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Novartis begins shipment of Fluvirin® seasonal influenza vaccine for the U.S. market ahead of schedule

Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




* Novartis Vaccines ships doses of seasonal influenza vaccine to
the U.S. market aided by an expedited FDA review

* Providing 30 million doses of Fluvirin vaccine in the U.S., to
support the annual seasonal influenza vaccination campaign

* Early delivery of vaccine will allow public health officials to
begin the vaccination campaign weeks ahead of the normal schedule


Basel, August 5, 2009 - Novartis Vaccines has started shipping
seasonal influenza vaccine to U.S. healthcare facilities for the
2009-2010 season. The company delivered Fluvirin® influenza virus
vaccine, which has been approved by the U.S. Food and Drug
Administration (FDA), to the U.S. weeks ahead of schedule in
anticipation of the increased demand for seasonal influenza vaccine
created by the current global (A) H1N1 influenza pandemic.

"With the (A) H1N1 influenza pandemic underway, it is important that
we take every possible precaution to help protect U.S. citizens from
all circulating strains of influenza," said Andrin Oswald, CEO of
Novartis Vaccines and Diagnostics. "By receiving the seasonal
influenza vaccine early, physicians and public health officials can
better prepare for the upcoming flu season."

An estimated 36,000 people in the United States die each year from
the flu and another 200,000 are hospitalized[1]. Early arrival of the
seasonal influenza vaccine will also allow public health officials to
begin administering vaccinations weeks ahead of their normal
schedule, which is in accordance with guidelines from the Advisory
Committee on Immunization Practices (ACIP) of the U.S. Centers for
Disease Control and Prevention (CDC)[2]. Federal health officials
advise that the single best way to protect against the flu is to get
vaccinated each year, and that in general anyone who wants to reduce
their chances of getting the flu can get vaccinated[3].

Novartis Vaccines will provide the U.S. market with approximately 30
million doses of Fluvirin vaccine, indicated for patients 4 years and
older. Fluvirin vaccine contains antigens to the three influenza
virus strains for this year's vaccine recommended by the World Health
Organization (WHO):

* A/Brisbane/59/2007, IVR-148 (H1N1)
* A/Uruguay/716/2007, NYMC X-175C (H3N2) (an
A/Brisbane/10/2007-like virus)
* B/Brisbane/60/2008[4]

"Novartis Vaccines committed early on that we would not let
production of a pandemic vaccine get in the way of our ongoing
commitment to provide seasonal influenza vaccine for the U.S.
market," Oswald said. "We have been able to meet that promise with
the early delivery of Fluvirin to the U.S. Our next goal will be to
bring an (A) H1N1 influenza vaccine for public health use as soon as
possible."

About seasonal influenza
Seasonal influenza is a highly communicable, acute viral infection
that predominantly attacks the respiratory tract and sometimes the
lungs. It can cause mild to severe illness and can lead to death[5].

The number of people in the U.S. who die every year from the flu is
similar to the more than 40,000 people in the U.S. estimated to die
from breast cancer every year[6] and about half of the estimated
70,000 people who die annually of diabetes and its complications[7].
During the 2007-2008 seasonal influenza season, 83 children were
reported to have died of influenza-related causes[8]. Of the 63 whose
vaccination status was known, 58 (92 percent) were not vaccinated
according to recommendations[9]. Final numbers for the 2008-2009 flu
season are not yet available.

Influenza vaccination is one of the most effective public health
interventions ever implemented, sparing millions of people from
complications of the infectious disease. Use of currently available
seasonal flu vaccines has been calculated to save more than 8 million
lives annually, translating to one person saved every five
seconds[10].

ACIP recommends seasonal influenza vaccinations as the principal
method of preventing seasonal influenza. The vaccine is recommended
for those at greatest risk for serious complications, including:

* Children between 6 months and 18 years of age
* Pregnant women
* People 50 years of age and older
* People of any age with certain chronic health conditions, such as
asthma, diabetes or heart disease
* People in nursing homes and other long-term care facilities,
* Household contacts of person at high risk for complications from
influenza,
* Household contacts and out-of-home caregivers of children less
than 6 months of age
* Healthcare workers[11]

