Novartis edges ahead of Merck KGaA in MS race

* Lower dose of FTY720 filed for U.S. and EU approval

* Merck's cladribine faces delay at FDA

* Clinical studies highlight promise of oral drugs

By Sam Cage

ZURICH, Jan 20 (Reuters) - Swiss drugmaker Novartis (NOVN.VX) has edged ahead of German rival Merck KGaA (MRCG.DE) in the race to get the first oral multiple sclerosis treatment to market, having now filed for approval in the United States and Europe.

Novartis's FTY720 against the debilitating nervous disease is competing with Merck MGaA's pill cladribine and is now in the lead after U.S. regulators held up an application from the German group in November. [ID:nGEE5AT1KS]

The two treatments are expected to take a sizable chunk of the $8.6 billion market for MS since they are easier to take than the injectables from Teva (TEVA.O), Biogen Idec (BIIB.O), Bayer BAYG.DE and Merck KGaA itself that currently dominate.

However both experimental drugs have serious side effects because they interfere with the body's immune system and the companies have to convince physicians and investors the balance of risk and benefit stacks up.

MS can cause mild symptoms in some people and permanent disability in others. Symptoms may include numbness or weakness in one or more limbs, partial or complete loss of vision, tingling or pain, an electric-shock sensation with certain head movements, tremors and an unsteady gait.

"The long-awaited arrival of oral formulations for the treatment of relapsing-remitting multiple sclerosis is welcome news for the estimated 2.5 million people worldwide who have this chronic, disabling disease," William Carroll wrote in a New England Journal of Medicine (NEJM) editorial.

LOWER DOSE BETTER

Novartis said on Wednesday it had filed FTY720, also known as fingolimod, for approval in the United States and European Union at the lower dose of 0.5 milligrams, which data showed had the best benefit-risk profile.

The NEJM published data from two late-stage trials of FTY720, one of the big hopes in Novartis's pipeline, which showed the drug was effective in reducing relapses, disability progression and lesions.

In the one-year TRANSFORMS study involving 1,292 patients, the lower dose of FTY720 cut relapses by more than 50 percent compared with Biogen Idec's Avonex. Headline data from the second FTY720 trial, FREEDOMS, had already been released.

The NEJM also published previously released late-stage data on cladribine which showed sufferers were less likely to become disabled and brain scans showed the medicine cut the risk of damaging lesions. [ID:nLT891251]

"The studies in this issue of the Journal provide a new horizon for patients with relapsing-remitting multiple sclerosis and a welcome increase in the range of treatment options," Carroll wrote in his editorial.

"Time will determine the long-term effectiveness of these treatments in delaying the development of irreversible disability, and as ongoing, real-life experiments they will contribute to our understanding of this enigmatic disease." (Additional reporting by Ludwig Burger in Frankfurt; Editing by Ben Hirschler/Greg Mahlich)