New analysis shows Novartis drug Gilenya significantly reduced rate of brain volume loss across three large Phase III studies

• Data show reductions in rate of brain volume loss by about one-third compared to interferon beta-1a IM or placebo in studies with over 3,600 patients with relapsing MS
• Gilenya is the first oral disease modifying treatment to show consistent effect on brain volume loss, an important indicator of disease progression
• Analysis of FREEDOMS II, a Phase III study, confirms Gilenya consistently reduces annualized relapse rates across disease activity, gender, age and prior treatment
• Safety profile of Gilenya reinforced in patients treated up to four years; overall more than 56,000 patients treated with Gilenya worldwide

Basel, March 21, 2013 - New data presented at the 65th annual meeting of the American Academy of Neurology (AAN) show Gilenya® (fingolimod), the first oral disease modifying therapy approved to treat relapsing forms of multiple sclerosis (MS), significantly and consistently reduced the rate of brain volume loss. Results also showed that Gilenya reduced annualized relapse rates across important subgroups; and additional data reinforce Gilenya's safety profile in patients treated up to four years.

"Loss of brain volume is a consequence of multiple sclerosis and is a key MRI correlate of disease progression," said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals AG. "The findings reported show the effect of Gilenya across a variety of important disease measures and support evidence for initiating early use of this highly effective treatment in patients with relapsing MS."

Data shows consistent reduction in rate of brain volume loss
In a new analysis of over 3,600 patients from three large Phase III studies (TRANSFORMS, FREEDOMS, and FREEDOMS II) Gilenya showed a significant reduction in the rate of brain volume loss vs. a comparator - consistent with previously reported results[1]. In the TRANSFORMS study over one year, Gilenya reduced the rate of brain volume loss by -32% (p<0.001) compared to Avonex® (interferon beta-1a IM), a commonly prescribed injectable treatment[1]. Over two years, Gilenya reduced the rate of brain volume loss compared to placebo by 35% (p<0.001) in the FREEDOMS study, and by 33% (p<0.001) in the FREEDOMS II study, respectively[1].

The data also showed that brain volume, at baseline, consistently correlated with the level of disease severity and disability. Lower brain volume was linked with more severe disease and disability, while higher brain volume correlated with less severe levels. In addition, traditional markers of disease activity (such as MRI lesion counts) at baseline were predictive of the rate of brain volume loss over two years.

New results highlight consistent efficacy and long-term safety profile
Separately, a recent subgroup analysis (n=1083) of FREEDOMS II, the third large Phase III Gilenya study, supports the known efficacy of Gilenya treatment. Specifically, results show Gilenya consistently reduced annualized relapse rates (ARR) compared to placebo in patients with relapsing-remitting MS, across gender, age, prior treatment, and baseline disease activity[2].

New extension data from FREEDOMS II (n=632) reinforce the known safety profile of Gilenya in patients treated up to four years[3]. More than eight out of ten patients (83%) completed the extension study, which identified no unexpected safety concerns[3].

Gilenya was approved based on the largest Phase III program in relapsing-remitting MS at the time of submission. With up to seven years of clinical trial experience (Phase II and III) and over two years of real-world use, there is increasing experience of Gilenya's long-term effectiveness and safety profile in more than -56,000 patients worldwide[4].

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[5],[6]. Gilenya is thought to act on inflammatory processes implicated in the MS disease process[5],[6].

Data has shown significant efficacy with Gilenya in reducing relapses and significant slowing of six-month disability progression sustained at four years[7]. Nearly half of Gilenya patients were disease-free after one year of treatment[8] and in the pivotal FREEDOMS study eight out of ten patients remained on treatment at two years[9]. Gilenya is the only treatment shown to consistently decrease brain volume loss, the best characterized magnetic resonance imaging (MRI) predictor of long-term disability.

Gilenya has demonstrated superior efficacy compared to Avonex® (interferon beta-1a IM), a commonly prescribed treatment, showing a 52% relative reduction in annualized relapse rate (primary endpoint) at one year in a pivotal head-to-head trial in patients with relapsing-remitting multiple sclerosis[10]. In a post hoc sub-group analysis, Gilenya showed a 61% relative reduction in annualized relapse rate compared to interferon-beta-1a (IM) at one year in subgroups of patients with highly active relapsing-remitting MS not responding to interferon treatment[11].

In clinical trials, Gilenya was generally well-tolerated with a manageable safety profile. The most common side effects were headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related side effects included transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular edema and mild bronchoconstriction[9],[10]. The rates of infections overall, including serious infections, were comparable among treatment groups, although a slight increase in lower respiratory tract infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups[9],[10].

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by express or implied discussions regarding potential new indications or labeling for Gilenya or regarding potential future revenues from Gilenya. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Gilenya to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gilenya will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Gilenya will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Gilenya could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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References:
[1] Cohen J. et al. Fingolimod-effect on brain atrophy and clinical/MRI correlations in Three Phase 3 studies - TRANSFORMS, FREEDOMS and FREEDOMS II. Abstract Presented at AAN, San Diego, March 2013.
[2] Goodin D. et al. Fingolimod reduces annualized relapse rates in patients with relapsing-remitting multiple sclerosis: FREEDOMS II study subgroup analysis. Abstract Presented at AAN, San Diego, March 2013.
[3] Vollmer T. et al. Long-term safety of fingolimod in patients with relapsing-remitting multiple sclerosis: Results from phase 3 FREEDOMS extension study. Abstract Presented at AAN, San Diego, March 2013.
[4] Novartis data on file.
[5] Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic effects in the immune and the central nervous system. Br J Pharmacol 2009;158(5):1173-1182.
[6] Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.
[7] Kappos L. et al. Phase 3 FREEDOMS study extension: fingolimod (FTY720) efficacy in patients with relapsing-remitting multiple sclerosis receiving continuous or placebo-fingolimod switched therapy for up to 4 years. Poster presented at: 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012: Lyon, France. Poster P979.
[8] Khatri B. et al. Fingolimod treatment increases the proportion of patients who are free from disease activity in multiple sclerosis compared to interferon beta-1a: results from a phase 3 active controlled study (TRANSFORMS). Abstract presented at: 64th AAN Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract PD5:006.
[9] Kappos L. et al; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401.
[10] Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-415.
[11] Havrdová E, et al. Clinical outcomes in subgroups of patients with highly active relapsing-remitting multiple sclerosis treated with Fingolimod (FTY720): Results from the FREEDOMS and TRANSFORMS phase III studies. Poster presented at ECTRIMS, Amsterdam, October 2011.

Avonex® is a registered trademark of Biogen Idec.

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Posted: March 2013

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