Biogen’s Multiple Sclerosis pill succeeds at a late phase clinical trial

By Dr. Ananya Mandal, MDOct 24 2011

Biogen Idec Inc. has reported success in a late stage clinical trial of its oral multiple sclerosis drug BG-12, a competitor's of Teva Pharmaceutical Industries’ Laquinimod. A 240-milligram dose of BG-12 administered two or three times a day significantly reduced the proportion of patients who relapsed by 49% and 50%, respectively, after two years compared with a placebo.

“BG-12 may be a valuable treatment option for MS patients, combining strong efficacy, a favorable safety profile and oral administration,” said Dr. Ralf Gold at St. Josef-Hospital/Ruhr-University at Bochum, Germany. “Preclinical research has shown that BG-12 has anti-inflammatory and neuroprotective effects. If the clinical responses seen in Define are replicated in its second Phase 3 trial, BG-12 has the potential to provide a new approach to treating multiple sclerosis and be an important step forward for patients.”

The company noted that these data were presented in a late-breaking oral presentation at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis in Amsterdam.

If approved, BG-12 may generate as much as $3 billion in annual revenue in the next seven years, or about 20 percent of the MS market, said Michael Yee, an analyst with RBC Capital Markets. “This was the de-risking event,” Yee said. “It suggests there are no issues to be concerned about at this time for BG-12.” Yee said the information also removes concerns the drug wouldn’t perform well in a trial called Confirm, that like Define is part of the third and last phase of studies generally required for U.S. regulatory approval. Biogen will present data from Confirm later this year, Doug Williams, the company’s head of research and development, said today in the statement.