FDA Grants Priority Review Status to Prevnar 13 Marketing Application

Collegeville, Pennsylvania (ots/PRNewswire) -

-- Candidate vaccine designed to protect against the 13 most
prevalent serotypes associated with pneumococcal disease --

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that the U.S. Food and Drug Administration (FDA) granted
priority review to the company's Biologic License Application (BLA)
for Prevnar 13*, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria
CRM(197) Protein), which was submitted on March 31. Priority review
designation is given to products that, if approved, would be a
significant therapeutic or public health advance. Based on this
designation, Wyeth expects a regulatory decision within six months.

Wyeth is seeking an indication in the U.S. for Prevnar 13 for the
prevention of invasive pneumococcal disease (IPD) and otitis media
caused by the 13 serotypes included in the investigational vaccine in
children aged two months through five years. Seven of these serotypes
(4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar(R),
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein)
- the current global standard in PD prevention in infants and young
children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are
associated with the greatest remaining burden of invasive disease.
Both Prevnar 13 and Prevnar use CRM(197) - an immunological carrier
protein with a 20-year history of use in pediatric vaccines.

"Since its launch in 2000, our 7-valent pneumococcal vaccine,
Prevnar, has significantly reduced the incidence of pneumococcal
disease among infants and young children in the United States.
Recently, however, disease due to pneumococcal serotypes not found in
Prevnar, particularly serotype 19A, have increased in prevalence in
many regions of the world, and are a significant public health
concern," says Emilio Emini, Ph.D., Executive Vice President, Vaccine
Research and Development, Wyeth Pharmaceuticals. "Prevnar 13, which
builds on the scientific foundation of Prevnar, is designed to
provide protection against the 13 most prevalent serotypes associated
with pneumococcal disease."

The Prevnar 13* submission to the FDA includes data from 13 Phase
3 studies, involving more than 7,000 infants and young children.

The Company initiated its global pediatric filings in late 2008
and, to date, has submitted regulatory applications for the 13-valent
candidate vaccine in more than 40 countries worldwide. Prevnar 13
also is being studied in global Phase 3 clinical trials in adults,
with regulatory submissions expected in 2010.

Pneumococcal Disease

Pneumococcal disease is complex and describes a group of
illnesses, all caused by the bacterium Streptococcus pneumoniae.
Pneumococcal disease affects both children and adults, and includes
invasive infections such as bacteremia/sepsis and meningitis, as well
as pneumonia and otitis media (middle ear infection).

Following the inclusion of Prevnar(R) into the routine pediatric
immunization schedule in the United States, there has been a 98
percent (95% CI: 97%-99%) reduction in vaccine-type IPD and a 77
percent reduction in all IPD among children younger than 5 years of
age through 2005, compared with a pre-licensure baseline. In
addition, the incidence of disease caused by the seven conjugate
vaccine serotypes declined 55 percent (95% CI: 51%-58%) among adults
50 years of age or older, an unvaccinated group. The Centers for
Disease Control and Prevention has reported an increase in the
incidence of IPD due to non-vaccine serotypes in children younger
than 5 years of age and in adults 40 years of age and older; it is
unknown whether these effects would be observed in other populations.

Most recently, serotype 19A, which is included in the candidate
vaccine, has been increasing in prevalence in many regions of the
world and is frequently resistant to antibiotics. In fact, serotype
19A has emerged as the predominant invasive pneumococcal serotype in
the United States.

Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria
CRM(197) Protein), is indicated for active immunization of infants
and toddlers against serious invasive disease caused by Streptococcus
pneumoniae, including bacteremia (bloodstream infection) and
meningitis (infection of the membranes surrounding the brain and
spinal cord) caused by the seven serotypes in the vaccine. The seven
serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B,
9V, 14, 18C, 19F, and 23F) are the strains that most commonly caused
these serious diseases in children prior to the introduction of the
vaccine. The routine vaccination schedule is 2, 4, 6, and 12 to 15
months of age.

Prevnar is also indicated for immunization of infants and
toddlers against otitis media (ear infections) caused by the seven
serotypes included in the vaccine. Protection against ear infections
is expected to be less than that for invasive disease.

As with any vaccine, Prevnar may not protect all individuals
receiving the vaccine from serious invasive disease cause by S.
pneumoniae. This vaccine should not be used for treatment of active
infection.

Important Safety Information for Prevnar

In clinical trials, the most frequently reported adverse events
included injection site reactions, fever (less than or equal to 38
degreesC/100.4 degreesF), irritability, drowsiness, restless sleep,
decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevnar.
Hypersensitivity to any vaccine component, including diphtheria
toxoid, is a contraindication to its use. Prevnar does not protect
100% of children vaccinated. Immunization with Prevnar does not
substitute routine diphtheria immunization.

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, nutritionals 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. In particular,
clinical trial data are subject to differing interpretations, and the
views of regulatory agencies, medical and scientific experts and
others may differ from ours. There can be no assurance that Prevnar
13 will ever receive regulatory approval or be successfully developed
and commercialized. Other risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by forward-looking statements include, among others, risks related to
our proposed merger with Pfizer, including satisfaction of the
conditions of the proposed merger on the proposed timeframe or at
all, contractual restrictions on the conduct of our business included
in the merger agreement, and the potential for loss of key personnel,
disruption in key business activities or any impact on our
relationships with third parties as a result of the announcement of
the proposed merger; 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; the outcome of
government investigations; 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; global
economic conditions; interest and currency exchange rate fluctuations
and volatility in the credit and financial markets; 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, 2008, which was
filed with the Securities and Exchange Commission on February 27,
2009. 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.

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

Contact:
Media, Lili Gordon of Wyeth Pharmaceuticals, +1-484-865-6671; or
Douglas Petkus, +1-973-660-5218, or Investors, Justin Victoria,
+1-973-660-5340, both of Wyeth