Novartis drug Gilenya® (fingolimod) has more than 20,000 patient-years of exposure and shows up to 71% reduction in annualized relapse rates in MS patients with highly active disease
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Novartis International AG /
Novartis drug Gilenya® (fingolimod) has more than 20,000 patient-years of
exposure and shows up to 71% reduction in annualized relapse rates in MS
patients with highly active disease
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The issuer is solely responsible for the content of this announcement.
* Analyses presented at 5(th) Joint Triennial Congress of ECTRIMS and ACTRIMS
showed relapse rate reductions were consistent among subgroups of
fingolimod-treated patients that had highly active disease in pivotal
clinical trials
* Fingolimod demonstrated reductions in rates of brain atrophy compared to
interferon beta-1a IM regardless of disease activity
* To date, approximately 25,000 patients treated with fingolimod and more than
20,000 patient-years of exposure; more than 20,000 patients on commercial
drug
Basel, October 17, 2011 - Novartis will showcase data from 13 abstracts on
fingolimod (Gilenya(®)), at the 5th Joint Triennial Congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and
Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)
taking place from 19-22 October in Amsterdam.
The data being presented for fingolimod at ECTRIMS/ACTRIMS highlight the
Novartis clinical trial program for sphingosine 1-phosphate receptor (S1PR)
modulators. Fingolimod targets MS via effects on the immune system and new pre-
clinical data to be presented at ECTRIMS/ACTRIMS supports an additional
potential direct effect on the central nervous system (CNS)[1,2], although the
clinical relevance of this remains to be determined. Additional clinical data
describe efficacy in subgroups of patients with highly active disease in the
pivotal Phase III studies.
"Gilenya has already demonstrated significant efficacy in large scale clinical
trials which is reinforced by these important data presented at ECTRIMS/ACTRIMS
reflecting different patient populations in need of a new treatment," said David
Epstein, Head of the Pharmaceuticals Division at Novartis Pharma AG. "These
findings will help further solidify the role of Gilenya in the treatment of MS
within its approved indication."
Data highlights include:
Fingolimod 0.5 mg significantly reduced annualized relapse rates (ARR) by up to
71% (from 61% to 71%) compared to interferon beta-1a IM and compared to placebo
in relapsing-remitting multiple sclerosis (MS) patients with high disease
activity despite previous MS disease-modifying treatment. Although the reduction
in ARR in another subgroup of patients, those patients with rapidly evolving
severe relapsing-remitting MS, was directionally consistent with other subgroup
data, statistical significance was not achieved compared to interferon beta-1a
IM due to the small number of patients in this subgroup[3]. (Abstract P473)
* In relapsing-remitting MS patients with high disease activity despite
previous MS disease-modifying treatment, the relative reduction of ARR
ranged from 61% compared to interferon beta-1a in TRANSFORMS to 62%-71%
compared to placebo in FREEDOMS.
* In the European Union, Gilenya 0.5 mg is approved for the treatment of
relapsing-remitting MS in patients with high disease activity despite
treatment with interferon beta, and in patients with rapidly evolving severe
relapsing-remitting MS.
Fingolimod 0.5 mg reduced the rate of brain atrophy, or brain volume loss,
compared to interferon beta 1a IM over 12 months, irrespective of disease
activity prior to study start as shown in an analysis of the pivotal Phase III
TRANSFORMS study[3]. (Abstract P907)
A five year Phase II study extension showed that patients with relapsing MS
treated with fingolimod maintained low disease activity with a safety profile
consistent with that seen in other fingolimod clinical trials. Of the original
281 patients at the start of the Phase II study, approximately 50% (140
patients) completed five years of treatment[4]. (Abstract P978)
In addition to the data presentations, onsite at the RAI Exhibition and
Conference Centre there will be a Novartis symposium, 'Fingolimod: pioneering
innovation in MS treatment', taking place on Friday 21st October, 12:45 - 13:45
CET. There will also be three interactive 'MS Innovation Exchanges,' including
two October 20 and one on October 21. The 'MS Innovation Exchanges' are an
opportunity for healthcare professionals to learn about innovations in patient
care, neuroimaging and patient outcomes. Healthcare professionals should visit
the Novartis booth for more information. In addition, a press briefing will be
taking place on Friday, October 21 from 15:30-17:00 CET.
