Sanofi pasteur Supplies Prototype Vaccinefor Italian Government Pandemic Initiatives
Lyon, France (ots/PRNewswire)
- Influenza Vaccine Worldwide Leader sanofi pasteur Contributes to Italian Influenza Pandemic Preparedness
Sanofi pasteur, the vaccines business of the sanofi-aventis Group(EURONEXT: SAN; NYSE: SNY), has supplied to the Italian Ministry of Health a stock of pre-pandemic vaccine against the H5N1 avian influenza virus strain.Theavian H5N1 strain is one of the candidates that could lead to a global influenza pandemic, although currently there is no transmission to and among humans. Under the agreement with the Italian Ministry of Health, sanofi pasteur may also provide pandemic vaccine in the event of a pandemic being declared, once theactual virus strain responsible is identified.
According to the terms of the contract, sanofi pasteur has supplied,in bulk concentrate form,theH5N1 pre-pandemic vaccine produced in its facility in Val de Reuil,France.Formulation and filling of the vaccine can be carried out, at any time, at the request of the Italian Ministry of Health. If formulated at a concentration of 15 micrograms of H5N1 antigen per dose, the stock delivered is expected to allow the preparation of 185,000 doses of vaccine.
The contract with the Italian Ministry of Health will be carriedout in collaboration with Sanofi Pasteur MSD, sanofi pasteur's joint venture with Merck&Co. Inc. for the development and distribution of vaccines in Europe; It constitutes yet another step in sanofi pasteur' s support to theefforts to prepare the world for the possibility of an influenza pandemic.
- Recently, sanofi pasteur, announced that preliminary results of clinical trials fielded in France of an adjuvanted candidate H5N1 pre-pandemic influenza vaccine (the one supplied to the Italian government) demonstrated a good immune response in a significant number of volunteers. This was the first trial of an H5N1 pre-pandemic influenza vaccine candidate that compared vaccines with and without adjuvants.
The data will be submitted as part of the company's core "mock up" vaccine dossier to the European Agency for the Evaluation of Medicinal Products (EMEA). The core dossier has been developed in strict accordance to the EMEA guidelines. This process is expected to reduce the time necessary for approval of a pandemic vaccine in Europe once a strain is identified and a pandemic is declared. Follow-up studies, currently being planned, will be performed using vaccine produced at large scale, which will mimic the manufacturing scale that will be used during adeclared pandemic
- Sanofi pasteur has entered into an agreement with the French Ministry of Health to produce pre-pandemic vaccine in 2005 in order to create a 1.4 million dose stockpile with the H5N1 candidate studied in the above-mentioned trial. By this agreement, the company could also provide enough vaccine to protect up to 28million people in France in the event of a pandemicbeing declared, once the actual virus strain responsible is identified.
- Sanofi pasteur has entered into a series of contracts with the US government to increase that country's pandemic preparedness efforts. The contracts include investigational doses for clinical trials; bulk vaccine for stockpiles; establishment and maintenance of laying flocks to enable year-round egg production (not just seasonal), as well as a contract to speed the production process for new cell culture influenza vaccines, including the design of a US-based cell-culture vaccine manufacturing facility.
- A contract has also been signed with the Australian government for the supply of vaccine in the event of a pandemic influenza outbreak. There are also contacts concerning pandemic preparedness between sanofi pasteur and other governments in Europe and worldwide.
- Sanofi pasteur is investing in a major expansion of its influenza vaccine production capacity in the US, and also of its vaccine production capacity in France (Val de Reuilfacility).
- In addition, sanofi pasteur is the only vaccine manufacturer to participate in FLUPAN, an EU-funded collaboration. FLUPAN partners include the National Institute for Biological Standards & Control (NIBSC -UK), the University of Reading (UK), IstitutoSuperiore di Sanita, (Italy),the Health Protection Agency (UK), and the University of Bergen(Norway). FLUPAN is intended to improve the level of pandemic preparedness in the EU. Sanofi pasteur is to produce a vaccine to combat another strain with pandemic potential (H7N1) that will be used in a FLUPAN clinical study.
Influenza Overview
Influenza is a highly contagious virus that is spread easily from person to person, primarily when an infected individual coughs or sneezes. An influenza pandemic is a global epidemic of an especially virulent virus, against which humans have little or no immunity, 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 to650,000 deaths in industrialized nations alone. Its impact will most likely beeven more devastating in developing countries. These reasons have lead many countries like Italy to organise national plans against influenza pandemic
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, andvaccines. The sanofi-aventis Group is listed in Paris(EURONEXT: SAN) and in New York (NYSE:SNY).
Sanofipasteur, the vaccines business of the sanofi-aventis Group, sold more than abillion doses of vaccine in 2005, making it possible to protect more than 500 million people across the globe, which is about 1.5 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 definedin the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statementsthat 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 thecontrol of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, theforward-looking information and statements. These risks and uncertainties include those discussed or identified inthe 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 forthe 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-aventisGroup subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.
sanofi pasteur
Alain BERNAL
Vice-PresidentCorporate Communications
Tel:+33-(0)4-37-37-78-97
Fax:+33-(0)4-37-37-77 89
sanofi pasteur
Len LAVENDA
U.S.Media Relations
Tel:+1-570-839-4446
Len.Lavenda@sanofipasteur.comContact:
sanofi pasteur: Alain BERNAL, Vice-President Corporate
Communications, Tel:+33-(0)4-37-37-78-97, Fax:+33-(0)4-37-37-77 89.
sanofi pasteur: Len LAVENDA, U.S.Media Relations,
Tel:+1-570-839-4446, Len.Lavenda@sanofipasteur.com