European Commission approves new label for Novartis drug Glivec® extending adjuvant therapy to three years for certain GIST patients

Novartis International AG /
European Commission approves new label for Novartis drug Glivec® extending
adjuvant therapy to three years for certain GIST patients
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* Approval based on Phase III study showing significant recurrence-free and
overall survival after three years of adjuvant Glivec in adults with KIT+
GIST[1]
* Adults with KIT+ GIST are at risk of recurrence following surgical removal
of the primary tumor; extended treatment may delay onset of recurrence[2]
* Glivec is the only available therapy in the EU for the treatment of post-
surgical KIT+ GIST
Basel, February 27, 2012 - Novartis announced today that the European Commission
(EC) has approved an update to the Glivec(®) (imatinib)* label to include 36
months of treatment after surgery for adults with KIT (CD117)-positive
gastrointestinal stromal tumors (GIST) who met the inclusion criteria of the
pivotal study. This extended treatment regimen has been shown to improve
recurrence-free survival and overall survival for these patients with KIT+ GIST
compared to patients who received 12 months of treatment after surgery[3].

Adults with KIT+ GIST are at risk of recurrence following surgical removal of
the primary tumor. Although complete surgical removal is possible in most
patients with KIT+ GIST, many patients develop tumor recurrence or metastasis
following surgery and survival following recurrence is poor[2]. The newly
updated label states that treatment with Glivec beyond 36 months may delay the
onset of tumor recurrences further, while noting that an effect on overall
survival has not been determined.

The EC decision follows a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) and applies in all 27 European Union (EU) member
states, plus Norway and Iceland. Approval was based on data from an
international, multicenter, open-label, Phase III clinical trial first presented
at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO)
plenary session in June 2011[1].

Results of the study showed that at five years, 66% of patients taking Glivec
for three years after surgery for KIT+ GIST remained free of cancer recurrence
compared to 48% who had received Glivec for only one year after surgery
(p<0.0001). In addition, at five years, 92% of patients taking Glivec for three
years after surgery were alive compared to 82% who had received Glivec for only
one year after surgery (p=0.0187)[3].

"This approval marks a key milestone in advancing the post-surgical treatment of
GIST for certain patients in Europe, where Glivec is the only available therapy
in this setting, " said Hervé Hoppenot, President, Novartis Oncology. "With this
clinical evidence, physicians now have a strong basis for recommending three
years of treatment for these patients with KIT+ GIST after surgery."

Gastrointestinal stromal tumors, or GIST, are a rare, life-threatening cancer of
the gastrointestinal tract. They are often difficult to diagnose and to treat
because they may not cause any physical symptoms[4]. In the EU, the incidence of
GIST is estimated to be more than 5,000 cases each year[5], [6].

Study details
This multicenter, prospective, randomized study for the evaluation of adjuvant
treatment with Glivec of histologically confirmed KIT+ GIST( )was conducted by
the Scandinavian Sarcoma Group (SSG) and the Sarcoma Group of the
Arbeitsgemeinschaft Internistische Onkologie (AIO)[5].

The primary endpoint was to compare, within the first five years, recurrence-
free survival in patients with a greater than 50% estimated risk of GIST disease
recurrence, following diagnosis and treatment with adjuvant Glivec for either
12 or 36 months. The secondary endpoints included overall survival and treatment
safety[1]. Inclusion criteria for risk of recurrence was defined as tumor
diameter >5.0 cm and mitotic count >5/50 high power fields (HPFs); or tumor
diameter >10.0 cm, any mitotic count; or tumor of any size with a mitotic count
>10/50 HPFs; or tumors ruptured into the peritoneal cavity.

