Lyon, France (ots/PRNewswire) -
- Data Show That the Vaccine is Safe, Demonstrates Immunogenicity
and Provides Future Direction for Development
Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
announced today that preliminary results of clinical trials fielded
in France of an adjuvanted candidate H5N1 pre-pandemic influenza
vaccine demonstrated a good immune response in a significant number
of volunteers. This is the first trial of an H5N1pre-pandemic
influenza vaccine candidate that compared vaccines with and without
Preliminary results showed that the vaccine is safe and
well-tolerated in 300 healthy volunteers. A 30 microgram-dose with an
adjuvant in a two-dose regimen demonstrated an immune response at
levels consistent with requirements of regulatory agencies for
licensure of seasonal influenza vaccine.
Sanofi pasteur characterized the preliminary results as a sign of
progress and providing direction for further development of a
pandemic influenza vaccine. The company also noted that immune
responses were detected in a number of volunteers receiving lower
doses. Subsequent trials will explore different dosages, which may be
helpful in answering questions about dose-sparing strategies and
which is being widely discussed among the public health community.
The trial was sponsored by sanofi pasteur and fielded in three
sites in France: Necker and Cochin Hospitals in Paris, and Garches
Hospital, with Professor Jean-Louis Bresson as the principal
The vaccine used the reference strain provided by the UK's
National Institute for Biological Standards and Control (NIBSC).
Assays were performed at NIBSC and the UK Health Protection Agency.
As definitive results become available, they will be presented and
published, as well as submitted to appropriate regulatory authorities
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 a declared pandemic.
This is one of a number of initiatives by the company to help
prepare the world for the possibility of an influenza pandemic.
- 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 Reuil facility).
- Sanofi pasteur has entered into an agreement with the French
Ministry of Health to produce pre-pandemic vaccine in 2005 to create
a1.4 million dose stockpile with the H5N1 candidate studied in this
trial. By this agreement, the company could also provide enough
vaccine to protect up to 28 million people in the event of a pandemic
being declared, once the actual virus strain responsible is
- 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
- 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), Istituto Superiore 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 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 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
to 650,000 deaths in industrialized nations alone. Its impact will
most likely be even more devastating in developing countries.
Sanofi-aventis 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).
Sanofipasteur, the vaccines business of the sanofi-aventis Group,
sold nearly a billion doses of vaccine in 2004, making it possible to
protect more than 500million 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, pleasevisit: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," "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 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, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the 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-aventis subsidiaries in the United States include
Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi
Vice President Corporate Communications
ots Originaltext: sanofi-aventis Group
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Contact: Original-Content von: sanofi-aventis Group, übermittelt durch news aktuell
Sanofi pasteur, Alain BERNAL, Vice President Corporate
Communications, Tel:+33-(0)4-37-37-78-97, Fax:+33-(0)4-37-37-72-76.
Sanofi pasteur, Len LAVENDA, U.S.Media Relations,