NOVARTIS N : New study first to confirm Sandostatin® LAR® controls tumor growth in patients with rare gastrointestinal tumors

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  * Data show significant 66% reduction in risk of disease
    progression versus placebo

  * Sandostatin LAR more than doubled time without tumor growth for a
    median of 14 months compared to six months on placebo

  * Results support Sandostatin LAR as first treatment after surgery
    in certain patients with newly diagnosed neuroendocrine tumors
    (NETs)


Basel, January  13,  2009  - Sandostatin®  LAR®  (octreotide  acetate
suspension for injection) demonstrated antitumor benefit in  patients
with metastatic neuroendocrine tumors (NETs) of the midgut, according
to interim data presented today  at the 2009 Gastrointestinal  Cancer
Symposium of the American Society of Clinical Oncology.

After six months of treatment, patients receiving Sandostatin LAR had
a 66% reduction in risk  of disease progression compared to  patients
taking placebo (P=0.000072). This reduction is based on findings that
Sandostatin LAR halted tumor growth in 69% of patients, compared with
39% of patients receiving placebo. Patients who took Sandostatin  LAR
had no tumor progression for a median of 14.3 months, compared to six
months for patients on  placebo. This beneficial  effect was seen  in
patients   with   either    functioning   (hormone   secreting)    or
non-functioning (non-secreting) NETs.

The  findings  are  from  a  Phase  IIIb,  multicenter,  prospective,
randomized, placebo-controlled,  double-blind,  study  called  PROMID
(Placebo-controlled   prospective    Randomized    study    on    the
antiproliferative  efficacy  of  Octreotide  LAR  in  patients   with
metastatic neuroendocrine MIDgut tumors).

"Sandostatin LAR has  a proven  track record of  treating the  severe
diarrhea and flushing associated  with neuroendocrine tumors and  now
this study demonstrates that Sandostatin LAR also helps control tumor
growth in  patients  with  metastatic neuroendocrine  tumors  of  the
midgut," said  PROMID  Lead  Investigator  Professor  Rudolf  Arnold,
Philipps-University  Marburg,  Germany.  "In  addition,  we  saw  the
greatest benefit in those patients  who were newly diagnosed and  who
had fewer liver  metastases (<10% hepatic  tumor load),  underscoring
the importance of early treatment."

This is  the  first  placebo-controlled  study  to  confirm  previous
findings that suggested treatment with Sandostatin LAR could  achieve
stabilization of tumor growth in up  to 50% of patients with NETs  of
various origin[1].

"In recent  years, a  growing  body of  evidence has  suggested  that
Sandostatin LAR provides antitumor effects,  but these are the  first
data to  confirm  this  effect  from  a  well-designed,  prospective,
placebo-controlled study,"  said David  Epstein, President  & CEO  of
Novartis Oncology. "Studies are also underway to evaluate the benefit
of combination therapy  of Sandostatin LAR  with our  investigational
mTOR inhibitor, RAD001, in patients with various types of NETs."

About NETs
The term "neuroendocrine  tumor" or  "NET," as defined  by the  World
Health  Organization,  refers   to  a  diverse   mixture  of   tumors
originating from  the  interface  between  the  endocrine  (hormonal)
system and  the nervous  system, and  includes carcinoid  tumors  and
pancreatic  NETs.  Treatment  options  for  patients  with  NETs  are
limited, with surgery being the only chance for cure. When the  tumor
is inoperable,  the  objectives  of  treatment  are  to  control  the
potentially life-threatening symptoms  (syndromes) caused by  hormone
secretion and to extend patient survival by reducing tumor volume  or
by stopping the tumor  from growing. The  PROMID study included  only
patients with well-differentiated metastatic midgut tumors.

About PROMID
PROMID is a  Phase IIIb  study conducted at  18 sites  in Germany  to
evaluate the antitumor  effect of  Sandostatin LAR  in patients  with
NETs. The study  included 85  patients who were  treated with  either
Sandostatin LAR or placebo until  tumor progression. All patients  in
the study were treatment-naïve, had locally inoperable or  metastatic
NETs with the primary tumor within the midgut, were without  curative
therapeutic options  and had  tumors  that were  functionally  active
(i.e. tumors  that secrete  various  hormones and  bioactive  amines,
causing symptoms such as diarrhea or flushing) or inactive. The study
was sponsored by Novartis.

