Novartis drug Gilenya® showed positive clinical outcomes for relapsing-remitting MS patients in third large Phase III clinical trial
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Novartis drug Gilenya® showed positive clinical outcomes for relapsing-remitting
MS patients in third large Phase III clinical trial
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* Once-daily oral MS medicine showed a 48% relative reduction in annualized
relapse rate, meeting primary endpoint in Phase III placebo-controlled study
* Significant reduction in brain volume loss demonstrated, reinforcing strong
efficacy benefit in key secondary endpoint
* Safety and tolerability were broadly consistent with previous clinical
trials
Basel, December 15, 2011 - Novartis announced today new data from the Phase III
2309 study showing patients with relapsing-remitting multiple sclerosis (RRMS)
treated with Gilenya(®) (fingolimod) had a statistically significant 48%
reduction in annualized relapse rates (ARR) at 24 months compared to placebo.
Study 2309 is the third Phase III clinical trial to demonstrate a significant
reduction of relapse rates with Gilenya treatment in patients with RRMS. The two
previous Gilenya studies involved a two-year, placebo-controlled trial and a
one-year, head-to-head trial against interferon-beta-1a (IM) in which the once-
daily oral medicine showed a 54% and a 52% relative reduction in ARR,
respectively[1],[2].
A reduction of brain volume loss, a pre-defined key secondary endpoint for study
2309, also achieved statistical significance for Gilenya-treated patients
compared to placebo. Brain volume loss is valued as a predictor of long-term
disability[3] and study 2309 is the third Phase III clinical trial where Gilenya
demonstrated high efficacy in this MRI (magnetic resonance imaging) measure
compared to control.
"Study 2309 confirms the efficacy of Gilenya across several key measures,
including reductions in annualized relapse rate and reductions in brain volume
loss," said David Epstein, Head of the Pharmaceuticals Division at Novartis
Pharma AG. "With more than 20,000 patient years of fingolimod exposure to date,
Gilenya continues to demonstrate its value to patients and the MS community. We
are looking forward to presenting the full data to the clinical community at a
scientific congress next year."
Gilenya-treated patients had a 17% and 28% reduction in three-month and six-
month confirmed disability progression, compared to placebo as measured by EDSS
(expanded disability status scale), respectively, which were not statistically
significant. A post-hoc analysis of the data showed that this result is likely
due to a high variability in EDSS measurements among patients with low baseline
scores (i.e. 0.0 and 1.0).
A subsequent analysis that applied a more rigorous definition of EDSS disability
progression reduced the impact of this variability. Specifically, Gilenya-
treated patients showed approximately a 34% reduction of six-month confirmed
disability progression compared to placebo when a 1.5 point increase in EDSS was
used to define progression in patients with baseline EDSS scores of zero, rather
than the pre-specified 1.0 point increase. This disability reduction outcome is
in range with what was seen in previous clinical trials. Further, study 2309
showed a statistically significant difference from placebo in the Multiple
Sclerosis Functional Composite (MSFC), an alternative disability scale pre-
defined in the clinical trial.
"The results of this third Phase III study of Gilenya confirm data from the
previous two studies that this drug is highly effective in relapsing forms of
MS," said Peter Calabresi, M.D., Professor of Neurology, Johns Hopkins
University. "The absence of an effect on disability in this trial is in contrast
to the previous placebo comparison trial and seems to relate to inaccuracies of
the EDSS scale at the low end where there is known to be quite a bit of
variability. Nonetheless, there was a reduction of disability in line with
previous trials if one employs a more rigorous definition of change, which is in
keeping with the observed reduction in brain atrophy as well as other functional
outcome measures of disease progression."
Safety and tolerability were broadly consistent with the safety profile of
fingolimod as characterized in the previous Phase III clinical trials. There
were no deaths in fingolimod treated patients in the trial. Symptomatic
bradycardia and associated AV-conduction blocks were rare and none required
symptomatic treatment at the fingolimod 0.5 mg dose. As in previous studies,
other adverse events which were observed more frequently in fingolimod-treated
patients included liver transaminase elevations, hypertension and lymphopenia.
The overall rate of infections was similar between fingolimod- and placebo-
treated patients. Although herpes viral infections were reported more frequently
with fingolimod in this trial, updated integrated analyses of all controlled
clinical trials from the fingolimod development program show no differences in
the incidence of herpes viral infections between fingolimod and placebo
treatment groups. Malignancies were equally distributed across treatment groups
in this study with the exception of basal cell carcinomas of the skin which,
although of low incidence, were more frequently reported in fingolimod treated
patients.
Study 2309 was a two-year placebo-controlled, parallel-group, multi-center Phase
III clinical trial evaluating the efficacy and safety of Gilenya (fingolimod)
0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS). Study
2309 was primarily performed to provide specific safety data for the Gilenya New
Drug Application (NDA) that was submitted to the US Food and Drug Administration
in December 2009.
The study included 1083 patients across 126 sites in eight countries with most
of patients enrolled in the United States, and had a central MRI review and
independent EDSS raters. The study included three arms and patients with RRMS
were randomized 1:1:1 to fingolimod 1.25 mg, fingolimod 0.5 mg or placebo.
Patients who were randomized to the fingolimod 1.25 mg arm were switched to 0.5
mg during the course of the study in a blinded manner based on a determination
of superior benefit-risk profile for the 0.5 mg dose in the Phase III studies
FREEDOMS and TRANSFORMS.
About Gilenya(®) (fingolimod)
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(®)
(interferon-beta-1a IM), 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.(1) In a recent sub-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.[4]
Gilenya is generally a highly effective once-daily oral MS treatment without
label restrictions specific to treatment duration. 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 more than 25,000 patients having been treated as of mid October 2011 in
clinical trials and in a post-marketing setting. Currently, there is more than
20,000 patient years of exposure. 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.[1],[2]
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.[1],[2]
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "looking forward to," 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 regulatory actions or delays or
government regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; 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 2010, the Group's
continuing operations achieved net sales of USD 50.6 billion, while
approximately USD 9.1 billion (USD 8.1 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 121,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] 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.
[2] 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.
[3] Popescu V. et al. Brain atrophy in MS: long-term prognostic value. Poster
presented at ECTRIMS, Amsterdam, October 2011.
[4] 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.
Avonex® is a registered trademark of Biogen Idec.
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Datum: 15.12.2011 - 07:15 Uhr
Sprache: Deutsch
News-ID 97265
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