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Impressum
Bankleitzahlen - online.de


Novartis MF59® adjuvanted cell culture-based vaccine shows strong immune response in A(H1N1) clinical trials

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




* First pilot trial of investigational A(H1N1) vaccine with 100
subjects indicates strong, potentially protective, immune
response in 80% of subjects after one dose, more than 90% after
two doses.

* MF59® adjuvanted cell culture-based A(H1N1) vaccine was well
tolerated, pain at the injection site the most frequent adverse
event.

* Larger pivotal trials with both cell culture and traditional egg
based vaccines under way to include more than 6000 adults and
children.

Basel, September 3 2009 - A pilot trial of Novartis adjuvanted cell
culture-based A(H1N1) vaccine[1] indicates that the "swine flu"
vaccine elicited a strong immune response and was well tolerated. The
trial was run by the UK's University of Leicester and University
Hospitals of Leicester. The vaccine, to be called Celtura®, was
tested with 100 healthy volunteers, aged between 18 and 50.

The trial evaluated the tolerability and immunogenicity of the
vaccine. Different schedules and timing between vaccinations were
tested. The vaccine schedule comprised one or two doses of 7.5µg
MF-59® adjuvanted surface-antigen A/California/2009 vaccine derived
from cell-culture. Results showed that the serum antibody responses
were highest among subjects who received two doses of vaccine,
however a single vaccine dose also induced responses associated with
protection against influenza. Hemagglutination-inhibition titres
reached 1:40 or greater in 80 percent and more than 90 percent of
those receiving one dose and two doses respectively. These would
satisfy the immunogenicity criteria as set out by European and US
regulators. The findings showed that it is possible to induce
protective antibodies against A(H1N1) infection within two weeks of
administration of a single low-dose adjuvanted vaccine.
Non-adjuvanted formulations were not evaluated in the study.

Additional pivotal clinical trials, with larger numbers of subjects
and sponsored by Novartis, are already under way around the world.
They will include more than 6000 adults and children.

"The pilot trial results are encouraging," said Dr. Andrin Oswald,
CEO of Novartis Vaccines and Diagnostics. "The study suggests that
while two doses seem to provide better protection, one dose of our
adjuvanted Celtura vaccine may be sufficient to protect adults
against the swine flu. This is important information for public
health authorities who prepare for vaccination in the coming months
with limited vaccine supply."

The pilot trial was led by Dr. Stephenson of the Department of
Infection, Immunity and Inflammation at the University of Leicester.
He is a clinical senior lecturer at the University, and a consultant
in infectious diseases at the University Hospitals of Leicester NHS
Trust. Dr. Stephenson said "the aim of the trial was to find out how
many doses and what type of vaccine is needed to give protection.
These initial results should help to plan vaccination campaigns in
the autumn, including doses and timings. We concluded that the
MF59-adjuvanted A(H1N1) vaccine of low antigen content was well
tolerated and generated antibody responses associated with protection
against influenza, even after a single dose."

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "potentially," "to include,"
"will," "encouraging," "suggests," "may," "should," "plan", "or
similar expressions, or by express or implied discussions regarding
potential marketing approvals for an influenza A(H1N1) vaccine,
potential production timing and volumes for such a vaccine or
regarding potential future revenues from such a 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 influenza A(H1N1)
vaccines will be approved for sale in any market. Nor can there be
any guarantee that influenza A(H1N1) vaccines will be produced by any
particular date, or in any particular volumes. Neither can there be
any guarantee that influenza A(H1N1) vaccines will achieve any
particular levels of revenue in the future. In particular,
management's expectations could be affected by, among other things,
unexpected clinical trial results, including unexpected new clinical
data from the ongoing trials of the A(H1N1) vaccine, and unexpected
additional analysis of existing clinical data regarding the vaccine;
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, and unexpected difficulties with the
established egg-based manufacturing process; competition in general;
government, industry and general public pricing pressures; the
company's ability to obtain or maintain patent or other proprietary
intellectual property protection; 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 Novartis division 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



###

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

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 +41 61 324 Edwin Valeriano +1 212 830
Hungerbuehler 8425 2456
Isabella Zinck +41 61 324
7188
e-mail: e-mail:
investor.relations@novartis.com investor.relations@novartis.com


Footnote
[1] Development of Novartis' cell-based influenza vaccine,
construction of the cell-based influenza manufacturing facility at
Holly Springs, NC and purchase of H1N1 antigen and adjuvant are being
funded in whole or in part with Federal funds from the Office of
Public Health Emergency Preparedness, Office of Research and
Development Coordination, under Contract Numbers HHSO100200600012C,
HHSO100200900101C and HHSO100200800072I, respectively.



--- 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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