Sanofi-Aventis – Sanofi Pasteur

About

– Revenue: €2,861 million in 2008 (+9.6% over 2007).
– Net sales: €2,533 millions in 2006 (+22.7% over 2005).
– Sales Growth in 2008: Pediatric Vaccines (+21.9%).
– Sales of Menactra, meningitis vaccine, in 2007: 415 million euros (+87%). In 2008/2009, production capacities should reach 8 to 10 million doses and 20 million by 2010.
– Vaccines Production Doses: >1.6 billion in 2007 ; >1 billion in 2006.
– More than 1 million euros invested every day in R&D.
– Nearly 1.5 billion euros invested in 5 years in production capacity.

Business

2009
– Acquisition of Mérieux Alliance‘s French subsidiary ShanH, which owns a majority stake in Shantha, based in Hyderabad, India.
Shantha Biotechnics awarded contracts by a United Nations agency for supplies of pentavalent vaccine SHAN5 (combination vaccine of Diphtheria, Pertussis, Tetanus, Haemophilus influenza B, and Hepatitis B). The contracts, worth $340 million, cover the period 2010-2012.
– Exclusive, world-wide licensing agreement with Syntiron, biotech company located in St. Paul, Minnesota, with mission in the prevention and treatment of human disease resulting from bacterial infection, to develop and commercialize its prophylactic vaccine against Staphylococcus, including Methicillin-Resistant Stapyhylococcus aureus.
– Global partnership agreement with the Alliance for Rabies Control to raise awareness about the importance of rabies prevention and control in the fight against this deadly infection.
– Expansion of dengue vaccine clinical program in Latin America with a new multicenter study in children and adolescent in Mexico, Colombia, Honduras and Puerto Rico. This new multicenter study complements an earlier study in Mexico and an ongoing study in Peru.

2008
– Exclusive collaboration and commercialization agreement with Crucell N.V. for Crucell‘s rabies monoclonal antibodies, next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis.
– Collaborative research and license agreement with the Statens Serum Institut of Denmark for the development and marketing of a new vaccine against tuberculosis.
FDA licenses DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) for the 5th consecutive dose for children 4 years through 6 years of age. Licensed in 2002 for 4 consecutive doses, administered at 2, 4, 6, and 15 to 20 months of age.
FDA licenses Pentacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for use in infants and children 6 weeks through 4 years of age. Four-dose series at 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6 weeks of age. According to the current Recommended Childhood Immunization Schedule of the U.S. Centers for Disease Control and Prevention, up to 23 injections are needed by the time a child reaches 18 months of age with single-entity vaccines. Pentacel vaccine could reduce that number of shots by 7.
– 6 million doses of StamarilTM1 yellow fever vaccine shipped upon UNICEF‘s request to respond to the yellow fever epidemic in Latin America. Brazil received 4 million doses and Paraguay, 2 million.
– New, state-of-the-art research facility at the company’s historic Connaught Campus in north Toronto, Ontario, Canada, to boost innovation in vaccine research. The Government of Ontario will contribute 13.9 million Canadian dollars through the Biopharmaceutical Investment Program.
– Sanofi Pasteur acquires Acambis for £285 million.
– First international vaccine company to enter the Japanese pediatric vaccine market with ActHIB, marketed by Daiichi-Sankyo Co. Ltd.
– Sanofi Pasteur and Chumakov Institute russian academy medical sciences providers of inactivated polio vaccine IMOVAX PolioTM for Russia National “Project Health”.

2007
– Agreements with Acambis to license a single dose vaccine against Japanese encephalitis, ChimeriVax, in endemic countries of Asia Pacific, including Thailand, the Philippines, Malaysia, Indonesia, China, Japan, and parts of Australia, and for the development of a vaccine to prevent West Nile virus disease.
– Partnership with Institut Pasteur to develop a vaccine against malaria.

2006
– Partnership with the Pediatric Dengue Vaccine Initiative to help develop and make a Dengue vaccine widely available.
– Agreement with Emergent Biosolutions to jointly develop a new vaccine for Meningitis B.

2005
– Agreement with Eisai Co. Ltd. to license novel adjuvant, E6020, for use in the development of new vaccines.
– Agreement with Becton, Dickinson and Company to license Micro-Delivery technology for use in the administration of human vaccine products.

