LYON, France and SWIFTWATER, Pa., April 1 /PRNewswire-FirstCall/ -- 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.C6(R) 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.C6(R) 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.C6(R) 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
* 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.
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 .
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: http://www.sanofipasteur.com/
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.
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