Sanofi pasteur Broadens Pandemic Preparedness With First Clinical Trial of Novel Cell Based H7N1 Vaccine

Lyon, France (ots/PRNewswire) - Sanofi pasteur, the vaccines
business of the sanofi-aventis Group, has within the framework of
FLUPAN, a collaborative research project funded by the European
Commission, generated the first clinical trial lot of a new
generation of H7N1 pandemic vaccine. This trial will broaden Sanofi
pasteur's pandemic preparedness program initiated with the
development of H5N1 vaccines.

The H7N1 vaccine was produced at Sanofi pasteur's Marcy l'Etoile
facility in France using the PER.C6(R) cell-based technology from its
partner Crucell N.V. allowing an alternative production process
expected to offer advantages over traditional manufacturing methods.

This phase I clinical trial, initiated today in Bergen, Norway is
the first to assess the safety and ability to generate an immune
response of a split, inactivated prototype pandemic H7N1 vaccine
produced on cells.

"The H7N1 vaccine strain was developed from an avian influenza
virus (bird flu) by the UK's National Institute for Biological
Standards and Control (NIBSC) and the University of Reading (UK). A
highly pathogenic H7N1 avian influenza virus which caused outbreaks
in Italian poultry in 1999 has been modified, so that it is safe to
use and grows well in mammalian cell culture." commented Dr John
Wood, FLUPAN Coordinator.

Two influenza subtypes, H5 and H7 have recently caused highly
pathogenic avian influenza. While most vaccine development has
focused on H5N1 strains, avian H7 containing viruses remain a
significant pandemic threat and have caused infections in humans in
Europe over the last three years [1].

"The FLUPAN coordinated study started today at the Haukeland
University Hospital, University of Bergen (Norway). A total of 60
healthy adults aged 20 to 40 will be vaccinated with one of four
formulations: two dosages (12 microg and 24 microg) with or without
an aluminium hydroxide adjuvant, an additive commonly used to
increase the immune response to vaccines," said Dr Lars R. Haaheim,
Principal Investigator, University of Bergen.

Sanofi pasteur selected PER.C6(R) cells for their high
susceptibility to influenza viruses, thereby making the production of
large amounts of influenza vaccine feasible for both pandemic and
seasonal strains.

Pandemic Influenza Overview

Influenza is 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, with the potential to
cause severe morbidity and mortality. According to the World Health
Organization (WHO), the next pandemic is likely to result in 1 to 2.3
million hospitalisations and 280,000 to 650,000 deaths in
industrialized nations alone. Its impact is expected to be even more
devastating in developing countries. In an attempt to minimize the
impact of a pandemic, many countries are developing national and
transnational plans against an eventual influenza pandemic situation.

Several strains of influenza virus are potentially pandemic. An
H7N7 strain was responsible for a large outbreak of fowl plague in
Netherlands in 2003 which spread to 89 humans. While symptoms were
mostly mild, one case died from pneumonia in combination with acute
respiratory distress syndrome as a result of the infection. The virus
was also seen to be transmitted to family contacts. [1, 2].

About FLUPAN,

FLUPAN is a European Union (EU) funded collaboration, intended to
improve the level of pandemic preparation in the European Union.
There are six European partners in FLUPAN: National Institute for
Biological Standards and Control (NIBSC), UK; University of Reading,
UK; Istituto Superiore di Sanita, Italy; Heath Protection Agency, UK;
University of Bergen, Norway; and Sanofi pasteur, the vaccines
business of the sanofi-aventis Group, France. For more information,
please visit www.nibsc.ac.uk/spotlight/fluplan.htlm.

About Crucell

Crucell N.V. is a Dutch biotechnology company (Euronext, NASDAQ:
CRXL; Swiss Exchange: CRX) focused on research, development and
worldwide marketing of vaccines and antibodies that prevent and treat
infectious diseases. For more information, please visit
www.crucell.com.

About Sanofi pasteur and Crucell exclusive agreement

Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
entered on December 31, 2003 into a strategic and exclusive agreement
with Crucell N.V. to further develop, manufacture and market
cell-based novel influenza vaccine products based on Crucell's
proprietary PER.C6(R) cell line technology. The agreement covers both
pandemic and seasonal influenza vaccines.

Crucell's PER.C6(R) technology is a cell line developed for the
large-scale manufacture of biological products including vaccines.

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 other projects in the U.S. and
Europe, with the goal of developing a vaccine to protect against a
pandemic influenza virus.

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).

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 [3].

- 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. By this
agreement, the company could also 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 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 [4].

- 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 $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 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).

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.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] Fouchier RA, Schneeberger PM, Rozendaal FW, et al. Avian
influenza A virus (H7N7) associated with human conjunctivitis and a
fatal case of acute respiratory distress syndrome. Proc Natl Acad Sci
U S A 2004 Feb 3;101(5):1356-61.

[2] Tweed SA, Skowronski DM, David ST, et al. Human illness from
avian influenza H7N3, British Columbia. Emerg Infect Dis 2004
Dec;10(12):2196-9.

[3] 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.

[4] 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: + 33-4-37-37-78-97
Fax: +33-4-37-37-77 89
Len Lavenda
Sanofi pasteur
U.S. Media Relations
Tel: +1-570-839-4446
Len.Lavenda@sanofipasteur.com

ots Originaltext: sanofi-aventis Group
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Sanofi Pasteur, Alain Bernal, Vice-President Corporate
Communications, Tel: +33-4-37-37-78-97, Fax: +33-4-37-37-77-89. Len
Lavenda, Sanofi Pasteur, U.S. Media Relations, Tel: +1-570-839-4446,
Len.Lavenda@sanofipasteur.com


	hier anmelden...