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Sanofi pasteur Awarded $97 Million HHS Contract to Accelerate Cell-Culture Pandemic Influenza Vaccine Development

Lyon, France and Swiftwater, Pennsylvania (ots/PRNewswire)

- Major U.S. Public Health Initiative Complements sanofi pasteur's
Leadership in Global Pandemic Preparedness
Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
has been awarded a $97 million contract from the U.S. Health and
Human Services Department (HHS) 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 manufacturing facility. Sanofi
pasteur, the global leader in influenza vaccines, has assembled
dedicated teams at its Swiftwater, PA, and Marcy L'Etoile, France,
sites to support this critical project.
The five-year agreement, the majority of which will be completed
in three years, is part of the U.S. government's effort to increase
influenza vaccine manufacturing capacity in the event of a pandemic
or other influenza health emergency and is sanofi pasteur's seventh
global initiative to help protect the public from a pandemic's
serious health impact.
As a result of the agreement, sanofi pasteur will accelerate  its
cell-culture influenza vaccine program which is based on the PER.C6â
cell-line technology of Crucell N.V., a Dutch biotechnology company.
In addition, sanofi pasteur will deliver to the HHS a feasibility
plan for the construction of a U.S.-based and licensed cell-culture
production plant for supplying up to 300 million monovalent influenza
vaccine doses annually. This would add substantial capacity in the
event of a pandemic. The HHS contract does not encompass the actual
construction of the facility.
Under the HHS agreement, sanofi pasteur will undertake three major
initiatives involving resources in several countries including sanofi
pasteur's U.S. headquarters in Swiftwater, PA, the company's R&D and
production site in Marcy l'Etoile, France, and Crucell's company
headquarters and research center in Leiden, The Netherlands. The
first initiative is the acceleration of sanofi pasteur's development
of a cell-culture influenza vaccine. At the end of three years, Phase
1 and 2 clinical studies will be completed and Phase 3 will be
underway.
The second initiative is the creation and design of a
manufacturing process to produce the new cell-culture influenza
vaccine in large quantities. Under the terms of the contract, sanofi
pasteur will accelerate the existing project in order to complete a
design approximately two years earlier than originally intended. The
company will entirely refit a vaccine development facility for the
project and design and test the process from small to mid-sized
industrial scale.
The third initiative is the preparation of a comprehensive
feasibility plan for establishing a cell-culture vaccine
manufacturing facility in the U.S. The plan will include feasibility
studies and basic and detailed engineering plans covering the
construction and validation of the proposed plant. The contract does
not include the actual construction of the plant.
In December 2003, sanofi pasteur and Crucell entered into a
strategic agreement to further develop and commercialize a new
influenza vaccine based on Crucell's proprietary PER.C6â cell line
technology.
Lonza Biologics plc., a biotechnology contract manufacturer and
subsidiary of The Lonza Group, will contribute to key activities
related to the scale up to very large volumes of PER.C6â cell culture
and engineering design of the production facility.
About cell-culture technology
Cell culture is an emerging technology that eliminates chicken
eggs for the production of influenza vaccine. Vaccines are a biologic
product in which a selected strain of influenza virus is grown in a
medium. Chicken eggs have provided the most advantageous and reliable
method for producing influenza vaccine. With cell culture, the virus
is grown on specially selected cell lines instead of eggs. Besides
eliminating the need for chicken eggs, the cell culture process has
the potential to reduce from four weeks to two or three weeks the
start-up time for manufacturing once the virus strain has been
identified and could result in a more predictable manufacturing
process.
An influenza pandemic is a global epidemic of an especially
virulent virus with the potential for severe morbidity and mortality.
According to the 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.
Sanofi pasteur's Global Commitment to Pandemic Preparation
The HHS contract is one of many pandemic initiatives that sanofi
pasteur has with government agencies and academic institutions around
the world:
  • The contract with the HHS is sanofi pasteur's fourth pandemic-related agreement with the U.S. government. Last May, sanofi pasteur contracted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, 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. This past September the company signed a contract with the HHS to produce two million doses of bulk vaccine derived from the H5N1 viral strain. In November 2004, the HHS awarded a separate contract to sanofi pasteur for the establishment and maintenance of flocks of egg-laying hens to ensure the company's ability to manufacture pandemic influenza vaccine at current full capacity on a year-round basis. The flocks are scheduled to be fully available by September.
  • FLUPAN: Sanofi pasteur is the only vaccine manufacturer to participate in this collaboration funded by the European Union (E.U.) with the U.K.'s National Institute for Biological Standards and Control (NIBSC) and the University of Reading. 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 study.
  • Sanofi pasteur is one of several manufacturers asked by the World Health Organization (WHO) in February 2004 to produce avian influenza vaccine candidates for use in clinical studies to determine safety, immunogenicity, and proper schedule and dosage. This year sanofi pasteur will complete production of clinical lots of an H5N1 egg-based influenza vaccine using a strain provided by the U.K.'s National Institute for Biological Standards and Control (NIBSC). The clinical lots are being developed as part of an E.U. program 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.
  • Australia has a contractual commitment 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 flu supply as well. Sanofi pasteur was awarded 35% of the inter-pandemic annual supply.
About sanofi-aventis
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 Statement
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" 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 and Aventis, including those listed under
"Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's
annual report on Form 20-F for the year ended December 31, 2003 and
those listed under "Cautionary Statement Regarding Forward-Looking
Statements" and "Risk Factors" in Aventis's annual report on Form
20-F for the year ended December 31, 2003. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to
update or revise any forward-looking information or statements.

Contact:

Michel Joly, Deputy Vice President, Communications and Vice President
Brand and Scientific Communication, Sanofi-aventis, Tél :
+33-(0)1-53-77-47-86, Mobile : +33-(06)-73-19-51-19, fax :
+33-(0)1-53-77-41-74; Beth Waters, Senior Vice President
Communications, Sanofi pasteur, Tél : +33-(0)4-37-37-73-99, Mobile :
+1-917-770-21-44, Fax : +33-(0)4-37-37-79-76 ; Len Lavenda, Sanofi
pasteur U.S. Media Relations, Tél. : +1-570-839-4446,
Len.Lavenda@sanofipasteur.com

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