Afinitor® approved in EU as first treatment proven to benefit patients with advanced kidney cancer after failure of targeted therapy

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* Afinitor more than doubled median time without tumor growth and
reduced the risk of disease progression or death by 67% compared
with placebo

* Patients with advanced kidney cancer have limited options once
they experience tumor progression after VEGF-targeted therapy

* Several European treatment guidelines recently updated to
recommend Afinitor as second-line therapy for advanced kidney
cancer

* Phase III trials underway to explore potential in multiple
additional cancers

Basel, August 6, 2009 - The European Commission (EC) has approved
Afinitor® (everolimus) tablets for the treatment of patients with
advanced renal cell carcinoma (RCC) whose disease progressed on or
after treatment with vascular endothelial growth factor
(VEGF)-targeted therapy.

Nearly 40% of all RCC patients have advanced cancer at time of
diagnosis, meaning that their tumors have spread outside of the
kidneys[1]. Standard initial treatment for these patients may include
VEGF-targeted therapies[2]. Prior to Afinitor, there were no proven
treatment options for advanced RCC patients whose cancer progressed
while on or after treatment with VEGF-targeted therapy.

"This approval means that across Europe thousands of patients with
advanced kidney cancer now have the opportunity for a clear treatment
path with Afinitor if their disease progresses after treatment with a
targeted therapy," said David Epstein, President and CEO, Novartis
Oncology, Novartis Molecular Diagnostics.

The EC based its approval of Afinitor on data from a pivotal Phase
III trial demonstrating that Afinitor, when compared with placebo,
more than doubled the median time without tumor growth or death in
patients with advanced kidney cancer whose disease progressed
following prior VEGF-targeted therapy (4.9 vs. 1.9 months).
Additionally, the data showed Afinitor reduced the risk of disease
progression or death by 67% based on the primary endpoint of
progression-free survival (PFS) (hazard ratio=0.33 with 95%
confidence interval 0.25 to 0.43; P<0.0001)[3].

Several European treatment guidelines have been updated to recommend
Afinitor as a second-line advanced kidney cancer therapy after
progression on targeted therapies, including those from the European
Association of Urology (EAU), the Spanish Oncology Genitourinary
Group (SOGUG), the European Organisation for Research and Treatment
of Cancer (EORTC), the European Society for Medical Oncology (ESMO)
and the UK Consensus Guidelines[4],[5],[6],[7],[8].

The EC decision applies in all 27 European Union (EU) member states.
Afinitor is currently under regulatory review in Switzerland, Japan
and other countries.

Study details
The approval is based on data from RECORD-1 (REnal Cell cancer
treatment with Oral RAD001 given Daily), the largest Phase III
clinical trial to study the effects of an oral mTOR inhibitor in
advanced RCC patients whose cancer progressed despite prior
VEGF-targeted treatment[9]. In February 2008, based on a
recommendation from an independent data monitoring committee,
Novartis stopped the trial after interim results showed that patients
receiving Afinitor experienced a significant delay in cancer
progression or death compared with patients receiving placebo.

This international, multicenter, randomized, double-blind clinical
trial involved 416 patients with advanced RCC whose cancer progressed
despite prior treatment with sunitinib or sorafenib. Prior therapy
with bevacizumab, interferon alfa and interleukin-2 was allowed.
Patients were randomized to receive Afinitor (10 mg) daily or
placebo, in conjunction with best supportive care. The primary
endpoint of the study was PFS, which was assessed via a blinded,
independent, central radiological review[9].

About RCC
Renal cell carcinoma, which accounts for approximately 2% of all new
cancers, is often referred to as kidney cancer[10]. The occurrence
rates of RCC are rising steadily around the world due, in part, to
smoking and obesity[11]. In the EU, there were more than 63,000 new
cases of RCC diagnosed and more than 26,000 people died from the
disease in 2006[12].

In RCC, cancer cells develop in the lining of the kidney's tubes and
grow into a tumor. If left untreated, the tumor can spread to
neighboring lymph nodes and eventually to other organs[13],[14].

About Afinitor
In the EU, Afinitor is indicated for patients with advanced RCC whose
disease progressed on or after treatment with VEGF-targeted therapy.
Afinitor is also approved in the US to treat advanced RCC after
failure of treatment with sunitinib or sorafenib.

In cancer cells, Afinitor continuously targets mTOR, a protein that
acts as a central regulator of tumor cell division, blood vessel
growth and cell metabolism. Afinitor is being studied in multiple
cancer types, including RCC, neuroendocrine, breast, gastric and
hepatocellular carcinoma (HCC), as well as tuberous sclerosis complex
(TSC) and non-Hodgkin's lymphoma.

The active ingredient in Afinitor is everolimus, which is available
in different dosage strengths under the trade name Certican® for the
prevention of organ rejection in heart and kidney transplant
recipients. Certican was first approved in the EU in 2003.

For more information on Afinitor, visit www.afinitor.com.

