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Media releases

June 05, 2013 07:15 CET

New data at ENS show Novartis drug Gilenya benefited patients by improving all four key measures of multiple sclerosis

  • Gilenya improved the key measures: brain volume loss, MRI lesion activity, relapse rates and disability progression

  • Switching to Gilenya from interferon increased the proportion of patients disease free after one year of treatment
  • Gilenya resulted in sustained reduction of annualized relapse rate and the rate of brain volume loss in patients switched from interferon treatment

Basel, June 5, 2013 - New data will be presented at the 23rd meeting of the European Neurological Society (ENS) that show how Novartis' Gilenya® (fingolimod), the first once-daily oral therapy approved to treat people with relapsing multiple sclerosis (RMS), positively impacted the key measures for multiple sclerosis (MS) - relapse rates, brain volume loss, lesions and disability progression[1]-[3]. Improving these key measures led to favorable clinical outcomes[1]-[2].

New findings from the TRANSFORMS study showed that a greater proportion of patients were disease free after one year on Gilenya treatment compared to interferon. For patients on interferon during the first year, the proportion who were disease free during the second year increased after they were switched from interferon to Gilenya treatment[1]. These findings suggest that switching from interferon to Gilenya is beneficial for patients with RMS to achieve and maintain long-term disease-free status[1].

In a separate analysis, patients with high disease activity who were switched to Gilenya from interferon experienced improved disease measures (annualized relapse rate and reduction in the amount of brain volume loss), regardless of previous treatment[2].

Further presentations at ENS will show how the targeted effect of Gilenya on the central nervous system is considered to contribute anti-inflammatory effects in MS[4] and also support a positive benefit-risk profile for Gilenya[5].

"There is currently no cure for MS, and therefore it is imperative that treatments work positively to limit symptoms, disease activity and ultimately disease progression, thus reducing the burden for patients." said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "These new analyses are very encouraging in that they not only support the role of Gilenya as having an anti-inflammatory effect but also highlight how Gilenya can improve the key measures of this debilitating disease."

Additional findings from FREEDOMS and TRANSFORMS support the clinical relevance of brain volume loss in MS, reinforcing the link between loss of brain volume and disease severity including the volume of brain lesions and disability, a key measure of disease burden[3]. Gilenya is the only approved MS treatment shown to consistently reduce brain volume loss across studies with a significant effect seen as early as six months[7]-[9]. A low rate of brain volume loss with Gilenya was sustained for up to four years in Phase III studies and for up to seven years in patients after completing a Phase II study[9],[10].

Novartis MS portfolio highlights at ENS include:

  • One oral and six poster presentations show how Gilenya improved the key disease measures in MS - brain volume loss, disease status, physical disability and relapses[1]-[3],[5],[11]-[13].
  • Two poster presentations show how Gilenya's targeted mode of action may affect inflammation, neuro-degeneration and repair[4],[14].
  • Four poster presentations reinforce the tolerability and safety profile of Gilenya[15]-[18].
  • Two poster presentations highlight the increasing experience with Gilenya in a real-world setting[19],[20].

During the ENS congress, Novartis will present a symposium 'Time matters: early and enduring treatment options in MS', on Monday, June 10th, 2013 at 11:45 - 13:15 hrs., in the Plenary Hall, Fira de Barcelona-Recinto Gran Via, Barcelona.

In addition to marketed products Gilenya and Extavia® (interferon beta-1b for subcutaneous injection) the Novartis MS portfolio includes investigational compounds BAF312 (siponimod), and AIN457 (secukinumab), a fully human monoclonal antibody inhibiting interleukin-17A (IL-17A), a key pro-inflammatory cytokine.

About Multiple Sclerosis
While its exact cause is unknown, multiple sclerosis (MS) is an autoimmune disease of the central nervous system (CNS) that causes the body to turn against itself by mistaking normal cells for foreign cells[21]. In MS the myelin sheath, the covering that protects nerve fibers, is damaged by the inflammation that occurs when the body's immune cells attack the nervous system[22]. This neuro-inflammatory damage can occur in any area of the brain, optic nerve and spinal cord and cause a range of physical and mental problems including loss of muscle control and strength, vision, balance, sensation and mental function[23]. Up to 2.5 million people worldwide are affected by MS[24], most often younger people between the ages of 20 and 40[25].

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[26],[27]. It is thought that Gilenya works in two ways against the destructive processes that drive MS disease progression by affecting not only the immune system to reduce inflammatory damage but also the CNS to promote neuroprotection and repair[27]. Gilenya is thought to act by preventing lymphocytes (the cells that cause inflammation and damage in the CNS) from leaving the lymphoid tissues, thus reducing their entry into the central nervous system and potential for damage. Gilenya is also able to cross the blood-brain barrier and thought to act on the neurodegeneration process in the brain and spinal cord[26],[27].

