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* 43-44 pct of patients show no disease activity after 2 yrs
* Merck’s cladribine leading race to be first oral MS drug
* German drugmaker’s shares up 3.4 percent
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By Ben Hirschler and Ludwig Burger
LONDON/FRANKFURT, Sept 11 (Reuters) - A new analysis of data from a clinical trial of Merck KGaA’s oral drug cladribine has underscored its potential as a treatment for multiple sclerosis, researchers said on Friday.
The fresh finding from the Phase III trial showed a short course of cladribine tablets significantly increased the proportion of patients without disease activity after two years.
Research presented at the European Committee for Treatment and Research in Multiple Sclerosis congress in Duesseldorf, Germany, found 43 and 44 percent of patients treated with two different doses of cladribine had an absence of disease activity, compared with 16 percent of those on placebo.
Lead investigator Peter Rieckmann of Germany’s Bamberg Hospital said achieving such long-term remission was a very important goal in treating the condition.
Headline results of the trial, dubbed Clarity, were first presented in April.
“Again quite positive data. We already know cladribine’s good efficacy from earlier Clarity analyses,” said analysts at DZ Bank in Frankfurt.
Shares in Merck rose 3.4 percent by 1230 GMT, outperforming a 0.5 percent gain in the European healthcare index.
The German drug maker is leading the race to develop the first multiple sclerosis drug that can be taken orally, rather than by injection or infusion.
Previous assessments of the study had shown that patients on low-dose cladribine ran a 58 percent lower risk of suffering a relapse over the course of a year than a control group on placebo.
In addition, cladribine had been shown to lower the risk of disability progression by more than 30 percent and there were also sustained reductions in brain lesions, as measured by magnetic resonance imaging (MRI).
Cladribine, like a rival oral drug called FTY720 from Swiss drug maker Novartis, appears more effective than current leading treatments.
But both experimental drugs cause side effects because they interfere with the body’s immune system. As a result, the companies must persuade regulators and physicians that the balance of risk and benefit stacks up.
Cladribine and Novartis’s FTY720 are expected to take a sizable chunk of the $8.6 billion market for MS treatments, currently dominated by injectables from Teva, Biogen Idec, Bayer and Merck KGaA itself.
Merck does not give an estimate for annual peak sales for the pill but analysts at Piper Jaffray have recently predicted 626 million euros, with other brokerages expecting more.
Merck submitted a marketing application for cladribine in Europe in July and expects to file in other countries, including the United States, this month. (Editing by Karen Foster)