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2014-04-07

Novartis International AG: Novartis meningitis B vaccine Bexsero® receives FDA Breakthrough Therapy designation in the US

Novartis International AG / Novartis meningitis B vaccine Bexsero® receives
FDA Breakthrough Therapydesignation in the US . Processed and transmitted by
NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the
content of this announcement.
* The designation highlights the potential of Bexsero to meet the urgent need
for a licensed vaccine in the US against unpredictable and devastating
meningitis B[1]
* Bexsero, already approved in Europe, Canada and Australia, is the only
broad coverage meningitis B vaccine that can be used from two months of
age[2],[3],[4],[5]
* Bexsero was recently provided to two US universities under an
Investigational New Drug (IND) designation; Novartis plans to file in the
US as early as Q2 2014[6],[7]

Basel, April 7, 2014
-
Novartis announced today that Bexsero®(Meningococcal Group B Vaccine [rDNA,
component, adsorbed]) has received a Breakthrough Therapy designation from
the United States Food and Drug Administration (FDA). Bexsero is already
approved in Europe, Canada and Australia to help protect against invasive
meningococcal disease caused by serogroup B (meningitis B)[2],[3],[4],[5].
Novartis plans to file for US licensure of Bexsero as early as Q2 2014; exact
timing will depend on guidance from the FDA. This is the fourth Breakthrough
Therapy designation for Novartis, underscoring leadership in developing
innovative therapies and vaccines[8],[9],[10].

This announcement comes on the heels of a landmark decision from regulators in
the UK, where the Joint Committee on Vaccination and Immunisation (JCVI)
recommended the inclusion of Bexsero in the country's National Immunisation
Programme (NIP) for routine use in infants from two months of age[11].

In the last four months, Novartis has provided nearly 30,000 doses of Bexsero
to students and staff at Princeton University and the University of
California Santa Barbara (UCSB) following meningitis B outbreaks on their
campuses under an Investigational New Drug (IND) designation from the
FDA[6],[7],[12]. Further, the US Centers for Disease Control and Prevention
(CDC) have recommended including the incoming freshman class at Princeton
University in the at-risk group to receive Bexsero.

"The recent outbreaks on US university campuses have shown that meningitis B
is unpredictable and can strike at any time with devastating consequences,"
said Andrin Oswald, Division Head, Novartis Vaccines. "A US license for
Bexsero is the only sustainable solution to ensure timely responses to future
outbreaks and to provide access to parents and physicians across the country.
We will continue to work with the FDA to bring Bexsero to the US as soon as
possible."

According to the FDA, Breakthrough Therapy designation is intended to expedite
the development and review of new medicines that treat serious or
life-threatening conditions. The designation includes all of the fast track
program features, as well as more intensive FDA guidance[13]. Meningitis B is
the leading cause of bacterial meningitis and septicemia in the developed
world[14]. With vaccines currently available in the US to help prevent the
other four most common serogroups that cause meningococcal disease (A, C, Y
and W), a licensed vaccine offering protection against serogroup B remains an
unmet public health need in the US[1]. Today's announcement also highlights
Novartis' leadership in developing innovative vaccines against meningococcal
disease, as the only company with licensed vaccines for all five main
serogroups that together cause the majority of cases in the world.

