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Novartis To Continue Multiple Sclerosis Drug Trials June, 2008

Swiss drugmaker Novartis AG (NVS) said Thursday it will continue with trials for its oral multiple sclerosis drug FTY720, following a notification of trial safety issues.

The Basel-based company said it was recently notified of two infection-related incidents among FTY720 patients, including one fatality. Novartis said one case involved the use of very high doses of steroids, and the second case involved the delayed use of antiviral therapy.

After review of the cases by the independent U.S. Data Safety Monitoring Board, it was recommended that all FTY720 clinical trials in multiple sclerosis should continue as planned, the company said.

"Novartis is in active discussions with health authorities as well as internal and external experts to further develop measures to enhance patient and investigator awareness regarding risk of infections and how these risks may be reduced," Novartis spokesman Jeffrey Lockwood stated in an e-mail.

Novartis said the role of FTY720 - or fingolimod - in these cases is unclear since similar clinical outcomes have been observed in patients not involved in the trials and who weren't treated with FTY720. However, the role of FTY720 cannot be excluded since the development compound's mode of action leads to suppression of the body's immune system, which can increase the risk of various infections.

Earlier this spring, the drugmaker said it planned to file for regulatory approval of FTY720 in Europe and the U.S. by the end of 2009. It said intermediate study results showed sustained benefits in patients with relapsing MS after three years of continuous treatment. Data showed that 68%-73% of patients in the study remained free from relapses.

According to the company, MS is the most common disorder of the central nervous system in young adults. MS causes problems with muscle control and strength, vision, balance, sensation and cognitive function.

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