COLLEGEVILLE, Pa., May 29 /PRNewswire-FirstCall/ -- 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.
SOURCE Wyeth Pharmaceuticals
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Related links:
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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