Pressmeddelande -
SANOFI PASTEUR DELIVERS MORE H5N1 VACCINE FOR U.S. GOVERNMENT PANDEMIC INITIATIVES
~ New investigational doses include formulation with an adjuvant; Additional stockpile vaccine prepared ~
Swiftwater, Pa., and Lyon, France February 6, 2006
Sanofi pasteur, the vaccines business of
the sanofi-aventis Group (NYSE: SNY), has delivered more H5N1 vaccine to the U.S. government
including investigational doses formulated with an adjuvant.
Sanofi pasteur has shipped to the U.S. National Institutes of Health (NIH), part of the U.S
Department of Health and Human Services (HHS), 15,000 investigational doses of a vaccine to
protect against the H5N1 influenza strain.
Prepared with different levels of antigen, the
investigational doses will be used in the NIHs clinical studies to determine the optimal formulation
of the vaccine. The investigational doses include the use of the adjuvant, aluminum hydroxide
(alum), that could increase the vaccines effectiveness and enable the use of less antigen in each
dose. The end result could be a greater number of doses available to immunize more people.
In addition, the company has completed production of additional bulk-concentrate of the H5N1
vaccine antigen for the U.S. government stockpile. Once the optimal dosage is established, the
bulk-concentrate antigen will be ready for final formulation and filling into doses.
The additional H5N1 bulk-concentrate vaccine represents a broadening of a contract the company
signed in September 2005 with the U.S. Department of Health and Human Services (HHS) to
produce a stockpile of the H5N1 vaccine valued at $100 million. The additional bulk concentrate
vaccine just produced is valued at $50 million and will support U.S. Department of Defense
requirements.
These activities are further examples of sanofi pasteurs commitment to global pandemic
preparedness. The H5N1 viral strain has been identified by global health authorities as being a
potential cause of a pandemic.
The bulk-concentrate and the investigational doses were produced at sanofi pasteurs U.S. site in
Swiftwater, PA.
As the world leader in research, development and manufacturing of influenza vaccine, sanofi
pasteur is actively involved in other projects in the U.S. and Europe with the goal of developing a
vaccine to protect against a pandemic influenza virus.
Sanofi pasteurs Global Commitment to Pandemic Preparation
Þ In the U.S., sanofi pasteur has a number of pandemic-related agreements with the U.S.
government involving development of pandemic vaccine stockpiles, production of investigational
doses and the development cell-culture technology, including:
· In May 2004, sanofi pasteur contracted with the NIAID to produce 8,000 investigational
doses of the H5N1 influenza strain. The doses were shipped to the NIAID earlier this year.
The clinical studies for the vaccine are being conducted by the NIAID.
· In September 2004, the company signed a contract with HHS to produce two million doses
of bulk vaccine derived from the H5N1 viral strain. The bulk doses were produced and are
being stored, and can be formulated and filled upon government request.
· In November 2004, the HHS awarded a contract to sanofi pasteur 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.
· In April 2005, the HHS awarded a contract to sanofi pasteur to accelerate the development
of a cell-culture influenza vaccine in the U.S. and the design of a U.S.-based cell-culture
vaccine manufacturing facility.
· In September 2005, the HHS awarded a contract to sanofi pasteur to produce a vaccine to
help protect against the H5N1 influenza virus strain. The $150 million contract calls for
sanofi pasteur to manufacture the vaccine in bulk-concentrate form at its U.S. headquarters
in Swiftwater, PA. The agreement provides for additional fees to be paid to sanofi pasteur
for storage of the vaccine as well as for formulation and filling of the vaccine upon
government request.
Þ In Europe, sanofi pasteur initiated and runs a large range of projects.
· In France, sanofi pasteur sponsored the first clinical trials of an H5N1 pre-pandemic
influenza vaccine candidate that compared vaccines with and without adjuvants.
Preliminary results of the trial, announced on Dec. 15, 2005, demonstrated a good
immune response in a significant number of volunteers. The trials are being undertaken
to speed the time for regulatory review should a pandemic vaccine be needed quickly.
The strain was provided by the U.K.'s National Institute for Biological Standards and
Control (NIBSC). The clinical lots are being developed in collaboration with the French
health authorities, NIBSC and the European Agency for the Evaluation of Medicinal
Products (EMEA). The data from these studies will be used to submit a mock dossier
submitted to the EMEA to accelerate the license approval process in the event of a
pandemic.
· In France, sanofi pasteur was recently awarded a contract by the French Ministry of
Health to produce pre-pandemic vaccine in 2005 to create a 1.4 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 identified.
· Sanofi pasteur is the only vaccine manufacturer to participate in FLUPAN, a European
Union (EU) funded collaboration. FLUPAN partners include 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.
Þ In Australia:
· 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.
About sanofi-aventis
Sanofi-aventis is the worlds 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 diseases, 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 more than a billion 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 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
opérations, 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 sanofiaventis,
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 Pasteur Inc.
sanofi pasteur sanofi pasteur
Alain BERNAL Len LAVENDA
Vice-President Corporate Communications U.S. Media Relations
Tel: + 33-(0)4-37-37-78-97 Tel: +1-570-839-4446
Fax: +33-(0)4-37-37-72-76 Len.Lavenda@sanofipasteur.com
Vice President Communications sanofi pasteur: Alain BERNAL U. S. Media Relations: Len LAVENDA
Tel.: +1 570 839 7187 - Fax: +1 570 839 0955 - Sanofi Pasteur Inc. - Discovery Drive - Swiftwater, PA 18370-0187 - USA - www.sanofipasteur.com