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Major Adult Vaccine Clinical Trial for Pneumonia Prevention Begins

Geschrieben am 23-09-2008

Collegeville, Pennsylvania (ots/PRNewswire) -

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

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

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
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.

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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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