Novartis successfully demonstrates capabilities of cell-based
technology for production of A(H1N1) vaccine
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* First results achieved with A(H1N1) wild type strain shows
significant time savings of cell-based production over egg-based
manufacturing approach confirming its value in pandemic
situations.
* Based on this success Novartis expects to be able to achieve
rapid production and scale up of influenza A(H1N1) vaccine
manufacture with reassortant seed.
* More than thirty governments have made influenza A(H1N1) vaccine
supply requests to Novartis for cell-based and egg-based antigen
and MF59®.
Basel, June 12 2009 - Novartis has successfully completed the
production of the first batch of influenza A(H1N1) vaccine, weeks
ahead of expectations. Cell-based manufacturing technology[1] allows
vaccine production to be initiated once a pandemic virus strain is
identified without the need to adapt the virus strain to grow in
eggs, as with traditional vaccine technologies. This advance has cut
weeks off the time required to begin vaccine production. This first
batch of ten liters of wild type influenza A(H1N1) vaccine monobulk
will be used for pre-clinical evaluation and testing and is also
being considered for use in clinical trials. It demonstrates the
value of the cell-based production approach, that is also being used
by Novartis with reassortant influenza A(H1N1) seed.
The Novartis state of the art cell-culture vaccine production
facility is located in Marburg, Germany. As well as speed, another
advantage of cell-based production is the ability to rapidly increase
production, so the facility has the potential to produce millions of
doses of vaccine each week. A second facility, in collaboration with
the US Department of Health and Human Services, is under construction
in Holly Springs, North Carolina[1].
"The speed advantages of our cell-based production approach and our
unwavering commitment to address this public health emergency have
resulted in our ability to provide the fastest possible response to
this outbreak," said Dr. Andrin Oswald, CEO of Novartis Vaccines and
Diagnostics. "This achievement is also a testament to the technical
skills and innovation of Novartis Vaccines and Diagnostics people and
our partners. I believe it highlights our reputation as a leader in
influenza vaccine research, development and production."
Based on this success with the wild type, Novartis expects to be able
to achieve rapid scale up of influenza A(H1N1) vaccine manufacture
with reassortant seed which was provided by the Centers for Disease
Control and Prevention (CDC) on May 27th. The company plans to start
clinical trials with that vaccine in July and expects licensure in
the fall of 2009.
More than thirty supply requests received from Governments
More than 30 governments have made requests to Novartis to supply
them with influenza A(H1N1) vaccine ingredients. These are a
combination of pre-existing pandemic vaccine supply agreements and
new requests for vaccines across all our production platforms
including egg-based manufacturing. The US Department of Health and
Human Service's $289 million order in May 2009[1] with Novartis was
the largest of the US government's commitments to influenza A(H1N1)
vaccine ingredients. That order included Novartis proprietary
adjuvant MF59®, which can be added to influenza vaccines to help
stimulate the human body's immune response to the vaccine. Data
published in April 2009 in the Proceedings of the National Academy of
Sciences of the United States of America reinforced the potentially
broad applicability of MF59. MF59 is the only influenza adjuvant with
an established safety profile which is supported by more than ten
years of clinical safety data in Europe, and more than 40 million
doses of commercial use in the influenza vaccine Fluad®. Fluad is
licensed in Europe but not the US.
The Novartis pandemic vaccine developmental program began in 1997
under the leadership of Dr. Rino Rappuoli who is Head of Research at
Novartis Vaccines.
Footnote
[1] Development of Novartis' cell-based influenza vaccine,
construction of the cell-based influenza manufacturing facility at
Holly Springs, NC and purchase of H1N1 antigen and adjuvant are being
funded in whole or in part with Federal funds from the Office of
Public Health Emergency Preparedness, Office of Research and
Development Coordination, under Contract Numbers HHSO100200600012C,
HHSO100200900101C and HHSO100200800072I, respectively.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "potential," "commitment,"
"expects," "plans", "can", "potentially", or similar expressions, or
by express or implied discussions regarding potential marketing
approvals for an influenza A(H1N1) vaccine, potential production
timing and volumes for such a vaccine or regarding potential future
revenues from such a vaccine. 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 influenza A(H1N1) vaccines
will be approved for sale in any market. Nor can there be any
guarantee that influenza A(H1N1) vaccines will be produced by any
particular date, or in any particular volumes. Neither can there be
any guarantee that influenza A(H1N1) vaccines will achieve any
particular levels of revenue in the future. In particular,
management's expectations could be affected by, among other things,
unexpected clinical trial results, including unexpected new clinical
data and unexpected additional analysis of existing clinical data;
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; competition in general; government, industry
and general public pricing pressures; the company's ability to obtain
or maintain patent or other proprietary intellectual property
protection; 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 Novartis division 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 AG 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 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
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
http://www.novartis.com.
###
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