* Files New Drug Application with U.S. regulator
* Move comes two months after European filing
* Merck ahead in race to bring first MS pill to market
FRANKFURT, Sept 30 (Reuters) - Germany's Merck KGaA filed for approval of its multiple sclerosis (MS) pill cladribine in the United States in a bid to bring the first oral treatment against the debilitating disease to market.
The drugs-to-chemicals hybrid said on Wednesday it submitted a New Drug Application with the U.S. Food and Drug Administration (FDA), two months after regulatory filing in Europe.
The move follows a pivotal Phase III clinical trial, which showed in January that cladribine reduced the number of relapses per year in patients with some forms of MS by 58 percent compared with a placebo.
In a best-case scenario, the pill would come to the U.S. market in the second quarter of 2010, and European market launch would ideally be in the last quarter of 2010, the head of Merck's drugs unit Elmar Schnee told Reuters earlier this month.
The filing helps the German drugmaker make headway over Swiss rival Novartis, which is planning to seek U.S. and European approval for an MS pill known as FTY720 at the end of this year.
Cladribine and 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.
The company has declined to give an estimate for annual peak sales for the pill but analysts at Piper Jaffray have recently predicted 626 million euros ($918 million), with other brokerages expecting more.
Biogen Idec is also developing an oral MS drug, known as BG-12, but it is not as far advanced as Merck or Novartis.
(Reporting by Ludwig Burger; editing by Elaine Hardcastle)