Glivec receives US approval as first treatment to reduce risk of cancer returning in patients with gastrointestinal stromal tumors

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* Use of Glivec after surgery shows significant benefit for
gastrointestinal stromal tumor (GIST) patients, dramatically
reducing risk of relapse

* GIST, a life-threatening cancer, recurs in as many as one of two
patients; recurrent tumors are often more aggressive than primary
tumors

* For GIST patients who were assigned to Glivec, more than nine out
of 10 remained cancer-free based on a 14-month median follow up

Basel, December 19, 2008 - Novartis announced today that Glivec®
(imatinib)* has been approved by the US Food and Drug Administration
(FDA) for the post-surgery treatment of adult patients following
complete surgical removal of Kit (CD117)-positive gastrointestinal
stromal tumors (GIST).

Glivec is now the only post-surgery treatment indicated to delay the
return of this highly aggressive cancer, filling a major need for
GIST patients. The filing received FDA priority review status in
August of this year, with regulatory reviews currently underway in
other regions, including the European Union and Switzerland.

GIST is a life-threatening cancer of the gastrointestinal tract.
After initial removal, GIST tumors can return in as many as one of
two patients[1]. Recurrent GISTs are often more aggressive than
primary tumors, with relapses associated with lower survival
rates[2].

"After surgery, my doctor told me there was a high likelihood that my
gastrointestinal tumors would come back. I immediately searched for a
possible solution and found the Glivec clinical trial, which aimed to
help patients like me," said Roslyn Fuller, a GIST patient. "This FDA
approval is good news for me and other GIST patients who will now
have the option to start treatment with Glivec earlier to help
prevent recurrence."

The approval for this new indication is based on data from a National
Cancer Institute-sponsored Phase III study that showed a dramatic
reduction in the return of GIST after surgery in patients treated for
about one year with Glivec versus placebo. Based on a 14-month median
follow up, 91.6% of Glivec patients remained cancer-free compared
with 80.2% of those taking placebo[3].

"When Glivec was first approved for the treatment of inoperable
and/or metastasized Kit-positive GIST six years ago, it
revolutionized the treatment of this life-threatening cancer," said
David Epstein, President and CEO, Novartis Oncology. "This latest FDA
approval means patients can benefit from Glivec earlier in the course
of their disease."

Glivec is now approved for nine indications, including the treatment
of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+
CML), Kit (CD117)-positive gastrointestinal stromal tumors which
cannot be surgically removed and/or have already spread to other
parts of the body (metastasized) and five other rare diseases.

Filing data
The FDA regulatory filing for the adjuvant GIST indication was based
on data from a Phase III, double-blind, randomized, multicenter,
international study of more than 700 GIST patients who had undergone
surgery to remove their tumors. The efficacy endpoint of the study
was recurrence-free survival (RFS), defined as the time from the date
of randomization to the date of recurrence or death from any cause.
Participants were randomized to receive either Glivec 400 mg/day or a
matching placebo for one year[4].

With a median follow-up of 14 months, there were 30 RFS events out of
359 patients in the Glivec arm (8.4%) compared to 70 RFS events out
of 354 patients in the placebo arm (19.8%) (hazard ratio=0.398 [95%
CI: 0.259, 0.610], p<0.0001). This follow up is too short to evaluate
survival[3].

The study, known as ACOSOG Z9001, was conducted at multiple cancer
centers throughout the US and Canada under a Cooperative Research and
Development Agreement between Novartis and the National Cancer
Institute. The study was led by the American College of Surgeons
Oncology Group (ACOSOG) in association with the Duke Clinical
Research Institute[4].

The investigators reported that Glivec therapy was generally well
tolerated by most patients, with side effects similar to those
observed in previous clinical trials with Glivec. The most
frequently reported adverse reactions were diarrhea, fatigue, nausea,
edema, decreased hemoglobin, rash, vomiting and abdominal pain. No
new adverse reactions were reported in the adjuvant GIST treatment
setting that had not been previously reported in other patient
populations including patients with unresectable and/or malignant
metastatic GIST[4].

About gastrointestinal stromal tumors
Gastrointestinal stromal tumors (GIST) belong to a group of cancers
known as soft tissue sarcomas. The most common sarcomas, they can be
found most often in the stomach and small intestine. The incidence of
GIST is estimated to be 4,500 - 6,000 new cases per year in the US
(15-20 cases per million population)[5], of which more than 90% are
Kit-positive[6]. Kit - also known as CD117 - is a protein that, when
mutated, has been identified as one of the major causes of GIST.
Glivec inhibits the activity of several proteins such as Kit.

