2013-10-03 07:18:03 -
Novartis International AG /
Real-world evidence showed superiority of Novartis' Gilenya® to reduce MS
relapse rates compared to interferons or glatiramer acetate
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* Real-world data showed Gilenya reduced the annualized relapse rate and risk
of relapse by around 50% versus interferons or glatiramer acetate
* Reducing the frequency and probability of future relapses in patients with
MS is a key treatment goal, as relapses can significantly advance an
individual's level of disability
* Recovering from a relapse can take weeks or months for a patient with MS,
and approximately half of all relapses may leave lasting effects
The digital press release with multimedia content can be accessed here:
Basel, October 3, 2013 - Novartis announced today findings from an international
multiple sclerosis (MS) registry and a US health claims data base which showed
the real-world superiority of Gilenya(®) (fingolimod) in reducing risks of
relapses compared to standard therapies-. These data confirm the positive
results seen in clinical trials with Gilenya, and were presented at the ongoing
29th Congress of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS) in Copenhagen, Denmark.
Relapses can make life unpredictable for patients with MS and they can
potentially significantly advance an individual's level of disability. MS
patients' clinical outcomes are regularly assessed and switching between
disease-modifying therapies (DMTs), to reduce the rate or likelihood of a
relapse, is a frequent treatment strategy.
"Controlling relapses and preventing disability are key treatment goals for
patients with MS." said David Epstein, Division Head of Novartis
Pharmaceuticals. "It is encouraging to see that the benefits of Gilenya, which
is the only disease modifying treatment proven in clinical studies to have a
superior relapse reduction compared to an active comparator, are now confirmed
in the real-world setting."
The 'MSBase study', a global, longitudinal, observational registry for MS
involving 60 centers in 26 countries and US administrative claims data from the
'IMS PharMetrics Plus(TM) Database' were interrogated for information on the
impact on MS relapses of switching to either oral Gilenya or to one of the
standard injectable therapies - an interferon or glatiramer acetate.
Collectively, analysis of patient data from these large, real-world databases
(416 patients from MSBase and 933 patients from the IMS PharMetrics Plus(TM)
Database) showed that treatment with Gilenya reduced the annualized relapse rate
and risk of relapse by approximately 50% compared to therapy with an interferon
or glatiramer acetate treatment-. They also showed that even amongst
patients with MS who have a history of relapse, switching to Gilenya was
associated with significant and clinically meaningful reductions in the number
of relapses and the probability of experiencing a relapse compared to switching
to an interferon or glatiramer acetate,.
Following first approvals in 2010, once daily oral Gilenya is now available in
more than 75 countries and more than 71,000 patients have been treated in both
the clinical trial and post-marketing settings with over 87,000 patient years of
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
Gilenya is the only oral MS treatment that provides early and long-term
reduction in the rate of brain volume loss and high efficacy across all 4
disease activity measures (disability progression, relapses, MRI activity, brain
volume loss)-. 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 "goal," "can," "may,"
"potentially," "goals," 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 with Gilenya 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 approved for any
additional indications or labeling in any market. Nor 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.
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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Fingolimod and Interferon/Glatiramer therapies in a switch population using
propensity-matched data from MSBase. 29th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
2. Bergvall N, Raquel Lahoz R et al. Relapse rates among patients with
multiple sclerosis who switch from interferon therapy to fingolimod or
glatiramer acetate: a retrospective US claims database analysis. 29th
Congress of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS) in Copenhagen, Denmark.
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history of relapses treated with fingolimod compared with interferons or
glatiramer acetate for the treatment of multiple sclerosis: a retrospective
US claims database analysis. 29th Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen,
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