Three hundred ninety-seven patients entered the study and the median follow-up
was 54 months, from date of randomization to data cut-off. Recurrence-free
survival was significantly longer in the 36-month group compared to the 12-month
group (HR 0.46, 95% CI 0.32-0.65; p<0.0001; five-year recurrence-free survival
66% vs. 48%, respectively). Patients assigned to 36 months of Glivec had
significantly longer overall survival (HR 0.45, 95% CI 0.22-0.89; p=0.0187;
five-year overall survival 92% vs. 82%, respectively). Almost all patients
experienced side effects while taking Glivec. Glivec was generally well
tolerated. The proportion of patients who discontinued Glivec during the
assigned treatment period for reasons other than GIST recurrence was 26% in the
36-month group and 13% in the 12-month group[1].

Novartis provided the study drug and supported the study financially. Additional
funding was received from the Academy of Finland, Cancer Society of Finland,
Sigrid Juselius Foundation and Helsinki University Research Funds.

About Glivec (imatinib)
Glivec(®) (imatinib) is approved in more than 110 countries for the treatment of
all phases of Ph+ CML, for the treatment of adult patients with KIT (CD117)-
positive gastrointestinal stromal tumors (GIST), which cannot be surgically
removed and/or have metastasized and for the treatment of adult patients
following complete surgical removal of KIT+ GIST.

Glivec Important Safety Information
Glivec can cause fetal harm in pregnant woman. Glivec has been associated with
severe edema (swelling) and serious fluid retention. Cytopenias (anemia,
neutropenia, thrombocytopenia) are common, generally reversible and usually
managed by withholding Glivec or dose reduction. Monitor blood counts regularly.
Severe congestive heart failure and left ventricle dysfunction, severe liver
problems including cases of fatal liver failure and severe liver injury
requiring liver transplants have been reported. Use caution in patients with
cardiac dysfunction and hepatic dysfunction. Monitor carefully.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in
patients with KIT+ GIST. Skin reactions, hypothyroidism in patients taking
levothyroxine replacement, GI perforation, in some cases fatal and tumor lysis
syndrome, which can be life threatening, have also been reported with Glivec.
Correct dehydration and high uric acid levels prior to treatment. Long-term use
may result in potential liver, kidney, and/or heart toxicities; immune system
suppression may also result from long-term use. In patients with
hypereosinophilic syndrome and heart involvement, cases of heart disease have
been associated with the initiation of Glivec therapy. Growth retardation has
been reported in children taking Glivec. The long-term effects of extended
treatment with Glivec on growth in children are unknown.

The most common side effects include fluid retention, muscle cramps or pain and
bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased
hemoglobin, abnormal bleeding, nausea, fatigue and rash. Glivec should be taken
with food and a large glass of water.

Please see full Prescribing Information.

Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "may, " "recommending, " or similar expressions, or by
express or implied discussions regarding potential new indications or labeling
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
labeling in any additional markets. 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; government, industry and general public pricing pressures;
competition in general; unexpected manufacturing issues; 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´s
continuing operations 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 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.

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

References

[1] Joensuu H, et al. Twelve vs. 36 months of adjuvant imatinib (IM) as
treatment of operable GIST with a high risk of recurrence: Final results of
a randomized trial (SSGXVIII/AIO). 47th Annual Meeting of the American
Society of Clinical Oncology. Abstract No. LBA1. June 5, 2011.

[2] National Comprehensive Cancer Network (NCCN): Clinical Practice Guidelines
in Oncology: Soft Tissue. Version 2, 2011.

[3] Glivec (imatinib) prescribing information. Basel, Switzerland: Novartis
International AG.

[4] American Cancer Society. Cancer Reference Information. Detailed Guide for
Gastrointestinal Stromal Tumors.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003103-pdf.pdf.

[5] The World Factbook. European Union Population. CIA.gov; July 2010. Available
from: https://www.cia.gov/library/publications/the-world-
factbook/geos/ee.html. Accessed February 2012.

[6] Joensuu H. Current perspectives on the epidemiology of gastrointestinal
stromal tumors. European Journal of Cancer Supplements. March 2006; Volume
4, Issue 3: 4-9.

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