Novartis data at AAN reinforces commitment to address high unmet medical need and to provide a treatment at every …

Basel, March 13, 2013 - New data will be presented at the 65th annual meeting of the American Academy of Neurology (AAN) that show continued innovation within the Novartis Multiple Sclerosis (MS) portfolio[1]. Growing clinical trial and real-world experience with Gilenya (fingolimod), the first once-daily oral therapy approved to treat people with relapsing MS (RMS),will be highlighted[2-7]. Updates on studies of Gilenya in people with primary-progressive MS (PPMS)[8] and the investigational agent BAF312 (siponimod) in people with secondary-progressive MS (SPMS) will also be communicated[9].

"Novartis is pleased to present new data that underscore Gilenya`s pioneering role in the treatment of MS," said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals AG. "These results, as well as updates on our investigational MS compound BAF312 (siponimod) show that we are making real progress in our commitment to address unmet medical need in MS and to provide a treatment at every stage of the disease."

Data from three large Phase III studies will highlight the efficacy of Gilenya in reducing the rate of brain volume loss[2], the best characterized magnetic resonance imaging (MRI) predictor of long-term disability. There will also be a presentation on the INFORMS study, which is evaluating Gilenya in patients with PPMS[8]. This form of MS affects about 10% of people with MS and follows a steady course of worsening neurologic function for which there are no approved disease modifying treatments[12].

Additional data will showcase Gilenya`s high efficacy and well characterized and manageable safety profile[4,10,11].Latest information shows that the growing real-world and clinical trial experience base for Gilenya now encompasses more than 50,000 patients and 60,000 patient years of exposure worldwide[13].

New details will be provided on the design of a Phase III study evaluating the efficacy, safety and tolerability of BAF312 (siponimod) in patients with SPMS, which is a sub-type of MS where there are limited treatment options[9]. The vast majority (85%) of people with relapsing-remitting MS will transition to SPMS; 50% within 10 years of disease onset and 90% within 25 years[14].

During the AAN congress, Novartis will present a Corporate Therapeutic Update, "The Gilenya Experience: A Focus on the Patient in Clinical Practice," on Tuesday 19 March at 19:00 - 22:00 PDT at the San Diego Marriott Marquis. Novartis will also host a Patient Advocacy Forum.

Additionally, to support the exchange of educational information within the MS community, the Novartis exhibit at the congress will showcase an expanded Gilenya online and social media platform including the new Gilenya Facebook and GilenyaGo Twitter accounts, YouTube channel, and Gilenya.com mobile site.

Novartis MS portfolio highlights at AAN include:

Gilenya (fingolimod) in relapsing-remitting MS

Fingolimod - effect on brain atrophy and clinical/MRI correlations in three Phase III studies - TRANSFORMS, FREEDOMS and FREEDOMS II. Platform presentation, S51.006 Cohen: 21 March, 15:15 hrs. PDT.

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Novartis data at AAN reinforces commitment to address high unmet medical need and to provide a treatment at every ...