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Novartis announces presentation of data at AAN showing Gilenya® slowed the rate of brain volume loss in MS patients


April 30, 2014 - London

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

The digital press release with multimedia content can be accessed here:

Gilenya BVL global press release AAN congress

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 of0.5% 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.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "to be," "growing," "may," "can," "committed," "onging," "investigational," "being developed," "being investigated," "exploring," or similar terms, or by express or implied discussions regarding potential future indications or labeling for Gilenya, potential future marketing submissions or approvals for the other investigational compounds in the Novartis MS portfolio, or regarding potential future revenues from any or all of the products and investigational compounds in the Novartis MS portfolio, including Gilenya. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking 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 any of the investigational compounds in the Novartis MS portfolio will be submitted or approved for sale in any market, or at any particular time.Neither can there be any guarantee that any of the products and investigational compounds in the Novartis MS portfolio will be commercially successful in the future. In particular, management's expectations regarding these products could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. 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, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

References
[1] De Stefano N et al. Proportion of patients with BVL comparable to healthy adults in fingolimod phase 3 MS studies. Abstract presented at: 66th AAN Annual Meeting; April 26 - May 3, 2014; Philadelphia, Pennsylvania. Oral session S13:006.
[2] Hedman AM et al. Human Brain Changes Across the Life Span: a review of 56 longitudinal magnetic resonance imaging studies. Human Brain Mapping 2012; 33: 1987-220
[3] Barkhof F et al. Imaging outcomes for neuroprotection and repair in multiple sclerosis trials. Nat Rev Neurol. 2009;5(5):256-266.
[4] Bermel RA & Bakshi R. The measurement and clinical relevance of brain atrophy in multiple sclerosis. Lancet Neurol. 2006;5(2):158-170.
[5] Di Stefano N et al. Clinical Relevance of Brain Volume Measures in Multiple Sclerosis. CNS Drugs 2014; published online January 22nd
[6] Pérez-Miralles F et al. Clinical impact of early brain atrophy in clinically isolated syndromes. Mult Scler. Published online: 7 May, 2013.
[7] Filippi M et al. Evidence for widespread axonal damage at the earliest clinical stage of multiple sclerosis. Brain. 2003;126(Pt 2):433-437.
[8] Filippi M et al. The contribution of MRI in assessing cognitive impairment in multiple sclerosis. Neurology 2010; 75: 2121-28
[9] Calabrese M et al. Cortical lesions and atrophy associated with cognitive impairment in relapsing-remitting multiple sclerosis. Arch Neurol. 2009 Sep;66(9):1144-50.
[10] Bakshi R et al. Regional brain atrophy is associated with physical disability in multiple sclerosis: semiquantitative magnetic resonance imaging and relationship to clinical findings. J Neuroimaging. 2001 Apr;11(2):129-36.
[11] Zivadinov R et al. Evolution of cortical and thalamus atrophy and disability progression early relapsing-remitting MS during 5 years. Am J Neuroradiol 34; 1931-39
[12] Popescu V et al; on behalf of the MAGNIMS Study Group. Brain atrophy and lesion load predict long term disability in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2013 Mar 23.
[13] Houtchens MK et al. Thalamic atrophy and cognition in multiple sclerosis. Neurology 2007; 69: 1213-223
[14] http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/. Accessed April 2014.
[15] http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/symptoms/index.aspx. Accessed April 2014.
[16] http://www.msif.org/includes/documents/cm_docs/2013/m/msif-atlas-of-ms-2013-report.pdf?f=1. Accessed April 2014.
[17] http://emsp.org/multiple-sclerosis/ms-fact-sheet. Accessed April 2014.
[18] Filippi M et al. Association between pathological and MRI findings in multiple sclerosis. Lancet Neurol. 2012 Apr;11(4):349-60.
[19] Kutzelnigg A et al. Cortical demyelination and diffuse white matter injury in multiple sclerosis. Brain. 2005 Nov;128(Pt 11):2705-12.
[20] Sormani MP, Arnold DL & De Stefano N. Treatment effect on brain atrophy correlates with treatment effect on disability in multiple sclerosis. Ann Neurol. 2014 Jan;75(1):43-9.
[21] Cohen JA et al.; for TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-415.
[22] Kappos L et al.; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.
[23] Montalban et al. Long-term efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis previously treated with interferon beta-1a or disease-modifying therapies: A Post-hoc analysis of the TRANSFORMS 4.5 year extension study. European Neurological Society, June 10, 2013 P539.
[24] 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.
[25] Chin PS et al. Early effect of fingolimod on clinical and MRI related outcomes in relapsing multiple sclerosis. Poster presented at: 28th congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012; Lyon, France. Abstract P459.
[26] Bergvall et al. Efficacy of fingolimod in pre-treated patients with disease activity: pooled analyses of FREEDOMS and FREEDOMS II. Abstract presented at: 66th AAN Annual Meeting; April 26 - May 3, 2014; Philadelphia, Pennsylvania. Poster P03.174.
[27] 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.
[28] Chun J & Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.
[29] Data on file. Novartis Pharmaceuticals.

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