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[5].
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[6]. 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[5,7].
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[5,7].
The following key Novartis data will be presented during the ECTRIMS/ACTRIMS
congress:
1. Abstract P473: Clinical and magnetic resonance imaging outcomes in
subgroups of patients with highly active relapsing-remitting multiple
sclerosis treated with fingolimod (FTY720): results from the FREEDOMS and
TRANSFORMS phase 3 studies
2. Abstract P907: Fingolimod (FTY720) reduces brain volume loss over 12 months
compared with intramuscular interferon beta-1a: subgroup analyses of
TRANSFORMS data based on inflammatory disease activity
3. Abstract P320: A controlled study on the effect of fingolimod (FTY720) on
the immune response following seasonal influenza vaccination and tetanus
toxoid booster injection in patients with Multiple Sclerosis
4. Abstract P369: Brain distribution of BZM055, an imaging analog of
fingolimod (FTY720), in non-human primate
5. Abstract P978: Long-term fingolimod (FTY720) in relapsing MS: 5-year
results from an extension of a phase II, multicenter study show a sustained
low level of disease activity
6. Abstract P239: Effect of fingolimod (FTY720) on disability progression:
Application of a transition model to EDSS data collected in the FREEDOMS
and TRANSFORMS trials
7. Abstract P494: Fingolimod (FTY720) modulates microglial activation to
augment markers of remyelination
8. Abstract P930: Oral fingolimod (FTY720) in Japanese patients with relapsing
multiple sclerosis: results of a 6-month, randomized, double-blind,
placebo-controlled, phase 2 study
9. Abstract P460: Oral fingolimod (FTY720) in Japanese patients with relapsing
multiple sclerosis: Results of a 12-month, phase 2 extension study
10. Abstract P961: Nervous system and immune system effects of sphingosine 1-
phosphate receptor 5 deletion in mice alters experimental autoimmune
encephalitis progression and the efficacy of fingolimod
11. Abstract P552: Treatment experience, burden and unmet needs (TRIBUNE) in
multiple sclerosis study: patient preferences for MS treatments
12. Abstract P767: T-Cell response against varicella zoster virus in fingolimod
treated patients with multiple sclerosis
13. Abstract P823: Sphingosine 1-phosphare receptor antagonists promote axonal
ensheathment by human fetal oligodendrocyte progenitors
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "will," "to be presented," "potential," 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. 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 product 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 healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only 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. Headquartered in Basel, Switzerland, 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.
References
1. Tamagnan G. et al. Brain distribution of BZM055, an imaging analog of
fingolimod (FTY720), in non-human primate. Data Presented at ECTRIMS,
Amsterdam, October 2011.
2. Noguchi K. et al. Nervous system and immune system effects of sphingosine
1-phosphate receptor 5 deletion in mice alters experimental autoimmune
encephalitis progression and the efficacy of fingolimod. Data Presented at
ECTRIMS, Amsterdam, October 2011.
3. 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. Data
Presented at ECTRIMS, Amsterdam, October 2011.
4. Montalban X et al. Long-term fingolimod (FTY720) in relapsing MS: 5-year
results from an extension of a phase II, multicenter study show a sustained
low level of disease activity. Data Presented at ECTRIMS, Amsterdam, October
2011.
5. Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing
Multiple Sclerosis. N Eng J Med. 2010; 362:402-415.
6. Novartis data on file.
7. Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing
Multiple Sclerosis. N Eng J Med. 2010; 362:387-401.
# # #
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