Sanofi Pasteur Receives Order from U.S. Government to Produce New Influenza A(H1N1)...
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Sanofi Pasteur Receives Order from U.S. Government to Produce New Influenza
A(H1N1) Vaccine
- Initial U.S. order for bulk vaccine valued at $190 million -
SWIFTWATER, Pa. and LYON, France, May 25 /PRNewswire/ -- Sanofi Pasteur, the
vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY),
announced today it has received the first of what is expected to be a series
of orders from the U.S. Department of Health and Human Services (HHS) to
commence production of a vaccine to help protect against the new influenza
A(H1N1) virus.
This order from HHS was issued pursuant to an existing pandemic stockpile
contract between Sanofi Pasteur and the U.S. government that allows HHS to
purchase vaccines for viruses with pandemic potential. In addition to this
initial HHS order, the company is in discussions with other governments to
address their needs for A(H1N1) vaccine.
The HHS order provides for the production of the bulk vaccine and related
activities. The dosage requirements for the new vaccine are yet to be
determined and will be based on clinical trials, which could begin as early as
August. Final formulation, filling and distribution of the vaccine also have
not been established at this time. The order is in the amount of $190 million.
"This initial order for A(H1N1) vaccine received today under our existing
contract is part of a major effort by Sanofi Pasteur to support global public
health efforts to prepare the world for the possibility of an influenza
pandemic," said Wayne Pisano, President and CEO of Sanofi Pasteur. "Production
of a new vaccine is not a simple task and there are a number of necessary and
complex steps that must be taken before a vaccine can be made available to the
public, but we have experience on our side. Previously, we developed and
licensed the first pre-pandemic vaccine for H5N1 and we look forward to
further demonstrating our experience and expertise in vaccine development as
we prepare for this new threat from A(H1N1)."
Sanofi Pasteur is awaiting receipt of the seed virus to be used for vaccine
production from the U.S. Centers for Disease Control and Prevention (CDC).
Once the seed is received, Sanofi Pasteur will begin development efforts to
prepare a working seed for vaccine production. Sanofi Pasteur is prepared to
commence commercial scale production in June following certification of the
working seed by the U.S. Food and Drug Administration (FDA). The company
currently estimates it will have the first bulk concentrate vaccine in a few
months. However, the company will be better able to determine the timing once
the seed virus is received and development of working seed is underway.
Sanofi Pasteur operates influenza vaccine production facilities in the United
States - Swiftwater, Pa. - and in France - Val de Reuil. Production of the new
A(H1N1) vaccine for HHS will initially occur in Sanofi Pasteur's recently
licensed influenza vaccine production facility in Swiftwater. Once ongoing
seasonal influenza production concludes in the second facility in Swiftwater,
A(H1N1) vaccine production can occur in both Swiftwater facilities.
"Our philosophy is to maintain flexibility in our influenza vaccine
production, to enable us to answer public health needs wherever they are,"
said Pisano. "We know that seasonal influenza remains a global threat, and in
many countries, especially developing countries, H5N1 is still a greater
threat than A(H1N1). To this end, we continue our active discussions with WHO
and governments around the world to ensure the accessibility of our
life-saving vaccines to the greatest number of people."
Sanofi Pasteur Influenza Vaccine Production
Sanofi Pasteur operates influenza vaccine production facilities in Swiftwater,
Pa. and Val de Reuil, France.
In Swiftwater, Sanofi Pasteur has two licensed influenza production
facilities. On May 6, 2009, the FDA licensed Sanofi Pasteur's new influenza
vaccine manufacturing facility in Swiftwater. When operating at full capacity,
the new facility will have a capacity of approximately 100 million doses of
seasonal influenza vaccine per year. An existing facility in Swiftwater is
capable of producing 50 million doses per year and currently is producing
vaccine for the 2009/2010 season. In total, the company will have a capacity
equivalent to approximately 150 million doses of trivalent seasonal influenza
vaccine per year in the United States when both facilities are operating at
full capacity. The A(H1N1) production can occur in both Swiftwater
facilities.
In Val De Reuil, Sanofi Pasteur is currently producing the trivalent seasonal
influenza vaccine for the 2009/2010 season, with the capacity of 120 million
doses per year. Sanofi Pasteur's production facility in Val De Reuil is also
capable of producing the new A(H1N1) vaccine.
Sanofi Pasteur produces approximately 40 percent of the influenza vaccines
distributed worldwide and in the United States produced more than 45 percent
of the influenza vaccines distributed for the 2008/2009 influenza season. The
company also has developed the first and only U.S.-licensed avian influenza
vaccine for humans. More information about Sanofi Pasteur's pandemic
preparedness efforts can be found at www.pandemic.influenza.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops
and distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more
than 1.6 billion doses of vaccine in 2008, making it possible to immunize more
than 500 million people across the globe. A world leader in the vaccine
industry, Sanofi Pasteur offers the broadest range of vaccines protecting
against 20 infectious diseases. The company's heritage, to create vaccines
that protect life, dates back more than a century. Sanofi Pasteur is the
largest company entirely dedicated to vaccines. Every day, the company invests
more than EUR 1 million in research and development. For more information,
please visit: www.sanofipasteur.com or www.sanofipasteur.us.
Forward Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include financial projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations with
respect to future events, operations, products and services, and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions. Although sanofi-aventis'
management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties,
many of which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include those discussed or identified in the public filings with the SEC and
the AMF made by sanofi-aventis, including those listed under "Risk Factors"
and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2008. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking information
or statements.
Contacts
Global Media Relations US Media Relations
Pascal Barollier Donna Cary
T. +33-(0)4-37-37-50-38 T. +1-570-957-0717
pascal.barollier@sanofipasteur.com donna.cary@sanofipasteur.com
www.sanofipasteur.com www.sanofipasteur.us
SOURCE Sanofi Pasteur
Global Media Relations, Pascal Barollier, +33-(0)4-37-37-50-38,
pascal.barollier@sanofipasteur.com; or US Media Relations, Donna Cary,
+1-570-957-0717, donna.cary@sanofipasteur.com
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