- 85,000 Expected to Enroll in Phase 4 Study Initiated Pre-Registration
-

    COLLEGEVILLE, Pa., Sept. 23 /PRNewswire/ -- Wyeth Pharmaceuticals, a
division of Wyeth (NYSE: WYE), today announced the initiation of the
Community Acquired Pneumonia Immunization Trial in Adults a major study in
adults of an investigational 13-valent conjugate vaccine designed to help
prevent pneumococcal pneumonia -- the leading cause of bacterial pneumonia
in adults.

    In Europe and the United States, pneumococcal pneumonia is the most
common community-acquired bacterial pneumonia, for which the adult
mortality rate averages between 10 to 20 percent. That rate may exceed 50
percent in high-risk groups worldwide.

    The results from this trial are not intended or required for inclusion
in Wyeth's currently planned regulatory filings for the use of the
13-valent pneumococcal conjugate candidate vaccine in adults. Rather, this
study is being initiated proactively as part of a Phase 4 commitment, and
in agreement with the U.S. Food and Drug Administration (FDA).

    The Community Acquired Pneumonia Immunization Trial in Adults is a
double-blind, placebo-controlled study expected to enroll approximately
85,000 participants 65 years of age and older. The study is being conducted
by the Julius Center for Health Sciences and Primary Care at the University
Medical Center Utrecht in the Netherlands. Participants in the trial will
receive either Wyeth's investigational 13-valent pneumococcal conjugate
vaccine or placebo.

    "We are very excited to conduct this major trial addressing the
important disease of adult pneumonia," says Marc Bonten, M.D., principal
investigator of the trial and Professor of Molecular Epidemiology of
Infectious Diseases, Department of Medical Microbiology, Julius Center for
Health Sciences and Primary Care, University Medical Center Utrecht. "The
primary goal of the trial is to evaluate whether the vaccine is effective
in preventing the onset of community acquired pneumonia caused by the
serotypes included in the vaccine. The trial will also evaluate whether the
vaccine is effective in preventing all-cause pneumonia and invasive
pneumococcal disease."

    The investigational 13-valent vaccine being evaluated in this trial in
adults uses Wyeth-pioneered conjugation technology, and is based on the
science of PREVENAR(TM) (Pneumococcal Saccharide Conjugated Vaccine,
Adsorbed). PREVENAR is indicated for active immunization of infants and
children from 6 weeks through 9 years of age against invasive disease,
pneumonia and otitis media caused by Streptococcus pneumoniae serotypes 4,
6B, 9V, 14, 18C, 19F and 23F. The study vaccine includes six serotypes (1,
3, 5, 6A, 7F and 19A), in addition to the seven serotypes included in
PREVENAR. The 13-valent pneumococcal conjugate vaccine is currently being
studied in late-stage global clinical trials in both infants and adults.

    "Pneumococcal pneumonia in adults represents a significant burden, both
clinically and economically," says Emilio Emini, Ph.D., Executive Vice
President, Vaccine Research and Development, Wyeth Pharmaceuticals. "This
will be an important trial to evaluate our conjugate vaccine's potential to
address this medical need."

    About Pneumonia and Pneumococcal Disease

    Pneumonia is a leading cause of death and hospitalization, costing
health care systems billions of dollars and an estimated 600,000 adult
deaths worldwide each year. Pneumococcal disease is caused by the bacterium
Streptococcus pneumoniae and the term describes a group of illnesses,
including invasive infections, such as bacteremia/sepsis and meningitis, as
well as pneumonia and upper respiratory tract infections. Although all age
groups may be affected, the highest rate of pneumococcal disease occurs in
young children and older adults. In addition, persons suffering from a wide
range of chronic conditions (eg, diabetes, cardiovascular disease) and
immune deficiencies are at increased risk.

    Important Safety Information for PREVENAR(TM)

    In clinical studies (n=18,168) in children, 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(TM).
Hypersensitivity to any vaccine component, including diphtheria toxoid, is
a contraindication to its use. PREVENAR does not provide 100% protection
against vaccine serotypes or protect against nonvaccine serotypes.

    As many pathogens other than the pneumococcal serotypes represented in
the vaccine may contribute to the burden of pneumonia, protection against
all clinical pneumonia is expected to be lower than for invasive
pneumococcal disease.

    PREVENAR is not indicated for use in adults or in infants younger than
6 weeks of age.

    About Wyeth Pharmaceuticals

    Wyeth Pharmaceuticals, a division of Wyeth, 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 that 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, without
limitation, the inherent uncertainty of the timing and success of, and
expense associated with, research, development, regulatory approval and
commercialization of our products and 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; emerging data on our products and pipeline 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" in
our Annual Report on Form 10-K for the year ended December 31, 2007, which
was filed with the Securities and Exchange Commission on February 29, 2008.
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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