About Glivec
Glivec is approved in more than 90 countries including the US, EU and
Japan for the treatment of all phases of Ph+ CML. Glivec is also
approved in the US, EU and other countries for the treatment of
patients with Kit (CD117)-positive gastrointestinal tumors (GIST),
which cannot be surgically removed and/or have already spread to
other parts of the body (metastasized). In Japan, Glivec is approved
for the treatment of patients with Kit (CD117)-positive GIST. In the
EU, Glivec is also approved for the treatment of adult patients with
newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in
combination with chemotherapy and as a single agent for patients with
relapsed or refractory Ph+ ALL. Glivec is also approved for the
treatment of adult patients with unresectable, recurrent and/or
metastatic dermatofibrosarcoma protuberans (DFSP) who are not
eligible for surgery. Glivec is also approved for the treatment of
patients with myelodysplastic/myeloproliferative diseases (MDS/MPD).
Glivec is also approved for hypereosinophilic syndrome and/or chronic
eosinophilic leukemia (HES/CEL).

The effectiveness of Glivec is based on overall hematological and
cytogenetic response rates and progression-free survival in CML, on
hematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on
hematological response rates in SM, HES/CEL, on objective response
rates and progression-free survival in unresectable and/or metastatic
GIST, on recurrence free survival in adjuvant GIST, and on objective
response rates in DFSP. Increased survival in controlled trials has
been demonstrated only in newly diagnosed chronic phase CML and GIST.

Not all indications are available in every country.

Glivec contraindications, warnings and adverse events
The majority of patients treated with Glivec in clinical trials
experienced adverse events at some time. Most events were of mild to
moderate grade and treatment discontinuation was not necessary in the
majority of cases.

The safety profile of Glivec was similar in all indications. The most
common side effects included nausea, superficial edema, muscle
cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia,
arthralgia, hemorrhage, fatigue, headache, joint pain, cough,
dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid
retention, as well as neutropenia, thrombocytopenia and anemia.
Glivec was generally well-tolerated in all of the studies that were
performed, either as monotherapy or in combination with chemotherapy,
with the exception of a transient liver toxicity in the form of
transaminase elevation and hyperbilirubinemia observed when Glivec
was combined with high dose chemotherapy.

Rare/serious adverse reactions include: sepsis, pneumonia,
depression, convulsions, cardiac failure, thrombosis/embolism, ileus,
pancreatitis, hepatic failure, exfoliative dermatitis, angioedema,
Stevens-Johnson syndrome, renal failure, fluid retention, edema
(including brain, eye, pericardium, abdomen and lung), hemorrhage
(including brain, eye, kidney and gastrointestinal tract),
diverticulitis, gastrointestinal perforation, tumor hemorrhage/
necrosis, hip osteonecrosis/avascular necrosis.

Patients with cardiac disease or risk factors for cardiac failure
should be monitored carefully and any patient with signs or symptoms
consistent with cardiac failure should be evaluated and treated.
Cardiac screening should be considered in patients with HES/CEL, and
patients with MDS/MPD with high level of eosinophils (echocardiogram,
serum troponin level).

Glivec is contraindicated in patients with known hypersensitivity to
imatinib or any of its excipients. Women of childbearing potential
should be advised to avoid becoming pregnant while taking Glivec.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "risk," "can," "likelihood," "aimed
to," "will," or similar expressions, or by express or implied
discussions regarding potential new indications or labelling for
Glivec or regarding potential future revenues from Glivec. 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 Glivec to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that Glivec will be approved for any additional indications or
labelling in any market. Nor can there be any guarantee that Glivec
will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Glivec 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; 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] Van den Abbeele A., Benjamin R., Blanke C, et al. Clinical
Management of GIST. Recurrence patterns and prognostic factors for
survival. 2003;1-24.
[2] Life Raft Group. Managing Initial Recurrence.
http://www.liferaftgroup.org/gist_recurrence.html. Accessed November
2008.
[3] Gleevec® (imatinib mesylate) tablets prescribing information.
East Hanover, NJ: Novartis Pharmaceuticals Corporation; November
2008.
[4] Z9001: A Phase III Randomized Double-blind Study of Adjuvant
STI571 (Glivec®) Versus Placebo in Patients Following the Resection
of Primary Gastrointestinal Stromal Tumor (GIST).
http://www.cancer.gov/clinicaltrials/ACOSOG-Z9001. Accessed November
2008.
[5] American Cancer Society. Cancer Reference Information. Detailed
Guide for Gastrointestinal Stromal Tumors. Key Statistics.
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x
_What_Are_the_Key_Statistics_About_Gastrointestinal_Stromal_Tumors.asp?rnav=cri.
Accessed November 2008.
[6] US Department of Health and Human Services. Agency for Healthcare
Research and Quality (AHRQ). Technology Assessment: Report on the
Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries
Versus Currently Covered Therapy, Part 2. Imatinib for
Gastrointestinal Stromal Tumors (GISTs). Available at:
http://www.ahrq.gov/clinic/ta/gist/gist1.htm. Accessed November 2008.

* Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and
Israel.

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