Novartis International AG : Novartis receives positive CHMP opinion for Ilaris® to treat patients whose acute gouty arthritis

   Novartis International AG : Novartis receives positive CHMP opinion for
 Ilaris® to treat patients whose acute gouty arthritis cannot be managed with
                               standard of care

Novartis International AG / Novartis receives positive CHMP opinion for
Ilaris® to treat patients whose acute gouty arthritis cannot be managed with
standard of care . Processed and transmitted by Thomson Reuters ONE. The
issuer is solely responsible for the content of this announcement.

  *CHMP endorsed the use of Ilaris in patients with acute gouty arthritis,
    who suffer frequent attacks and for whom current treatments are unsuitable
    or ineffective
  *Ilaris, the only approved fully human monoclonal antibody targeting
    interleukin-1 beta (IL-1 beta), inhibits inflammation through sustained
    neutralization of IL-1 beta
  *Current therapies do not offer relief to certain groups of gouty arthritis
    patients, particularly those with serious comorbidities, during their
    severe, crippling attacks[1],[2]

Basel, January 18,  2013 -  Novartis announced  today that  the Committee  for 
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
has adopted a positive opinion for the use of llaris (canakinumab, ACZ885)  in 
the treatment  of patients  with  acute gouty  arthritis who  suffer  frequent 
attacks, and  whose symptoms  cannot or  should not  be managed  with  current 
treatment options.

"Novartis welcomes the  decision by  the CHMP in  support of  the approval  of 
Ilaris  in  the   EU,"  said   David  Epstein,  Division   Head  of   Novartis 
Pharmaceuticals. "When approved,  lIaris will provide  a new treatment  option 
for patients who have endured  frequent and crippling gouty arthritis  attacks 
and where existing therapies do not offer relief. We look forward to receiving
the final decision from the European Commission in the coming months."

Ilaris is the only available fully human monoclonal antibody that specifically
targetsIL-1 beta  and,  when approved,  will  offer patients  suffering  gouty 
arthritis attacks rapid pain relief via a single subcutaneous injection of 150

Gouty arthritis,  commonly referred  to as  gout, is  a serious,  chronic  and 
progressive  inflammatory  disease   that  generally  affects   1  to  4%   of 
adults[3-7].  Gouty  arthritis  is  associated  with  a  high  prevalence   of 
comorbidities, such as  hypertension, kidney  disease, diabetes,  dyslipidemia 
and cardiovascular disease. These conditions can lead to contraindications for
existing therapies and complications for disease management[1],[2],[8],[9].

When approved, Ilaris will be specifically indicated for the 'symptomatic
treatment of adult patients with frequent gouty arthritis attacks (at least 3
attacks in the previous 12 months) in whom non-steroidal anti-inflammatory
drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do
not provide an adequate response, and in whom repeated courses of
corticosteroids are not appropriate'. Since urate lowering therapy (ULT) is
generally advised in these patients, Ilaris may provide sufficient pain relief
to allow initiation or continuation of ULT.

Data from two Phase III trials and their extensions, which informed the CHMP's
positive opinion for Ilaris in  gouty arthritis, showed that patients  treated 
with Ilaris  experienced significantly  greater pain  relief compared  to  the 
injectable steroid triamcinolone acetonide  (TA)[10]. The majority of  adverse 
events (AEs) were mild  to moderate, with  infections (e.g. upper  respiratory 
tract infections and nasopharyngitis) being the most frequent of them.

The European Commission generally follows the recommendations of the CHMP  and 
usually  delivers  its  final  decision  within  three  months  of  the   CHMP 

About Ilaris Phase III Studies
Ilaris has been assessed for the treatment of acute gouty arthritis attacks in
two multicentre, randomized, double-blind, active-controlled studies in
patients with frequent gouty arthritis attacks (>=3 in the previous year) who
were unable to use NSAIDs or colchicine (due to contraindication, intolerance
or lack of efficacy). The studies were 12weeks in duration followed by 12
week double-blind initial extensions[10].

