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Merck Serono's MS drug approved in Russia

Merck Serono's oral relapsing-remitting multiple sclerosis (RRMS) drug cladribine has been approved in Russia

Merck Serono's oral relapsing-remitting multiple sclerosis (RRMS) drug cladribine has been approved in Russia and is expected to be made available there in early 2011 under the trade name Movectro.

Merck claim that the Russian registration is a result of the data from the Clarity study, a placebo-controlled phase III clinical trial in relapsing-remitting MS, evaluating cladribine tablets.

The primary endpoint of the clarity study was reduced relapse rates, while the secondary endpoints were the risk of disability progression, and MRI measures of disease activity at 96 weeks.

To date Merck has submitted regulatory applications for cladribine tablets in about 40 countries.

Elmar Schnee, member of the Merck board and head of Merck Serono division, said: "This approval for cladribine tablets means that people with multiple sclerosis in Russia are expected to benefit soon from this oral treatment. We expect other regulatory approvals in the near future."

Gavin Giovannoni of the UK's Blizard Institute of Cell and Molecular Science and principal investigator of CLARITY, said the approval will "transform the way Russian patients with relapsing-remitting MS and physicians approach therapy options".

Getting approval in Russia gives Merck a lead over Novartis in the eastern European markets with its rival oral MS product. However, the Swiss major is ahead in the US, after the US Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of fingolimod, also known as FTY720, last month.

In June, Merck resubmitted cladribine with the FDA, seven months after receiving a 'refuse to file' letter from the agency for the treatment. Merck is also hoping for a positive response from advisors to the European Medicines Agency (EMA) in the third quarter.

12th July 2010

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