• Data from single-arm extension of head-to-head TRANSFORMS study show sustained reduction in relapses and rate of brain volume loss in patients on continuous Gilenya treatment for up to 4.5 years
• Reductions in relapses and MRI measures were observed in patients
• Extension study results demonstrated once-daily oral Gilenya was generally well-tolerated with a safety profile consistent with pivotal trials
• As of February 2012, approximately 36,000 patients have been treated in clinical trials and in the post-marketing setting

Basel, June 11, 2012 – New long-term data for Gilenya® (fingolimod), the only oral therapy approved to treat people with relapsing forms of multiple sclerosis (MS), show a sustained efficacy benefit and a consistent safety profile with up to 4.5 years of continuous treatment1.

“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,” said Tim Wright, Global Head of Development, Novartis Pharma. “Furthermore, patients who switched to Gilenya showed a reduction in relapses and improvements in MRI measures in the extension compared to the core study.”

Patients in the switch group also displayed a slowing of brain atrophy following the switch to Gilenya.

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