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

Major U.S. public health initiative complements sanofi pasteur's leadership

in global pandemic preparedness



Apr 01, 2005, 00:00 ET from Sanofi pasteur

    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
       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:
 http://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.
 
      Your Contacts:
      Len Lavenda
      sanofi pasteur U.S. Media Relations
      Tel: 570-839-4446
      Len.Lavenda@sanofipasteur.com
 
      Sherri Michelstein
      Cooney/Waters Group
      Tel: 212-886-2200
 
 

SOURCE Sanofi pasteur
    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
       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:
 http://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.
 
      Your Contacts:
      Len Lavenda
      sanofi pasteur U.S. Media Relations
      Tel: 570-839-4446
      Len.Lavenda@sanofipasteur.com
 
      Sherri Michelstein
      Cooney/Waters Group
      Tel: 212-886-2200
 
 SOURCE  Sanofi pasteur