Origins
– 1897: Marcel Mérieux creates the Mérieux Biological Institute in Lyon. Richard Slee creates the Pocono Biological Laboratories, in Swiftwater, Pennsylvania in the U.S.
– 1914: John FitzGerald creates Connaught Laboratories, part of the University of Toronto.
– 1968: Rhône-Poulenc acquires 51% of the capital of the Institut Mérieux.
– 1974: Pasteur Institute creates Pasteur Production, a subsidiary specializing in manufacturing vaccines.
– 1978: Connaught Laboratories in Canada acquires the vaccine manufacturing facility (Merrell-National Laboratories) at Swiftwater, Pennsylvania, U.S.
– 1985: Pasteur Production, the vaccines branch of the Institut Pasteur, is acquired by the Mérieux Institute, and Pasteur Vaccins is created.
– 1989: The Mérieux Institute acquires the Connaught Laboratories in Canada and its subsidiaries and becomes a world leader in human biology.
– 1990: Creation of Pasteur Mérieux Serums & Vaccins.
– 1994: Pasteur Mérieux Sérums & Vaccins becomes a wholly owned subsidiary of Rhône-Poulenc.
– 1996: Pasteur Mérieux Connaught, new name of Pasteur Mérieux Serums et Vaccins.
– 1999: Rhône-Poulenc and Hoechst unite their Life Sciences activities in Aventis. Pasteur Mérieux Connaught changes its name to Aventis Pasteur.
– 2004: Merger of Aventis with and into Sanofi. Aventis Pasteur, the vaccine division of the Sanofi-Aventis Group, changes its name to Sanofi Pasteur.

Vaccine History
– 1907: Producción de sueros.
– 1922: Primera vacuna antitétanica.
– 1939: Nueva aplicación de la reacción percutánea.
– 1939: Primera utilización de la tuberculina de Mérieux.
– 1946: Suero contra pertussis.
– 1953: Vacuna contra la fiebre amarilla.
– 1955: Primera vacuna contra la poliomielitis inactivada inyectable de Salk.
– 1960: Primera vacuna contra la poliomielitis inactivada inyectable de Lépine.
– 1962: Primera vacuna oral contra la poliomielitis a virus vivos atenuados de Sabin.
– 1963: Prueba de multipunción de tuberculina.
– 1968: Vacuna contra el sarampión.
– 1968: Vacuna contra la gripe.
– 1970: Vacuna contra la rubéola (sobre células diploides humanas).
– 1974: Primera vacuna contra las infecciones por meningococos de grupo A.
– 1975: Primera vacuna contra las infecciones por meningococos de los grupos A+C.
– 1975: Vacuna antidiftérica, antitetánica, antipertúsica y antipoliomielítica (inyectable).
– 1977: Primera vacuna antirrábica (sobre células diploides humanas).
– 1981: Primera vacuna de plasma contra la hepatitis B.
– 1982: Primera vacuna contra la poliomielitis inyectable de Salk (sobre células vero).
– 1985: Primera vacuna antirrábica (sobre células vero).
– 1986: Vacuna triple viral (contra el sarampión, la parotiditis y la rubéola).
– 1987: Vacuna contra la hepatitis B (basada en ingeniería genética).
– 1987: Primera vacuna conjugada contra infecciones por Haemophilus influenzae tipo b.
– 1988: Primera vacuna oral contra la poliomielitis de Sabin (células vero).
– 1988: Primera vacuna antitifoidea (polisacáridos).
– 1992: Vacuna acelular contra pertussis con toxoides antidiftérico y antitetánico para adultos.
– 1993: Vacuna antidiftérica, antitetánica, antipertúsica (de germen entero) y contra infecciones por Haemophilus influenzae tipo b.
– 1993: Primera vacuna pentavalente antidiftérica, antitetánica, antipertúsica (de germen entero), antipoliomielítica y contra infecciones por Haemophilus influenzae tipo b (galardonada con el premio Galien en 1994).
– 1996: Vacuna contra la hepatitis A.
– 1997: Primera vacuna pentavalente con pertusis acelular.
– 1998: Vacuna antidiftérica, antitetánica, antipertúsica (acelular) y antipoliomielítica.
– 1999: Vacuna de refuerzo antitetánica, antidiftérica y antipoliomielítica para adultos.
– 2004: Primera vacuna tetravalente conjugada contra infecciones por meningococos.

FLUPAN
– Sanofi Pasteur: Only vaccine manufacturer to participate in FLUPAN.
FLUPAN: Collaborative research project funded by the European Commission in September 2001, specific RTD programme “Quality of Life and Management of Living Resources”, directed towards improved preparation for an influenza pandemic.
FLUPAN partners: National Institute for Biological Standards and Control, UK; University of Reading, UK; Istituto Superiore di Sanita, Italy; Heath Protection Agency, UK; Sanofi Pasteur, France; University of Bergen, Norway.

