Merck KgAA Is Leading Contender to Release First Oral MS Drug
JANUARY 24, 2009, 12:08 P.M. ET
By KEITH J. WINSTEIN
online.wsj.com
German drug maker Merck KGaA became the leading contender in the race to release the first oral medicine for multiple sclerosis, after the company announced promising results from a late-stage clinical trial.
Current drugs for MS, in which the body's immune system attacks nerve cells in the brain, leading to tingling, numbness and eventual paralysis, are all injections or infusions.
But several companies -- including Biogen Idec Inc., Novartis AG, and Merck -- are competing to develop pills that could be taken orally. Such drugs could take sales from current injectables from Biogen, Pfizer Inc. and Teva Pharmaceuticals Inc.
Merck on Friday said its cladribine pill met the primary goal of a company-run study on 1,326 patients with relapsing-remitting multiple sclerosis, the most common form of the disease.
Based on the data, the company said it would apply for approval from U.S. and European regulators later this year. That puts Merck about six months ahead of Novartis's pill, analysts estimated, and about two years ahead of Biogen's.
In the study, about 440 people received treatment with a fake pill for two years. The rate of relapses, or flare-ups of the disease's symptoms, was about one every three years. Among 880 patients treated with cladribine, the rate was about one relapse every seven years, a significant improvement.
The study wasn't a straight comparison of Merck's pill versus a placebo. Patients who suffered more than one relapse, or who became more disabled, were given a "rescue option" of an injectable treatment, which may have skewed the results. Merck declined to say how many study patients were given the rescue treatment.
Write to Keith J. Winstein at keith.winstein@wsj.com
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