Novartis biological drug Ilaris® approved in EU to treat children and adults with CAPS, a rare debilitating auto-inflammatory disease

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* First drug approved in EU for patients as young as four years old
with cryopyrin-associated periodic syndrome (CAPS)[1]

* Approval based on positive data showing Ilaris produced rapid and
sustained remission of CAPS symptoms in up to 97% of patients[2]

* Ilaris is a monoclonal antibody that selectively targets and
blocks interleukin-1 beta (IL-1ß), the trigger for inflammation
and tissue damage in CAPS patients[1],[2],[3]

* Studies ongoing in groups of patients with other diseases
involving IL-1ß such as COPD, type 2 diabetes and gout - one of
the most painful forms of arthritis

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Basel, October 28, 2009 - The new biological medicine Ilaris®
(canakinumab) has been approved in the European Union (EU) to treat
adults and children as young as four years old with
cryopyrin-associated periodic syndrome (CAPS), a rare life-long
auto-inflammatory disease with debilitating symptoms and few
treatment options[1],[2],[3].

The accelerated EU decision follows approvals in the US and
Switzerland, where Ilaris was granted priority review in view of the
significant unmet medical need. Ilaris is the only medicine approved
in the EU for CAPS patients as young as four years old, and for
patients with the most debilitating form of CAPS, neonatal-onset
multisystem inflammatory disease (NOMID)[4]. It is a fully human
monoclonal antibody given by injection under the skin once every two
months - the longest dosing interval of any available
treatment[2],[5],[6].

"We are excited by the latest approval because Ilaris represents a
significant therapeutic advance for patients with this debilitating
and sometimes fatal disease," said Joe Jimenez, CEO of the Novartis
Pharmaceuticals Division. "Ilaris is the outcome of our
pathways-driven search for innovative medicines that are tailored to
the needs of patients. Initially we studied Ilaris in a very rare
disease with a well-understood genetic profile, and now that its
efficacy has been proven, we are able to move ahead rapidly with
development in other diseases characterized by the same inflammatory
process."

The regulatory submission was supported by data showing that Ilaris
produced rapid and sustained remission of symptoms in up to 97% of
CAPS patients, with most of them responding within hours of the first
injection[2].

Ilaris, previously known as ACZ885, targets and normalizes the
production of a protein within the immune system called interleukin-1
beta (IL-1ß)[1],[3],[7]. In CAPS patients, IL-1ß is overproduced
causing widespread inflammation and tissue damage[3],[8],[9].
Symptoms, such as debilitating fatigue, fever, joint pain and
conjunctivitis, can be present from infancy and continue throughout
the patient's life[2],[3].

If left untreated, CAPS may have serious consequences such as
deafness, bone deformities, erosive joint destruction, and central
nervous system damage leading to loss of vision[1],[2],[3]. Around
25% of patients develop amyloidosis, a condition in which the
build-up of proteins can cause vital organs to fail, resulting in
renal failure and requiring kidney transplantation. Approximately 20%
of patients with NOMID, the most severe form of CAPS, die before
reaching adulthood[2],[3],[10].

CAPS is believed to occur in around one in 2,500 people in the
EU[3],[11], but fewer than 1,000 cases have been reported worldwide
due to poor diagnosis[1],[3]. CAPS includes three distinct
autoinflammatory disorders of increasing severity: familial cold
auto-inflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), and
NOMID[2],[3]. Ilaris is the only treatment indicated in the EU and
Switzerland to treat all three disorders[1],[4].

Studies with ACZ885 are ongoing in other diseases in which IL-1ß
plays an important role, such as chronic obstructive pulmonary
disease (COPD), type 2 diabetes, systemic juvenile idiopathic
arthritis (SJIA), and gout - one of the most painful forms of
arthritis. Not all potential patients with these diseases would be
eligible for treatment with ACZ885, if approved.

The CAPS filing was based on a clinical trial program involving more
than 100 patients. Data from a pivotal study published in The New
England Journal of Medicine show that Ilaris produced a rapid,
complete and sustained response in most patients[2]. None of the
patients treated with Ilaris (0 out of 15) experienced a disease
outbreak or 'flare' compared to 13 of the 16 patients who received
placebo (0% vs. 81% respectively, p<0.001)[2].

"In CAPS studies, symptoms improved within 24 hours after patients
received a single dose of Ilaris. The disease was barely detectable
in the blood after two weeks and the remission of symptoms was
sustained for six months," said Helen J. Lachmann, MD of the UK
National Amyloidosis Centre at the Royal Free and University College
Medical School in London, UK. "By effectively turning off the disease
activity, Ilaris has the potential to transform patients' lives by
offering long-term control of their disease."

