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sanofi pasteur Signs Contract With U.S. Government for Stockpile of New Type of H5N1 Pre-Pandemic Vaccine

Swiftwater, Pennsylvania. and Lyon, France, November 20
(ots/PRNewswire)

- New Pre-Pandemic Vaccine Will Provide Additional Level of
Preparedness
sanofi pasteur, the vaccines business of the sanofi-aventis Group
(NYSE: SNY; EURONEXT: SAN) has signed a contract with the Office of
Public  Health and Emergency Preparedness, a division of the U.S.
Department of  Health and Human Services (HHS) for the production of
bulk concentrate of a  new type of H5N1 pre-pandemic vaccine. This
contract covers clade 2 of the  H5N1 virus (A/Indonesia) for use in
the U.S. government stockpile. Previous  stockpile contracts covered
the clade 1 form of H5N1.
Manufacturing and stockpiling more than one clade of H5N1 vaccine
is strategic because circulating H5N1 influenza strains are mutating
and diverging into distinct antigenic groups. Stockpiling bulk
material representative of strains constituting additional variants
of the virus will allow manufacturers to gain experience with the
production of these vaccines at full industrial-scale and will
provide a supply of pre-pandemic vaccine more quickly, should it be
needed.
The agreement is valued at up to US$117.9 million. The final value
will depend on the number of doses that can be formulated from the
bulk material. The bulk concentrate is being produced now. Potency
testing will be conducted over the next few months to determine the
concentration of the bulk material.
The H5N1 clade 2 bulk material is being manufactured from a seed
virus provided by the U.S. Centers for Disease Control and
Prevention. The seed virus is a laboratory version of the wild-type
virus and was extensively tested for safety prior to delivery to
sanofi pasteur.
Analysis of viruses isolated from animals and humans since the
emergence of the H5N1 virus in Hong Kong in 1997 shows that the
majority of H5N1 viruses circulating during the past four years has
since separated into two distinct clades of closely-related viruses.
Clade 1 viruses circulated in Cambodia, Thailand and Vietnam, and
were responsible for human infections in those countries in 2004 and
2005. Clade 2 viruses circulated in birds in China and Indonesia in
2003-2004. In 2005-2006, Clade 2 viruses spread westward to the
Middle East, Europe and Africa[1].
These activities are further examples of sanofi pasteur's
commitment to global pandemic preparedness. The H5N1 viral strain has
been identified by global health authorities as being a potential
cause of a pandemic.
Pandemic Influenza Overview
Influenza is a disease caused by a highly infectious virus that
spreads 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, newly infectious for
humans, and for which there is no preexisting immunity. This is why
these pandemic strains have such potential to cause severe morbidity
and mortality. According to the World Health Organisation (WHO), the
next pandemic is likely to result in 1 to 2.3 million
hospitalisations and 280,000 to 650,000 deaths in industrialised
nations alone. Its impact is expected to be even more devastating in
developing countries. In an attempt to minimise the impact of a
pandemic, many countries are developing national and transnational
plans against an eventual influenza pandemic situation.
sanofi pasteur and Pandemic Preparedness
sanofi pasteur, the vaccines business of the sanofi-aventis Group,
is committed to global pandemic preparedness. As the world leader in
research, development and manufacturing of influenza vaccine, sanofi
pasteur is actively involved in projects in the U.S. and Europe, with
the goal of developing a vaccine to protect against a pandemic
influenza virus.
sanofi pasteur is also investing in a major expansion of its
influenza vaccine production capacity in the U.S. and also of its
vaccine production capacity in France (Val de Reuil facility).
In Europe, sanofi pasteur initiated and runs a large range of
projects:
  • In France, sanofi pasteur sponsored the first clinical trials of an H5N1 influenza vaccine candidate that compared vaccines with and without adjuvants[2].
  • In France, sanofi pasteur was awarded a contract by the French Ministry of Health to produce a 1.4 million dose stockpile of the H5N1 candidate studied in the above-mentioned trial. Under this agreement, the company could also be called upon to provide enough vaccine to protect up to 28 million people in France in the event of a pandemic being declared, once the actual virus strain responsible is identified.
  • In Italy, in February 2006, sanofi pasteur provided candidate H5N1 vaccine to the Ministry of Health and entered into an agreement to provide an actual pandemic strain of vaccine, once a pandemic has been declared.
  • In Austria, in October 2006, data from the first, phase 1 clinical trial with sanofi pasteur's H5N1 pre-pandemic vaccine was presented at the International Conference for Influenza Vaccines. The data showed that the vaccine induces antibodies that neutralise recent H5N1 circulating viruses that were not included in the original vaccine formulation, further demonstrating the value of sanofi pasteur candidate vaccine for pandemic preparedness.
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 of cell culture technology, including:
  • In May 2004, sanofi pasteur contracted with the U.S. National Institutes for Allergy and Infectious Diseases (NIAID) to produce investigational doses. The doses were shipped to the NIAID in March 2005. The studies were completed in 2005 and the results were published in New England Journal of Medicine[3].
  • 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 to design 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 US$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.
  • In February 2006, sanofi pasteur supplied NIAID with 15,000 investigational doses of H5N1 vaccine formulated with and without alum adjuvant for use in NIAID-sponsored clinical studies.
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.
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 organisation, 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).
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. The company
offers the broadest range of vaccines, providing protection against
20 bacterial and viral diseases. For more information, please visit:
www.sanofipasteur.us <outbind://151-00000000D35C41F7166D904585130A25C
C107654C40C3A00/Documents%20and%20Settings/Len.Lavenda/Local%20Settin
gs/Temporary%20Internet%20Files/OLK77/www.sanofipasteur.us> or
www.sanofipasteur.com <http://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 events,
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, 2005. Other than as required by applicable
law, sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.
References:
1. <http://www.who.int/csr/disease/avian_influenza/guidelines/reco
mmendationvaccine.pdf>
2. Bresson JL, Perronne C, Launay O, et al. Safety and
immunogenicity of an inactivated split-virion influenza
A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet
2006 May 20;367(9523):1657-64
3. Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety
and immunogenicity of an inactivated subvirion influenza A (H5N1)
vaccine. N Engl J Med 2006 Mar 30;354(13):1343-51
sanofi pasteur
    Alain BERNAL
    Vice-President Corporate Communications
    Tel: +33-(0)4-37-37-78-97
    Fax: +33-(0)4-37-37-77 89
    Len LAVENDA
    U.S. Media Relations
    Tel: +1-570-839-4446
     Len.Lavenda@sanofipasteur.com

Contact:

sanofi pasteur, Alain BERNAL, Vice-President Corporate
Communications, Tel: +33-(0)4-37-37-78-97, Fax: +33-(0)4-37-37-77
89; Len LAVENDA, U.S. Media Relations, Tel: +1-570-839-4446,
Len.Lavenda@sanofipasteur.com

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