Gilenya data at AAN to highlight Novartis leadership in innovation with new MS assessment methods to benefit patients …

New analysis will confirm high efficacy of Gilenya in achieving 'no evidence of disease activity' (NEDA4) in previously-treated highly-active RMS patients

Separate analyses will show adding brain shrinkage to an existing assessment tool enhances ability to predict disability progression in relapsing MS (RMS)

Early data on a novel method to assess motor function in patients with MS and its potential clinical application will also be presented at AAN

Basel, 13 April 2015 - Novartis announced today new Gilenya analyses to be presented at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington, DC, USA from April 18-25, 2015, showing how Novartis is advancing methods assessing the impact of relapsing multiple sclerosis (RMS) for patients and physicians. Data will show how adding brain shrinkage (brain volume loss) to an existing tool to assess MS disease activity (m-Rio) will give a more precise prediction of the likelihood of future disability progression. Accurate assessment of disease activity is key to guide treatment decisions in RMS.

A pooled analysis from the two-year phase III FREEDOMS and FREEDOMS II trials will further confirm Gilenya's high efficacy in previously-treated patients with highly-active RMS in achieving 'no evidence of disease activity' (NEDA4) across four key measures: relapses, MRI lesions, brain shrinkage and disability progression[1],[2]. Achieving NEDA4 is especially critical for highly-active RMS patients, who are likely to lose more physical and cognitive functions over time despite being treated.

"Novartis is committed to innovation beyond the research and development of new treatments, to help physicians and patients improve how multiple sclerosis is managed," said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. "These Gilenya data and new methods of assessing the impact of MS have the potential to give physicians a more comprehensive picture of an individual's disease and allow patients to better understand their MS."

Additional data will also be presented on ASSESS-MS, a project in early development which uses an innovative movement recording system and aims to quantify an individual's level of disability in a non-invasive, patient-friendly manner. It measures a patient's movements using the Microsoft Kinect* sensor with machine learning algorithms. Developed in collaboration with leading MS experts and Microsoft Research, ASSESS-MS may have the potential to change how neurological dysfunction and disability progression are assessed in MS patients[3],[4],[5].

Novartis MS portfolio highlights at AAN will include three poster presentations on ASSESS-MS; 16 presentations on Gilenya trial analyses; and one poster presentation on BAF312, an S1P-modulator that is being investigated for secondary progressive MS (SPMS).

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 nerves and spinal cord through inflammation and tissue loss[6] The evolution of MS results in an increasing loss of both physical and cognitive (e.g. memory) function[7]. This has a substantial negative impact on the approximately 2.3 million people worldwide affected by MS[8], a disease that most often begins in early adulthood[9].

People with MS can be diagnosed with relapsing forms of MS (RMS), which include relapsing remitting MS (RRMS) and secondary progressive MS (SPMS)[10], or with primary progressive MS (PPMS). The loss of physical and cognitive function in RMS is driven by two types of damage that result in the loss of neurons and brain tissue - distinct inflammatory lesions (referred to as focal damage), and more widespread inflammatory neurodegenerative processes (referred to as diffuse damage). Focal damage results in the loss of brain tissue and can clinically present as relapses. Diffuse damage starts early in the disease, often goes unnoticed and is also associated with loss of brain tissue and accumulated loss of function[11-13].

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Gilenya data at AAN to highlight Novartis leadership in innovation with new MS assessment methods to benefit patients ...