Data at ECTRIMS to confirm Novartis' Gilenya® long-term efficacy on reducing brain volume loss and real-world relapse …

New four-year data will show continued Gilenya treatment reduced brain volume loss in MS patients compared to delaying treatment with Gilenya by two years Data will strengthen the link between brain volume loss and disability progression, highlighting the importance of reducing brain volume loss in patients with MS Real-world patient data will confirm superiority of Gilenya compared to standard therapies (interferon and glatiramer acetate) in reducing MS relapse rates

Basel, September 25, 2013 - New data showing the benefits of Gilenya (fingolimod) on patient outcomes in multiple sclerosis (MS) will be presented at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, adding to the growing evidence base for Gilenya in both clinical trial and real-world settings.

New four-year data from the pivotal FREEDOMS and FREEDOMS extension studies plus a separate analysis of three studies (FREEDOMS, FREEDOMS II and TRANSFORMS) will show the benefits of continued Gilenya treatment on brain volume loss compared to delayed treatment of two years. These data will reinforce what we know about the correlation between brain volume loss and disability, underlining the need for effectively addressing brain volume loss in patients with MS. Data from international and U.S. real-world databases will also confirm the favorable effect of Gilenya on reducing relapse rates for patients with MS.

"It`s very encouraging for patients that we continue to confirm the long term benefits Gilenya delivers in MS," said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "These new data will emphasize the importance of reducing brain volume loss and relapse rates for patients, with increasing evidence on the effectiveness of Gilenya from both clinical and real-world settings."

Novartis MS portfolio highlights at ECTRIMS include:

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).

About Multiple Sclerosis 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[1]. 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[2]. 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[3]. Up to 2.5 million people worldwide are affected by MS[4], most often younger people between the ages of 20 and 40[5].

About Gilenya 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[6]-[7]. 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[7]. 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[6]-[7]. Gilenya is also able to cross the blood-brain barrier and act on the neurodegeneration process in the brain and spinal cord[6]-[7].

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[8]-[13]. In clinical trials, Gilenya exhibited a well-characterized safety profile and very good tolerability profile[9],[10]. The most common side effects were headache, hepatic enzymes increased, influenza, sinusitis, diarrhea, back pain, and cough[9],[10]. To date, more than 71,000 patients have been treated with Gilenya demonstrating a positive benefit-risk profile in clinical study and real-world settings[14].

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

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Data at ECTRIMS to confirm Novartis' Gilenya® long-term efficacy on reducing brain volume loss and real-world relapse ...