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FDA Advisory Panel Recommends Licensure of sanofi pasteur's ADACEL(TM) Vaccine for Combined Protection against Tetanus, Diphtheria and Pertussis

Lyon, France (ots/PRNewswire)

- Vaccine Leader Looks to Introduce First Pertussis Booster for
Both Adolescents and Adults in United States
Sanofi pasteur, the vaccines business of the sanofi-aventis Group
(NYSE: SNY), announced today that the Vaccines and Related Biological
Products Advisory Committee (VRBPAC) of the U.S. Food and Drug
Administration (FDA) voted unanimously to recommend licensure of
ADACEL(TM) (Tetanus Toxoid and Reduced Diphtheria Toxoid and
Acellular Pertussis Vaccine Adsorbed) Vaccine for protection against
tetanus, diphtheria and pertussis in adolescents and adults aged
11-64 years.
ADACEL vaccine is the first booster to address pertussis
protection across a wide range of ages including adolescents and
adults. These age groups are at a growing risk of contracting and
transmitting the disease.
The number of reported cases of pertussis - commonly known as
whooping cough - continues to rise at a rate of great concern to the
public health and medical communities. The U.S. Centers for Disease
Control and Prevention (CDC) has received 19,000 case reports for
2004, a nearly 40 percent increase over 2003, and the highest number
in four decades. Various studies indicate that the actual number of
pertussis cases is many times greater than what is reported.
Approximately two-thirds of all cases occur in adolescents and
adults. Although pertussis in adolescents and adults is often thought
of as relatively mild, many in these age groups who contract the
disease experience prolonged coughing, vomiting, missed school or
work, and various complications. Due to similarities of symptoms,
pertussis may initially be mistaken for other viral illnesses such as
bronchitis, influenza, or even the common cold. In fact, it is within
the first two weeks, often before a noticeable cough develops, when
pertussis is most contagious.
Additionally, pertussis is easily transmitted to unimmunized or
partially immunized infants and young children who are more
vulnerable to serious pertussis-related complications or death. In
effect, preventing pertussis in adolescents and adults could provide
another means of preventing the spread of the disease, particularly
to infants and young children.
"The dramatic increase in pertussis and the growing number of
outbreaks are a critical reminder that we need to bring this serious
disease under control," said David R. Johnson, MD, MPH, director,
scientific and medical affairs, sanofi pasteur. "We are very pleased
that the Advisory Committee has recognized the need for ADACEL
vaccine for adolescents and adults because it will be an expansion of
sanofi pasteur's pertussis portfolio that will represent a new
approach to disease prevention in the U.S."
Although the FDA is not bound by the Advisory Committee's
recommendation, the agency considers it carefully when deciding
whether to license a vaccine for marketing.
In making its recommendation, the FDA Advisory Committee reviewed
the results of four principle clinical studies that included more
than 7200 individuals who were evaluated for safety. The
immunogenicity profile of ADACEL vaccine was documented in a
randomized subset of participants enrolled in the studies. Across the
four trials, a total of 4,342 ADACEL and Td vaccine recipients were
evaluated for their immune responses to vaccination.
ADACEL vaccine is currently licensed and marketed in Canada and
Germany.
Risk of Pertussis
Pertussis is a highly contagious respiratory disease marked by
severe coughing. Its common name, whooping cough, comes from the
"whoop" sound patients make when they try to inhale during or after a
severe coughing spell.
There are both severe and milder forms of pertussis. Although
pertussis can occur at any age, severe pertussis disease usually
occurs in infants and young children who have not been fully
vaccinated and who are at higher risk for serious complications -
such as pneumonia and seizures - and death. The pertussis immunity
induced by early childhood vaccinations or by natural disease wears
off, leaving adolescents and adults once again susceptible to
pertussis. While they may not always experience the debilitating
effects of the disease that infants do, infected adolescents and
adults often have prolonged illness and can easily transmit the
illness to unimmunized and partially immunized infants and young
children. Additionally, adults older than 55 years of age may be at
considerable risk for certain complications associated with
pertussis.
Mild pertussis disease is difficult to diagnose because its
