Lyon, France (ots/PRNewswire) -
- Submits Supplemental License Application
Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
is seeking US government approval to broaden the age indication for
its new meningococcal vaccine Menactra(TM) (Meningococcal [Groups A,
C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine).
The company has filed a supplemental application with the US Food and
Drug Administration (FDA) to amend the vaccine's license to include
children aged 2 through 10 years. The FDA licensed Menactra vaccine
on January 14 this year for use among 11 through 55 year olds.
Menactra vaccine is the world's first quadrivalent conjugate
vaccine licensed for the prevention of meningococcal disease and is
designed to offer protection against four serogroups of Neisseria
meningitidis (A, C, Y, and W-135), the bacterium that causes
"The additional age indication would help protect a younger
segment of the population against a serious and devastating disease,"
said Michael Decker, MD, MPH, vice president, scientific and medical
affairs at sanofi pasteur US. "At the same time, it has the potential
benefit of increasing meningococcal immunization rates because the
2-10 age group generally are seen by a pediatrician on a regular
basis for the recommended schedule of childhood vaccinations."
Studies have demonstrated that serogroups C, Y and W-135 account
for about 48% of meningococcal disease in 2 through 5 year-olds and
65% in 5 through 11 year-olds.
On February 10 this year, the US Centers for Disease Control and
Prevention's (CDC) Advisory Committee on Immunization Practices
(ACIP) recommended immunization with Menactra vaccine for young
adolescents at the pre-adolescent visit (11-12 year old), adolescents
at high school entry (15 year old) and college freshmen living in
dormitories. The committee recognized the need to reduce the threat
of this potentially fatal bacterial infection among segments of the
population found to be at increased risk of infection relative to the
The supplemental license application is based upon three clinical
studies. Two were randomized, multi-center, active-controlled,
modified double-blind clinical studies of children aged 2 through 10
years comparing the safety and immunogenicity of Menactra vaccine to
Menomune(R)-A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups
A, C, Y and W-135 Combined), sanofi pasteur's currently-licensed
polysaccharide meningococcal vaccine. The third was a Phase 2,
controlled, multi-center, open-label study of children aged 3 through
5 years who had been vaccinated previously with Menactra vaccine
approximately two years earlier. The objective of this study was to
evaluate the antibody memory response to the vaccine.
Overall, data presented in the studies demonstrated that for
children aged 2 through 10 years Menactra vaccine is safe and
immunogenic. In addition, compared to Menomune vaccine, Menactra
vaccine resulted in longer-term persistence of bactericidal antibody,
improved production of high avidity antibody, and the establishment
of immune memory. No clinically significant adverse events were
identified after a 6-month controlled follow-up.
There are risks associated with all vaccines. In the studies, the
immediate reactions were uncommon and consisted primarily of local
redness at or near the injection site. They were reported for the
most part as mild reactions and were reversible. Solicited systemic
reactions were similar among the study groups and were described for
the most part as mild, reversible, and of short duration. The most
common complaints were irritability and drowsiness.
In general, the benefits of a successful conjugate vaccine include
longer-lasting immune responses and boostable memory responses.
Sanofi pasteur is the sole supplier of Menactra(TM) vaccine.
About Meningococcal Disease
Meningococcal disease is a rare but serious bacterial infection
that strikes between 1,500 and 3,400 Americans every year, causing
meningitis or sepsis in the majority of cases. Approximately 10
percent of individuals who contract meningococcal disease will die.
Of those who survive, up to one in five suffer permanent disabilities
such as hearing loss, neurological damage and limb amputations.
Meningococcal disease often begins with symptoms that can be mistaken
for common viral illnesses, such as the flu. However, unlike more
common infections, meningococcal disease can progress very rapidly
and kill an otherwise healthy young person in 48 hours or less.
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.
ots Originaltext: sanofi-aventis
Im Internet recherchierbar: http://www.presseportal.ch
Michel Joly, Deputy Vice President, Communications and Vice President
Brand and Scientific Communication, Sanofi-aventis Tél :
+33-1-53-77-47-86 fax : +33-1-53-77-41-74; Len Lavenda Sanofi pasteur
U.S. Media Relations, Tél. : +1-570-839-4446,
Len.Lavenda@sanofipasteur.com, Beth Waters, Senior Vice President
Communications, Sanofi pasteur, Tél : + 33-4-37-37-73-99 Fax :