Influenza Vaccine

Production
– 2 facilities in Swiftwater, Pennsylvania, United States. In total, approximately 150 million doses of trivalent seasonal influenza vaccine per year.
– 1 facility in Val De Reuil, France. Capacity of 120 million doses per year.
– All facilities designed and built to be able to switch from seasonal influenza vaccine production to pandemic influenza vaccine production.
– Seasonal Influenza Vaccine Production Doses: 180 million in 2007 (40% of world market).
– More than 45% of the influenza vaccines distributed for the 2008/2009 influenza season in the United States.

2009
FDA licenses new facility in Swiftwater. Capacity of approximately 100 million doses of seasonal influenza vaccine per year.
– Sanofi Pasteur receives seed virus and order to produce new influenza A(H1N1) vaccine by U.S. Government.
– INTANZA/IDflu, first intradermal influenza vaccine, approved in the European Union.
– Agreement with the Mexican authorities to build new facility. Signed in Mexico City during French President Nicolas Sarkozy’s State Visit. Sanofi Pasteur to manufacture influenza vaccine in collaboration with Birmex, a Mexican federal vaccine manufacturer.
– EMERFLU, pandemic influenza vaccine for humans, approved in Australia.
– Sanofi Pasteur receives order from French Government to produce novel influenza A(H1N1) vaccine. 28 million doses and option for an additional 28 million doses.
– Agreement with Butantan Institute for the production and supply of a vaccine against the novel A(H1N1) influenza virus for the Brazilian Government. Initial supply of 1 million doses in final presentation and 17 million doses in bulk form. The agreement includes an option for an additional 15 million doses.
FDA licensure of Influenza A (H1N1) 2009 Monovalent Vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
– Additional order from the U.S. Department of Health and Human Services to produce vaccine to help protect against the Influenza A (H1N1) 2009 virus. The new order is for the production of bulk antigen equivalent to 27.3 million doses based on 15 mcg of antigen per dose. Committed to the U.S. government a total of 75.3 million doses of Influenza A (H1N1) 2009 Monovalent Vaccine.
Agence française de sécurité sanitaire des produits de santé grants marketing authorization in France for Panenza, non-adjuvanted Influenza A(H1N1) 2009 monovalent vaccine.

2008
– The U.S. Department of Health and Human Services (HHS) accepts $192 million of H5N1 bulk vaccine antigen to produce approximately 38.5 million doses of vaccine. Multi-year contract with HHS as part of its pandemic program.
– Donation of 60 million doses of H5N1 vaccine to the World Health Organization over 3 years for the establishment of an H5N1 vaccine global stockpile.

2007
– $77.4 million contract by the U.S. Department of Health and Human Services to retrofit existing influenza vaccine manufacturing facility. The new $150 million, 13,000 square-meter vaccine manufacturing plant is designed to more than double the site’s capacity to over 100 million doses of influenza vaccine per year.
FDA licenses H5N1 vaccine, 1st avian influenza vaccine for humans in U.S.
– Support and ready to supply a significant number of doses of H5N1 vaccine
for the establishment of an international stockpile through a World Health Organization partnership.
– Agreement with the Chinese authorities to build a facility to manufacture influenza vaccine, during an official ceremony attended by Hu Jintao, President of the People’s Republic of China, and Nicolas Sarkozy, President of the French Republic, in China for a State Visit.

2006
– Deliver of more H5N1 vaccine to the U.S. National Institutes of Health, part of the U.S. Department of Health and Human Services, including investigational doses formulated with an adjuvant, aluminum hydroxide, for U.S. government pandemic initiatives.
– Completed production of additional bulk-concentrate of the H5N1 vaccine antigen for the U.S. government stockpile valued at $50 million to support U.S. Department of Defense requirements.
– Contract with the Office of Public Health and Emergency Preparedness, a division of the U.S. Department of Health and Human Services, for the production of bulk concentrate of a new type of H5N1 pre-pandemic vaccine.
– Stock supply to the Italian Ministry of Health of pre-pandemic vaccine against the H5N1 avian influenza virus strain.
– Contract by the French Ministry of Health to produce pre-pandemic H5N1 vaccine to create a 1.4 million dose stockpile. By this agreement, the company could also provide enough vaccine to protect up to 28 million people in the event of a pandemic.
– Contracts with other governments in Europe, Australia and worldwide for the supply of vaccine in the event of a pandemic influenza outbreak.
– Completed shipping 50 million doses of influenza vaccine (Fluzone, Influenza Virus Vaccine) to the U.S. market.
– Completed production of more than 170 million doses of influenza vaccine.

