New analysis shows Novartis drug Gilenya significantly reduced rate of brain volume loss across three large Phase III studies
• Data show reductions in rate of brain volume loss by
about one-third compared to interferon beta-1a IM or placebo in
studies with over 3,600 patients with relapsing MS
• Gilenya is the first oral disease modifying treatment to
show consistent effect on brain volume loss, an important indicator
of disease progression
• Analysis of FREEDOMS II, a Phase III study, confirms Gilenya
consistently reduces annualized relapse rates across disease
activity, gender, age and prior treatment
• Safety profile of Gilenya reinforced in patients treated up
to four years; overall more than 56,000 patients treated with
Gilenya worldwide
Basel, March 21, 2013 - New data presented at the 65th annual
meeting of the American Academy of Neurology (AAN) show
Gilenya® (fingolimod), the first oral disease modifying therapy
approved to treat relapsing forms of multiple sclerosis (MS),
significantly and consistently reduced the rate of brain volume
loss. Results also showed that Gilenya reduced annualized relapse
rates across important subgroups; and additional data reinforce
Gilenya's safety profile in patients treated up to four
years.
"Loss of brain volume is a consequence of multiple sclerosis and is
a key MRI correlate of disease progression," said Dr. Timothy
Wright, Global Head Development, Novartis Pharmaceuticals AG. "The
findings reported show the effect of Gilenya across a variety of
important disease measures and support evidence for initiating
early use of this highly effective treatment in patients with
relapsing MS."
Data shows consistent reduction in rate of brain volume loss
In a new analysis of over 3,600 patients from three large Phase III
studies (TRANSFORMS, FREEDOMS, and FREEDOMS II) Gilenya showed a
significant reduction in the rate of brain volume loss vs. a
comparator - consistent with previously reported results[1]. In the
TRANSFORMS study over one year, Gilenya reduced the rate of brain
volume loss by -32% (p<0.001) compared to Avonex®
(interferon beta-1a IM), a commonly prescribed injectable
treatment[1]. Over two years, Gilenya reduced the rate of brain
volume loss compared to placebo by 35% (p<0.001) in the FREEDOMS
study, and by 33% (p<0.001) in the FREEDOMS II study,
respectively[1].
The data also showed that brain volume, at baseline, consistently
correlated with the level of disease severity and disability. Lower
brain volume was linked with more severe disease and disability,
while higher brain volume correlated with less severe levels. In
addition, traditional markers of disease activity (such as MRI
lesion counts) at baseline were predictive of the rate of brain
volume loss over two years.
New results highlight consistent efficacy and long-term safety
profile
Separately, a recent subgroup analysis (n=1083) of FREEDOMS II, the
third large Phase III Gilenya study, supports the known efficacy of
Gilenya treatment. Specifically, results show Gilenya consistently
reduced annualized relapse rates (ARR) compared to placebo in
patients with relapsing-remitting MS, across gender, age, prior
treatment, and baseline disease activity[2].
New extension data from FREEDOMS II (n=632) reinforce the known
safety profile of Gilenya in patients treated up to four years[3].
More than eight out of ten patients (83%) completed the extension
study, which identified no unexpected safety concerns[3].
Gilenya was approved based on the largest Phase III program in
relapsing-remitting MS at the time of submission. With up to seven
years of clinical trial experience (Phase II and III) and over two
years of real-world use, there is increasing experience of
Gilenya's long-term effectiveness and safety profile in more than
-56,000 patients worldwide[4].
About Gilenya
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[5],[6]. Gilenya is thought to act
on inflammatory processes implicated in the MS disease
process[5],[6].
Data has shown significant efficacy with Gilenya in reducing
relapses and significant slowing of six-month disability
progression sustained at four years[7]. Nearly half of Gilenya
patients were disease-free after one year of treatment[8] and in
the pivotal FREEDOMS study eight out of ten patients remained on
treatment at two years[9]. Gilenya is the only treatment shown to
consistently decrease brain volume loss, the best characterized
magnetic resonance imaging (MRI) predictor of long-term
disability.
Gilenya 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) at one year in a pivotal head-to-head trial in patients
with relapsing-remitting multiple sclerosis[10]. In a 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[11].
In clinical trials, Gilenya was generally well-tolerated with a
manageable safety profile. 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[9],[10]. 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[9],[10].
Gilenya is licensed from Mitsubishi Tanabe Pharma
Corporation.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified 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 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 128,000
full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis.
References:
[1] Cohen J. et al. Fingolimod-effect on brain atrophy and
clinical/MRI correlations in Three Phase 3 studies - TRANSFORMS,
FREEDOMS and FREEDOMS II. Abstract Presented at AAN, San Diego,
March 2013.
[2] Goodin D. et al. Fingolimod reduces annualized relapse rates in
patients with relapsing-remitting multiple sclerosis: FREEDOMS II
study subgroup analysis. Abstract Presented at AAN, San Diego,
March 2013.
[3] Vollmer T. et al. Long-term safety of fingolimod in patients
with relapsing-remitting multiple sclerosis: Results from phase 3
FREEDOMS extension study. Abstract Presented at AAN, San Diego,
March 2013.
[4] Novartis data on file.
[5] Brinkmann V. FTY720 (fingolimod) in multiple sclerosis:
therapeutic effects in the immune and the central nervous system.
Br J Pharmacol 2009;158(5):1173-1182.
[6] Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod
(FTY720) in Multiple Sclerosis. Clin Neuropharmacol. 2010
March-April;33(2):91-101.
[7] Kappos L. et al. Phase 3 FREEDOMS study extension: fingolimod
(FTY720) efficacy in patients with relapsing-remitting multiple
sclerosis receiving continuous or placebo-fingolimod switched
therapy for up to 4 years. Poster presented at: 28th Congress of
the European Committee for Treatment and Research in Multiple
Sclerosis; October 10-13, 2012: Lyon, France. Poster P979.
[8] Khatri B. et al. Fingolimod treatment increases the proportion
of patients who are free from disease activity in multiple
sclerosis compared to interferon beta-1a: results from a phase 3
active controlled study (TRANSFORMS). Abstract presented at: 64th
AAN Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract
PD5:006.
[9] Kappos L. et al; for FREEDOMS Study Group. A placebo-controlled
trial of oral fingolimod in relapsing multiple sclerosis. N Engl J
Med. 2010;362(5):387-401.
[10] Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study
Group. Oral fingolimod or intramuscular interferon for relapsing
multiple sclerosis. N Engl J Med. 2010;362(5):402-415.
[11] Havrdová E, et al. Clinical outcomes in subgroups of
patients with highly active 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.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com
Katrina Lucking
Novartis Global Pharma Communications
+41 79 171 8267 (mobile)
katrina.lucking@novartis.com
e-mail: media.relations@novartis.com
For Novartis multimedia content, please visit
www.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
Samir Shah +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Stephen Rubino +1 862 778
8301
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
Posted: March 2013
