Phase 3 Data Indicate Investigational 13-valent Vaccine May Broaden Protection Against Pneumoccocal Disease in Children Younger than Two

Washington (ots/PRNewswire) -

- Data presented at the joint annual meeting of ICAAC and IDSA

- Results suggest candidate vaccine may be as effective as
Prevnar for the seven shared serotypes, and provide expanded coverage
for six additional serotypes

- Wyeth on track to complete U.S. filing for pediatric use in the
first quarter of 2009, with other pediatric global filings expected
at the same time, or possibly earlier

Data from a pivotal trial and three other Phase 3 studies
presented today indicate that Wyeth's (NYSE: WYE) investigational
13-valent pneumococcal conjugate vaccine (PCV13) may offer broader
protection against pneumococcal disease (PD) in infants and young
children compared to Prevnar(R), Pneumococcal 7-valent Conjugate
Vaccine (Diphtheria CRM197 Protein).

Specifically, the data indicate that PCV13 may be as effective as
Prevnar (also referred to as PCV7) in helping to prevent invasive
pneumococcal disease (IPD) due to the seven serotypes shared by the
vaccines, and may provide expanded coverage for six additional
serotypes found worldwide. The data were presented at the joint
annual meeting of the Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC) and the Infectious Diseases Society of
America (IDSA) in Washington, D.C.

The candidate vaccine includes the 13 most common pneumococcal
serotypes associated with serious PD. Seven of these (4, 6B, 9V, 14,
18C, 19F and 23F) are included in Prevnar -- 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 burden of residual, or remaining, invasive disease. Both
vaccines contain CRM197 -- an immunological carrier protein with a
20-year history of use in pediatric vaccines.

"These new data suggest that the 13-valent pneumococcal vaccine
has the potential to address a critical unmet need," says Emilio A.
Emini, Ph.D., Executive Vice President, Vaccine Research and
Development, Wyeth Pharmaceuticals. "Based on the known prevalence of
pneumococcal serotypes, it is estimated that the candidate vaccine
has the potential to cover up to 92 percent of invasive pneumococcal
disease in infants and young children worldwide. Given the global
burden of serious pneumococcal disease, this candidate vaccine is
designed to provide more comprehensive protection."

The Company expects to complete its U.S. filing for pediatric use
of the vaccine in the first quarter of 2009, with other pediatric
global filings expected at the same time, or possibly earlier. The
13-valent candidate vaccine is also being studied in global Phase 3
clinical trials in adults, with regulatory filings expected in 2010.

Pneumococcal disease affects both children and adults, and is a
leading cause of illness and death worldwide. Pneumococcal disease
describes a group of illnesses, all caused by the bacterium
Streptococcus pneumoniae, that include invasive infections such as
bacteremia/sepsis and meningitis, as well as pneumonia and otitis
media. Most recently, the pneumococcal 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.

Phase 3 Data Results

The data presented today represent four of 13 core Phase 3
studies in the pediatric clinical trial program intended to support
regulatory filings for licensure of the 13-valent vaccine.

European Pivotal Data

The pivotal Phase 3 trial (#G-2117), conducted in Germany with
604 infants, compared the candidate PCV13 to Prevnar. The
immunogenicity assessments were conducted at one month after
completion of the infant vaccination series (using a vaccination
schedule of 2, 3 and 4 months). The immunogenicity objectives of the
study were to:

-- Compare the immune responses elicited by PCV13 and Prevnar against
each of the seven pneumococcal serotypes common to the two vaccines.
-- Evaluate the immune response elicited by the six additional
pneumococcal serotypes included in the 13-valent vaccine.

On the basis of a prospectively defined set of immunogenicity
criteria, the results of the study indicated that the responses
elicited by PCV13 for all 13 serotypes were comparable
(scientifically referred to as "non-inferior") to those of Prevnar.
Additionally, PCV13 elicited functional (biologically active)
antibodies for all 13 serotypes. The results of this study also
indicated that the safety and tolerability of PCV13 and Prevnar were
comparable.