2005
– Contracts by the U.S. Department of Health and Human Services to accelerate the development of a cell-culture influenza vaccine in the U.S., $160 million investment
for a new influenza vaccine manufacturing facility, which double its U.S. production capacity, and to produce a stockpile of the H5N1 vaccine valued at $150 million.
FDA approves new Fluzone influenza vaccine formulation that does not contain a preservative at any stage in the manufacturing process, for populations 6 months and older.

2004
– Contract with the U.S. National Institute of Allergy and Infectious Diseases to produce 8,000 investigational doses of the H5N1 influenza strain.
– Contracts with the U.S Department of Health and Human Services to produce 2 million doses of bulk vaccine derived from the H5N1 viral strain and to expand and safeguard the egg supply needed to produce influenza vaccine and to formulate each year investigational doses for a potential pandemic influenza vaccine.

Fluzone (2009)
– Initial US approval in 1980.
– Indicated for persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. 0.25 mL dose formulated to contain a total of 22.5 mcg (7.5 mcg of each strain) of influenza virus hemagglutinin. 0.5 mL dose formulated to contain a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin.
– Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal as a preservative. Each 0.5 mL dose contains 25 mcg mercury.
– Prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, Octylphenol Ethoxylate (TritonTM X-100), prod ucing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.
– High-Dose: Indicated for persons 65 years of age and older, approved by the FDA in 2009. Each 0.5 mL dose is formulated to contain a total of 180 mcg (60 mcg of each strain) of influenza virus hemagglutinin.
– No controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose.
– Vaccination may not protect all recipients.
– Post-Marketing Experience: Thrombocytopenia, lymphadenopathy; Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema); Guillain-Barré syndrome, convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia; Vasculitis, vasodilatation/flushing; Dyspnea, pharyngitis, rhinitis; Stevens-Johnson syndrome; Pruritus, asthenia/fatigue, pain in extremities, chest pain.
– Egg protein can induce immediate hypersensitivity reactions among persons who have egg allergy, including anaphylaxis, angioedema, hives, and asthma.
– Animal reproduction studies not conducted.
– Not known whether can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
– Not known whether is excreted in human milk.
– Immune response and safety evaluated in 31 children between the ages of 6-36 months. Safety and effectiveness in children below the age of 6 months not established.
– Not evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Former Members

David J. Williams
– Board of directors of Xcellerex Inc. and Executive Board of VaxInnate since 2009.
– Chairman and Chief Executive (2002-2008) and Chief Operating Officer (1998-2002) of Sanofi Pasteur. Joined as finance manager in 1978.
– Audit and Healthcare Consulting Group at Pricewaterhouse Coopers.
– Board of Directors of the International AIDS Trust, the Biotechnology Industry Organization, AllOne Health Group Blue Cross of Northeastern Pennsylvania and the Hospital Service Association of Northeastern Pennsylvania.
– Led the Vaccine Policy Working Group of PhRMA, the U.S. pharmaceutical industry’s trade association.
– First liaison member of the Advisory Committee on Immunization Practices to the U.S. Centers for Disease Control and Prevention, which sets immunization policy in the United States.
– Undergraduate degree by the University of Scranton, past member of the Board of Trustees and Board of Regents.
– Founding member of the Partnership for Prevention and founding board member of the Medical Education Development Consortium.
– Spending his retirement serving as a consultant to several vaccine and biotech companies.

Robert Becker
– Vice President and Business Development of VaxInnate Corporation since December 2005.
– Vice President of Corporate Development of Sanofi Pasteur until December 2005 (joined in 1990).
– Junior facility positions at Loyola University Chicago and University of Illinois in the field of Immunology.
– Ph.D. in Microbiology and Immunology from the University of Kansas and MBA from Columbia University.

Michel Gréco
– Board of Directors of Immutep S.A. (2005), the International AIDS Vaccine Initiative, the Aeras Global Tuberculosis Vaccines Foundation, Intercell AG (Austria), ID Biomedical Corporation (2002), and the International Vaccine Institute.
– Chair of WHO‘s Initiative for Vaccine Research Advisory Committee and Strategic Advisory Group of Experts.
– President of the European Vaccine Manufacturers.
– Chairman of IFPMA biological group.
– Member of the European Union Task Force on Bioterrorism.
– Board member of the French Pharmaceutical Association and president of its European Affairs Commission.
– Supervisory Board, Deputy Chief Executive Officer, President and Chief Operating Officer of Aventis Pasteur (1998-2003).
– President and Chief Executive Officer (1994-1998) of Pasteur Mérieux MSD, a European joint venture between Aventis Pasteur and Merck and Co.
– Master’s degree from Institut d’Etudes Politiques de Paris and MBA from the Richard Ivey School of Business Administration University of Western Ontario.

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