Biogen Idec’s new oral pill for multiple sclerosis passed its first pivotal trial back in April, and today the company got the confirmation it was looking for from a second major study.
The Weston, MA-based biotech company (NASDAQ: BIIB) said today that dimethyl fumarate (BG-12) met its main goal of reducing multiple sclerosis flare-ups over a two-year period in a study of 1,430 patients with relapsing forms of MS. As a twice-daily pill, the Biogen Idec drug was able to reduce MS flare-ups by 44 percent when compared to a placebo, and by 51 percent when it was given three times a day, the company said. Both doses of the new treatment showed “favorable” safety and tolerability, Biogen Idec said, that was similar to what scientists saw this spring in another study of about 1,200 patients. The drug also met all its secondary goals in the study, in both doses, the company said.
Shares of Biogen Idec rose by $8.20 a share, or 7.6 percent, to $115.07 at 10:06 am Eastern time after the news.
“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 executive vice president of R&D, 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.”
The new oral drug is critical for Biogen’s long-term competitive standing as the world’s largest maker of multiple sclerosis drugs. Biogen’s key franchises today are with the injectable therapies interferon beta (Avonex), and natalizumab (Tysabri). But each of these products has its weaknesses—patients tend to relapse on interferons over time and grow weary of the injections, while Tysabri is dogged by a dangerous side effect known as PML. Many of the 400,000 U.S. patients with multiple sclerosis have long desired oral pill alternatives, and haven’t had one until recently. Swiss pharmaceutical giant Novartis won FDA approval a year ago for fingolimod (Gilenya). Another oral MS drug from Hawthorne, NY-based Acorda Therapeutics (NASDAQ: ACOR) called dalfampridine (Ampyra) is cleared by the FDA to improve walking ability of MS patients.
Thomas Wei, an analyst with Jefferies & Co, wrote earlier this week that he heard positive feedback about the oral MS drug from Biogen, when he surveyed 17 neurologists at a recent medical meeting called ECTRIMS. He has a $124 a share price target on Biogen stock.
“Many physicians deferred judgment when asked about BG12, citing the lack of head-to-head data relative to other oral therapies,” Wei wrote in an Oct. 24 note. “However, there was universal acknowledgment that the data from the first Phase 3 trial of BG12 was highly robust. For those willing to give an opinion, we found that BG12 was always the oral drug of choice.”
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