[Today's BIIB-ELN CC was one of the strangest I’ve heard –it seemed the answer to almost every question was a laconic, “No,” with no added color. Why even hold a CC under such circumstances?]
By DAVID ARMSTRONG Staff Reporter of THE WALL STREET JOURNAL November 9, 2004
An experimental multiple sclerosis drug, Antegren, prevents more relapses than drugs already on the market, according to some partial clinical-trial data released by Biogen Idec Inc. of the U.S. and Elan Corp. of Ireland.
Antegren is one of the most anticipated new drugs of the year. The U.S. Food and Drug Administration is widely expected to approve the drug this month after granting Antegren an expedited, priority review earlier this year.
The companies said Antegren -- whose chemical name is natalizumab -- reduced the rate of relapses 66% compared with a placebo's rate of reduction during the first year of treatment. A relapse is considered a temporary worsening of symptoms, such as difficulty walking, blurriness, tingling and numbness. Multiple sclerosis is a chronic disease of the central nervous system that affects about 400,000 people in the U.S.
The companies said the data, covering 942 patients, also show that four MS drugs on the market reduced the relapse rate 29% to 32% compared with a placebo after two years. Biogen and Elan said they didn't expect the relapse rate to change much at the two-year point. The two-year results will be released next year.
A number of analysts expect Antegren to be a blockbuster drug, with annual sales of more than $2 billion. The drug works by binding to cells that are believed to damage brain tissue and cause inflammation, thereby preventing the cells from crossing from the blood stream and into the brain.
The release of the data surprised investors, who had been told the companies wouldn't release clinic trial results until the FDA approved the drug. The companies said they decided to put out partial data now -- minus the actual rates of symptom reduction for each drug in the trials -- because trial investigators were briefed on the numbers at a meeting over the weekend.
Stephen Reingold, the vice president for research at the National Multiple Sclerosis Society, said the released results were significant, but not definitive. He said the placebo control groups in every clinical trial are unique, making comparisons difficult. The only way to know if Antegren is better than existing therapies is to conduct clinical trials comparing the drug directly to drugs on the market, he said.
The chief executive of Serono SA, the maker of rival MS drug Rebif, criticized Biogen for releasing only selected data. Ernesto Bertarelli said the failure to disclose full clinical trial results suggests some of the data is "not as pleasing as they like."
At 4 p.m. in New York Stock Exchange composite trading, Elan was up 4%, or $1.12, to $29 a share, while Biogen shares were down 46 cents to $60.40 on the Nasdaq Stock Market.
Investors and patients also are expecting results from a second trial involving Antegren that is being scrutinized by the FDA. That trial is investigating whether or not Antegren works better in combination with Avonex, an existing MS drug from Biogen. Those results, expected to be released this month, are critical to determining just how successful Antegren will be for Biogen.
Doctors, meanwhile, are eager to review data studying the effect Antegren has on slowing the progression of the disease. <<
Market Data 
Markets 
AI
