Biogen, Elan Expect FDA to OK Antegren

Biogen Idec Inc. and Elan Pharmaceuticals Inc. said Monday that their experimental drug for multiple sclerosis significantly reduced the relapse rate of patients who received it in a clinical trial.

The companies said they believed the intravenous drug, Antegren, would receive Food and Drug Administration approval this month, becoming the first new treatment for multiple sclerosis in more than a decade.

Analyst Jennifer Chao of Deutsche Bank Securities projected Antegren sales of $240 million for next year, and analysts have said Antegren could one day become a $1-billion-a-year product. That would be a boost for the biotechnology community in San Diego County, where the companies plan to manufacture the drug.

Data released Monday showed a 66% reduction in the relapse rate in patients taking Antegren compared with patients receiving a placebo. By contrast, existing treatments, including Biogen Idec’s Avonex, reduce relapse rates by 30% to 40%.

Multiple sclerosis is a nerve disorder that over time can cause blurred vision, impaired speech and reduced muscle control. The disease is marked by periods of flare-ups, or relapses, and good health, or remissions. About half of all patients end up being permanently disabled.

Stephen C. Reingold, research head of the National Multiple Sclerosis Society, cautioned against comparing drugs that haven’t been tested in head-to-head trials. Reingold noted that Antegren had not yet been shown to slow progression of multiple sclerosis.

“The data reported today is promising and hopeful for people with MS,” Reingold said Monday. But “I don’t think we have a clue [about] which medication is better than the other.”

The companies should know early next year whether Antegren slows the course of multiple sclerosis, said Burt A. Adelman, head of research and development at Biogen Idec.

However, Adelman said there was an association between relapses and disease progression.

“The profound effect we are reporting today encourages us that we would in fact see an important effect on disability,” he said.

Adelman said Biogen Idec would consider head-to-head trials, but he also left little doubt that he thought Antegren was better than existing drugs.

“The magnitude of the difference in relapse rates with Antegren versus historical agents is very significant,” he said.

Biogen Idec is based in Cambridge, Mass., and resulted from the 2003 merger of San Diego-based Idec Pharmaceuticals and Biogen. Elan is based in Ireland.

Biogen Idec is completing a $380-million drug factory in Oceanside, where it eventually plans to produce Antegren.

Biogen Idec’s shares fell 46 cents to $60.40 on Nasdaq. The company’s stock is up nearly 60% since January, on enthusiasm about Antegren.