Lyon, France et Swiftwater, Pennsylvanie (ots/PRNewswire) -
- First Combination Vaccine Candidate in the U.S. Designed to
Protect Infants and Young Children against Diphtheria, Tetanus,
Pertussis, Polio, and Hib
Sanofi pasteur, the vaccines business of the sanofi-aventis Group
(EURONEXT: SAN), (NYSE: SNY), announced today the acceptance of a
Biologics Licensing Application (BLA) by the U.S. Food and Drug
Administration (FDA) for PENTACEL(TM) vaccine[i], a pediatric
combination vaccine candidate that targets diphtheria, tetanus,
pertussis, polio, and Haemophilus influenzae type b (Hib).
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.
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 five separate vaccine injections may be
required during well-child visits. If licensed, PENTACEL vaccine
could reduce that number by two.
"PENTACEL vaccine could be easily integrated into the recommended
childhood vaccination schedule," said Steven Black, MD, co-director,
Kaiser Permanente Pediatric Vaccine Study Center. "In addition, this
combination vaccine has the potential to protect against five
diseases in a single injection."
The regulatory submission of PENTACEL vaccine is based on results
of clinical studies involving more than 5,000 children in
multi-center trials[ii] 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.
Sanofi pasteur has been committed to pediatric immunization since
it first introduced a diphtheria, tetanus and pertussis vaccine in
1941. In 1996, sanofi pasteur was also 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(TM) (Tetanus
Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
Adsorbed) as a booster dose for protection against tetanus,
diphtheria and pertussis in adolescents and adults 11-64 years of
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.
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.
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 continue to rise 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[iii].
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% die 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.
Haemophilus influenzae type b disease, also called invasive Hib
disease, is caused by a bacterium, Haemophilus influenzae type b. Hib
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,[iv] and ongoing vaccination is critical in preventing a
resurgence of invasive Hib disease, which was the leading cause of
bacterial meningitis in children under five years of age before
vaccines were introduced.
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 nearly a billion 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," "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, 2004. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update or revise
any forward-looking information or statements.
Sanofi-aventis Group subsidiaries in the United States include
Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi
[i] The full chemical name for PENTACEL(TM) vaccine is:
(Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate] - ActHIBÒ
Reconstituted with Diphtheria and Tetanus Toxoids and Acellular
Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine
[ii] 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
[iii] 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.
[iv] 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
@@start.t1@@ sanofi pasteur sanofi pasteur
Alain BERNAL Len LAVENDA
Vice-President Corporate Communications U.S. Media Relations
Tel: +33-(0)4-37-37-78-97 Tel: +1-570-839-4446
Fax: +33-(0)4-37-37-77 89 Len.Lavenda@sanofipasteur.com@@end@@
ots Originaltext: sanofi-aventis Group
Im Internet recherchierbar: http://www.presseportal.ch
sanofi Pasteur, Alain BERNAL, Vice-President Corporate
Communications, Tel: +33-(0)4-37-37-78-97, Fax: +33-(0)4-37-37-77-89;
sanofi pasteur, Len LAVENDA, U.S. Media Relations, Tel: