Biogen's MS drug meets study goal

Biogen Idec's experimental multiple sclerosis drug met the main goal in the first of two important late-stage studies, the US…

Biogen Idec's experimental multiple sclerosis drug met the main goal in the first of two important late-stage studies, the US biotechnology company said.

Biogen shares rose more than 5 per cent amid optimism the drug, if approved will strengthen Biogen's position in the highly competitive market for multiple sclerosis drugs.

The drug, BG-12, also met the secondary goals of the study, according to Biogen, which sells the multiple sclerosis treatments Tysabri and Avonex.

In the study of more than 1,200 patients, BG-12 administered either twice or three times a day showed a highly statistically significant reduction in the number of patients who relapsed at two years compared with placebo.

Many analysts had not expected the drug to achieve a statistically significant result when given only two times a day.

"BG-12 is not assumed in our model and could be a modest contributor over time to offset flat to declining sales of Tysabri and Avonex," said Geoff Meacham, an analyst at JP Morgan in a research note. "Overall, BG-12 data, while positive, are not enough for us to move to a more positive stance." The company has a "neutral" rating on the stock.

This week, at the annual meeting of the American Academy of Neurology, data will be presented from rival companies, including Teva Pharmaceutical, which could give an indication of how BG-12 might stack up against new competitors.

"While today's news is a positive and above expectations, we are still cautious going into the AAN meeting this week, given data from other developmental compounds should highlight the growing competition in the MS space," Meacham said.

While most MS drugs are currently injected or infused, the battleground is increasingly for pills, such as BG-12, that can be taken orally.

Strong competition is expected from Novartis AG's recently launched oral pill Gilenya, and an experimental drug in development from Teva Pharmaceutical Industries called laquinimod, is also seen as potentially strong competition. Teva will be releasing additional data about the drug at the AAN meeting.

An injectable drug being developed by Genzyme, which recently agreed to be acquired by Sanofi-Aventis SA could also present competition as it has shown superior efficacy, but some analysts are concerned about its side effect profile.

The overall incidence of side effects was similar among patients taking BG-12 and those taking a placebo.

Biogen released initial top-line results of the study, and said full data would be presented at a future medical meeting.

Results from a second Phase III study are expected in the second half of this year.

Reuters