The biotechnology company on Wednesday reported positive results from the second of two phase 3 trials on its MS drug candidate BG-12. In a two-year study, a twice daily dosage reduced the annualized relapse rate for MS patients by 44 percent compared to a placebo. At three times a day dosage, relapse rates were reduced by 51 percent. Perhaps more important, BG-12 performed better than a competing Teva Pharmaceuticals (NASDAQ:TEVA) MS drug, Copaxone, which reduced the relapse rate by 29 percent compared to a placebo. The results of this second study follow the release of positive results of a first phase 3 study in April.
Weston, Massachusetts-based Biogen Idec already makes its MS drugs Tysabri and Avonex at its facility in Research Triangle Park, North Carolina. Tysabri is administered by intravenous infusion; Avonex is an injectable drug. Industry observers are excited about BG-12 because it is a pill that would be a welcome alternative for many MS patients.
“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.”
Williams added that the company is working to prepare regulatory submissions with the goal of “making BG-12 available to MS patients as quickly as possible.”
Biogen Idec investors cheered the news, which comes two days before the company is scheduled to release third-quarter financial results. Biogen Idec shares jumped more than 7 percent to $115 in mid-morning trading. But Teva shares fell by more than 5 percent on the news.