2013-09-25 07:19:02 -
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
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* 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 real-
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 real-world
* 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
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,"
"pipeline," "investigational," or similar expressions, or by express or
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 or otherwise.
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 131,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit www.novartis.com
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Accessed September 2013.
about-ms/symptoms/index.aspx. Accessed September 2013.
 Multiple Sclerosis International Federation. Atlas of MS [online].
Available at: www.atlasofms.org. Accessed September 2013.
. Accessed September
 Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic
effects in the immune and the central nervous system. Br J Pharmacol
 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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