Novartis receives European Commission approval for Gilenya®, the first oral multiple sclerosis treatment for use in the EU
0
Novartis International AG /
Novartis receives European Commission approval for Gilenya®, the first oral
multiple sclerosis treatment for use in the EU
Processed and transmitted by Thomson Reuters.
The issuer is solely responsible for the content of this announcement.
* Gilenya approved in the EU for people with highly active relapsing-remitting
multiple sclerosis (RRMS) despite treatment with beta interferon, or in
patients with rapidly evolving severe RRMS
* Gilenya showed superior efficacy to interferon beta-1a IM, a commonly
prescribed treatment, reducing relapses by 52% (p<0.001) at one year
* Two-year, placebo-controlled study demonstrated that Gilenya significantly
reduced the risk of disability progression
Basel, March 21, 2011 - The European Commission has granted Novartis approval
for Gilenya(®) (fingolimod) 0.5 mg daily as a disease modifying therapy in
patients with highly active relapsing-remitting multiple sclerosis (RRMS)
despite treatment with beta interferon, or in patients with rapidly evolving
severe RRMS.
"Today marks an important step forward in the way we manage this chronic,
debilitating disease in Europe, " said Professor Hans-Peter Hartung, Professor
and Chairman, Dept. of Neurology, Heinrich-Heine University, Germany. "Gilenya
is the first approved therapy for MS that offers significant efficacy in a
capsule, which for many patients will come as a welcome additional option."
The approval was based on the largest clinical trial program( )submitted to date
for a new MS drug, and included data from clinical studies showing significant
efficacy in reducing relapses, the risk of disability progression, and the
number of brain lesions detected by magnetic resonance imaging (MRI), a measure
of disease activity[1], [2].
"Today´s announcement marks another major regulatory approval and we are pleased
that Gilenya will become available to more eligible MS patients, " said David
Epstein, Division Head of Novartis Pharmaceuticals. "Novartis is dedicated to
bringing innovative new treatments to patients where there is significant unmet
need. Gilenya has been in clinical development for MS since 2003 and we are
grateful for the commitment of those involved, especially the trial
participants, who have contributed significantly to the development of this
novel medicine."
Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a
new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. In
MS, the immune system damages the covering that protects nerve fibers in the
central nervous system (CNS), which includes the brain and spinal cord. The
novel mechanism of Gilenya is thought to work by reducing the immune system´s
attack on the CNS by retaining certain white blood cells (lymphocytes) in the
lymph nodes. This prevents the white blood cells from reaching the CNS, where
they could potentially attack the protective covering around the nerve fibers,
resulting in less inflammatory damage to the nerve cells.( )The white blood cell
retention is reversible if Gilenya treatment is stopped.
The EU application included data showing Gilenya 0.5 mg reduced relapses by 52%
(P<0.001) at one year compared with interferon beta-1a IM (Avonex(®)), one of
the most commonly prescribed treatments for MS Data from a two-year placebo-
controlled study showed a reduction in the risk of disability progression among
Gilenya patients (30% reduction confirmed at three-month follow-up visit P=0.02,
compared with placebo)[2]. In clinical studies, treatment with Gilenya also
resulted in statistically significant reductions in brain lesion activity as
measured by MRI.
Gilenya has been studied in more than 4000 MS patients. The most common side
effects are headache, liver enzyme elevations, influenza, diarrhea, back pain,
and cough. Other Gilenya-related side effects include 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]
Avonex(® )is a registered trademark of Biogen Idec.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "will, " "dedicated, " "commitment, " "potentially, " or
similar expressions, or by express or implied discussions regarding the timing
of the launch of Gilenya in Europe, 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 launched in any
particular European country 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; government, industry and general public pricing
pressures, including governmental reimbursement issues; competition in general;
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; 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 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, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. 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 119,000 full-time-equivalent associates (including 16,700 Alcon
associates) and operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com.
References
1. Cohen et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing
Multiple Sclerosis. N Engl J Med. Vol.362 No.5, Feb 4, 2010 (printed version)
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 (printed version).
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Julie Morrow
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 696 7581 (direct)
+41 79 593 4202 (mobile) +41 79 357 3259 (mobile)
eric.althoff@novartis.com julie.morrow@novartis.co
e-mail: media.relations@novartis.com
For Novartis multimedia content, please visitwww.thenewsmarket.com/Novartis
For questions about the site or required registration, please
contact:journalisthelp@thenewsmarket.com.
Novartis Investor Relations
Central phone: +41 61 324 7944
Susanne Schaffert +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Richard Jarvis +1 212 830 2433
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
e-mail: investor.relations@novartis.com e-mail:
investor.relations@novartis.com
--- End of Message ---
Novartis International AG
Postfach Basel
WKN: 904278;ISIN: CH0012005267;
Media release (PDF):
http://hugin.info/134323/R/1498377/433974.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novartis International AG via Thomson Reuters ONE
[HUG#1498377]
CH0012005267
