FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine

FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine

January 26, 2007

- If Approved, Pentacel Vaccine Would be the First
Pediatric Combination Vaccine in the U.S. to Immunize
Against Diphtheria, Tetanus, Pertussis, Polio, and
Haemophilus Influenzae Type b (Hib) -


    BETHESDA, Md., Jan. 26 /Xinhua-PRNewswire/ -- Sanofi
pasteur, the vaccines business of the sanofi-aventis Group
(NYSE: SNY; EURONEXT: SAN), is pleased that the members of
an advisory committee to the U.S. Food and Drug
Administration (FDA) voted nearly unanimously today that
the company's pentavalent combination vaccine for use in
pediatric patients is both safe and efficacious.
Pentacel(R) (DTaP-IPV-Hib) vaccine(1) protects against
diphtheria, tetanus, pertussis, polio, and Haemophilus
influenzae type b (Hib).

    According to the current Recommended Childhood and
Adolescent Immunization Schedule from the Advisory
Committee on Immunization Practices (ACIP) of the U.S.
Centers for Disease Control and Prevention (CDC), up to 23
injections are needed through 18 months of age. The use of
Pentacel vaccine could reduce that number of shots by
seven.

    The regulatory submission of Pentacel vaccine is based
on results of clinical studies involving more than 5,000
children in multi-center trials(2) conducted in the U.S.
and Canada. Pentacel vaccine is licensed for pediatric use
in nine countries, including Canada, where it has been used
universally in infants and young children since 1998 for the
prevention of diphtheria, tetanus, pertussis, polio and Hib.
Over 12.5 million doses of Pentacel vaccine have been
distributed in Canada.  

    Pentacel vaccine is the first DTaP-based combination
vaccine candidate for use in infants in the U.S. that
includes both polio and Hib vaccine components. The
diphtheria, tetanus, and pertussis components in Pentacel
vaccine are based on the formulation in DAPTACEL(R) --
Diphtheria and Tetanus Toxoids and Acellular Pertussis
Vaccine Adsorbed (DTaP vaccine) -- which was introduced by
sanofi pasteur in the U.S. in 2002. In clinical trials,
Pentacel vaccine was administered as a four-dose series --
at 2, 4, 6, and 15-18 months of age -- concomitantly with
other recommended childhood vaccines.

    Sanofi pasteur's U.S. operations in Swiftwater, PA has
long been committed to providing vaccines to prevent
childhood diseases. In 1987, it licensed the first
Haemophilus influenzae type b (Hib) conjugate vaccine. And
in 1996, it was the first company to license a diphtheria,
tetanus, and acellular pertussis vaccine for use in infants
-- Tripedia(R), Diphtheria and Tetanus Toxoids and Acellular
Pertussis Vaccine Adsorbed. In 2005, sanofi pasteur
continued its tradition of innovation by introducing
Menactra(R), Meningococcal (Groups A, C, Y and W-135)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine to
protect against meningococcal disease in adolescents and
adults, 11-55 years of age, and ADACEL(R), Tetanus Toxoid,
Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
Adsorbed as a booster dose for protection against tetanus,
diphtheria and pertussis in both adolescents and adults
11-64 years of age.  

    About Diphtheria

    Diphtheria is a disease caused by a bacterium,
Corynebacterium diphtheriae, that 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 or
sneezed. Although diphtheria disease is rare in the U.S., it
appears that C diphtheriae continues to circulate in areas
of the country with previously endemic diphtheria.
Diphtheria also occurs in many other parts of the world.

    About Tetanus

    Tetanus is a severe, frequently fatal disease caused by
an exotoxin produced by Clostridium tetani, a bacterium that
is found in the environment. Tetanus is not transmitted from
person to person. Rather, Clostridium tetani enters the body
through an open wound, including lacerations, abrasions and
puncture wounds. The toxin causes neuromuscular
dysfunction, with rigidity and spasms of skeletal muscles.
The muscle spasms usually start in the jaw (which is why
the disease is sometimes called "lockjaw") and
neck and may spread to many other muscles, leading to
generalized paralysis.   

    About Pertussis

    Pertussis, a highly contagious disease of the
respiratory tract, is caused by exposure to bacteria
(Bordetella pertussis) found in the mouth, nose and throat
of an infected person. Pertussis is primarily spread by
direct contact with discharge from the nose or throat of
infected individuals. 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. Despite widespread
vaccination, reports of pertussis outbreaks continue to in
the U.S. At particular risk are newborns and babies who
have not yet been fully vaccinated against pertussis, iii
who are more likely to have severe pertussis, and who face
the possibility of serious complications and death. Over
the last decade, 80% of pertussis deaths have occurred in
infants under 6 months of age.(3)

    About Polio

    Poliomyelitis (polio) is a highly infectious disease
caused by a virus that invades the nervous system and can
cause severe paralysis. The virus enters the body through
the mouth and multiplies in the intestine. Initial symptoms
are fever, fatigue, headache, vomiting, stiffness in the
neck, and pain in the limbs. One in 200 infections leads to
irreversible paralysis (usually in the legs). Among those
paralyzed, 5-10% dies when their breathing muscles become
immobilized. Polio mainly affects children under five years
of age. Naturally occurring polio was eliminated in the U.S.
in 1979 and in the Western Hemisphere by 1991; however,
worldwide efforts are continuing towards eradication of
this contagious and devastating disease.

    About Hib

    Haemophilus influenzae type b (Hib) disease is caused
by a bacterium that enters the body through the nose or
throat and then can spread to cause meningitis (an
infection of the coverings of the brain and spinal cord),
blood stream infection, pneumonia, infection of the
epiglottis, and other serious infections. Hib disease can
cause mental retardation in young children and be a
life-threatening infection. The Hib bacterium is still
circulating in the U.S. today.(4) Ongoing vaccination is
critical in preventing a resurgence of Hib, which was the
leading cause of bacterial meningitis in children under
five years of age before vaccines were introduced.  

    About sanofi-aventis 

    Sanofi-aventis is one of the world's leading
pharmaceutical companies. Backed by a world-class R&D
organization, sanofi-aventis is developing leading
positions in seven major therapeutic areas: cardiovascular,
thrombosis, oncology, metabolic diseases, central nervous
system, internal medicine and vaccines. Sanofi-aventis 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: 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.

    (1) The true name for Pentacel(R) vaccine is:
Diphtheria and Tetanus
        Toxoids and Acellular Pertussis Adsorbed,
Inactivated Poliovirus and
        Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Vaccine Combined

    (2) Herz A, Black S, Shinefield H, Noriega F,
Greenberg, D. Safety of
        DTaP-IPV//PRP-T (PENTACEL) administered at 2, 4, 6,
and 15 to 18
        months of age. Annual meeting of the Pediatric
Academic Societies 
        2005

    (3) Vitek CR, Pascual FR, Baugham, AL, Murphy TV.
Increase in deaths from
        pertussis from young infants in the United States
in the 1990s. 
        Pediar
        Infect Dis J. 2003:22:628:634.6

    (4) Donnelly, M.J, Herold, B.C., Jenkins, S.G., Daum,
R.S. Obstacles to
        the elimination of Haemophilus influenzae type b
disease: Three
        illustrative cases. Pediatrics. Vol. 112, No. 6,
December 2003, pp.
        1465-1466    


    For more information, please contact:

     Pascal Barollier
     International Media Relations
     Tel:   [phone]
     Email: [e-mail]

     Len Lavenda
     U.S. Media Relations
     Tel:   [phone]
     Email: [e-mail]


SOURCE  sanofi pasteur