Novartis receives Complete Response letter from the US Food and Drug Administration for its investigational vaccine Menveo®

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Cambridge, MA, June 30, 2009 - Novartis Vaccines and Diagnostics
received feedback from the US Food and Drug Administration (FDA) in
the form of an initial regulatory determination on the Biologics
License Application (BLA) for the investigational vaccine Menveo®.

The FDA has requested additional information on the clinical and the
CMC (Chemistry Manufacturing and Control) sections of the BLA. No new
clinical trials are required, and it is expected that Novartis will
be able to respond to all questions fully in 2009. The BLA was
submitted on August 28, 2008 for use of Menveo in subjects age 11 -
55.

In clinical trials, Menveo has been shown to elicit a protective
immune response against four of the most common serogroups - A, C,
W-135 and Y - of Neisseria meningitides, also known as meningococcus.
These serogroups can cause potentially deadly bacterial infections
and account for most cases of meningococcal disease worldwide.

"Meningococcal disease is a devastating illness that can result in
rapid death or have long-lasting repercussions for survivors and
their families," said Andrin Oswald, CEO of Novartis Vaccines and
Diagnostics. "We are dedicated to applying our industry-leading
technology and expertise to further the development of Menveo and
other vaccines that elicit robust, long-lasting, protective immune
responses for all age groups at risk."

About the Novartis Vaccines global meningococcal franchise
Menveo is based on the same proprietary technology Novartis Vaccines
pioneered to produce Menjugate®, a meningococcal serogroup C
conjugate vaccine approved outside the US since 2000 for use in
individuals from age 2 months through adulthood.

Studies have reported that Menveo generates a robust immune response
against the four vaccine-preventable serogroups, A, C, W-135 and Y in
people across age groups from infancy to adulthood. A Phase II study
in infants published in the January 9, 2008, issue of the Journal of
the American Medical Association reported that Menveo is the first
meningococcal vaccine candidate to elicit a robust immune response in
infants[1]. There is no vaccine currently licensed in the US for use
in infants.

Novartis Vaccines is a global leader in providing vaccines to protect
against deadly meningococcal disease. Through industry-leading
scientific expertise, the company is focused on extending critical
meningococcal vaccines research. In addition to Menveo, Novartis
Vaccines is developing a recombinant vaccine for its potential to
provide broad coverage against multiple strains of serogroup B, for
which no vaccine is currently available. The company has already
distributed more than 26 million doses of Menjugate around the world
and produced MenZB®, a vaccine against a strain of meningococcus B
specific to a recent outbreak in New Zealand.

About meningococcal disease, a leading cause of bacterial meningitis
Meningococcal disease can manifest as bacterial meningitis - an
infection of the protective coverings of the brain and spinal cord -
or meningococcemia - a bloodstream infection[2]. It is caused by the
bacterium Neisseria meningitidis (N. meningitidis). The symptoms,
which can include sudden onset of fever, rash, headache and stiff
neck, can progress rapidly. Even with early and appropriate
treatment, between 10% and 14% of meningitis cases are fatal,
typically within 24 to 48 hours[4],[5]. For those who survive, as
many as 19% suffer serious long-term consequences such as deafness,
neurological damage or limb loss.

Because invasive meningococcal disease can progress so rapidly, high
levels of circulating antibodies are critical for protection. Immune
memory typically takes up to five days to develop, so there often is
not enough time for immune memory to mount a protective response[3].

Five serogroups cause the majority of meningococcal disease
worldwide: A, B, C, W-135 and Y[1]. Distribution of serogroups
varies widely from geographic region to region and changes over
time. In the US, the prevalence of serogroup Y has increased over
the last few years (from 9% of reported cases in 1990-92 to 39% in
2006)[3]. Serogroups B and C are predominant in Europe. While Asia
has primarily seen serogroup A, recent outbreaks of serogroup C have
been noted. The dynamic and unpredictable nature of meningococcal
disease epidemiology warrants a vaccine that offers broad serogroup
protection[6].

For more information, please visit www.meningitis.com.

The foregoing release contains forward-looking statements that can be
identified by terminology such as "expected," "will," "can,"
"dedicated," "potential," or similar expressions, or by express or
implied discussions regarding potential marketing approvals for
Menveo or regarding potential future revenues from Menveo. 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 Menveo to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that Menveo will be approved for sale in any market. Nor can there be
any guarantee that Menveo will achieve any particular levels of
revenue in the future. In particular, management's expectations
regarding Menveo could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally,
including an unexpected inability to meet the requirements of the
FDA: 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 Vaccines and Diagnostics is a division of Novartis focused
on the development of preventive treatments. The division has two
businesses: Novartis Vaccines and Chiron. Novartis Vaccines is the
world's fifth-largest vaccines manufacturer and second-largest
supplier of flu vaccines in the US. The division's products also
include meningococcal, pediatric and travel vaccines. Chiron, the
blood testing business, is dedicated to preventing the spread of
infectious diseases through the development of novel blood-screening
tools that protect the world's blood supply.

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 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
98,000 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.] Snape, MD et al. Immunogenicity of a Tetravalent Meningococcal
Glycoconjugate Vaccine in Infants: A Randomized Controlled Trial.
Journal of the American Medical Association. 2008;299(2): 173-184
[2.] Centers for Disease Control and Prevention. Epidemiology and
Prevention of Vaccine-Preventable Diseases (The Pink Book: Course
Textbook). 10th Edition, 2nd printing. February 2008 update.
Available at: http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm
[3.] Novartis Vaccines and Diagnostics, Scientific Platform:
Meningococcal Diseases, Revised December 11, 2008
[4.] Centers for Disease Control and Prevention. Prevention and
Control of Meningococcal Disease - Recommendations of the Advisory
Committee on Immunization Practices. MMWR 2005; 54 (RR07): 1-21.
[5.] World Health Organization. Meningococcal meningitis Fact sheet.
May 2003. Available at:
http://www.who.int/mediacentre/factsheets/fs141/en/
[6.] Harrison, Lee H. Prospects for Vaccine Prevention of
Meningococcal Infection, Clinical Microbiology Reviews: January 2006
: 142-16

# # #

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