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Wyeth Pharmaceuticals

Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers

Collegeville, Pennsylvania (ots/PRNewswire)

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation to the Company's investigational
13-valent pneumococcal conjugate vaccine for infants and toddlers.
Wyeth is seeking a pediatric indication for active immunization
against invasive pneumococcal disease (IPD) and otitis media caused
by serotypes included in the vaccine. The vaccine includes six new
serotypes (1, 3, 5, 6A, 7F and 19A) in addition to the seven
serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in PREVNAR(R),
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein),
also known as PCV7.
"While the incidence of pneumococcal disease has been
substantially reduced since our introduction of PREVNAR in the United
States, pneumococcal disease remains a health threat to children,
specifically as emerging strains, such as 19A, become more
prevalent," says Emilio Emini, Ph.D., Executive Vice President,
Vaccine Research and Development, Wyeth Pharmaceuticals. "With that
in mind, we are very pleased that the FDA has granted Fast Track
designation to our investigational 13-valent vaccine for pediatric
use."
Fast Track designation is designed to facilitate review of
products that address serious or potentially life threatening
conditions for which there is an unmet medical need. With Fast Track
designation, Wyeth plans to submit the biologics license application
on a rolling basis as sections of the application are completed,
enabling the FDA to begin review sooner.
The Company expects to complete its U.S. filing for pediatric use
of the vaccine in the first quarter of 2009. Wyeth is also exploring
opportunities to accelerate the timing of pediatric filings of the
vaccine in the rest of the world from its current target of the first
quarter of 2009. Wyeth's investigational 13-valent pneumococcal
conjugate vaccine is being studied in Phase 3 global clinical trials
in both infants and adults.
Wyeth recently has achieved significant success in bringing new
products to market. In the first quarter of 2008 alone, Wyeth
obtained three new product approvals in the following therapeutic
areas: major depressive disorder, Hemophilia A and opioid-induced
constipation.
Pneumococcal Disease
According to the World Health Organization (WHO), pneumococcal
disease is the number one vaccine-preventable cause of death in
children younger than 5 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 once other
pneumococcal vaccines offering broader protection become available,
countries can assess whether it would be helpful to switch to these
vaccines.
Pneumococcal disease affects both children and adults and is a
leading cause of illness and death worldwide. Pneumococcal disease is
caused by the bacterium Streptococcus pneumoniae and describes a
group of illnesses, including invasive infections, such as
bacteremia/sepsis and meningitis, as well as pneumonia and upper
respiratory tract infections, including otitis media.
Important Safety Information about PREVNAR
In clinical trials (n=18,168), 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 provide
100 percent protection against vaccine serotypes or protect against
nonvaccine serotypes.
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. These risks and
uncertainties 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.
Web site: http://www.wyeth.com

Contact:

Media, Lili Gordon, Wyeth Pharmaceuticals, +1-484-865-6671, or Doug
Petkus, Wyeth, +1-973-660-5218; or Investors, Justin Victoria, Wyeth,
+1-973-660-5340

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