Advisory Panel Recommends FDA Licensure of Aventis' Menactra(TM) Vaccine for Protection Against Meningococcal Disease

Advisory Panel Recommends FDA Licensure of Aventis' Menactra(TM)
Vaccine for Protection Against Meningococcal Disease
- First Candidate Quadrivalent Conjugate Meningococcal Vaccine - 


SWIFTWATER, Pa., Sept. 22  /PRNewswire-FirstCall/ -- Aventis (NYSE:AVE), part
of the sanofi-aventis Group, announced today that the Vaccines and Related
Biological Products Advisory Committee of the U.S. Food and Drug Administration
(FDA) voted unanimously to recommend licensure of Menactra(TM) (Meningococcal
[Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate) Vaccine
for protection against invasive meningococcal disease in adolescents and adults
aged 11-55 years.

Menactra vaccine is the first quadrivalent conjugate meningococcal vaccine for
the prevention of meningococcal disease, a serious bacterial infection that can
cause meningitis and sepsis (blood infection).  This vaccine is designed to
offer protection against four of the most common serogroups (A, C, Y, W-135)
that cause meningococcal disease.

"Meningococcal meningitis is a potentially deadly infectious disease which
affects children, adolescents and young adults in the U.S., and we are very
pleased with the positive response from the FDA's Advisory Committee regarding
our conjugate vaccine candidate, Menactra, that has the potential for
substantial control of this serious disease," said Michael Decker, MD, MPH,
vice president, scientific and medical affairs at Aventis Pasteur, the human
vaccines business of Aventis, part of the sanofi-aventis Group.  "Conjugate
vaccines have been shown to induce a better and longer-lasting immune response
than polysaccharide vaccines, and we believe that Menactra vaccine will offer
these benefits to our nation's adolescents and young adults."

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 safety and
immunogenicity data from six pivotal studies.  The vaccine was shown to be
immunogenic, safe and well tolerated.

Aventis Pasteur is currently constructing a new, state-of-the-art production
facility at its U.S. site in Swiftwater, Pennsylvania, to produce Menactra
meningococcal vaccine.  The new facility is intended to ensure Aventis
Pasteur's ability to meet anticipated global demand for the product.

"Aventis Pasteur is committed to satisfying all FDA requirements for vaccine
licensure and, if licensed by the FDA, we intend to have the vaccine available
as quickly as possible," said Dr. Decker.

About Meningococcal Disease

Meningococcal disease is a rare but devastating bacterial infection that
strikes between 2,500 and 3,000 Americans every year, causing meningitis or
sepsis in the majority of cases. Approximately 10 percent of individuals who
contract meningococcal disease will die.  Of survivors, up to one in five
suffer long-term permanent disabilities such as hearing loss, brain damage and
limb amputations.  Meningococcal disease often begins with symptoms that can be
mistaken for common viral illnesses, such as the flu.  But unlike more common
infections, meningococcal disease can progress very rapidly and kill an
otherwise healthy young person in 48 hours or less.

Although disease rates are highest in infants, rates begin to rise again in
early adolescence and peak between the ages of 15 and 24.  During the 1990s,
one study reported substantially increased incidence among 15- to 24-
year-olds.  Moreover, the fatality rate among people in this age group can
reach 25 percent.  Up to 83 percent of the cases in this age group were caused
by the potentially vaccine-preventable serogroups that are included in Menactra
vaccine.

About Conjugate Vaccine Technology

The current FDA-licensed meningococcal disease vaccine, Menomune(R)-
A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135
Combined), is made from a long chain of polysaccharides that come from the
outer coat of the meningococcus bacterium, providing a limited duration of
immunity.  Duration of protection against meningococcal disease with
Menomune-A/C/Y/W-135 vaccine is approximately three to five years.

Menactra vaccine is a conjugate vaccine, created by attaching the meningococcal
polysaccharides to a carrier protein.  Historically, conjugate vaccines have
been shown to induce boostable memory responses and longer-lasting immune
responses than polysaccharide vaccines.  Since 1990, widespread use of
conjugate vaccines in the U.S. against Haemophilus Influenzae type b (Hib) and
Streptococcus pneumoniae have substantially reduced incidence of infections
caused by these bacteria, both of which were common causes of meningitis.