A total of 454 patients were randomized to receive a single dose of Ilaris 150
mg via subcutaneous injection or TA 40 mg via intramuscular injection[10].

Pain intensity in the overall study population was statistically significantly
lower for Ilaris 150mg compared to TA at 72hours (-10.7mm, p<0.0001),  with 
an absolute mean decrease in VAS  score of approximately -50mm. Reduction  in 
pain was  observed  as  early  as  6hours after  dosing  in  both  groups.  A 
statistically significant  difference  between treatments  was  observed  from 
24hours to 7 days. Ilaris also reduced the risk of subsequent attacks[10].

Safety results showed an increased incidence of AEs for Ilaris compared to TA,
with 66% vs. 53% of  patients reporting any adverse event  and 20% vs. 10%  of 
patients reporting an infection adverse event over 24 weeks[11].

A sub-analysis of these studies included 101 patients unable to use NSAIDs and
colchicine, and on stable ULT or unable to use ULT. Pain relief was similar to
that shown in the total study population (-10.2mm for Ilaris 150mg  compared 
with TA at 72hours, p=0.0208)[12].

About Ilaris
Ilaris is a selective, fully human, monoclonal antibody that inhibits IL-1
beta, which is an important part of the body's immune system defenses[11].
Excessive production of IL-1 beta plays a prominent role in certain
inflammatory diseases. Ilaris works by neutralizing IL-1 beta for a sustained
period of time, therefore inhibiting inflammation.

Ilaris is  approved  in more  than  60 countries,  including  in the  EU,  US, 
Switzerland and  Japan  for  the treatment  of  Cryopyrin-Associated  Periodic 
Syndromes (CAPS),  a  suite  of  rare,  life-long,  genetic,  autoinflammatory 
diseases with debilitating  symptoms[11]. Ilaris  is being  investigated in  a 
number of inflammatory conditions, which include, systemic juvenile idiopathic
arthritis (SJIA), Tumor Necrosis Factor Receptor-Associated Periodic  Syndrome 
(TRAPS), Familial Mediterranean  Fever (FMF) and  cardiovascular disease.  Not 
all patients with these diseases would be eligible for treatment with  Ilaris, 
if approved for the applicable disease.

In the US, Novartis  continues to work with  the Food and Drug  Administration 
(FDA) to determine the next steps  for ACZ885 in gouty arthritis, following  a 
Complete Response letter received in August 2011 with a request by the  Agency 
for  additional  clinical  data  to  evaluate  the  benefit  risk  profile  in 
refractory patients.

About Gouty Arthritis
Gouty arthritis is the most common form of inflammatory arthritis in
adults[7],[13]. The chronic and progressive disease is characterized by
recurrent attacks in select joints[3]. These attacks occur when the body has a
strong inflammatory response to uric acid crystals forming in the affected
joint, typically of the toe, foot, ankle, or knee[3],[14]. The intense
inflammatory response associated with these attacks may cause severe pain and
debilitating symptoms that can last a week or more[3],[14],[15].

Treatments currently available to  manage the pain  and inflammation of  gouty 
arthritis attacks,  such  as NSAIDs,  colchicine  or corticosteroids,  may  be 
inadequate or inappropriate  in patients who  have certain coexisting  medical 
problems[2],[11],[16]. As a result, there is a significant unmet medical  need 
among individuals with gouty arthritis.

