Biogen Idec Inc., the world’s largest maker of multiple sclerosis medicines, said its experimental MS pill BG-12 was safe and reduced the risk of patients relapsing in a second late-stage clinical trial.
The study evaluated BG-12 and Copaxone, an injected treatment from Teva Pharmaceutical Industries Ltd. It found Biogen’s pill reduced the annual rate of relapse by 44 percent when taken twice daily, and by 51 percent when taken three times a day compared with placebo, meeting the trial goals, the Weston-based company said today in a statement. Copaxone reduced the rate by 29 percent versus placebo.
Investors had been awaiting the data since Biogen reported positive results in April from an earlier study. The pill may become one of the best options to treat MS, with the potential to garner up to $3 billion in annual revenue, said Michael Yee, an analyst with RBC Capital Markets in San Francisco.
“These data generally ‘confirm’ BG-12’s efficacy and clearly show that it’s likely a more effective drug than Teva’s Copaxone,’’ Mark Schoenebaum, an analyst with ISI Group in New York, wrote in a note to clients today. “On a scale of 1-10, with ‘10’ being absolute best case, we would put these data at perhaps 8 or 9.’’
BG-12 also showed a “favorable’’ safety profile, Biogen said. The study, dubbed Confirm, was done as part of the third and final phase of testing usually required for U.S. approval.
Biogen gained 8.7 percent to $116.20 as of 7:56 a.m. New York time in early trading. The shares were up 59 percent this year before today.
Copaxone is the Israeli drugmaker’s best-selling medicine, accounting for 23 percent of Teva’s second-quarter revenue. Teva fell as much as 5.8 percent in Tel Aviv and was down 5.4 percent to 137.3 shekels at 1:30 p.m.
BG-12 also reduced the number of new lesions compared with placebo more than Copaxone, and showed a greater reduction in the proportion of patients who relapsed. BG-12 lowered the proportion by 34 percent taken twice daily and 45 percent taken three times a day, compared with 29 percent for Copaxone.
The most common form of MS is relapsing-remitting, characterized by flare-ups followed by periods of recovery. MS affects about 2.1 million people in the world, with about 400,000 patients in the U.S., according to the National Multiple Sclerosis Society. The chronic disease attacks the central nervous system and can cause numbness in limbs, paralysis and vision loss.
“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,’’ Doug Williams, Biogen’s head of research and development, said in the statement today. “We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible.’’
Biogen’s top-selling medicines, Avonex and Tysabri, are given by injection. The drugs generated revenue of $2.52 billion and $900 million, respectively, for the company in 2010.
“This could be well-positioned as a very preferred first- or primarily second-line therapy,’’ RBC’s Yee said of BG-12 in a telephone interview last week after data from the earlier study were presented. “I think this drug could take up to 20 percent of the market.’’