Aventis Pasteur licensed the first conjugate vaccine in 1987 for protection
against Haemophilus Influenzae type b, a leading cause of serious systemic
bacterial disease in the U.S.  Since the introduction of Hib conjugate vaccines
such as ProHIBit, Haemophilus b Conjugate Vaccine (Diphtheria
Toxoid-Conjugate), incidence of Hib invasive disease among children aged 4
years or younger has declined by 98 percent.

Impact of Conjugate Meningococcal Vaccine in the United Kingdom

Experience in the United Kingdom (U.K.) suggests that conjugate meningococcal
vaccines provide significant benefits over traditional vaccines. From 1999 to
2000, the U.K. ran a national campaign to immunize 15 million children under
age 17 with a conjugate vaccine that offered protection against one serogroup
(the C serogroup) of meningococcal bacteria, which causes a greater proportion
of cases in the U.K. than in the U.S.  The campaign resulted in an 85 percent
overall decline in cases and a 90 percent reduction in deaths from
meningococcal serogroup C disease within one year.

Disease rates also declined 60 percent among unvaccinated children.  This "herd
immunity" effect is a result of the conjugate vaccine's ability to prevent
carriage of the bacteria in the nose and throat and, thus, transmission of the
bacteria to other persons.  Carriage rates in children 15 to 17 years old
decreased by 66 percent.

Obtaining similar public health benefits in the U.S. would require a vaccine
that protects against multiple serogroups of meningococcal bacteria. Four
serogroups (C, Y, W-135 and B) predominate in the U.S.  Menactra vaccine
contains three of these four serogroups, representing approximately two-thirds
of meningococcal disease overall and up to 83 percent in the adolescent
population.  In the U.K., by contrast, two serogroups (C and B) predominate.
Currently there is no vaccine available in the U.S. or the U.K. against
meningococcal disease caused by the B serogroup.

About Aventis

Aventis is dedicated to treating and preventing disease by discovering and
developing innovative prescription drugs and human vaccines.  In 2003, Aventis
generated sales of euro 16.79 billion, invested euro 2.86 billion in research
and development and employed approximately 69,000 people in its core business.
Aventis corporate headquarters are in Strasbourg, France.  For more
information, please visit: http://www.aventis.com/.

Aventis Pasteur, the vaccines business of Aventis, part of the sanofi-aventis
Group, produced 1.4 billion doses of vaccine in 2003, making it possible to
protect 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:
http://www.aventispasteur.com/.

Aventis Forward Looking Statement

Statements in this document containing projections or estimates of revenues,
income, earnings per share, capital expenditures, capital structure, or other
financial items; plans and objectives relating to future operations, products,
or services; future economic performance; or assumptions underlying or relating
to any such statements, are forward-looking statements subject to risks and
uncertainties.  Actual results could differ materially depending on factors
such as the timing and effects of regulatory actions, the results of clinical
trials, the company's relative success developing and gaining market acceptance
for new products, the outcome of significant litigation, and the effectiveness
of patent protection.  Additional information regarding risks and uncertainties
is set forth in the current Annual Report on Form 20-F of Aventis on file with
the Securities and Exchange Commission and in the current Annual Report --
"Document de Reference" -- on file with the "Autorite des marches financiers"
in France.

   Your Contacts:
   Len Lavenda                             Sherri Michelstein
   Aventis Pasteur US Media Relations      Cooney/Waters Group
   Tel.: [phone]                      Tel.: [phone]
   

DATASOURCE: Aventis Pasteur; sanofi-aventis Group



CONTACT:  Len Lavenda of Aventis Pasteur US Media Relations,

[phone], ; or Sherri Michelstein of

Cooney-Waters Group, [phone], for Aventis Pasteur and sanofi-aventis

Group 



Web site:  http://www.aventis.com/

http://www.aventispasteur.com/ 

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