Important safety information
As is the case with most drugs and vaccines, there is a chance that a
serious allergic reaction, serious illness or even death could occur
as a result of vaccination with Fluvirin vaccine. The most common
side effect of vaccination with Fluvirin influenza virus vaccine is
soreness at the injection site. Less common side effects include
fever, malaise, myalgia and allergic reactions. Fluvirin vaccine
should not be administered to anyone with a history of
hypersensitivity to any component of the vaccine, including eggs, egg
products or thimerosal. Generally, persons should not be vaccinated
during an acute febrile illness. Vaccination should be delayed in
persons with an active, unstable neurological disorder, but should be
considered when the disorder has been stabilized. The occurrence of
any neurological symptoms or signs following administration of any
vaccine is a contraindication to further use. Fluvirin vaccine is not
indicated for use in children under four years of age. Persons should
consult with their healthcare providers if they are pregnant and/or
are taking other medications. Fluvirin vaccine may not protect 100%
of individuals who are susceptible to influenza. Before administering
Fluvirin vaccine, please see full prescribing information.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "can," "committed,"
"would," "commitment," "goal," "recommends," "recommended," or
similar expressions, or by express or implied discussions regarding
Novartis' potential production output for Fluvirin and A(H1N1)
vaccines, and regarding potential future revenues from Fluvirin
vaccine. 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
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Novartis will achieve any particular production output
for its Fluvirin or A(H1N1) vaccines, or indeed that the A(H1N1)
vaccine will be approved for sale in any market. Nor can there be any
guarantee that Fluvirin vaccine will achieve any particular levels of
revenue in the future. In particular, management's expectations 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; unexpected
manufacturing difficulties or delays; 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 and molecular diagnostics 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 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 each of 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 Centers for Disease Control and Prevention, "Key Facts about
Influenza and the Influenza Vaccine," available at
www.cdc.gov/flu/keyfacts.htm, accessed on July 20, 2009
2. The Centers for Disease Control and Prevention, "Key Facts About
Seasonal Flu Vaccine," available at
http://www.cdc.gov/FLU/protect/keyfacts.htm, accessed on July 28,
2009
3. The Centers for Disease Control and Prevention, "2008-09 Influenza
Prevention & Control Recommendations: Timing of Vaccination,"
available at http://www.cdc.gov/FLU/PROFESSIONALS/acip/timing.htm,
accessed on July 20, 2009
4. World Health Organization, "Recommended composition of influenza
virus vaccines for use in the 2009-2010 northern hemisphere influenza
season," available at
http://www.who.int/csr/disease/influenza/recommendations2009_10north/en/index.html,
accessed on July 20, 2009
5. Novartis Vaccines & Diagnostics, Inc., "Seasonal Influenza Fact
Sheet," available at
http://www.novartis.com/downloads/newsroom/seasonal-flu-fact-sheet.pdf,
accessed on July 20, 2009
6. The Centers for Disease Control and Prevention, "Breast Cancer
Statistics," available at www.cdc.gov/cancer/breast/statistics,
accessed on July 20, 2009
7. The Centers for Disease Control and Prevention, "National Diabetes
Fact Sheet, United States 2005," available at
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf, accessed on July
20, 2009
8. The Centers for Disease Control and Prevention, "Questions and
Answers: 2007-2008 Influenza (Flu) Season," available at
http://www.cdc.gov/flu/about/qa/season.htm, accessed on July 20, 2009
9. The Centers for Disease Control and Prevention, "Influenza
Activity-United States and Worldwide, 2007-08 Season," Morbidity and
Mortality Weekly Report, June 27, 2008
10. Novartis Vaccines & Diagnostics, Inc., "Agrippal Product
Monograph"
11. The Centers for Disease Control and Prevention, "2008-09
Influenza Prevention & Control Recommendations: Persons for Whom
Annual Vaccination is Recommended," available at
http://www.cdc.gov/flu/professionals/acip/persons.htm, accessed on
July 20, 2009

# # #

Novartis Media Relations


Central media line : +41 61 324 2200
Eric Althoff Beth Birke
Novartis Global Media Relations Novartis Vaccines and
+41 61 324 7999 (direct) Diagnostics
+41 79 593 4202 (mobile) +1 617 871 4281 (direct)
eric.althoff@novartis.com beth.birke@novartis.com


e-mail: media.relations@novartis.com

Novartis Investor Relations


Central phone: +41 61 324
7944
Ruth Metzler-Arnold +41 61 324 North America:
9980
Pierre-Michel +41 61 324 Richard Jarvis +1 212 830
Bringer 1065 2433
John Gilardi +41 61 324 Jill Pozarek +1 212 830
3018 2445
Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830
8425 2456
Isabella Zinck +41 61 324
7188

e-mail: e-mail:
investor.relations@novartis.com investor.relations@novartis.com



--- End of Message ---

Novartis International AG
Posfach Basel

WKN: 904278; ISIN:
CH0012005267; Index: SLCI, SMI, SPI, SLIFE;
Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Copyright © Hugin AS 2009. All rights reserved.



 
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