The safety findings observed in the PROMID study were consistent with
those seen in previous  studies of Sandostatin  LAR in patients  with
NETs. The most  frequently observed serious  adverse events  affected
the gastrointestinal  tract (octreotide  LAR  arm: n=6,  placebo  arm
n=8), the hematopoetic system (octreotide  LAR arm: n=5, placebo  arm
n=1) and the  general health status  (fatigue, fever; octreotide  LAR
arm: n=7, placebo  arm n=2).  Serious adverse events  occurred in  11
Sandostatin  LAR  treated   patients  and   10  placebo   recipients.
Discontinuation of treatment because  of adverse effects occurred  in
two of 42 patients in the octreotide  LAR and in zero of 43  patients
in the placebo arm.

About Sandostatin LAR
Sandostatin LAR is a long-acting, injectable depot dosage formulation
of octreotide acetate, a somatostatin analog that exerts similar
pharmacologic effects on the human body as the natural hormone
somatostatin. However, octreotide is even more potent than
somatostatin at inhibiting growth hormone, glucagon and insulin.
Based on these attributes, octreotide has been used to treat the
clinical syndromes associated with NET. In addition, octreotide
substantially reduces and in many cases can normalize growth hormone
and/or IGF-1 levels in patients with acromegaly, a disease caused by
a pituitary adenoma.

Sandostatin, the immediate release formulation of octreotide  acetate
for subcutaneous injection or intravenous infusion was first approved
in New Zealand in December 1987. In June 1995, the long-acting  depot
formulation, which Novartis markets  as Sandostatin LAR was  approved
in France. Through more  than a decade and  600,000 patient years  of
experience, Sandostatin  Injection/Sandostatin  LAR  has  achieved  a
long-standing   track   record   of   sustained   efficacy   with   a
well-established safety profile.

Sandostatin LAR important safety information
Among the very common (>= 1/10) adverse drug reactions observed in
clinical studies with Sandostatin LAR are diarrhea, abdominal pain,
nausea, constipation, flatulence, headache, cholelithiasis,
hyperglycaemia and injection-site localized pain.

Common (>= 1/100, < 1/10) adverse drug reactions include dyspepsia,
vomiting, abdominal bloating, steatorrhoea, loose stools,
discoloration of feces, dizziness, hypothyroidism, thyroid
dysfunction (e.g., decreased thyroid stimulating hormone [TSH],
decreased Total T4 and decreased Free T4), cholecystitis, biliary
sludge, hyperbilirubinaemia, hypoglycaemia, impairment of glucose
tolerance, anorexia, elevated transaminase levels, pruritus, rash,
alopecia, dyspnoea and bradycardia.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "risk," "suggested," "could," or
similar expressions, or by express or implied discussions regarding
potential new indications or labeling for Sandostatin LAR, potential
future approvals for RAD001, or regarding potential future revenues
from Sandostatin LAR or RAD001. 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 to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Sandostatin LAR will be
submitted or approved for any additional indications or labeling in
any market. Nor can there be any guarantee that RAD001 will be
approved for sale for any oncology indication in any market. Neither
can there be any guarantee that Sandostatin LAR or RAD001 will
achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Sandostatin LAR and
RAD001 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 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 AG 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 these areas. In 2007,  the
Group's  continuing  operations   (excluding  divestments  in   2007)
achieved net sales  of USD  38.1 billion and  net income  of USD  6.5
billion. Approximately USD 6.4 billion was invested in R&D activities
throughout the Group. Headquartered  in Basel, Switzerland,  Novartis
Group companies employ approximately 97,000 full-time associates  and
operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.

References
[1] Arnold et al Clin Gastro Hepatol 2005; Saltz et al. Cancer  1993;
Arnold et al. Gut 1996; Di Bartolomeo et al Cancer 1996

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