Novartis International AG : Novartis confirms growing Gilenya® clinical and real-world experience as number of patients treated

 Novartis International AG : Novartis confirms growing Gilenya® clinical and
 real-world experience as number of patients treated increases to over 63,000

Novartis International AG / Novartis confirms growing Gilenya® clinical and
real-world experience as number of patients treated increases to over 63,000 .
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responsible for the content of this announcement.

  *Growing global evidence base reinforces consistent and sustained  efficacy 
    of first once-daily oral multiple sclerosis treatment
  *Up to seven years of clinical trial experience (Phase II and III) and over
    two years of real-world use
  *Gilenya is the only approved  MS treatment shown to consistently  decrease 
    brain volume loss across studies with  a significant effect seen as  early 
    as six months
  *Low rate of brain volume loss with Gilenya sustained for up to four  years 
    in Phase  III  studies  and  for  up to  seven  years  in  patients  after 
    completing a Phase II study

Basel, March  26, 2013-  Latest global  patient-use data  show that  Gilenya^® 
(fingolimod) has been  used to  treat more  than 63,000  patients in  clinical 
trials and the post-marketing setting[1].

"As the first once-daily  oral MS therapy, we  are pleased Gilenya has  played 
such an important role in addressing unmet medical need in the MS community in
the two years following  initial approvals," said David  Epstein, Head of  the 
Pharmaceuticals Division  of  Novartis  Pharma  AG.  "Our  growing  experience 
reinforces Gilenya's  high efficacy  and very  good tolerability  profile  and 
Novartis remains  committed  to  ensuring eligible  patients  have  access  to 
Gilenya."

Gilenya is the only  approved treatment shown  to consistently decrease  brain 
volume loss[2],[3]. Brain volume loss  is the best magnetic resonance  imaging 
(MRI) correlate of  long-term disability.  New data presented  at the  recent 
65th Annual Meeting American Academy  of Neurology (AAN), showed that  Gilenya 
reduced the  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.[4] Patients from a Phase II study who remained on treatment  for 
up to seven years experienced consistently low rates of brain volume loss[5].

Data has also shown significant efficacy with Gilenya in reducing relapses and
slowing of six-month disability progression sustained at four years[6]. Nearly
half of Gilenya patients were disease-free after one year of  treatment[7],[8] 
and in the pivotal FREEDOMS study, eight  out of ten patients on the  approved 
dose remained on treatment at two years[2].

In clinical trials Gilenya exhibited  a well-characterized safety profile  and 
very good tolerability profile[2],[3].

Gilenya was approved based on the largest phase III clinical trial program  in 
MS at  the time  of submission,  which included  a head-to-head  study  versus 
Avonex® (interferon beta-1a IM), a  commonly prescribed treatment. Gilenya  is 
now approved in 70 countries, and there is approximately 73,000 patient  years 
of exposure[1].

Up  to   2.5   million  people   worldwide   are  affected   with   MS[9],   a 
neurodegenerative condition that often  begins in early adulthood[10].  Around 
70% of newly  diagnosed patients with  MS are in  the prime of  their lives  - 
between 20 and 40 years of  age - so most people  are employed at the time  of 
diagnosis. This can have a significant impact on careers, quality of life  and 
families[11],[12].

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 
(S1PR) modulators.  Gilenya  is  thought  to  act  on  inflammatory  processes 
implicated in the MS disease process[13],[14].

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[3].
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[15].

In clinical trials Gilenya exhibited  a well-characterized safety profile  and 
very good  tolerability  profile[2],[3]. 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[2],[3]. 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[2],[3].

Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

Disclaimer
The  foregoing  release  contains  forward-looking  statements  that  can   be 
identified by terminology such as  "committed," 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 clinical  trial 
results, including  unexpected new  clinical  data and  unexpected  additional 
analysis  of  existing  clinical  data;  competition  in  general,   including 
potential competition from additional  newly-approved oral multiple  sclerosis 
treatments; unexpected regulatory actions  or delays or government  regulation 
generally;  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] Data on file. Novartis Pharma AG.
[2] 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.
[3] 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
[4] 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.
[5] Chin PS, Calabresi PA, Zhang Y,  von Rosenstiel P, Kappos L. Early  effect 
of fingolimod  on clinical  and  MRI related  outcomes in  relapsing  multiple 
sclerosis. Poster presented at:  28th Congress of  the European Committee  for 
Treatment and  Research  in Multiple  Sclerosis;  October 10-13,  2012:  Lyon, 
France. Abstract P459
[6] 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.
[7] 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   activecontrolled   study 
(TRANSFORMS). Abstract presented  at: 64th  AAN Annual  Meeting; April  21-28, 
2012; New Orleans, LA. Abstract PD5:006.
[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). Poster presented at: 64th AAN Annual Meeting; April 21-28, 2012;
New Orleans, LA. Poster PD5:006.
[9]  Multiple  Sclerosis  International  Federation.  Atlas  of  MS  [online]. 
Available at: www.atlasofms.org. Accessed January 2013.
[10] Declaration of the European Parliament  of 13 September 2012 on  tackling 
multiple                 sclerosis                  in                  Europe 
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2012-0357&format=XML&language=EN.
Accessed January 2013.
[11]   European   Multiple   Sclerosis   Platform,   MS   fact   sheet    2011 
http://www.ms-in-europe.org/multiple-sclerosis/index.php?kategorie=whatisms&cnr=6&anr=127.
Accessed January 2013.
[12]                Multiple                Sclerosis                Factsheet 
http://www.emsp.org/ms-need/content/factsheet.pdf Accessed January 2013.
[13] 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.
[14] Chun J, Hartung  HP. Mechanism of Action  of Oral Fingolimod (FTY720)  in 
Multiple Sclerosis. Clin Neuropharmacol. 2010 Mar-Apr;33(2):91-101.
[15] 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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