Finally, the study evaluated the immune responses elicited
against several components (hepatitis B, Haemophilus influenzae type
B and diphtheria) of the concomitantly administered Infanrix(R) hexa
(GlaxoSmithKline) pediatric vaccine. Immune responses to these
vaccine antigens were comparable when co-administered with either
PCV13 or Prevnar.

Overall, the results of this pivotal study suggest that PCV13 may
be as effective as Prevnar in helping to prevent pneumococcal disease
caused by the serotypes currently in Prevnar, and that PCV13 may
provide expanded coverage in helping to prevent PD caused by the six
additional serotypes.

Additional Phase 3 Data Presented at ICAAC/IDSA

Data from three additional Phase 3 European trials (France,
Poland and the U.K.) presented at the conference support the pivotal
study conclusion that PCV13 is well tolerated, immunogenic and has
the potential to provide direct protection against the 13 serotypes
included in the vaccine.

-- In the study conducted in France (n=613, #G-2119), three doses of
investigational PCV13 administered to infants elicited a significant
immune response to all 13 vaccine serotypes. In addition, immune
responses to antigens contained in the concomitantly administered
pediatric vaccine, Pentavac(TM) (Sanofi-Pasteur), were generally
comparable, whether given with PCV13 or Prevnar. Safety and
tolerability between the two vaccine groups were also comparable.
-- In the U.K. study (n=278, #G-2118), two doses of the candidate vaccine
given at 2 and 4 months were immunogenic for all serotypes.
Tolerability was comparable to Prevnar, and antibody responses were
comparable to concomitantly administered vaccines (Pediacel(R)
[Sanofi-Pasteur], NeisVac-C(R) [Baxster] and Menitorix(TM)
[GlaxoSmithKline]).
-- In the Poland study (n=269, #G-2116), the results indicated that the
immunogenicity and tolerability of PCV13 produced at manufacturing
scale were similar to that of the candidate vaccine produced at the
pilot scale, which was the type used in most of the Phase 3 clinical
trials.

Safety and tolerability of PCV13 and Prevnar were comparable in
all four studies and the most frequently reported adverse events
included injection site reactions, (redness [erythema], swelling
[induration], and tenderness), fever (greater than or equal to 38
degrees C/100.4 degrees F), irritability, drowsiness, restless sleep,
decreased appetite, vomiting, diarrhea and rash.

"Wyeth's 13-valent pneumococcal conjugate vaccine represents an
important scientific achievement, and demonstrates Wyeth's continuing
commitment to advance health care through pioneering science," adds
Dr. Emini. "The candidate vaccine builds on the scientific foundation
of Prevnar and has the potential to provide direct protection against
pneumococcal disease caused by the 13 most prevalent pneumococcal
serotypes worldwide."

Pneumococcal Disease

According to the World Health Organization (WHO), pneumococcal
disease is the number one vaccine-preventable cause of death in
children younger than five years of age. Due to the significant
burden of pneumococcal disease and demonstrated vaccine efficacy, WHO
recommends the priority inclusion of PCV7 in national childhood
immunization programs worldwide. WHO notes that if other pneumococcal
vaccines that offer expanded protection become available, countries
should assess whether it would be helpful to switch to these
vaccines.

Indication

Prevnar is indicated for active immunization of infants and
toddlers against 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 cause these
serious diseases in children. The routine 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 C/100.4 degrees 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.

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. As noted above, the clinical trial data
presented at the meeting reflect only four of 13 core Phase 3 studies
of PCV13 in the pediatric population and, accordingly, do not
represent the totality of data and other information that may affect
regulatory review and commercialization of PCV13. There can be no
assurance that PCV13 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, 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 of Wyeth Pharmaceuticals, +1-484-865-6671, or
Douglas Petkus of Wyeth, +1-973-660-5218; or Investors, Justin
Victoria of Wyeth, +1-973-660-5340