Novartis International AG: Data at ECTRIMS to confirm Novartis' Gilenya®
long-term efficacy on reducing brain volume loss and real-world relapse rates
Novartis International AG / Data at ECTRIMS to confirm Novartis' Gilenya®
long-term efficacy on reducing brain volume loss and real-world relapse rates
in MS . Processed and transmitted by Thomson Reuters ONE. The issuer is solely
responsible for the content of this announcement.
*New four-year data will show continued Gilenya treatment reduced brain
volume loss in MS patients compared to delaying treatment with Gilenya by
*Data will strengthen the link between brain volume loss and disability
progression, highlighting the importance of reducing brain volume loss in
patients with MS
*Real-world patient data will confirm superiority of Gilenya compared to
standard therapies (interferon and glatiramer acetate) in reducing MS
Basel, September 25, 2013- New data showing the benefits of Gilenya^®
(fingolimod) on patient outcomes in multiple sclerosis (MS) will be presented
at the 29^th Congress of the European Committee for Research and Treatment in
Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, adding to the growing
evidence base for Gilenya in both clinical trial and real-world settings.
New four-year data from the pivotal FREEDOMS and FREEDOMS extension studies
plus a separate analysis of three studies (FREEDOMS, FREEDOMS II and
TRANSFORMS) will show the benefits of continued Gilenya treatment on brain
volume loss compared to delayed treatment of two years. These data will
reinforce what we know about the correlation between brain volume loss and
disability, underlining the need for effectively addressing brain volume loss
in patients with MS. Data from international and U.S. real-world databases
will also confirm the favorable effect of Gilenya on reducing relapse rates
for patients with MS.
"It's very encouraging for patients that we continue to confirm the long term
benefits Gilenya delivers in MS," said Dr. Timothy Wright, Global Head
Development, Novartis Pharmaceuticals. "These new data will emphasize the
importance of reducing brain volume loss and relapse rates for patients, with
increasing evidence on the effectiveness of Gilenya from both clinical and
Novartis MS portfolio highlights at ECTRIMS include:
*Six poster presentations on the importance of, and impact of Gilenya on,
brain volume loss.
*Ten poster presentations on the efficacy of Gilenya both in clinical
trials and real-world settings.
*Nine posters, three oral presentations will reinforce the tolerability and
safety profile of Gilenya.
*Eight poster presentations discuss the real-world evidence for Gilenya.
*Nine poster presentations will reinforce success of Gilenya in a
*Eleven posters highlight the breadth of Novartis' pipeline.
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).
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. 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. 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. Up to 2.5 million people worldwide are affected by MS,
most often younger people between the ages of 20 and 40.
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-. 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. 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 act on the neurodegeneration process in the brain
and spinal cord-.
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-. In clinical trials, Gilenya
exhibited a well-characterized safety profile and very good tolerability
profile,. The most common side effects were headache, hepatic enzymes
increased, influenza, sinusitis, diarrhea, back pain, and cough,. To
date, more than 71,000 patients have been treated with Gilenya demonstrating a
positive benefit-risk profile in clinical study and real-world settings.
Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "to confirm," "will," "encouraging,"
"continue," "pipeline," "investigational," or similar expressions, or by
express or implied discussions regarding potential new indications or labeling
for Gilenya, potential future marketing approvals for investigational MS
therapies, or regarding potential future revenues from Gilenya or from such
investigational therapies. 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 other
Novartis investigational MS therapies will be submitted or approved for sale
in any country, or at any particular time. Neither can there be any guarantee
that such products will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding these products
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
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
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approximately 131,000 full-time-equivalent associates and operate in more than
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 http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/. Accessed September 2013.
 http://www.mssociety.org.uk/what-is-ms/information-about-ms/about-ms. Accessed September 2013.
Accessed September 2013.
 Multiple Sclerosis International Federation. Atlas of MS [online]. Available at: www.atlasofms.org.
Accessed September 2013.
 http://emsp.org/multiple-sclerosis/ms-fact-sheet. Accessed September 2013.
 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.
 Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin
Neuropharmacol. 2010 March-April;33(2):91-101.
 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.
 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.
 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.
 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.
 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.
 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.
 Novartis data on file.
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