By Naomi Kresge
Jan. 23 (Bloomberg) -- Merck KGaA, the German drugmaker seeking to be first with an oral medicine for multiple sclerosis, said its experimental pill cladribine prevented flare-ups of the debilitating neurological disease in a study.
Patients who took the pill suffered 55 to 58 percent fewer relapses, depending on the dose, than those who took a placebo during the two-year study, the Darmstadt, Germany-based company said today.
The German drugmaker said it is on track to submit an application for approval to European and U.S. regulators by the middle of this year. Merck shares climbed 5.53 euros, or 8.6 percent, to 69.89 euros in Frankfurt.
Cladribine tablets are among several oral medications for multiple sclerosis now in the final stage of clinical testing. Used to treat leukemia since the 1990s, the drug reduces the number of lymphocytes, white blood cells believed to be linked to multiple sclerosis, a disease in which the body’s immune system attacks the central nervous system. Side effects of headaches and cold symptoms were comparable in the dummy pill and cladribine patient groups, Merck said today.
Merck and Swiss drugmaker Novartis AG have said they will ask regulators in the U.S. and Europe this year to approve pills to treat the disease. Novartis released preliminary results last month showing its pill, known as fingolimod, cut relapse rates as much as 52 percent more than a standard therapy.
Merck already makes Rebif, one of the three beta interferons now commonly prescribed for multiple sclerosis. The injected drug, which will begin to lose patent protection in 2012, had 1.22 billion euros ($1.68 billion) in sales in 2007.
Patient advocates will be watching the long-term side effects of cladribine, which was given over a shorter time period to leukemia patients than it likely will be to multiple sclerosis sufferers, said Dr. Doug Brown, research manager for the Multiple Sclerosis Society in London, before today’s results were released. Brown said they will also want to see whether the oral medicines slow progression of the disease.
Merck and Novartis have said they will present full clinical trial results for their experimental pills at medical conferences later this year. Merck said the new study, which it funded, followed about 1,300 patients.
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