2009-11-17 07:18:02 -
London, November , 17, 2009
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* Interim clinical data from approximately 4,000 individuals
suggest that half a dose of the currently US-approved Novartis
unadjuvanted Influenza A(H1N1) 2009 vaccine met immunogenicity
criteria in adults and the elderly
* Data also show that Novartis MF59® adjuvant was well tolerated
and could potentially quadruple the Novartis A(H1N1) 2009
influenza vaccine supply
* MF59® adjuvant has an established safety profile supported by
clinical data from more than 33,000 study participants and 12
years of real life safety data with more than 45 million doses of
influenza vaccine administered since 1997 in Europe
Basel, November 17, 2009 - Novartis announced today new interim data
from ongoing clinical trials demonstrating that a single 7.5µg dose
of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of
the currently-approved US dose, fulfilled immune response criteria
associated with protection in adults and the elderly (>=65 years of
age).
The data also showed a single 3.75µg dose of MF59-adjuvanted A(H1N1)
2009 vaccine met serologic protection criteria against influenza
A(H1N1) in children ages 3 to 8, adults ages 18 to 64, and the
elderly. All A(H1N1) 2009 influenza study vaccines were manufactured
using the Novartis established seasonal Fluvirin® manufacturing
platform. Novartis has discussed these new data with the US Food and
Drug Administration (FDA) and is performing additional statistical
analysis suggested by the agency. It is still under evaluation
whether the antigen content per dose can be reduced in the US.
Current US guidelines for A(H1N1) 2009 vaccine use state that
adolescents, adults and the elderly are required to receive one 15µg
dose to achieve adequate protective antibody levels against the
A(H1N1) virus, and children 9 years of age and under are required to
receive two 15µg doses four weeks apart.
"These promising data suggest that many more people could potentially
be vaccinated with our current vaccines supply, protecting more
people earlier against the current pandemic," said Andrin Oswald, CEO
of Novartis Vaccines and Diagnostics. "The data also confirms the
antigen sparing potential of our proprietary adjuvant, MF59®. The
vaccines output of our Liverpool, U.K., based flu manufacturing
facility, fully dedicated to the US since the emergence of the
pandemic, could be quadrupled if vaccines are adjuvanted."
These interim data were generated from pivotal clinical studies
designed to evaluate the immunogenicity, safety and reactogenicity of
both MF59-adjuvanted and unadjuvanted, inactivated novel swine origin
A(H1N1) 2009 monovalent subunit influenza virus vaccine in 4,080 US
subjects. In the pediatric trial, the findings are based on 80% of
first dose data from 1,360 subjects ages 3 to 8 at day 22. In the
adult trial, the findings are based on 95% of first dose data at day
1 and day 8 and approximately 40% of first dose data at day 22 from
1,360 adult subjects and 1,360 elderly subjects. Second dose data and
data in ages 6-36 months of age are expected in December 2009.
About MF59
Novartis proprietary MF59 adjuvant has an established safety profile,
supported by more than 12 years of clinical safety data and more than
45 million doses of commercial use in Europe. The adjuvant has been
studied in clinical trials involving more than 33,000 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. Novartis also produces two A(H1N1) vaccines,
Focetria® and Celtura®, which contain MF59 and are available outside
the US. Currently, there are no approved vaccines in the United
States that contain MF59.
Novartis has been contracted by the US Department of Health and Human
Services (HHS) to produce 90 million doses of MF59 by the end of
November.[1]
About A(H1N1) 2009 Vaccine
Novartis influenza A(H1N1) 2009 monovalent vaccine, manufactured
using the established seasonal Fluvirin platform, is an inactivated
influenza virus egg-derived vaccine indicated for active immunization
of persons 4 years of age and older against influenza disease caused
by pandemic A(H1N1) 2009 virus. The vaccine was approved by the FDA
on September 15, 2009 as an unadjuvanted 15µg dose.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "may," "suggest," "could,"
"potentially," "promising," "potential," "expected," or similar
expressions, or by express or implied discussions regarding regarding
potential additional marketing approvals for Novartis' A(H1N1)
vaccines and adjuvants, potential new indications or labeling for
Novartis' A(H1N1) vaccines and adjuvants, potential future deliveries
of influenza vaccines and adjuvants, or regarding potential future
revenues from Novartis' A(H1N1) vaccines and adjuvants. 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 with Novartis' A(H1N1) vaccines
and adjuvants to be materially different from any future results,
performance or achievements expressed or implied by such statements.
Novartis' A(H1N1) vaccines will achieve any additional marketing
approvals. Nor can there be any guarantee that Novartis' A(H1N1)
vaccines and adjuvants will be approved for any additional
indications or labeling in any market. Nor can there be any guarantee
that Novartis will successfully meet its delivery obligations for its
A(H1N1) vaccines and adjuvants. Neither can there be any guarantee
that Novartis' A(H1N1) vaccines and adjuvants will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding Novartis' A(H1N1) vaccines and
adjuvants 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 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 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. HHS100200800072I.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@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
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Novartis International AG
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