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FTY720, a novel oral therapy in development for MS, shows sustained benefits for the majority of patients after three years of treatment
Date:4/15/2008

- Phase II study extension shows 68-73% of patients with multiple sclerosis remained relapse-free after three years of treatment with oral FTY720 - New data demonstrate 89% of patients free from active brain lesions - the

injury caused by MS - three years after starting treatment - MS, a devastating disease causing progressive disability, affects 2.5

million people worldwide including many young adults

- FTY720 regulatory filings planned before end of 2009 in US and EU

EAST HANOVER, N.J., April 15 /PRNewswire-FirstCall/ -- The investigational oral therapy FTY720 (fingolimod) continues to demonstrate sustained benefits in patients with multiple sclerosis (MS) after three years of treatment, according to new clinical data presented today from an ongoing Phase II study extension.

Results showed that 73% of patients who began the study on FTY720 5 mg remained free from relapses after three years, and 68% of those who began the study on FTY720 1.25 mg remained relapse-free. The figures after two years of treatment were 77% and 75% respectively. On the basis of comparable efficacy and a better safety profile, all patients have been transferred to FTY720 1.25 mg in the study extension.

The 36-month data also showed an average annualized relapse rate of 0.20, equivalent to one relapse in five years, while 89% of patients were free of the active brain lesions characteristic of MS as measured by magnetic resonance imaging (MRI) three years after starting treatment.

The results were presented at the 60th annual meeting of the American Academy of Neurology (AAN) in Chicago, USA.

"These new data demonstrate the exciting potential for FTY720 to reduce relapse rates in MS patients with a convenient once-daily pill," said Professor Giancarlo Comi, Professor of Neurology at the University Vita-Salute San Raffaele in Milan, Italy. "An effective oral treatment would be a significant breakthrough in the managemen
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SOURCE Novartis Pharmaceuticals Corporation
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