The foregoing release contains forward-looking statements that can be
identified by terminology such as "positive opinion," "endorsed," "will,"
"look forward to," "generally follows," "recommendation," "would," or similar
expressions, or by express or implied discussions regarding potential new
indications or labeling for Ilaris or regarding potential future revenues from
Ilaris. 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 Ilaris to be materially different
from any future results, performance or achievements expressed or implied by
such statements. There can be no guarantee that Ilaris will be submitted or
approved for any additional indications or labeling in any market. Nor can
there be any guarantee that Ilaris will achieve any particular levels of
revenue in the future. In particular, management's expectations regarding
Ilaris could be affected by, among other things, unexpected regulatory actions
or delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected additional
analysis of existing clinical data; 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 2011, the Group
achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion
(USD 9.2 billion excluding impairment and amortization charges) was invested
in R&D throughout the Group. Novartis Group companies employ approximately
127,000 full-time-equivalent associates and operate in more than 140 countries
around the world. For more information, please visit

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[1] Harrold LR, Yood RA, Mikuls TR, et al. Sex differences in gout
epidemiology: evaluation and treatment. Ann Rheum Dis 2006; 65(10):1368-72.
[2] Riedel AA, Nelson M, Wallace K, Joseph-Ridge N, Cleary M, Fam AG.
Prevalence of Comorbid Conditions and Prescription Medication Use Among
Patients With Gout and Hyperuricemia in a Managed Care Setting. J Clin
Rheumatol 2004; 10(6):308-14.
[3] Schumacher HR, Jr. The pathogenesis of gout. Cleve Clin J Med 2008; 75
Suppl 5:S2-4.
[4] Badley E, DesMeules M. Arthritis in Canada: an ongoing challenge. Ottawa:
Public Health Agency of Canada. 2003.
[5] Begg S, Vos T, Barker B, Stevenson C, Stanley L, Lopez AD, 2007. The
burden of disease and injury in Australia 2003. PHE 82. Canberra: AIHW.
[6] Annemans l, Spaepen E, Gaskin M, et al. Gout in the UK and Germany:
prevalence, comorbidities and management in general practice 2000-2005. Ann
Rheum Dis. 2008; 67(7):960-6.
[7] Zhu Y, Pandya B, Choi H. Increasing gout prevalence in the US over the
last two decades: The National Health and Nutrition Examination Survey
(NHANES). Presented at: The American College of Rheumatology Annual Scientific
Meeting, Oct, 2010, Atlanta, GA.
[8] Choi HK, Ford ES, Li C, Curhan G. Prevalence of the metabolic syndrome in
patients with gout: the Third National Health and Nutrition Examination
Survey. Arthritis Rheum 2007; 57(1):109-15.
[9] Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy
and safety of febuxostat in the treatment of the hyperuricemia of gout: the
CONFIRMS trial. Arthritis Res Ther; 12(2):R63.
[10] Schlesinger N, Alten RE, Bardin T, et al. Canakinumab for acute gouty
arthritis in patients with limited treatment options: results from two
randomised, multicentre, active-controlled, double-blind trials and their
initial extensions. Ann Rheum Dis 2012.
[11] Ilaris [prescribing information]. Surrey, UK: Novartis Pharmaceuticals UK
Ltd; 2013.
[12] Bardin T, So A, Alten R, et al. Efficacy and safety of canakinumab vs
triamcinolone acetonide in patients with gouty arthritis unable to use
nonsteroidal anti-inflammatory drugs and colchicine, and on stable urate
lowering therapy (ULT) or unable to use ULT. Abstract at: 2012 ACR/ARHP Annual
Meeting; November 9-14; Washington, D.C., USA.
[13] Silman AJ, Pearson JE. Epidemiology and genetics of rheumatoid
arthritis. Arthritis Res. 2002;4 Suppl 3:S265-72.
[14] Mandell BF. Clinical manifestations of hyperuricemia and gout. Cleve Clin
J Med 2008; 75 Suppl 5:S5-8.
[15] So A, De Meulemeester M, Pikhlak A, et al. Canakinumab for the treatment
of acute flares in difficult-to-treat gouty arthritis: Results of a
multicenter, phase II, dose-ranging study. Arthritis Rheum 2010;
[16] Jordan KM, Cameron JS, Snaith M, et al. British Society for Rheumatology
and British Health Professionals in Rheumatology guideline for the management
of gout. Rheumatology (Oxford) 2007; 46(8):1372-4.

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