Wyeth Provides Regulatory Update on Prevnar 13* in the United States
August 11 2009 - 4:30PM
PR Newswire (US)
-FDA extends review time by 90 days- COLLEGEVILLE, Pa., Aug. 11
/PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of
Wyeth (NYSE:WYE), announced it received notice that the action date
for the U.S. Food and Drug Administration's (FDA) review of the
Biologics License Application (BLA) for Prevnar 13(TM),
(Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197
Protein]) has been extended from September 30, 2009, to December
30, 2009. In response to an FDA request, Wyeth submitted additional
analytical method validation and specification information relating
to physical/chemical properties of the product in late July. FDA
considered this to be a major amendment and, as a result, they have
elected to extend the review cycle for Prevnar 13 by 90 days.
Prevnar 13 is under review for active immunization of infants and
young children for the prevention of invasive disease and otitis
media caused by 13 Streptococcus pneumoniae (S. pneumoniae)
serotypes. "This is a significant application that is under
priority review and we are working closely with the FDA on the
review, including conduct of the pre-approval inspections," says
Emilio Emini, Ph.D., executive vice president, Vaccine Research and
Development, Wyeth Pharmaceuticals. "Priority review designation is
given to products that, if approved, would be a significant
therapeutic or public health advance. We continue to believe that
our application supports the approval of Prevnar 13." Prevnar
13(TM) is based on the scientific foundation of Prevnar
(Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197
Protein]), the standard in pneumococcal disease prevention for
infants and young children. It contains the seven serotypes in
Prevnar (4, 6B, 9V, 14, 18C, 19F and 23F), plus six additional
serotypes (1, 3, 5, 6A, 7F and 19A) responsible for the greatest
remaining burden of invasive disease. Prevnar has been available in
the U.S. for more than nine years. It is currently available in 95
countries and more than 235 million doses have been distributed
worldwide. The Prevnar 13 submission is based on a clinical trial
program of 13 core Phase 3 studies involving more than 7,000
infants and young children. To date, the company has submitted
regulatory applications for Prevnar 13 in more than 50 countries
spanning six continents, with filings in additional countries
planned. In July, Prevenar 13*, as it is known outside the U.S.,
was approved in Chile for use in infants and young children. About
Pneumococcal Disease Pneumococcal disease is complex and describes
a group of illnesses all caused by the bacterium Streptococcus
pneumoniae. Pneumococcal disease is the leading cause of
vaccine-preventable death worldwide in children younger than 5
years of age and is estimated to cause up to one million deaths
worldwide in children each year. Pneumococcal disease affects both
children and adults, and includes invasive infections such as
bacteremia/sepsis and meningitis, as well as pneumonia and otitis
media. Important Safety Information for Prevnar 13* In clinical
studies, the most commonly reported adverse events in children were
injection site reactions, fever, irritability, decreased appetite,
and increased and/or decreased sleep. Risks are associated with all
vaccines, including Prevnar 13. Hypersensitivity to any vaccine
component, including diphtheria toxoid, is a contraindication to
its use. As with any vaccine, Prevnar 13 may not provide 100%
protection against vaccine serotypes or protect against nonvaccine
serotypes. Indication for Prevnar Prevnar 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 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 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 caused by S.
pneumoniae. This vaccine should not be used for treatment of active
infection. Important Safety Information for Prevnar Ask your
child's health care provider about the risks and benefits of
Prevnar and if Prevnar is right for your child. In clinical
studies, 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
for 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 Prevnar 13 will receive regulatory approval in the
United States or in other markets or will be commercially
successful. 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. *Trademark DATASOURCE: Wyeth
Pharmaceuticals CONTACT: Media, Natalie de Vane of Wyeth
Pharmaceuticals, +1-484-865-5139, or Douglas Petkus of Wyeth,
+1-973-660-5218, or Investors, Justin Victoria of Wyeth,
+1-973-660-5340
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