MADISON, NJ, March 1 /CNW/ - 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
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
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).
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:
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 (greater than or equal to 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 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
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.
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