Novartis inaugurates large-scale US based cell-culture influenza
vaccine manufacturing facility
2009-11-24 07:18:05 -
London, November , 24, 2009
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* Total investment of nearly USD 1 billion through a partnership
between Novartis and the US Department of Health and Human
Services
* Inauguration marks important milestone in using modern
biotechnologies for flu vaccine production to replace the 50
year-old egg-based process
* Facility designed to supply 150 million doses of pandemic vaccine
within 6 months of influenza pandemic declaration; facility ready
to respond to a pandemic as early as 2011 if licensed in an
emergency
Basel, November 24, 2009 - Today, Novartis officially inaugurated the
US's first ever large-scale flu cell culture vaccine and adjuvant
manufacturing facility in Holly Springs, North Carolina. The facility
is a result of a partnership between Novartis and the US Department
of Health and Human Services (HHS). It is the first of its kind in
the United States and highlights an important milestone in efforts to
improve influenza vaccine manufacturing technology in the US and
enhance domestic pandemic preparedness.
"We are proud to be one of the first companies to bring influenza
cell culture as well as adjuvant technology to the United States,"
said Daniel Vasella, CEO and Chairman of Novartis. "We have seen a
great need to invest into new technologies for flu vaccines that will
allow for quicker and more reliable production capacity. We are
pleased to be working closely with the US government to build a
world-class, state of the art manufacturing facility in the US that
will change the way we manufacture influenza vaccines in the future."
The total investment in the facility is nearly USD 1 billion, through
a partnership between Novartis and HHS to support the design,
construction, validation and licensing of the manufacturing facility
in Holly Springs.
The operations at this facility will use modern, cell culture-based
manufacturing technology. Cell culture-based production operations
are cleaner, can be scaled up more quickly to respond to a pandemic
and do not rely on eggs for rapid response to a pandemic. Cell
culture technology for influenza vaccines is not yet approved in the
US, however part of the HHS contract support for Holly Springs
includes funding for the development of a flu cell culture vaccine.
If licensed in an emergency, the facility will be ready to respond to
a pandemic as early as 2011. The plant is planned to be running at
full scale commercial production in 2013.
Novartis already operates a cell culture-based manufacturing plant in
Marburg, Germany. It is licensed to produce a seasonal cell
culture-based influenza vaccine, Optaflu®, which is approved in all
27 member states of the European Union as well as in Iceland and
Norway. It currently produces Celtura®, a H1N1 pandemic vaccine
licensed in Germany and Switzerland.
The Novartis Holly Springs facility can also start producing MF59®,
the Novartis proprietary adjuvant, as early as December 2009.
Although not yet approved in the US, studies with adjuvants are
currently underway in the US. Results of the most recent clinical
trials conducted with the Novartis MF59 adjuvanted cell culture-based
vaccine have shown that it is possible to induce protective antibody
levels against A(H1N1) infection within two weeks of administration
of a single low-dose adjuvanted vaccine. MF59 has also been shown to
provide cross-protection across similar strains of a H5N1 virus,
which is an additional important element for a pre-pandemic vaccine
given that mutations are a common feature of emerging influenza
strains.
As part of its partnership with HHS, Novartis is responsible for,
among other things, pre-construction document development, land use
and zoning, construction, commissioning, validation and licensing of
the facilities with the goals of regulatory licensure, manufacture
and release of seasonal and pre-pandemic vaccine, as well as
provision for pandemic vaccine supply in the event of a pandemic or
other vaccines or biologicals in the event of an emergency for an
emerging infectious disease. The partnership also requires Novartis
to provide two commercial-scale annual lots of pre-pandemic vaccine
for a minimum of three years. In addition, HHS has the right to
exercise options to purchase additional influenza vaccine over 17
years.
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.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "as early as," "will," "future,"
"planned," "can," or similar expressions, or by express or implied
discussions regarding the potential completion of the production
facility at Holly Springs, the timing of potential commencement of
and continued successful production of vaccines and adjuvants at
Holly Springs, regarding the potential marketing approval
cell-culture influenza vaccines, regarding the amounts to be paid by
the government under the agreement described in this release, or
regarding potential future revenues from vaccines produced at Holly
Springs. You should not place undue reliance on these statements.
Such forward-looking statements reflect the current views of the
Company regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results at the
Holly Springs facility to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that we will complete the Holly
Springs facility, commence production there, or successfully continue
production of vaccines there. Nor can there be any guarantee that any
of the products expected to be produced at the Holly Springs facility
will be approved for sale in any market. Neither can there be any
guarantee that we will be paid the full amount referred to in this
release. Neither can there be any guarantee that vaccines and
adjuvants to be produced at Holly Springs will achieve any particular
levels of revenue in the future. In particular, management's
expectations regarding the Holly Springs production facility and
vaccines produced there could be affected by, among other things,
unexpected regulatory actions or delays or government regulation
generally; unexpected construction difficulties or delays; unexpected
production difficulties or delays, including difficulties or delays
relating to the novel cell-culture production technique to be
employed there; 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.
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's. HHSO100200600012C, HHSO100200700030C,
HHSO100200900101C.
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 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 www.novartis.com.
# # #
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 +41 61 324 Richard Jarvis +1 212 830
Bringer 1065 2433
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3018 2445
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8425 2456
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e-mail: e-mail:
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Novartis International AG
Posfach Basel
WKN: 904278; ISIN:
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