Monday, January 26, 2009

The Race for a MS Pill

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.
Biogen shares fell 6.8% to $47.42 at 4 p.m. Friday in composite trading on the Nasdaq Stock Market. Merck's shares rose 8.6% in European trading to €69.89 ($90.75). The company is majority-owned by the Merck family of Germany.
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. The drug currently is used in injectable form to treat leukemia.
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 placebo for two years. The rate of relapses, or flare-ups of 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 so-called 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.
In a news release, Merck said cladribine patients had suffered more often than the placebo patients from a side effect known as lymphopenia, when the body lacks enough immune-system cells in the blood. The company didn't discuss the severity of the condition, its consequences or how often it occurred.
The company said it would present the study's full results at a coming medical conference.


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Libby said...

Cathy, isn't this the most EXCITING news ever?? i know it's not coming tomorrow, or maybe not even in time for me, but...think of all the people it may help in the future!

Cathy said...

This is indeed wonderful news.