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Bankleitzahlen - online.de


Novartis completes shipment of US supply of Fluvirin® seasonal influenza vaccine

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




* 27 million doses shipped to US market by Novartis - providing
more seasonal flu vaccine earlier than in any previous year

* Shipments completed ahead of normal seasonal vaccine delivery
schedules to allow for earlier vaccination

* First shipments of A(H1N1) vaccine delivered to US government
less than four months after the pandemic declaration by the WHO

Basel, October 6, 2009 - Novartis announced today that the company
has completed its entire shipment of seasonal influenza vaccine to
the United States for the 2009/2010 season. As previously
anticipated, the company delivered 27 million doses of Fluvirin®
influenza virus vaccine, which has been approved by the U.S. Food and
Drug Administration (FDA). Novartis completed this season's shipment
earlier than in previous years, in anticipation of demand for earlier
vaccination with seasonal influenza vaccine created by the current
global A(H1N1) influenza pandemic.

"Novartis is pleased to have delivered more seasonal influenza
vaccine to the US market by the end of September than we have in any
previous year allowing more people to get their vaccine early in the
season," said Andrin Oswald, CEO of Novartis Vaccines and
Diagnostics. "We are relieved to have been able to complete our
deliveries ahead of schedule despite the challenging task to produce
large quantities of A(H1N1) pandemic vaccines at the same time. We
hope that the early delivery of our Fluvirin vaccine will help
physicians and public health officials better prepare for the
upcoming flu season and balance the needs for pandemic and seasonal
vaccination."

On September 27, Novartis also began shipments of the first doses of
its influenza A(H1N1) 2009 monovalent vaccine[1] to the United
States. The early shipment is the first of an accelerated effort to
provide as much A(H1N1) vaccine as soon as possible, despite the low
yield seen with the initial production seed strain provided by the
World Health Organization. Production has switched to a new higher
yielding seed strain which will allow deliveries of higher volumes
later in the year.

Novartis Influenza A(H1N1) 2009 monovalent vaccine was approved by
the FDA on September 15, 2009. The A(H1N1) vaccine is an inactivated
subunit vaccine approved for active immunization of persons 4 years
of age and older, including patients with underlying chronic medical
conditions. The US Department of Health and Human Services (HHS)
awarded Novartis two contracts totaling USD 979 million for purchase
of H1N1 bulk vaccine and the Novartis proprietary MF59 adjuvant.

The Novartis seasonal influenza vaccine, Fluvirin is 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) in January 2009:

* 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[2]

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[3].

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[4] and about half of the estimated
70,000 people who die annually of diabetes and its complications[5].
During the 2007-2008 influenza season, 83 children were reported to
have died of influenza-related causes[6]. Of the 63 whose vaccination
status was known, 58 (92 percent) were not vaccinated according to
recommendations[7]. 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[8].

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[9]

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.

Important Safety Information for US Market
Adverse reaction information is based on studies conducted with
seasonal trivalent Influenza Virus Vaccine manufactured by Novartis
(Fluvirin). The most frequently reported adverse reactions are mild
hypersensitivity reactions (such as rash), local reactions at the
injection site, and influenza-like symptoms. For patients who have
experienced Guillain-Barré syndrome within 6 weeks of receipt of
prior influenza vaccine, the decision to administer Influenza A
(H1N1) 2009 Monovalent Vaccine should be based on careful
consideration of the potential benefits and risks. Immunocompromised
persons may have a reduced immune response to Influenza A (H1N1) 2009
monovalent vaccine.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "hope," "will," or similar
expressions, or by express or implied discussions potential future
deliveries of influenza vaccines, or regarding potential future
revenues from influenza vaccines. 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 successfully
meet its delivery obligations for its influenza vaccines. Neither
can there be any guarantee that Novartis' influenza vaccines will
achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Novartis' influenza
vaccines could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally;
unexpected manufacturing difficulties or delays, including unexpected
difficulties with our flu cell culture manufacturing facility and
processes; 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 Novartis Diagnostics. 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.
Novartis Diagnostics prevents the spread of infections through the
development and marketing of innovative technologies that enable
early detection of pathogens to protect the world's blood supply and
prevent the spread of infectious diseases.

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.

# # #

Footnotes
[1] This project has been funded in part with Federal funds from the
Office of the Assistant Secretary for Preparedness and Response,
Biomedical Advanced Research and Development Authority, under
Contract Number HHSO100200800072I.
[2] 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
[3] 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
[4] The Centers for Disease Control and Prevention, "Breast Cancer
Statistics," available at www.cdc.gov/cancer/breast/statistics,
accessed on July 20, 2009
[5] 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
[6] 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
[7] The Centers for Disease Control and Prevention, "Influenza
Activity-United States and Worldwide, 2007-08 Season," Morbidity and
Mortality Weekly Report, June 27, 2008
[8] Novartis Vaccines & Diagnostics, Inc., "Agrippal Product
Monograph"
[9] 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 Paul Newman
Novartis Global Media Relations Novartis Vaccines and Diagnostics
+41 61 324 7999 (direct) +1 (617) 871 7931 (direct)
+41 79 593 4202 (mobile) +1 (617) 710 8953 (mobile)
eric.althoff@novartis.com paulc.newman@novartis.com

nvd.communications@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 Bringer +41 61 324 1065 Richard Jarvis +1 212 830
2433
John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830
2445
Thomas Hungerbuehler +41 61 324 8425 Edwin Valeriano +1 212 830
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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