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Impressum
Bankleitzahlen - online.de


Novartis receives regulatory approval in Germany for Celtura®, a cell culture-based Influenza A(H1N1) pandemic vaccine

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




* Approval marks an important milestone in the process of replacing
50 year-old egg-based flu vaccine production with modern
biotechnology

* Clinical trials in more than 1,850 individuals across all age
groups show strong efficacy, that can induce immune responses
associated with protection against influenza in individuals from
3 to 50 years of age

* Novartis continues to pursue registration of Celtura in other
major countries


Basel, November 5, 2009 - Novartis announced today that it received
approval from the German regulatory authorities for its adjuvanted
cell culture-based Influenza A(H1N1) 2009 monovalent vaccine,
Celtura®. Novartis continues to pursue registration in other major
countries, including Japan and Switzerland.

Celtura is manufactured in Marburg, Germany and is an MF59®
adjuvanted inactivated influenza virus vaccine indicated for active
immunization of persons six months of age and older against influenza
disease caused by the novel pandemic A(H1N1) influenza virus. The
vaccine contains 3.75 micrograms (ug) of antigen and 0.125 ml of
MF59®. It will be offered in multi-dose vials and in single-dose
pre-filled syringes.

Clinical studies conducted with more than 1,850 subjects evaluated
Celtura's tolerability and immunogenicity. The studies showed that
even with the lowest antigen content (3.75 ug) a single Celtura dose
can induce immune responses associated with protection against
influenza in individuals from 3 to 50 years of age. Safety and
tolerability profiles were as expected. Local injection site
(redness, swelling and pain) and systemic complaints of mild fever,
headache and fatigue were the most frequent side effects reported.

Celtura uses a validated cell culture line for production of viral
antigen components rather than traditional chicken eggs. The
technology has previously been licensed in Europe for the production
of the seasonal flu vaccine, Optaflu®.

"Our modern cell culture technology can enable a faster start-up of
vaccine manufacturing, offering the ability to respond more quickly
to future pandemic threats", said Andrin Oswald, CEO of Novartis
Vaccines and Diagnostics. "We quickly ramped up capacity at our
licensed cell culture facility in Marburg, Germany to respond to the
need for a pandemic vaccine. Also we are close to completion of a
second cell culture-based influenza vaccine manufacturing site in the
US[1], which is being built in partnership with the US Department of
Health and Human Services (HHS)."

MF59 is an adjuvant with an established safety profile supported by
more than 12 years of clinical safety data in Europe and more than 45
million doses of commercial use in the influenza vaccine Fluad®
(licensed in Europe but not the US).

Novartis has already begun delivery of the company's egg-based
pandemic vaccines, Fluvirin® A(H1N1) monovalent vaccine to the US,
and Focetria® A(H1N1) monovalent vaccine to countries around the
world. The US Food and Drug Administration approved the Fluvirin
A(H1N1) vaccine on September 15, 2009, and the EMEA approved the
Focetria A(H1N1) vaccine on September 29, 2009.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "continues to pursue," "can,"
"potentially," "offering the ability," or similar expressions, or by
express or implied discussions regarding potential additional
marketing approvals for Novartis' A(H1N1) vaccines, 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' A(H1N1) vaccines
will be approved for sale in any additional countries. Nor can there
be any 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 continued unexpected
difficulties with seed virus yields, and 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.

References
[1] This project has been funded in whole or in part with Federal
funds from the Office of the Assistant Secretary for Preparedness and
Response, Biomedical Advanced Research and Development Authority,
under Contract No. HHSO100200900101C.

# # #

Novartis Media Relations


Central media line : +41 61 324
2200
Eric Althoff Paul Newman
Novartis Global Media Novartis Vaccines and Diagnostics
Relations +1 (617) 871 7931 (direct)
+41 61 324 7999 (direct) +1 (617) 710 8953 (mobile)
+41 79 593 4202 (mobile) paulc.newman@novartis.com
eric.althoff@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 Richard Jarvis +1 212 830
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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