European Committee Issued Positive Opinions to Extend Indication for PREVENAR to Include Pneumonia and Otitis Media

European Committee Issued Positive Opinions to Extend Indication for PREVENAR to Include Pneumonia and Otitis Media

March 01, 2007

    MADISON, N.J., March 1 /Xinhua-PRNewswire/ -- Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), has
received two positive opinions recommending approval for an
extension of the indication for PREVENARTM (Pneumococcal
Saccharide Conjugated Vaccine, Adsorbed) to the European
market by the Committee for Medicinal Products for Human
Use (CHMP).  The opinions recommend extending the
indications of PREVENAR to include active immunization
against pneumonia and acute otitis media (middle ear
infection) caused by vaccine serotypes.  PREVENAR is
currently approved for active immunization of children from
2 months to 5 years of age against sepsis, meningitis,
bacteraemic pneumonia and bacteraemia caused by
Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F
and 23F.  Pneumococcal disease is a significant concern to
children's health, estimated to result in more than one
million deaths each year in young children around the
world.

    "S. pneumoniae is the leading cause of bacterial
pneumonia in humans beyond the first few weeks of life and
is a major cause of death and illness worldwide," says
Peter Paradiso, Vice President, Scientific Affairs, Wyeth
Vaccines.  "It also is an important cause of acute
otitis media, which if left untreated, may lead to more
serious diseases such as mastoiditis and meningitis.  We
welcome the CHMP's recommendation for both new indications
in the EU which, if approved, will underscore the value of
PREVENAR in helping to protect infants and young children
from common pediatric illnesses caused by S.
pneumoniae."

    PREVENAR is the first and only conjugate vaccine shown
to be effective in reducing the incidence of pneumococcal
disease (PD) in infants and toddlers.  The CHMP
recommendations of PREVENAR will now be forwarded to the
European Commission (EC) for final approval, which is
anticipated in the second quarter of 2007. 
 
    Many health authorities have recognized the importance
of protecting infants and young children against
pneumococcal disease.  PREVENAR is a part of the routine
national childhood immunization schedule in 16 countries
worldwide, including Belgium, France, Germany, Greece,
Italy, Netherlands and the United Kingdom (UK).

    About Pneumonia

    Pneumococcal pneumonia is an infection of the lungs
caused by the bacterium Streptococcus pneumoniae.  There
are many causes of pneumonia, including bacteria, viruses
and other pathogens.  When S. pneumoniae invades the lungs,
the body's immune system responds, generating an
inflammatory response.  White blood cells, fluid and
cellular debris then fill the air spaces of the lower
respiratory tract causing physical symptoms such as
coughing, fever and shortness of breath.

    In prelicensure clinical trials, PREVENAR was found to
be 97.4 percent (95% CI: 82.7-99.9) efficacious in
preventing serotype-specific invasive pneumococcal
infections in infants who were fully vaccinated and 89.1
percent (95% CI: 73.7-95.85) efficacious for all cases of
invasive pneumococcal disease regardless of serogroup. 
Importantly, in this clinical study, PREVENAR was effective
in reducing the incidence of radiographically-confirmed
pneumonia in children younger than two years of age by 23.4
percent (95% CI: 5.2-38.1).  

    About Otitis Media

    Acute otitis media (AOM) is a common childhood disease
with important ramifications to the overall health of
infants and young children.  The peak incidence of AOM
occurs at 6 to 18 months of age, but it can also occur in
older children.  Complications of AOM include persistent
middle ear effusion, chronic otitis media, transient
hearing loss, or speech delays.

    PREVENAR has been shown to have an impact on AOM; in a
clinical study, PREVENAR reduced vaccine serotype cases of
AOM by 57 percent (95% CI: 44-67), cases of
culture-confirmed pneumococcal AOM by 34 percent (95% CI:
21-45) and all cases of AOM by 6 percent (95% CI: -4-16). 


    In the United States, a study found that following the
introduction of PREVENAR, otitis media outpatient visit
rates declined by 20 percent in children aged less than two
years, representing 246 fewer otitis media visits per 1,000
children in the United States.

    About Pneumococcal Disease

    Pneumococcal disease describes a group of illnesses
caused by the bacterium Streptococcus pneumoniae, also
known as pneumococcus.  This bacterial pathogen, which
affects both children and adults, is a major cause of death
and illness worldwide.  In fact, according to the World
Health Organization (WHO), pneumococcal disease is the
number one vaccine-preventable cause of death in children
younger than 5 years of age worldwide.

    Important Safety Information about PREVENAR

    In clinical trials (n=18,168), the most frequently
reported adverse events included injection site reactions,
fever (>/=38 degrees C/100.4 degrees F), irritability,
drowsiness, restless sleep, decreased appetite, vomiting,
diarrhea and rash.

    Risks are associated with all vaccines, including
PREVENAR.  Hypersensitivity to any vaccine component,
including diphtheria toxoid, is a contraindication to its
use.  PREVENAR does not provide 100 percent protection
against vaccine serotypes or protect against nonvaccine
serotypes.

    Wyeth Pharmaceuticals

    Wyeth Pharmaceuticals has leading products in the areas
of women's health care, infectious disease, gastrointestinal
health, central nervous system, inflammation,
transplantation, hemophilia, oncology, vaccines and
nutritional products.  

    Wyeth is one of the world's largest research-driven
pharmaceutical and health care products companies.  It is a
leader in the discovery, development, manufacturing and
marketing of pharmaceuticals, vaccines, biotechnology
products and non-prescription medicines that improve the
quality of life for people worldwide.  The Company's major
divisions include Wyeth Pharmaceuticals, Wyeth Consumer
Healthcare and Fort Dodge Animal Health.

    The statements in this press release that are not
historical facts are forward-looking statements based on
current expectations of future events and are subject to
risks and uncertainties that could cause actual results to
differ materially from those expressed or implied by such
statements. These risks and uncertainties include the
inherent uncertainty of the timing and success of, and
expense associated with, research, development, regulatory
approval and commercialization of our products, including
with respect to our pipeline products; government
cost-containment initiatives; restrictions on third-party
payments for our products; substantial competition in our
industry, including from branded and generic products; data
generated on our products; the importance of strong
performance from our principal products and our anticipated
new product introductions; the highly regulated nature of
our business; product liability, intellectual property and
other litigation risks and environmental liabilities;
uncertainty regarding our intellectual property rights and
those of others; difficulties associated with, and
regulatory compliance with respect to, manufacturing of our
products; risks associated with our strategic relationships;
economic conditions including interest and currency exchange
rate fluctuations; changes in generally accepted accounting
principles; trade buying patterns; the impact of
legislation and regulatory compliance; risks and
uncertainties associated with global operations and sales;
and other risks and uncertainties, including those detailed
from time to time in our periodic reports filed with the
Securities and Exchange Commission, including our current
reports on Form 8-K, quarterly reports on Form 10-Q and
annual report on Form 10-K, particularly the discussion
under the caption "Item 1A, Risk Factors." The
forward-looking statements in this press release are
qualified by these risk factors.  We assume no obligation
to publicly update any forward-looking statements, whether
as a result of new information, future developments or
otherwise.


    For more information, please contact:

    Media Contacts:

     Natalie de Vane
     Tel: [phone]

     Gill Markham
     Tel: [phone]

    Investor Contact:
     Justin Victoria
     Tel: [phone]


SOURCE  Wyeth Pharmaceuticals