September 10, 2010 / 10:27 AM / 9 years ago

UPDATE 1-Novartis MS pill gets first approval in Russia

* Hopes rise for U.S. approval of Gilenia on Sept. 21

* Rival Merck already had Russian approval for rival pill

* Novartis shares up 1.1 pct at 54.9 Swiss francs

* Sector index flat

(Adds detail, analyst comment, shares)

By Jason Rhodes

ZURICH, Sept 10 (Reuters) - Swiss drugmaker Novartis NOVN.VX has won its first approval for multiple sclerosis (MS) tablet Gilenya in Russia, raising hopes of U.S. Food and Drug Administration (FDA) approval later this month.

A unanimous recommendation for FDA approval by U.S. experts in June meant the drug — known as Gilenia in the United States — could be cleared on Sept. 21 to treat U.S. patients with relapsing MS, the most common form of the disease.

If successful, the drug will beat German group Merck KGaA’s (MRCG.DE) rival cladribine in the race to market in the U.S. [ID:nLDE65A0AV]

“We expect U.S. approval in September. Although we are concerned about the speed of the sales growth after launch, the U.S. approval could be a positive trigger for Novartis,” said Kepler Capital Markets analyst Tero Weckroth.

Novartis shares were 1.1 percent higher at 54.9 Swiss francs ($54.09) by 1019 GMT, outperforming a flat European pharmaceuticals sector .SXDP.

In July, Russia was the first country to approve Merck KGaA’s cladribine, giving the German drugmaker an edge in the emerging market against larger rival Novartis. [ID:nLDE66B0GB]

Later that month, the FDA accepted a reworked request by Merck KGaA for the drug, putting it back in the race to market a pill for MS in the U.S. [ID:nLDE66R07W]

Only injectable drugs are currently on offer to treat MS, in a market worth about $8.6 billion per year, with the main products offered by Biogen Idec Inc (BIIB.O), Bayer AG (BAYGn.DE), Novartis and Teva (TEVA.TA).

Other competing MS pills a year or two behind in development include laquinimod from Teva, teriflunomide from Sanofi-Aventis (SASY.PA) and BG-12 from Biogen. (Editing by Sharon Lindores) ($1=1.015 Swiss Franc)

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