FDA Grants Priority Review Status to Prevnar 13 Marketing Application



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

    COLLEGEVILLE, Pa., May 7 /PRNewswire-FirstCall/ -- 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 38A°C/100.4A°F),
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
    * Trademark



    




For further information:

For further information: 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

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