sanofi pasteur Seeks to Broaden Age Group for New Vaccine to Protect Against Meningococcal Disease
March 17 2005 - 8:00AM
PR Newswire (US)
sanofi pasteur Seeks to Broaden Age Group for New Vaccine to
Protect Against Meningococcal Disease Submits supplemental license
application SWIFTWATER, Pa., March 17 /PRNewswire-FirstCall/ --
Sanofi pasteur, the vaccines business of the sanofi-aventis Group
(NYSE:SNY), is seeking U.S. 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 U.S. 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 meningococcal infection.
"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. "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 U.S.
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 general population.
Immunization providers can order Menactra vaccine by visiting
http://www.vaccineshoppe.com/ or calling 1-800-VACCINE
(1-800-822-2463). 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. 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: http://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.
DATASOURCE: sanofi pasteur CONTACT: Len Lavenda, U.S. Media
Relations of sanofi pasteur, +1-570-839-4446, ; or Sherri
Michelstein of Cooney/Waters Group, +1-212-886-2200, for sanofi
pasteur Web site: http://www.sanofipasteur.com/
http://www.vaccineshoppe.com/
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