Novartis International AG /Novartis announces presentation of data at AAN showing Gilenya® slowed the rate of brain volume loss in MS patients . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

MS patients have accelerated brain volume loss (up to 3-5 times faster than people without MS), which is associated with physical & cognitive loss of function
Data at AAN showed significantly more Gilenya-treated patients (vs. patients on placebo) had brain volume loss rates comparable to people without MS
Brain volume loss, one of the four key measures of MS disease activity, starts early in the disease and is a predictor of long-term disability

Basel, April 30, 2014 - Novartis announced today new data presented at the 66th American Academy of Neurology (AAN) Annual Meeting, which showed more patients with relapsing multiple sclerosis (MS) treated with Gilenya® (fingolimod) achieved an average annual rate of brain volume loss within the range of those expected for healthy adults of a similar age vs. those patients taking placebo[1]. Everybody loses brain volume (also referred to as "shrinkage of the brain") as they age[1],[2], but people with MS experience shrinkage of the brain up to three to five times faster[1]-[4]. This acceleration starts early in people with relapsing MS, even before symptoms are apparent[5]-[8].

"These data are impressive as they show that Gilenya slows brain volume loss in relapsing MS patients, an important indicator of disease activity," said David Epstein, Division Head, Novartis Pharmaceuticals. "Brain volume loss is a topic of growing interest to the MS community as reducing it may benefit patients by slowing long term physical and cognitive loss of function."

Based on growing evidence, damage from lesions and brain volume loss leads to worsening of the symptoms for MS (e.g. problems walking or difficulties with mental tasks)[5],[9]-[11]. Brain volume loss is  strongly associated with long-term disability[4],[5],[11]-[13].

About the data at AAN

The average brain volume loss in people without MS ranges from 0.2% to 0.4% per year[1],[2], depending on age (as described in the literature). MS patients typically lose brain volume at an approximate rate of  0.5% to 1.35% per year[1],[3],[4].

Post hoc analyses presented at AAN showed that significantly more Gilenya treated patients had annual brain volume loss rates below 0.4% (within the range of people without MS), compared to placebo (37.2% vs 26.7% respectively, p=0.0001)[1].This effect was consistent across different age groups[1].

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerve and spinal cord[14]. The evolution of MS results in an increasing loss of both physical (e.g. difficulty with walking) and cognitive (e.g. problems with mental tasks or memory) function[15]. This has a substantial negative impact on the approximately 2.3 million people worldwide affected by MS[16], a disease that begins in early adulthood, most often between the ages of 20 and 40[17].

The loss of physical and cognitive function is driven by two main types of damage that both contribute to widespread loss of neurons (nerve cells in the brain and spinal cord that transmit impulses): discrete inflammatory lesions, focal damage, in the brain that can clinically manifest as relapses; and ongoing, more diffuse damage that starts early in the disease and causes the progressive loss of brain tissue, including neurons, and over time is associated with both physical and cognitive problems[18]-[20].

About Gilenya

Gilenya is the only oral disease modifying therapy (DMT) that works on four key measures of multiple sclerosis (MS) disease activity - relapses, MRI lesions, brain volume loss and disability progression[21]-[26].

Gilenya reduces both the distinct inflammatory lesions in the brain (focal damage) that can clinically manifest as relapses, and the ongoing, underlying damage in the brain (diffuse damage) that starts early in the disease[18]-[20],[27]-[29]. Diffuse damage often goes unnoticed, causes the loss of neurons and over time is associated with both physical and cognitive problems[18]-[20]. Gilenya's reduction of both focal and diffuse damage is due to its impact on the inflammatory process (peripheral action) and its ability to enter the CNS and impact from within the CNS (central action)[17]-[29]. It is by addressing both focal and diffuse damage that the course of MS can be effectively impacted, helping to preserve a patient's physical (e.g. difficulty with walking) and cognitive (e.g. problems with mental tasks or memory) function.

To date, more than 91,500 patients worldwide have been treated with Gilenya in both clinical trial and post-marketing setting[29].

About Novartis in Multiple Sclerosis

Novartis is committed to the research and development of new treatment options to offer the right treatment to the right patient at the right time, to meet patients' needs at every stage of disease with innovative and targeted drugs.

In addition to its ongoing development program for Gilenya in primary progressive MS (PPMS), pediatric MS and chronic inflammatory demyelinating polyneuropathy (CIPD), the Novartis MS portfolio includes Extavia® (interferon beta-1b for subcutaneous injection). Investigational compounds include BAF312 (siponimod), which is currently in Phase III clinical development and being developed as the first oral therapy for secondary progressive MS (SPMS), and VAY736, an anti-B-cell compound for MS that is currently being investigated in proof of concept studies. Novartis is also exploring the IL-17 pathway in MS.