New analysis indicates that Novartis drug Gilenya shows significant early effect on reducing brain volume loss at 6 months
• New analysis of two large Phase III studies demonstrates
a significant early treatment effect of Gilenya on relapses and MRI
outcomes, including brain volume loss, in MS patients
• Data show generally higher adherence rates for once-daily
oral Gilenya than injectable DMTs and positive real-world
experience
• Pooled analysis of core and long-term study data from over
3,500 patients reinforce known safety profile; more than 49,000
patients treated as of August 2012
Basel, October 12, 2012 - New data will be presented at the 28th
congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) that reinforce the generally early and
sustained efficacy benefit and long-term safety profile for
Gilenya® (fingolimod), the first once-daily oral therapy
approved to treat relapsing forms of multiple sclerosis
(MS)[1],[2].
"As the first once-daily oral MS therapy, growing real-world
experience reinforces Gilenya's high efficacy and long-term safety
profile," said David Epstein, Head of the Pharmaceuticals Division
of Novartis Pharma AG. "With data showing an early treatment effect
on relapses and brain volume loss, Gilenya continues to show
positive outcomes for patients and Novartis remains committed to
addressing the significant remaining unmet medical need in the MS
community."
Analysis shows significant early treatment effect with
Gilenya
A new post hoc analysis of two large Phase III studies shows
treatment with Gilenya 0.5 mg led to significant benefits on
relapse-related outcomes within the first three months and on brain
volume loss by six months compared to placebo[1].
There was a significant (p<0.05) Gilenya treatment effect on
time to first confirmed relapse within three months in both the
pivotal FREEDOMS study (n=1272), and FREEDOMS II, the second large
Phase III placebo-controlled study (n=1083). The differences
between Gilenya and placebo became persistently significant by Day
82 in FREEDOMS and Day 64 in FREEDOMS II, respectively[1].
Furthermore, in the FREEDOMS study, patients-treated with Gilenya
0.5 mg had on average a 35% reduction in brain volume loss compared
with placebo at the first MRI evaluation after six months of
treatment (mean percent brain volume change of -0.22 for Gilenya
vs. -0.34 for placebo; p=0.006). In FREEDOMS II, there was a 39%
reduction in brain volume loss (mean percent volume change of -
0.23 for Gilenya vs. - 0.38 for placebo; p=0.012) at six
months[1].
"Understanding the onset of efficacy is an important consideration
in the treatment of MS as early effective treatment may improve
patient outcomes," said Professor Ludwig Kappos, MD, Chair of
Neurology, University Hospital, Basel, Switzerland. "The new
analysis of Phase III data shows a significant early effect of
Gilenya on relapses and MRI measures, and further supports its role
as a valuable treatment option for relapsing-remitting MS."
New data published on real-world experience and patient
adherence
First results from the PANGAEA observational study in Germany
indicate that 90% of investigators and 91% of patients rated
Gilenya treatment success, defined as efficacy and tolerability, as
"Good" or "Very Good"[2]. PANGAEA is a German registry study aimed
to enroll a total of 4,000 patients with a follow-up of five years
designed to investigate the efficacy and safety of Gilenya in
everyday clinical practice. As of May 2012, one year after
initiation of the registry, more than 1,850 patients were enrolled
in 475 participating centers. These results also showed an overall
safety profile in line with previously reported data[2].
In addition, a separate analysis of time to discontinuation of
therapy among MS patients receiving Gilenya and other disease
modifying treatments (DMTs) using pharmacy claims in the US
(n=1891) show Gilenya-treated patients were significantly less
likely to discontinue treatment over the 12 month observation
period (Gilenya: 27.8%, other DMT cohorts: 42.7-54.5%; p<0.01)
and discontinued later than patients using injectable
DMTs[3].
Results from more than 3,500 patients further characterize
long-term safety profile
A new integrated analysis of safety data from Phase II, Phase III
and study extensions for fingolimod (all doses, n=3553) show a
safety profile generally consistent with previous results. The
total fingolimod exposure was 9,070 patient years, with 1,510
patients treated for more than three years and some for more than
seven years[4].