symptoms are not distinctive; usually a prolonged cough is present,
but without the "whoop." Although infants and young children may
experience mild pertussis disease, it is more often associated with
adolescents and adults.
"While adolescent and adult patients may be spared the
debilitating effects of pertussis, the fact that that their disease
is often not readily diagnosed means that they may unwittingly spread
it to others," said Dr. Johnson.
About Tetanus, Diphtheria, Pertussis
Tetanus is a severe, frequently fatal disease caused by an
exotoxin produced by bacteria (Clostridium tetani). The disease,
characterized by generalized rigidity and convulsive spasms of
skeletal muscles, causes paralysis, and usually starts at the top of
the body and works its way down. "Lockjaw," as the disease is
sometimes called, is often the first symptom, followed by stiffness
in the neck and difficulty swallowing. Muscle spasms may occur
frequently, lasting for several minutes and persisting for up to a
month. Symptoms of tetanus can appear anywhere from three days to
three weeks after exposure to the bacteria and may be accompanied by
fever, sweating, elevated blood pressure and rapid heartbeat. The
bacteria that cause tetanus are widespread and are found in soil and
in the intestinal tracts of animals and humans. It usually enters the
body through a wound or opening in the skin. Virtually all of the
cases of tetanus disease occurring in the U.S. are in adults not
up-to-date with booster vaccinations.
Diphtheria is caused by exposure to bacteria (Corynebacterium
diphtheriae) from an infected person and usually affects the tonsils,
throat, nose and/or skin. It is passed from person to person by
droplet transmission, usually by breathing in diphtheria bacteria
after an infected person has coughed, sneezed, or even laughed. It
can also be spread by handling used tissues or by drinking from a
glass used by an infected person. Symptoms usually appear two to five
days after infection and begin very much like a common cold. However,
symptoms can progress as a membrane grows and covers anywhere from a
small patch to most of the throat, potentially blocking the airway.
The infection releases a toxin that can lead to heart failure and
paralysis. If enough toxin is absorbed into the bloodstream, coma or
even death can occur in as little as a week. Diphtheria occurs rarely
in this country, but is occasionally imported from countries where it
is endemic. Ongoing vaccination to protect against diphtheria
continues to be recommended.
Pertussis, a highly contagious disease of the respiratory tract,
is caused by bacteria (Bordetella pertussis) found in the mouth, nose
and throat of an infected person. Pertussis is primarily spread when
someone with the disease coughs in close proximity to a person who is
susceptible. Classic, or severe, pertussis, as defined by the World
Health Organization, consists of at least 21 days of cough illness
(with the cough coming in spasms or paroxysms), associated whoops or
post-cough vomiting, and laboratory confirmation. Mild pertussis is
any laboratory-confirmed pertussis disease that is less than classic
disease. Pertussis can occur at any age. Approximately two thirds of
the cases reported in the US occur in adolescents and adults, while
the majority of the remaining reported cases affect children under 6
months of age. Pertussis is less common among children aged 6 months
through 10 years, who are protected by existing vaccination programs.
For young children, pertussis disease can result in significant
morbidity, hospitalization, serious long-term complications, and
death. Pertussis immunity, whether from childhood vaccination or
natural disease, is not lifelong; it must be boosted for adolescents
and adults to be protected.
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 950 million doses of vaccine in 2004, making it possible to
protect more than 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: www.sanofipasteur.com
Forward Looking Statement
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 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 and Aventis, including those listed under
"Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's
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's annual report on Form
20-F for the year ended December 31, 2003. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to
update or revise any forward-looking information or statements.

Contact:

Michel Joly, Brand and Scientific Communication, Sanofi-aventis, Tel
: +33-1-53-77-47-86, fax : +33-1-53-77-41-74; Len Lavenda, Sanofi
pasteur U.S. Media Relations, Tel. : +1-570-839-4446,
Len.Lavenda@sanofipasteur.com

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