Novartis will be presenting new data at the 23rd meeting of the European Neurological Society (ENS) which shows how Gilenya (fingolimod), the first once-daily oral therapy approved to treat people with relapsing multiple sclerosis (RMS), positively impacted the key measures for multiple sclerosis (MS) - relapse rates, brain volume loss, lesions and disability progression. Improving these key measures led to favourable clinical outcomes.

New findings from the TRANSFORMS study showed that a greater proportion of patients were disease free after one year on Gilenya treatment compared to interferon. For patients on interferon during the first year, the proportion who were disease free during the second year increased after they were switched from interferon to Gilenya treatment. These findings suggest that switching from interferon to Gilenya is beneficial for patients with RMS to achieve and maintain long-term disease-free status.

In a separate analysis, patients with high disease activity who were switched to Gilenya from interferon experienced improved disease measures (annualized relapse rate and reduction in the amount of brain volume loss), regardless of previous treatment.

Further presentations at ENS will show how the targeted effect of Gilenya on the central nervous system is considered to contribute anti-inflammatory effects in MS and also support a positive benefit-risk profile for Gilenya.

"There is currently no cure for MS, and therefore it is imperative that treatments work positively to limit symptoms, disease activity and ultimately disease progression, thus reducing the burden for patients," said Dr Timothy Wright, global head development, Novartis Pharmaceuticals. "These new analyses are very encouraging in that they not only support the role of Gilenya as having an anti-inflammatory effect but also highlight how Gilenya can improve the key measures of this debilitating disease."

Additional findings from FREEDOMS and TRANSFORMS support the clinical relevance of brain volume loss in MS, reinforcing the link between loss of brain volume and disease severity including the volume of brain lesions and disability, a key measure of disease burden. Gilenya is the only approved MS treatment shown to consistently reduce brain volume loss across studies with a significant effect seen as early as six months. A low rate of brain volume loss with Gilenya was sustained for up to four years in phase III studies and for up to seven years in patients after completing a phase II study.

During the ENS congress, Novartis will present a symposium 'Time matters: early and enduring treatment options in MS', on June 10, 2013 at Fira de Barcelona-Recinto Gran Via, Barcelona.

In addition to marketed products Gilenya and Extavia (interferon beta-1b for subcutaneous injection) the Novartis MS portfolio includes investigational compounds BAF312 (siponimod), and AIN457 (secukinumab), a fully human monoclonal antibody inhibiting interleukin-17A (IL-17A), a key pro-inflammatory cytokine.

While its exact cause is unknown, multiple sclerosis (MS) is an autoimmune disease of the central nervous system (CNS) that causes the body to turn against itself by mistaking normal cells for foreign cells. In MS the myelin sheath, the covering that protects nerve fibers, is damaged by the inflammation that occurs when the body's immune cells attack the nervous system. This neuro-inflammatory damage can occur in any area of the brain, optic nerve and spinal cord and cause a range of physical and mental problems including loss of muscle control and strength, vision, balance, sensation and mental function.

Gilenya is the first oral therapy approved to treat relapsing forms of MS and the first in a new class of compounds called sphingosine 1-phosphate receptor modulators. It is thought that Gilenya works in two ways against the destructive processes that drive MS disease progression by affecting not only the immune system to reduce inflammatory damage but also the CNS to promote neuroprotection and repair. Gilenya is thought to act by preventing lymphocytes (the cells that cause inflammation and damage in the CNS) from leaving the lymphoid tissues, thus reducing their entry into the central nervous system and potential for damage. Gilenya is also able to cross the blood-brain barrier and thought to act on the neurodegeneration process in the brain and spinal cord.

Gilenya is the only oral MS treatment that provides early and long-term reduction in the rate of brain volume loss and enduring high efficacy across all key disease activity measures. In clinical trials Gilenya exhibited a well-characterized safety profile and very good tolerability profile. The most common side effects were headache, liver enzyme elevations, influenza, diarrhoea, back pain, and cough. To date, approximately 63,000 patients have been treated with Gilenya demonstrating a positive benefit-risk profile in clinical study and real-world settings.

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

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