As of August 2012, more than 49,000 patients have been treated with
fingolimod in clinical trials and in the post-marketing setting,
and there is approximately 52,000 patient years of
exposure[5].
About Gilenya
Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the
first in a new class of compounds called sphingosine 1-phosphate
receptor (S1PR) modulators. It has demonstrated superior efficacy
compared to Avonex, a commonly prescribed treatment, showing a 52%
relative reduction in annualized relapse rate (primary endpoint)
and a 40% relative reduction in the rate of brain atrophy
(secondary endpoint) at one year in a pivotal head-to-head trial in
patients with relapsing-remitting multiple sclerosis[6]. In a
recent post hoc sub-group analysis, Gilenya showed a 61% relative
reduction in annualized relapse rate compared to interferon-beta-1a
(IM) at one year in subgroups of patients with highly active
relapsing-remitting MS not responding to interferon
treatment[7].
Gilenya is a generally highly effective once-daily oral MS
treatment. In clinical trials it was generally well tolerated with
a manageable safety profile, and there is increasing experience of
Gilenya's long-term effectiveness and safety profile, with
approximately 49,000 patients having been treated in clinical
trials and in a post-marketing setting[7]. Currently, there is
approximately 52,000 patient years of exposure[5].
In clinical trials, the most common side effects were headache,
liver enzyme elevations, influenza, diarrhea, back pain, and cough.
Other Gilenya-related side effects included transient, generally
asymptomatic, heart rate reduction and atrioventricular block upon
treatment initiation, mild blood pressure increase, macular edema,
and mild bronchoconstriction[6],[8]. The rates of infections
overall, including serious infections, were comparable among
treatment groups, although a slight increase in lower respiratory
tract infections (primarily bronchitis) was seen in patients
treated with Gilenya. The number of malignancies reported across
the clinical trial program was small, with comparable rates between
the Gilenya and control groups[6],[8].
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as "will," "committed," "may," 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 submitted or approved for any additional
indications or labeling in any market, or at any particular time.
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; 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.
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 2011, the
Group's continuing operations achieved net sales of USD 58.6
billion, while approximately USD 9.6 billion (USD 9.2 billion
excluding impairment and amortization charges) was invested in
R&D throughout the Group. Novartis Group companies employ
approximately 126,000 full-time-equivalent associates and operate
in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
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References:
[1] Chin P.S. et al. Early effect of fingolimod on clinical and MRI
related outcomes in relapsing multiple sclerosis. Abstract
Presented at ECTRIMS, Lyon, France, October 2012.
[2] Ziemssen T. et al. Study design and first interim results of a
registry study to establish long-term safety and pharmaco-economic
data on fingolimod (Gilenya®) in multiple sclerosis patients in
Germany (PANGAEA). Abstract Presented at ECTRIMS, Lyon, France,
October 2012
[3] Neetu A. et al. Comparison of Time to Discontinuation Among
Multiple Sclerosis Patients Receiving Fingolimod and Other
First-Line Disease Modifying Treatments. Abstract Presented at
ECTRIMS, Lyon, France, October 2012.
[4] Cohen J. et al. Long-term safety of fingolimod in relapsing
multiple sclerosis: update to integrated analyses of phase 2 and 3
studies and extension phases. Abstract Presented at ECTRIMS, Lyon,
France, October 2012.
[5] Novartis data on file.
[6] Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in
Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4,
2010;362:402-415.
[7] Havrdová E. et al. Clinical outcomes in subgroups of
patients with highly action relapsing-remitting multiple sclerosis
treated with Fingolimod (FTY720): Results from the FREEDOMS and
TRANSFORMS phase III studies. Poster presented at ECTRIMS,
Amsterdam, October 2011.
[8] Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in
Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4,
2010; 362:387-401.
Avonex® is a registered trademark of Biogen Idec.
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Posted: October 2012