Gilenya is the only oral MS treatment that provides early and long-term reduction in the rate of brain volume loss and enduring high efficacy across all key disease activity measures[6]-[10],[28]-[29]. In clinical trials Gilenya exhibited a well-characterized safety profile and very good tolerability profile. The most common side effects were headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough[7],[8]. To date, approximately 63,000 patients have been treated with Gilenya demonstrating a positive benefit-risk profile in clinical study and real-world settings[30].

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "suggest," "encouraging," "can," "investigational," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Gilenya, potential future marketing submissions or approvals for other MS products, or regarding potential future revenues from Gilenya or such other products. 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 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 any other MS products will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that Gilenya or any other such products 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; competition in general, including potential competition from additional newly-approved oral multiple sclerosis treatments; unexpected regulatory actions or delays or government regulation generally; 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 129,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References
[1] Hartung et al. Relationship between early disease activity and long-term clinical outcome: Results from the phase 3 TRANSFORMS study extension at 4.5 years in relapsing-remitting multiple sclerosis. European Neurological Society, June 9, 2013 P380.
[2] 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.
[3] Barkhof et al. Correlation of brain volume loss with MS duration, MRI activity and disability: impact of fingolimod across 3 Phase III trials. European Neurological Society, June 10, 2013 O325.
[4] Brinkmann et al. Primary target of fingolimod in the CNS and its role in pro-inflammatory cascade: sphingosine 1-phosphate receptor subtype-1 (S1P1). European Neurological Society, June 11, 2013 P846.
[5] Comi et al. Overall safety and relapse outcomes in fingolimod-treated patients previously exposed to natalizumab in the 4-month, open label FIRST study. European Neurological Society, June 10, 2013 P537.
[6] Chin PS, Calabresi PA, Zhang Y, von Rosenstiel P, Kappos L. 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.
[7] Kappos L, Radue E-W, O'Connor P, 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.
[8] 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.
[9] 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.
[10] Antel J, Montalban X, O'Connor P, et al. Long-term (7-year) data from a phase 2 extension study of fingolimod in relapsing multiple sclerosis. Poster presented at: 64th AAN Annual Meeting; April 21-28, 2012; New Orleans, LA. Poster P01.129.
[11] Bergvall et al. Improvement in physical disability with fingolimod: post-hoc analyses of FREEDOMS and TRANSFORMS. European Neurological Society, June 10, 2013 P541
[12] Bergvall et al. Effects of fingolimod on disability progression by EDSS score at baseline: post-hoc analyses of FREEDOMS and FREEDOMS II. European Neurological Society, June 10, 2013 P542.
[13] Nixon et al. Oral fingolimod versus natalizumab on measures of disease-freedom: indirect comparison of results from FREEDOMS and AFFIRM studies. European Neurological Society, June 10, 2013 P540.
[14] Slowik et al. FTY720 is neuroprotective after toxin-induced central nervous system demyelination. European Neurological Society, June 11, 2013 P850.
[15] Schuh et al. Atrioventricular conduction abnormalities after the first dose of fingolimod (Gilenya®) in patients with relapsing remitting multiple sclerosis: Design of a phase IIIb-study (START) European Neurological Society, June 10, 2013 P536.
[16] Marrosu et al. Safety and cardiac outcomes of fingolimod 0.5 mg in the Italian cohort from the 4-month, open-label, single-arm, multi-centre FIRST study. European Neurological Society, June 10, 2013 P538.
[17] LaGanke et al. No Effect on Incidence of Infection After Therapy Switch to Fingolimod. European Neurological Society, June 10, 2013 P545.
[18] Hughes et al. Cardiac Effects of Fingolimod in Patients With Multiple Sclerosis. European Neurological Society, June 10, 2013 P546.
[19] Fox et al. Treatment Satisfaction and Clinical Improvement After Switch to Fingolimod. European Neurological Society, June 10, 2013 P543.
[20] Crayton et al. Improved Quality of Life After Therapy Change to Fingolimod. European Neurological Society, June 10, 2013 P544.
[21] http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/. Accessed May 2013
[22] http://www.mssociety.org.uk/what-is-ms/information-about-ms/about-ms. Accessed May 2013
[23] http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/symptoms/index.aspx. Accessed May 2013.
[24] Multiple Sclerosis International Federation. Atlas of MS [online]. Available at: www.atlasofms.org. Accessed May 2013.
[25] http://emsp.org/multiple-sclerosis/ms-fact-sheet. Accessed May 2013.
[26] 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.
[27] Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.
[28] Montalban X, Barkhof F, Comi G, et al. Long-term comparison of fingolimod with interferon beta-1a: results of 4.5-year follow-up from the extension phase III TRANSFORMS study Poster presented at: 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-13, 2012; Lyon, France. Abstract P517.
[29] Kappos L, Radue E-W, O'Connor P, 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.
[30] Novartis data on file.

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