Ilaris was generally well tolerated and there was no consistent
pattern of adverse events apart from a slight increase in
infections[2]. Two patients experienced serious adverse events,
namely a lower urinary tract infection and vertigo[2]. The most
common adverse events were nasopharyngitis, diarrhea, influenza,
headache and nausea[2]. Ilaris was not associated with any severe
injection-site reactions and those that did occur were classified as
mild-to-moderate[2].

The EU approval was granted under exceptional circumstances, a common
practice with so-called orphan drugs. This reflects a need for
additional data due to factors such as the rarity of the disease or
lack of scientific knowledge. The situation is reviewed every year
until the European Medicines Agency (EMEA) is able to grant a normal
approval.

In addition to its orphan drug status for CAPS, Ilaris has been
designated as an orphan drug for treating SJIA, the most severe form
of arthritis in children, in the US, EU and Switzerland, and has
fast-track status for SJIA in the US. Orphan drugs are those
developed to treat diseases affecting fewer than 200,000 people (in
the US)[12] or fewer than five out of 10,000 people (in the EU)[13].

Ilaris was approved in Switzerland in July 2009 to treat all three
forms of CAPS in adults and children over four years old, and in the
US in June 2009 to treat two forms of CAPS, namely FCAS and MWS,
while a study in NOMID patients is under way. Priority reviews are
ongoing in other countries including Australia, Brazil and Canada.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "potential," "long-term," or
similar expressions, or by express or implied discussions regarding
potential additional indications 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 the Company 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 approved
for any additional indication. Nor can there be any guarantee that
Ilaris will achieve any levels of revenue in the future. In
particular, management's expectations regarding Ilaris 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; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; competition in general; government, industry and general
public pricing pressures; the impact that the foregoing factors could
have on the values attributed to the 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 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 each of these areas. In
2008, the Group's continuing operations achieved net sales of USD
41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 99,000 full-time-equivalent associates and operate in
more than 140 countries around the world. For more information,
please visit http://www.novartis.com.

References
[1.] National Horizon Scanning Centre. Canakinumab for cryopyrin
associated periodic syndrome. November 2008. Available at:
http://www.pcpoh.bham.ac.uk/publichealth/horizon/outputs/documents/2008/sept-dec/Canakinumab.pdf
Last accessed September 23, 2009.
[2.] Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, et al. Use of
Canakinumab in the Cryopyrin-Associated Periodic Syndrome. N Engl J
Med 2009; 360: 2416 - 2425
[3.] Durrant KLW, Goldbach-Mansky R, Hoffman H, Leslie K, Rubin B.
CAPS Cryopyrin-Associated Periodic Syndromes 2008. Available at:
http://www.nomidalliance.net/Download1.html. Last accessed September
23, 2009.
[4.] Ilaris (canakinumab) prescribing information.
[5.] Arcalyst (rilonacept) prescribing information.
[6.] Kineret (anakinra) prescribing information.
[7.] Kastner DL. Hereditary Periodic Fever Syndromes. Hematology 2005
- American Society of Hematology Education Program. 2005: 74-81.
Available at:
http://asheducationbook.hematologylibrary.org/cgi/reprint/2005/1/74
[8.] Joost PH, Drenth MD, Jos W.M. van der Meer. The Inflammasome - A
Linebacker of Innate Defense. N Engl J Med 2006 355(7): 730-732.
[9.] Lachmann HJ, Lowe P, Felix SD, et al. In vivo regulation of
interleukin 1 in patients with cryopyrin-associated periodic
syndromes. J Exp Med 2009. Published online April 13, 2009. Available
at: www.jem.org/cgi/doi/10.1084/jem.20082481.
[10.] Prieur A-M. CINCA syndrome. October 2003. Orphanet. Available
at: http://www.orpha.net/data/patho/Pro/en/CINCA-FRenPro3395.pdf
Last accessed September 23, 2009.
[11.] European Medicines Agency (EMEA). Pre-authorisation evaluation
of medicines for human use. Committee for orphan medicinal products.
Available at:
http://www.emea.europa.eu/pdfs/human/comp/opnion/17086808en.pdf. Last
accessed September 23, 2009.
[12.] Orphan Drug Act. US Food and Drug Administration. Section 526
(2), Line 2.
[13.] The orphan drug strategy. Europa: Gateway to the European
Union. Paragraph 1, Line 1.

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