Lyon, France and Swiftwater, Pennsylvania (ots/PRNewswire)
- Influenza Vaccine Leader Takes New Step in Global Pandemic
LYON, France and SWIFTWATER, Pennsylvania, September 15 /PRNewswire/
Sanofi pasteur, the vaccines business of the sanofi-aventis Group
(NYSE: SNY), has entered into an agreement with the U.S. Department
of Health and Human Services (HHS) to produce doses of a vaccine to
help protect against the H5N1 influenza virus strain, the so-called
avian strain. Scientists believe the H5N1 strain could become the
cause of a global influenza pandemic.
The contract is another major effort by sanofi pasteur to support
efforts in both the U.S. and Europe to prepare the world for the
possibility of an influenza pandemic.
The $100 million contract calls for sanofi pasteur to manufacture
the vaccine in bulk concentrate form at its U.S. headquarters in
Swiftwater, PA from early September through late October. The
agreement provides for additional fees to be paid to sanofi pasteur
for storage of the vaccine as well as for formulation and filling of
the vaccine upon government request.
Sanofi pasteur's Global Commitment to Pandemic Preparation
In the U.S., the contract with HHS is sanofi pasteur's fifth
pandemic-related agreement with the U.S. government.
- In May 2004, sanofi pasteur contracted with the NIAID to produce
8,000 investigational doses of the H5N1 influenza strain. The doses
were manufactured and shipped to the NIAID on March 2 and 3, 2005.
The clinical studies for the vaccine are being conducted by the
- In September 2004, the company signed a contract with HHS to
produce two million doses of bulk vaccine derived from the H5N1 viral
strain. The bulk doses were produced and are being stored, and can be
formulated and filled upon government request.
- In November 2004, the HHS awarded a contract to sanofi pasteur
for the establishment and maintenance of flocks of egg-laying hens to
allow the company to manufacture pandemic influenza vaccine at
current full capacity on a year-round basis. The flocks will be fully
available by September. In addition, the contract calls for sanofi
pasteur each year to produce investigational doses for a potential
pandemic influenza vaccine. This year the company will produce 3,000
investigational doses of a vaccine to protect against the H7N7
- In April 2005, the HHS awarded a contract to sanofi pasteur to
speed the production process for new cell culture influenza vaccines
in the U.S. and the design of a U.S.-based cell-culture vaccine
In Europe, sanofi pasteur initiated and runs a large range of
- Sanofi pasteur is sponsoring the first clinical trials to
determine the safety and immunogenicity of an H5N1 influenza vaccine.
The clinical trial is conducted in France. The strain was provided by
the U.K.'s National Institute for Biological Standards and Control
(NIBSC). The clinical lots are being developed in collaboration with
the French health authorities, NIBSC and the European Medicines
Agency (EMEA). The data from these studies will be used in a "mock
dossier" submitted to the EMEA to accelerate the license approval
process in the event of a pandemic.
- FLUPAN: Sanofi pasteur is the only vaccine manufacturer to
participate, along with the NIBSC and the University of Reading, in
this E.U.-funded collaboration. FLUPAN is intended to improve the
level of pandemic preparation in the E.U. The company will produce
pandemic influenza vaccine that will be used in a FLUPAN clinical
- Sanofi pasteur is in active discussions with governments, and
European authorities concerning production on H5N1 vaccines and
production option for pandemic vaccine.
In Australia, the government has a contract with sanofi pasteur
for the supply of pandemic vaccine should there be an outbreak of
pandemic influenza. The pandemic agreement was part of a three-year
contract that covers interpandemic influenza vaccine supply as well.
Sanofi pasteur was awarded 35% of the annual interpandemic vaccine
The new contract illustrates sanofi pasteur's continued commitment
toward the production of influenza vaccine to protect against
possible pandemic strains, both in the U.S. and throughout the world.
Reliable Influenza Vaccine Supplier for Years
Influenza vaccines leader sanofi pasteur operates two
manufacturing facilities to produce injectable influenza vaccine for
the world, in Val de Reuil in France and Swiftwater in the U.S.
New Influenza Facilities Under Construction
- Sanofi pasteur began construction of a new 145,000 square-foot,
$150 million manufacturing facility in Swiftwater that is currently
expected to be ready for production for the 2008 - 2009 influenza
season. The plant will replace the existing influenza manufacturing
plant in Swiftwater and will double the site's capacity for producing
- The company is also investing in a major expansion of its Val de
Reuil, France, vaccine production plant.
There have been 68 laboratory-confirmed human cases of H5N1 avian
influenza reported to the World Health Organization (WHO) between
December 16, 2004 and August 5, 2005. Scientists believe the H5N1
strain could become the cause of a global influenza pandemic.
Influenza is a highly contagious virus that is spread easily from
person to person, primarily when an infected individual coughs or
An influenza pandemic is a global epidemic of an especially
virulent virus with the potential for severe morbidity and mortality.
According to the World Health Organization (WHO), the next pandemic
is likely to result in 1 to 2.3 million hospitalizations and 280,000
to 650,000 deaths in industrialized nations alone. Its impact will
most likely be even more devastating in developing countries.
The sanofi-aventis Group is the world's third-largest
pharmaceutical company, ranking number one in Europe. Backed by a
world-class R&D organization, sanofi-aventis is developing leading
positions in seven major therapeutic areas: cardiovascular disease,
thrombosis, oncology, metabolic diseases, central nervous system,
internal medicine, and vaccines. The sanofi-aventis Group is listed
in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
sold nearly a billion doses of vaccine in 2004, making it possible to
protect more than 500 million people across the globe, which is about
1.4 million per day. The company offers the broadest range of
vaccines, providing protection against 20 bacterial and viral
diseases. For more information, please visit: www.sanofipasteur.com
Forward Looking Statements
This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995.
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 and expectations with respect to future operations,
products and services, and statements regarding future performance.
Forward-looking statements are generally identified by the words
"expect," "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, 2004. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or revise
any forward-looking information or statements.
Sanofi-aventis Group subsidiaries in the United States include
Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi
Vice-President Corporate Communications
U.S. Media Relations
Tel: + 33-(0)4-37-37-78-97
Fax: +33-(0)4-37-37-77 89
ots Originaltext: sanofi-aventis Group
Im Internet recherchierbar: http://www.presseportal.ch
sanofi pasteur, Alain Bernal, Len Lavenda, Vice-President Corporate
Communications, U.S. Media Relations, Tel: + 33-(0)4-37-37-78-97,
Tel: +1-570-839-4446, Fax: +33-(0)4-37-37-77 89,