SWIFTWATER, Pa., Nov. 9 /PRNewswire-FirstCall/ -- Aventis, part of the sanofi-aventis Group, has been awarded a contract by the U.S. Department of Health and Human Services (HHS) to establish and maintain flocks of egg-laying hens and to maintain other essential supplies to ensure its ability to manufacture pandemic influenza vaccine at current full capacity on a year- round basis. Currently, egg capacity exists only on a seasonal basis to support normal influenza vaccine production. Pandemic influenza planning is considered a major global public health priority.
Under the terms of the agreement, the company will receive $10 million for the first year of the contract. The government has the option to extend the agreement for up to four additional years, giving the contract a potential total value of $41 million over a five-year period. The agreement also calls for Aventis Pasteur, the human vaccines business of Aventis, part of sanofi-aventis Group, to manufacture, on an annual basis, investigational influenza vaccine of a candidate pandemic-like strain. HHS will identify the strain to be used in the investigational lot each year and will provide the reference virus on which each investigational lot will be based.
"As a global vaccine leader, Aventis Pasteur is committed to supporting international public health efforts to prepare for an influenza pandemic," said David J. Williams, chairman and chief executive officer of Aventis Pasteur. "The company is already involved in multiple pandemic vaccine development efforts in Europe and the United States. We welcome opportunities to discuss similar flock preservation initiatives with government health authorities around the world."
Aventis and Global Influenza Pandemic Planning
Aventis Pasteur is the only vaccine manufacturer selected to participate in FLUPAN, a 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.
Aventis Pasteur is also 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 dosage. In 2005, Aventis Pasteur will complete production of clinical lots of an H5N1 egg-based influenza vaccine using a strain provided by NIBSC. The clinical lots are being developed as part of an E.U. program in collaboration with the French health authorities, NIBSC and EMEA (European Medicines Agency). 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.
The H5N1 strain is an avian virus strain that emerged in Southeast Asia and other countries late last year and continues to circulate. It has the potential to become a human pandemic strain.
The HHS contract represents the third agreement that Aventis Pasteur has entered into with the U.S. Government. Earlier this year, Aventis 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 doses of the H5N1 influenza strain. Subsequently, the company signed a contract with HHS to produce 2 million doses of bulk vaccine derived from the same virus strain. Seed virus for the H5N1 vaccine being produced under the U.S. contracts was provided by NIAID. The seed virus is a reassortant containing two genes from the wild type virus that expresses the immunogenic antigens and was extensively tested prior to delivery to Aventis Pasteur.
Influenza epidemics occur every year and result in an average of 36,000 deaths and 200,000 hospitalizations in the United States, mostly among chronically ill persons and seniors, according to the Centers for Disease Control and Prevention (CDC). 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. Its impact will most likely be even more devastating in developing countries.
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, diabetes, central nervous system, internal medicine, vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York .
Aventis Pasteur, the vaccines business of Aventis, part of the sanofi-aventis Group, produced 1.4 billion doses of vaccine in 2003, making it possible to protect 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.aventispasteur.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 the management of Aventis and sanofi-aventis believe 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 Aventis and 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' 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' annual report on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, Aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Len Lavenda Michel Joly
Aventis Pasteur US Media Relations sanofi-aventis
Tel.: 570-839-4446 Tel.: +33 - (0)1-53-77-4786
Len.Lavenda@Aventis.com Cell phone: +33 6 73 19 51 19