Major Adult Vaccine Clinical Trial for Pneumonia Prevention Begins



    

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

    
    COLLEGEVILLE, Pa., Sept. 23 /CNW/ -- 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.
    



    




For further information:

For further information: Media, Lili Gordon, Wyeth Pharmaceuticals,
+1-484-865-6671, or Douglas Petkus, Wyeth, +1-973-660-5218, or Investors,
Justin Victoria, Wyeth, +1-973-660-5340

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WYETH PHARMACEUTICALS

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WYETH~~JULIUS CENTER FOR HEALTH SCIENCES AND PRIMARY CARE

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