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Novartis Says MS Drug Gilenya Shows Long-term Efficacy, Safety In Extended Study

Swiss drugmaker Novartis AG (NVS) on Monday said a new data for multiple sclerosis drug Gilenya (fingolimod) showed long-term efficacy benefit and a consistent safety profile.

Gilenya, licensed from Japan's Mitsubishi Tanabe Pharma Corp., is the only oral therapy approved to treat people with relapsing forms of multiple sclerosis.

The data from single-arm extension of phase III head-to-head TRANSFORMS study showed sustained reduction in relapses and rate of brain volume loss in patients on continuous Gilenya treatment for up to 4.5 years, the company noted

The results also showed improved efficacy for patients switched to Gilenya from Avonex (interferon-beta-1a IM), a commonly prescribed MS treatment from Biogen Idec Inc. (BIIB). Novartis noted that reductions in relapses and MRI measures were observed in these patients.

In the core TRANSFORMS study, Gilenya demonstrated superior efficacy to Avonex, reducing the annualized relapse rate by 52% at one year. The extension study showed that this low relapse rate was sustained in patients receiving continuous treatment with Gilenya for up to 4.5 years.

As per the study results, patients treated with Gilenya continuously maintained a low brain atrophy rate throughout the study as measured by assessing brain volume loss, which is valued as a predictor of long-term disability, the company said.

The company also said that these extension data also showed that long-term treatment with Gilenya was generally well tolerated with a safety profile consistent with pivotal trials.

Tim Wright, Global Head of Development, Novartis Pharma, said, "These data further reinforce our confidence in Gilenya's long-term effectiveness and safety profile. The TRANSFORMS extension study shows that MS patients treated continuously with Gilenya for up to four and a half years demonstrated sustained low levels of clinical and MRI activity."

"The results, which are consistent with the pivotal phase III studies, confirm that fingolimod is highly effective in treating relapsing forms of MS, and as the first available oral MS treatment, continues to be a valuable treatment option for appropriate patients," the company noted in its statement.

These data were presented at the 22nd Annual Meeting of the European Neurological Society, taking place 9-12 June 2012 in Prague, Czech Republic.

In the U.S., Novartis shares closed Friday's regular trading session at $52.47, up $0.29 or 0.56 percent.

Mitsubishi Tanabe shares are currently trading at 1,060 yen, down 13 yen or 1.21 percent in Japan.

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