Biogen Idec Passes Pivotal Trial With Oral MS Drug; Shares Climb

4/11/11Follow @xconomy

Biogen Idec is the world’s biggest maker of multiple sclerosis drugs, and today it just cleared a hurdle that might help it stay at the top of the heap for years to come.

The Weston, MA-based biotech giant (NASDAQ: BIIB) said today that its oral MS drug candidate, dimethyl fumarate (BG-12), met its main goal of reducing MS flare-ups over two years, when compared with a placebo, in a pivotal study of 1,200 patients known as DEFINE. The drug was found effective when given either twice a day or three times a day, Biogen Idec said. The Biogen treatment also met all of its secondary goals, such as reducing the number of new or enlarging brain lesions, and slowing the rate of disability from the neurodegenerative disorder—which, often over a period of years, robs people of their ability to walk.

“We are very pleased with these data and believe that BG-12 has the potential to offer MS patients a highly effective oral treatment option with a strong safety profile,” said Doug Williams, Biogen Idec’s executive vice president of research and development, in a statement.

Today’s statement from Biogen didn’t disclose any specific details about the safety profile, or the magnitude of the benefit patients experienced. The data is still being analyzed, and will be presented at a future scientific meeting, the company said. Plus, Biogen Idec needs to reproduce the benefit of the oral drug in one more ongoing pivotal trial, known (naturally) as CONFIRM.

The new oral drug is critical for Biogen’s competitive position. Biogen is the world’s largest maker of MS drugs on the strength of its 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 back in September for fingolimod (Gilenya). Another oral MS drug candidate from Germany-based Merck KGaA failed to win FDA clearance in February.

There’s no way to know how the Biogen oral drug stacks up with Novartis’s treatment until more complete data sets come out at scientific meetings, but optimism is in the air among Biogen shareholders this morning. Biogen stock climbed more than 5 percent to $77.37 at the opening bell of trading this morning.

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