Wyeth Submits European Marketing Authorization Application for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Young Children

Collegeville, Pennsylvania (ots/PRNewswire) -

- Approval sought for investigational vaccine for protection
against the 13 most prevalent serotypes associated with serious
pneumococcal disease

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that it has submitted a marketing authorization application
(MAA) to the European Medicines Agency (EMEA) for approval to market
its investigational 13-valent pneumococcal conjugate vaccine (PCV13)
for infants and young children. Wyeth is seeking an indication for
the prevention of pneumococcal disease (PD) caused by the 13
serotypes included in the investigational vaccine in infants and
children from two months to five years of age. The review of the MAA
will be coordinated by the EMEA for all 27 countries in the European
Union, as well as Norway, Iceland and Liechtenstein.

PCV13 includes the 13 most prevalent pneumococcal serotypes
associated with serious PD. Seven of these (4, 6B, 9V, 14, 18C, 19F
and 23F) are included in Prevenar* (Pneumococcal saccharide
conjugated vaccine, adsorbed) -- 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 remaining invasive disease. Both Prevenar (also known as
PCV7) and PCV13 use CRM197 -- an immunological carrier protein with a
20-year history of use in pediatric vaccines.

"Today's submission is an important milestone for Wyeth and
underscores the company's commitment to help protect current and
future generations from serious pneumococcal disease," says Emilio
Emini, Ph.D., Executive Vice President, Vaccine Research and
Development, Wyeth Pharmaceuticals. "Since its introduction, Prevenar
has had a substantial impact on public health, dramatically reducing
the rate of invasive pneumococcal disease where it is routinely used.
Our investigational 13-valent pneumococcal conjugate vaccine is
designed to broaden protection, with the potential to cover up to 92
percent of invasive pneumococcal disease in infants and young
children worldwide."

The PCV13 submission to EU regulators includes data from 12 Phase
3 studies, involving more than 7,000 infants and young children. Data
from these studies have demonstrated that, for the pneumococcal
serotypes common to both vaccines, the immunogenicity of PCV13 is
comparable to that of Prevenar using a pre-determined set of
immunological criteria. In addition, PCV13 elicits antibacterial
functional antibodies to the six additional serotypes. These
observations indicate that PCV13 may be as effective as Prevenar in
helping to prevent invasive pneumococcal disease (IPD) due to the
seven shared serotypes in the vaccines and may also be effective in
helping to prevent IPD due to the six additional serotypes. The
results also showed that the safety and tolerability of PCV13 and
Prevenar are comparable, and that PCV13 can be administered with
other commonly used pediatric vaccines.

Earlier this year, the U.S. Food and Drug Administration (FDA)
granted Fast Track designation to PCV13 for infants and toddlers.
Fast Track designation is designed to facilitate review of products
for serious or life-threatening conditions for which there is an
unmet medical need. The Company expects to complete its U.S. filing
for pediatric use of the vaccine in the first quarter of 2009, while
initiating other pediatric filings in the near term. PCV13 is also
being studied in global Phase 3 clinical trials in adults, with
regulatory filings expected in 2010.

Pneumococcal Disease

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.

Due to the significant burden of pneumococcal disease and
demonstrated vaccine efficacy, the World Health Organization (WHO)
recommends the priority inclusion of PCV7 in national childhood
immunization programs worldwide.

Important Safety Information for Prevenar (PCV7)

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. The frequency of
pneumococcal serotypes and serogroups can vary from country to
country, which could influence the effectiveness of the vaccine in
any given country.

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. The Phase 3 clinical trial data publicly
presented to date reflect only four of the 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
our regulatory submissions for PCV13 will be accepted for review by
regulatory agencies or 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.

*(Trademark)

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

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