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Switching to Novartis drug Gilenya from standard interferon shown to improve long-term outcomes for patients with multiple sclerosis


June 10, 2013 - London

Novartis International AG /Switching to Novartis drug Gilenya from standard interferon shown to improve long-term outcomes for patients with multiple sclerosis . Processed and transmitted by Thomson Reuters ONE.The issuer is solely responsible for the content of this announcement.

  • Gilenya resulted in almost 50% more patients being free of MS disease activity after the switch from standard interferon treatment
     
  • Annualized relapse rate reduced by >50% after 1 year for patients who switched from standard interferon treatment to Gilenya
     
  • Reduced rate of brain volume loss sustained for up to 4.5 years in patients with active disease, despite prior treatment, who switched from interferon to Gilenya
     

Basel, June 10, 2013 - Two new analyses from the Phase III TRANSFORMS study presented at the 23rd meeting of the European Neurological Society (ENS) in Barcelona, demonstrated how Novartis' Gilenya® (fingolimod) was effective against all four key measures of disease activity in multiple sclerosis (MS) - brain volume loss, lesion activity (measured by magnetic resonance imaging - MRI), relapse rates and disability progression. Improvements were seen in patients who switched from standard interferon (interferon beta-1a) treatment to Gilenya within 12 months of the switch and up to the end of the 4.5 year extension study[1],[2]

"Data have consistently shown that treatment with Gilenya leads to more patients staying disease free, compared to standard interferon treatment." said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "MS is a chronic neuroinflammatory and neurodegenerative illness where disease activity leads to accumulation of disability and loss of brain tissue. These new findings demonstrate the effect of Gilenya on these key disease measures, both in the early years and in the longer-term."

The new analysis evaluated the association between measures of disease activity (defined as relapses, 3-month disability progression or MRI activity) in the first year of therapy and long-term clinical outcomes. Gilenya increased the proportion of patients who were disease-free by almost 50% (from 44.3% to 66.0%) upon switch from interferon to Gilenya in year-1 to year-2[1]. Patients who had disease-activity at the end of the first year were significantly less likely to remain clinically disease free (OR= 0.63-0.35, p<0.05) during the following 3.5 years of the extension study[1].

A separate post-hoc analysis showed that patients who had disease-activity in the year prior to entering the study, despite prior treatment with a disease-modifying treatment, experienced sustained benefit on Gilenya with a lower annualized relapse rate (ARR) compared to those who were given interferon for the first year (ARR of between 0.19-0.22 compared to 0.31-0.32 respectively)[2]. In patients who were switched from interferon to Gilenya after one year, the ARR was reduced by more than 50% (from between 0.33-0.37 ARR on interferon to 0.14-0.16 ARR on Gilenya treatment) and remained low to the end of the study up to 4.5 years[2].

Further analysis showed that irrespective of prior treatment and disease activity, brain volume loss was significantly reduced (by about 50%) after one year in patients taking Gilenya compared to those taking interferon and this low rate was sustained until the end of the study while on Gilenya[2].  Similarly, a slowing / decrease in the rate of brain volume loss was observed in patients that switched from interferon to Gilenya after one year2. 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[3]-[5]. 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[6],[7]. Brain volume loss in MS occurs early and predicts long-term disability[8].

Additional data being presented at ENS (11th June 2013) show how Gilenya could have beneficial impact on MS through its well characterized effect on the immune system and also through a potential direct effect within the central nervous system[9].[10].

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[11] 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[12]. 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[13]. Up to 2.5 million people worldwide are affected by MS[14], most often younger people between the ages of 20 and 40[15].

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[16],[17]. 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[17]. 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[16],[17]. Gilenya is also able to cross the blood-brain barrier and act on the neurodegeneration process in the brain and spinal cord[16],[17].

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[3]-[6],[18]-[19]. In clinical trials, Gilenya exhibited a well-characterized safety profile and very good tolerability profile[4],[5]. The most common side effects were headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough[4],[5]. To date, approximately 63,000 patients have been treated with Gilenya demonstrating a positive benefit-risk profile in clinical study and real-world settings[20].

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "leads to," "being presented," "could," "potential," or similar expressions, or 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 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. Neither 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; 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] 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.  
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8] Popescu V, Agosta F, Hulst HE, 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 March 23.
[9] 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.
[10] Slowik et al. FTY720 is neuroprotective after toxin-induced central nervous system demyelination. European Neurological Society, June 11, 2013 P850.
[11] http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/. Accessed May 2013.
[12] http://www.mssociety.org.uk/what-is-ms/information-about-ms/about-ms. Accessed May 2013.
[13] http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/symptoms/index.aspx. Accessed May 2013.
[14] Multiple Sclerosis International Federation. Atlas of MS [online]. Available at: www.atlasofms.org. Accessed May 2013.
[15] http://emsp.org/multiple-sclerosis/ms-fact-sheet. Accessed May 2013.
[16] 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.
[17] Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.
[18] 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.
[19] 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.
[20] Novartis data on file.

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