reduction. BG-12 reduced new T1-hypointense lesions by 57% and 65%; Copaxone 41%. BG-12 reduced the proportion of patients who relapsed by 34% and 45%; Copaxone 29%. The safety profile looked "favorable," according to Biogen, adding that detailed data would be evaluated at an upcoming conference.
- here's the press release
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