Important safety information
Afinitor is contraindicated in patients with hypersensitivity to
everolimus, to other rapamycin derivatives or to any of the
excipients. Potentially serious adverse reactions to Afinitor include
non-infectious pneumonitis and infections, for which patients should
be monitored carefully and treated as needed. In addition,
non-infectious pneumonitis may require temporary dose reduction
and/or interruption or discontinuation. Patients with systemic
invasive fungal infections should not receive Afinitor. Oral
ulceration is a common side effect of Afinitor. Renal function, blood
glucose and hematological parameters should be evaluated prior to the
start of therapy with Afinitor and periodically thereafter.
Co-administration with CYP3A4 or P-glycoprotein inhibitors and
inducers should be avoided. If co-administration of a moderate CYP3A4
and/or PgP inhibitor or inducer cannot be avoided, dose adjustments
of Afinitor can be taken into consideration. The use of live vaccines
should be avoided by patients taking Afinitor. Afinitor should not be
used in patients with severe hepatic impairment. Patients with
galactose intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption should not take Afinitor. Caution should be used during
the peri-surgical period as Afinitor may impair wound healing.
Afinitor is not recommended during pregnancy or for women of
childbearing potential not using contraception. Afinitor may cause
fetal harm in pregnant women.

The most common adverse drug reactions (incidence >=1/10) include
stomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea,
mucosal inflammation, vomiting, cough, infections, peripheral edema,
pneumonitis, epistaxis, dry skin, pruritus, dyspnea and abnormal
taste, as well as decreased hemoglobin, lymphocytes, phosphate,
platelets, neutrophils, and increased cholesterol, triglycerides,
glucose, creatinine, aspartate aminotransferase and alanine
aminotransferase.

The most frequent grade 3-4 adverse reactions (incidence >=2%) were
lymphocytes decreased, glucose increased, hemoglobin decreased,
phosphate decreased, cholesterol increased, infections, stomatitis,
fatigue and pneumonitis.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "risk," "potential," "may," "can,"
"potentially," "should," or similar expressions, or by express or
implied discussions regarding future regulatory filings, marketing
approvals or potential new indications or labeling for Afinitor, or
regarding potential future revenues from Afinitor. 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 Afinitor to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that Afinitor will be approved for sale in any additional markets, or
that Afinitor will be approved for any additional indications or
labeling in any market. Nor can there be any guarantee that Afinitor
will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Afinitor 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 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 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.The University of Texas MD Anderson Cancer Center. Kidney Cancer.
Available at
http://www.mdanderson.org/patient-and-cancer-information/cancer-information/cancer-types/kidney-cancer/index.html.
Accessed June 2009.
2. National Comprehensive Cancer Network. "NCCN Clinical Practice
Guidelines in Oncology: Kidney Cancer." Available at
http://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf.
Accessed March 2009.
3. Afinitor® (everolimus) tablets prescribing information. Basel,
Switzerland: Novartis International AG; August 2009.
4. Ljungberg, B. et al. Guidelines on Renal Cell Carcinoma. European
Association of Eurology. March 2009. Available at
http://www.uroweb.org/fileadmin/tx_eauguidelines/2009/Full/RCC.pdf.
Accessed June 2009.
5. Bellmunt, J. et al. Recommendations from the Spanish Genitourinary
Group for the treatment of metastatic renal cell cancer. Cancer
Chemotherapy and Pharmacology. March 2009;63 Suppl 1:S1-13.
6. Reijke, T. et al. EORTC-GU expert opinion on metastatic renal cell
cancer. European Journal of Cancer. March 2009;45(5):765-73.
7. Escudier, B. et al. Renal cell carcinoma: ESMO Clinical
Recommendations for diagnosis, treatment and follow-up. Annals of
Oncology 20: Suppl 4:iv81-ivb2, 2009.
8. Nathan, P. et al. UK guidelines for the systemic treatment of
renal cell carcinoma. British Journal of Hospital Medicine. Vol. 70,
Iss. 5, May 13, 2009.
9. Escudier, B. et al. Phase-3 randomized trial of everolimus
(RAD001) vs. placebo in metastatic renal cell carcinoma. Presented at
the European Society for Medical Oncology (ESMO) 33rd Congress on
September 16, 2008.
10. McLaughlin JK, et al. Epidemiologic aspects of renal cell
carcinoma.Semin Oncol. 2006;33(5):527-533.
11. Eisen, et. al. Sorafenib for Older Patients with Renal Cell
Carcinoma. Journal of the Natational Cancer Institute.
2008;100(20):1454-1463.
12. Ferlay, J. et al. Estimates of the cancer incidence and mortality
in Europe in 2006. Annals of Oncology.18(3):581-92. March 2007.
13. National Cancer Institute. "General Information About Renal Cell
Cancer." Available at
http://www.cancer.gov/cancertopics/pdq/treatment/renalcell/patient.
Accessed March 2009.
14. American Cancer Society. "How Is Kidney Cancer (Renal Cell
Carcinoma) Staged?" Available at
http://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_How_is_kidney_cancer_staged_22.asp?rnav=cri.
Accessed March 2009.

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