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MarketScreener Homepage  >  Equities  >  London Stock Exchange  >  NOVARTIS    0HKE   CH0012005267

NOVARTIS (0HKE)
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NOVARTIS : A(H1N1) Pandemic Influenza vaccine Focetria® receives positive opinion from CHMP

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09/25/2009 | 11:35am CET

Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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* Significant milestone in bringing pandemic influenza vaccines to
market in Europe

* Novartis delivers first shipments of A(H1N1) vaccine to
governments in Europe just three months after the WHO declaration
of the pandemic

* Focetria formulated with MF59® adjuvant which can boost the
body's immune response and increase protective antibody levels
with less antigen than needed with non-adjuvanted vaccines


Basel, September 25, 2009 - Novartis announced today that Focetria®,
the Novartis Influenza A(H1N1) 2009 monovalent vaccine, has received
a positive opinion from the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMEA). The
positive opinion clears the way for European Union approval in all 27
Member States as well as in Iceland and Norway. Today's announcement
marks a significant milestone in bringing a pandemic vaccine to
market in Europe.

Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is
an inactivated influenza virus vaccine indicated for active
immunization of persons of six months of age and older against
influenza disease caused by the novel pandemic A(H1N1) influenza
virus. The pandemic vaccine has been developed using traditional
influenza manufacturing processes in an egg-based formulation.
Focetria contains MF59®, Novartis proprietary adjuvant, which has
been added to boost the immune response in individuals receiving the
vaccine. MF59 can elicit protective antibody levels with a lower
dose, just 7.5 micrograms of viral antigen versus 15 micrograms in
non-adjuvanted vaccines, potentially resulting in greater vaccine
supply.

Novartis has already started first deliveries of pandemic vaccines
under quarantine to governments in Europe, despite the initially low
yields with the current production seed strain provided by the World
Health Organization (WHO). A new seed strain could provide higher
volumes.

"Only three months after the declaration of the pandemic by the WHO,
Novartis was able to ship the first batches of our pandemic vaccine
under quarantine to governments in Europe pending EU approval," said
Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "This CHMP
positive opinion paves the way for EU approval, which will allow
governments to begin their vaccination campaigns with the goal of
reaching more patients before the rapidly spreading virus reaches
them. Several recent clinical trials suggest that just one dose of
pandemic vaccine can protect healthy adults, which means that now the
vaccine can be provided to more people than if two doses were
needed."

Focetria was previously approved by the EU in May 2007 as a mock-up
file to be used once the WHO declared a pandemic. This previous
approval was based on clinical studies involving the MF59 adjuvant
and different influenza strains with pandemic potential, including
H5N1 and H9N2.

Novartis also plans to begin delivery of its Fluvirin® A(H1N1)
monovalent vaccine to the US market by early October. The US Food and
Drug Administration approved this vaccine on September 15, 2009. Data
derived from recent clinical trials of Fluvirin conducted in Costa
Rica indicate that a single-dose regimen is as effective as a
two-dose regime in healthy adults ages 18-64 suggesting the potential
to extend A(H1N1) vaccine supply further to support public health
efforts. The trial was conducted in 784 healthy adults.

About MF59®
Novartis proprietary MF59 adjuvant has an established safety profile,
supported by more than 12 years of clinical safety data and more than
40 million doses of commercial use in Europe. The adjuvant has been
studied in clinical trials involving more than 26,000 people,
including children, and has been licensed for use in people 65 years
of age and over in the seasonal influenza vaccine, Fluad®, since 1997
in the European Union. Fluad is not licensed for sale in the U.S.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "can," "potentially," "could,"
"will," "suggest," "potential," "plans," "suggesting," or similar
expressions, or by express or implied discussions regarding potential
marketing approvals for Novartis' A(H1N1) vaccines, potential
production timing and volumes for such vaccines or regarding
potential future revenues from such 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 A(H1N1) vaccines will be
approved for sale in any market. Nor can there be any guarantee that
A(H1N1) vaccines will be produced by any particular date, or in any
particular volumes. Nor can there be any guarantee that A(H1N1)
vaccines will achieve any particular levels of revenue in the future.
In particular, management's expectations regarding A(H1N1) 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.

# # #

Novartis Media Relations


Central media line : +41 61 324 2200

Eric Althoff Paul Newman
Novartis Global Media Relations Novartis Vaccines and
+41 61 324 7999 (direct) Diagnostics
+41 79 593 4202 (mobile) +1 (617) 871 7931 (direct)
eric.althoff@novartis.com +1 (617) 710 8953 (mobile)
paulc.newman@novartis.com
email: media.relations@novartis.com



Novartis Investor Relations


Central phone: +41 61 324 7944
Ruth Metzler-Arnold +41 61 324 9980 North America:
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 Edwin +1 212
8425 Valeriano 830 2456
Isabella Zinck +41 61 324 7188

e-mail: 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;
http://hugin.info/134323/R/1343650/321900.pdf


Copyright © Hugin AS 2009. All rights reserved.
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