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Novartis on track to deliver Influenza A (H1N1) vaccine for the US |
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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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* Novartis on track to produce 90 million units of bulk antigen in
line with commitment to US Department of Health and Human
Services, despite very low yields of initial seed virus
* 90 million units of bulk antigen expected to result in 60 million
vaccine doses due to required overage and overfills in the
filling process of multi-dose vials and pre-filled syringes
* To date, Novartis has shipped more than 7.5 million doses of
Influenza A (H1N1) vaccines in multi-dose vials and pre-filled
syringes ready to use, and expects to reach 25 to 30 million
doses by the end of November
* Novartis also initiated deliveries against the 90 million doses
of proprietary adjuvant, which could be used to double the amount
of vaccine doses produced
Basel, October 29, 2009 - Novartis confirmed today that it has
shipped over 7.5 million doses of Influenza A(H1N1)[1] vaccine ready
to use and expects 25 to 30 million doses of unadjuvanted vaccine to
become available in pre-filled syringes and multi-dose vials by the
end of November. Smaller changes in delivery timelines and volumes
can result out of the variability of the underlying biological
production process. The deliveries are in line with commitments made
to the US Department of Health and Human Services (HHS).
In addition, the company is progressing with the production of its
proprietary adjuvant MF59(TM) for the US. Adjuvants have shown to be
antigen sparing and can double the number of vaccine doses produced.
"Overall, we are pleased with the progress achieved to date, given
the many challenges and uncertainties of the current pandemic. Not
only did we complete our commitment to provide seasonal vaccine ahead
of schedule, we are making every effort to make as much H1N1 vaccine
available as quickly as possible," said Andrin Oswald, CEO of
Novartis Vaccines and Diagnostics. "However, we acknowledge the
limitations of the old manufacturing sites and technologies for
influenza vaccines to rapidly respond to the needs of a pandemic.
Over the last three years, Novartis has made major R&D investments to
develop new technologies. And in partnership with HHS, we are
building the first cell based flu manufacturing facility in the US.
The opening of the site is planned later this year."
Production of the H1N1 vaccine is progressing, despite the unexpected
very low yields observed with the initial seed virus at 23 percent as
compared to average yield seen with seasonal vaccines. Novartis
started production with a new seed virus in the middle of September
which provides an improved yield of 63 percent. To date, 42 million
bulk units of vaccine have been produced. The company expects to
complete production of 90 million doses of bulk antigen by December
and will continue to rapidly fill-finish the bulk antigen as it is
produced and ordered by HHS.
Novartis is fully utilizing its manufacturing capacity and has
entirely dedicated one of its two major flu manufacturing sites,
based in Liverpool, U.K., to supplying H1N1 vaccine antigen for the
US. Production capacity at the Liverpool site has been maximized by
hiring and training 300 additional staff, as well as the acceleration
of the opening of a new facility and egg incubation unit at the site.
Following a more than USD 200 million investment over three years,
the additional facility was recently approved by the US Food and Drug
Administration (FDA) as suitable to manufacture vaccines for the USA.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "on track," "commitment,"
"expected," "expects," "could," "planned," "will," or similar
expressions, or by express or implied discussions regarding potential
future deliveries of A (H1N1) vaccines, or regarding potential future
revenues from A (H1N1) 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 with A (H1N1) vaccines to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that that Novartis will successfully meet its delivery obligations
for its A (H1N1) vaccines. Nor can there be any guarantee that the A
(H1N1) vaccines will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding the A
(H1N1) vaccines could be affected by, among other things, 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
regulatory actions or delays or government regulation generally;
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 http://www.novartis.com.
References
[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.
# # #
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 1065 Richard Jarvis +1 212 830
2433
John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830
2445
Thomas +41 61 324 8425 Edwin +1 212 830
Hungerbuehler Valeriano 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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