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Russia okays Merck KGaA's multiple sclerosis pill
Russia is the first country to approve Merck KGaA's (MRCG.DE) new multiple sclerosis pill cladribine, giving the German drugmaker an edge in the emerging market against larger rival Novartis AG.
Both companies have developed oral treatments for the debilitating neurological disorder that offer effective and convenient alternatives to injections, opening up a potential multibillion-dollar market opportunity.
Merck, which will now apply to have the drug listed for reimbursement in Russia, said on Monday it expected to launch its drug in the country for the treatment of relapsing-remitting multiple sclerosis (MS) under the trade name Movectro from early 2011.
Elmar Schnee, the head of its Merck Serono division, added that other regulatory approvals were likely in the near future.
The news is a boost for Merck, whose product has fallen behind Novartis's rival pill Gilenia in the world's biggest market, the United States, and Merck shares rose 0.4 percent by 0833 GMT, outstripping a flat European drugs sector .SXDP.
Gilenia last month won a ringing endorsement from a U.S. advisory panel, while cladribine faced a hold-up at the Food and Drug Administration last November, prompting a resubmission of the drug to the U.S. regulator in June. [ID:nLDE62O0CG]
In Europe, Schnee said on April 9 that European Medicines Agency experts would probably issue an assessment of the drug in the third quarter, adding he was confident about an approval.
Other competing MS pills a year or two behind in development include laquinimod from Teva Pharmaceutical Industries (TEVA.TA), teriflunomide from Sanofi-Aventis (SASY.PA) and BG-12 from Biogen Idec (BIIB.O).
Offering a pill for MS may win over some the 40 percent of MS patients who do not receive therapy and who may be deterred by painful injections and the flu-like symptoms associated with some of the existing drugs, analysts believe.