Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers

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 it has submitted a Biologic License Application (BLA) to
the U.S. Food and Drug Administration (FDA) for Prevnar 13(TM),
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197)
Protein). Last year, the FDA granted Prevnar 13 Fast Track
designation, which is designed to facilitate review of products that
address serious or potentially life-threatening conditions for which
there is an unmet medical need.

Prevnar 13 is designed to protect against the 13 most prevalent
serotypes associated with pneumococcal disease (PD), the leading
cause of vaccine-preventable death worldwide. 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.

"We are pleased that, with this milestone, we are now one step
closer to bringing Prevnar 13 to infants and children," says Emilio
Emini, Ph.D., Executive Vice President, Vaccine Research and
Development, Wyeth Pharmaceuticals. "Prevnar, our currently available
vaccine, has both proven clinical efficacy and documented
effectiveness, which has resulted in a significant public health
impact. Prevnar 13 builds on the scientific foundation of Prevnar
and, if approved, will provide coverage for the 13 most prevalent
pneumococcal serotypes associated with pneumococcal disease,
including serotype 19A, which has emerged as a serious public health
threat in the United States and around the world."

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 is
also 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 of which are caused by the bacterium Streptococcus
pneumoniae. PD 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 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.

Indication

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
Prevnar. 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 (greater than or equal to 38
degrees Celsius /100.4 degrees Fahrenheit), 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 our
regulatory submissions for Prevnar 13 will be accepted for review by
regulatory agencies or 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.

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

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