Novartis International AG : New analysis shows Novartis drug Gilenya®
significantly reduced rate of brain volume loss across three large Phase III
Novartis International AG / New analysis shows Novartis drug Gilenya®
significantly reduced rate of brain volume loss across three large Phase III
studies . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.
*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
*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. 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. 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.
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.
New extension data from FREEDOMS II (n=632) reinforce the known safety profile
of Gilenya in patients treated up to four years. More than eight out of ten
patients (83%) completed the extension study, which identified no unexpected
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.
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,. Gilenya is thought to act on inflammatory processes
implicated in the MS disease process,.
Data has shown significant efficacy with Gilenya in reducing relapses and
significant slowing of six-month disability progression sustained at four
years. Nearly half of Gilenya patients were disease-free after one year of
treatment and in the pivotal FREEDOMS study eight out of ten patients
remained on treatment at two years. 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. 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.
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,. 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,.
Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.
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.
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,
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 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.
 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.
 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.
 Novartis data on file.
 Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic
effects in the immune and the central nervous system. Br J Pharmacol
 Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in
Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.
 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
 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.
 Kappos L. et al; for FREEDOMS Study Group. A placebo-controlled trial of
oral fingolimod in relapsing multiple sclerosis. N Engl J Med.
 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.
 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.
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