By Mary Welch

Biogen Inc.'s blockbuster multiple sclerosis drug, Avonex, showed a highly statistically significant benefit in delaying the disease's development, which will allow Biogen to apply for a broader label.

"The first reaction is that this is a very positive development for Biogen," said Peter Drake, vice president and senior biotech analyst with Prudential Vector Healthcare of New York. "It gives them positive clinical indications of success before the trial ended and it allows Biogen to file and receive a broader label. I expect this will expand sales by 10 percent to 15 percent."

The CHAMPS study was stopped by an independent data monitoring committee after the drug showed a highly statistically significant beneficial effect on delaying the development of clinically definite multiple sclerosis (MS). The secondary endpoints of MRI analysis also were positive, supporting the primary endpoint.

The committee determined that a beneficial effect of Avonex on the primary endpoint had been established at the interim analysis, exceeding the pre-established criteria (p<0.029) required for early trial termination.

CHAMPS, which stands for Controlled High Risk Subjects Avonex Multiple Sclerosis Prevention Study, was a randomized, double-blind, placebo-controlled trial. The primary objective was to ascertain if Avonex is beneficial in delaying the onset of clinically definite MS in people who have experienced the recent onset of a first demyelinating event. Clinically definite MS is identified by the presence of at least two demyelinating events, separated by time and location in the central nervous system.

The CHAMPS study, which started in 1996, involved 383 patients in the U.S. and Canada. Patients received either 30 micrograms of Avonex or placebo injected intramuscularly once a week for up to three weeks.

Drake's projected 10 percent to 15 percent jump in sales is not a small matter. Avonex has been fueling Cambridge, Mass.-based Biogen's bottom line since it was introduced into the market in 1996. In 1999, Avonex's sales were $621 million, a jump of more than 50 percent over its 1998 sales of $395 million. International sales in 1999 totaled more than $170 million, representing an increase of more than 90 percent over the previous year.

Avonex (interferon beta-1a) is the world's leading multiple sclerosis drug, both in terms of number of patients and sales volume. Its market share is more than 2-to-1 over the other MS drugs on the market in the U.S. Some 83,000 patients are now on Avonex worldwide, an increase of almost 50 percent over the number of patients in 1998.

Avonex is currently approved for MS patients with relapsing and remitting symptoms and is in a Phase III trial in secondary, progressive MS. That trial should wrap up around the middle of the year.

"Biogen has the middle market and now they will be applying for a broader label for early MS," Drake said. "We've got data on the progressive MS trial coming out soon. In the next year, Avonex will be able to address all stages of the disease. It will follow the bell-shaped curve of the disease."

Such a broad label would give Biogen the upper marketing hand in an ever-increasing competitive market, Drake maintained.

Last week an FDA advisory committee recommended approval of Novantrone, which was developed by Immunex Corp., of Seattle, for treating patients with progressive multiple sclerosis. The company requested the FDA expand the drug's label to include its use to slow progression of neurologic disability and reduce the relapse rate in patients with progressive multiple sclerosis.

"We know Avonex works in patients in the mid-stage and now it works in early monosymptomatic patients," Drake said. "This puts another quiver in the arrow of Biogen's sales team. They'll go out and be able to differentiate themselves from the competitors."

Another advantage is that, assuming FDA approval of the broadened label, patients would be on Avonex earlier. "They start getting on Avonex sooner and as the disease progresses, they'll stay on Avonex," Drake said. "There's no reason to switch. This will be a strategic marketing barrier for Biogen against its competitors."

Biogen's stock (NASDAQ:BGEN) closed Tuesday at $94.375, up $8.125.