Meningitis B is a rare but aggressive disease that can kill or cause serious
life-long disability within 24 hours of onset[15]. Because initial symptoms
are often unspecific and flu-like, it can be difficult for even a healthcare
professional to diagnose the disease in its early stages[16]. About one in 10
of those with the disease will die despite appropriate treatment and of those
who do survive, one in five will suffer from devastating, life-long
disabilities such as brain damage, hearing loss or limb loss[15]. Vaccination
is therefore the best defense against the disease which leaves little time
for intervention.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "Breakthrough Therapy," "potential,"
"unpredictable," "plans," "will," "recommended," "can," or similar terms, or
by express or implied discussions regarding potential marketing
authorizations for Bexsero, or regarding potential future revenues from
Bexsero and other Novartis vaccines. You should not place undue reliance on
these statements. Such forward-looking statements are based on the current
beliefs and expectations of management regarding future events, and are
subject to significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
set forth in the forward-looking statements. There can be no guarantee that
Bexsero will be submitted or approved for sale in any additional markets, or
at any particular time. Nor can there be any guarantee that Bexsero or such
other Novartis vaccines will be commercially successful in the future. In
particular, management's expectations regarding Bexsero and such other
Novartis vaccines could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally; the
uncertainties inherent in research and development, including unexpected
clinical trial results and additional analysis of existing clinical data; the
company's ability to obtain or maintain proprietary intellectual property
protection; general economic and industry conditions; global trends toward
health care cost containment, including ongoing pricing pressures; unexpected
manufacturing issues, and other risks and factors referred to in Novartis
AG's current Form 20-F on file with the US Securities and Exchange
Commission. 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 2013,
the Group achieved net sales of USD 57.9 billion, while R&D throughout the
Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 136,000 full-time-equivalent associates and operate in more
than 140 countries around the world.
For more information, please visithttp://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis
athttp://twitter.com/novartis.

References
[1] Centers for Disease Control and Prevention. Epidemiology and Prevention of
Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 12th Edition,
2nd printing. May 2012 update. Available
at:http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html. Accessed on April
2014.

[2] EMA. Authorization Details for Bexsero. Available
at:http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici....
Accessed April 2014.

[3] EMA. EU Member States. Available
at:http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/....
Accessed April 2014.

[4] Health Canada. Bexsero. Available
at:http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_....
Accessed April 2014.

[5] Australian Government: Department of Health: Therapeutic Goods
Administration. Available
at:http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf. Accessed
April 2014.

[6] Centers for Disease Control and Prevention. Princeton University
Meningococcal Disease Outbreak. December 2013. Available
at:http://www.cdc.gov/meningococcal/outbreaks/princeton.html. Accessed April
2014.

[7] Centers for Disease Control and Prevention. University of California,
Santa Barbara Meningococcal Disease Outbreak. January 2014. Available
at:http://www.cdc.gov/meningococcal/outbreaks/ucsb.html. Accessed April 2014.

[8] Novartis Press Release. "Novartis compound LDK378 receives FDA
Breakthrough Therapy designation for ALK+ non-small cell lung cancer."
Available
at:http://www.novartis.com/newsroom/media-releases/en/2013/1685517.shtml.
Accessed April 2014.

[9] Novartis Press Release. "FDA grants Breakthrough Therapy designation to
Novartis' serelaxin (RLX030) for acute heart failure". Available
athttp://www.novartis.com/newsroom/media-releases/en/2013/1711047.shtml.
Accessed April 2014.

[10] Novartis Press Release. "Novartis receives FDA breakthrough therapy
designation for BYM338 (bimagrumab) for sporadic inclusion body myositis
(sIBM)." Available
at:http://www.novartis.com/newsroom/media-releases/en/2013/1723765.shtml.
Accessed April 2014.

[11] JCVI Minutes February 2014. Available
at:https://www.gov.uk/government/policy-advisory-groups/joint-committee-on-....
Accessed April 2014.

[12] Novartis Data on File.
[13] US Food and Drug Administration. Frequently Asked Questions: Breakthrough
Therapies. Available
at:http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandc....
Accessed April 2014.

[14] World Health Organization. Bacterial Meningitis. Available
at:http://apps.who.int/nuvi/meningitis/en/. Accessed April 2014.

[15] World Health Organization. Meningococcal Disease Fact Sheet 141.
Available at:http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed
April 2014.

[16] National Meningitis Association. "What are the Symptoms?" Available
at:http://www.nmaus.org/disease-prevention-information/what-are-the-symptoms/.
Accessed April 2014.

# # #

Novartis Media Relations

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