FDA Grants Priority Review Status to Prevnar 13 Marketing Application
May 07 2009 - 8:00AM
PR Newswire (US)
-- Candidate vaccine designed to protect against the 13 most
prevalent serotypes associated with pneumococcal disease --
COLLEGEVILLE, Pa., May 7 /PRNewswire-FirstCall/ -- Wyeth
Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today
that the U.S. Food and Drug Administration (FDA) granted priority
review to the company's Biologic License Application (BLA) for
Prevnar 13*, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria
CRM(197) Protein), which was submitted on March 31. Priority review
designation is given to products that, if approved, would be a
significant therapeutic or public health advance. Based on this
designation, Wyeth expects a regulatory decision within six months.
Wyeth is seeking an indication in the U.S. for Prevnar 13 for the
prevention of invasive pneumococcal disease (IPD) and otitis media
caused by the 13 serotypes included in the investigational vaccine
in children aged two months through five years. Seven of these
serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in
Prevnar(R), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria
CRM(197) Protein) - 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 remaining burden
of invasive disease. Both Prevnar 13 and Prevnar use CRM(197) - an
immunological carrier protein with a 20-year history of use in
pediatric vaccines. "Since its launch in 2000, our 7-valent
pneumococcal vaccine, Prevnar, has significantly reduced the
incidence of pneumococcal disease among infants and young children
in the United States. Recently, however, disease due to
pneumococcal serotypes not found in Prevnar, particularly serotype
19A, have increased in prevalence in many regions of the world, and
are a significant public health concern," says Emilio Emini, Ph.D.,
Executive Vice President, Vaccine Research and Development, Wyeth
Pharmaceuticals. "Prevnar 13, which builds on the scientific
foundation of Prevnar, is designed to provide protection against
the 13 most prevalent serotypes associated with pneumococcal
disease." The Prevnar 13* submission to the FDA includes data from
13 Phase 3 studies, involving more than 7,000 infants and young
children. The Company initiated its global pediatric filings in
late 2008 and, to date, has submitted regulatory applications for
the 13-valent candidate vaccine in more than 40 countries
worldwide. Prevnar 13 also is being studied in global Phase 3
clinical trials in adults, with regulatory submissions expected in
2010. Pneumococcal Disease Pneumococcal disease is complex and
describes a group of illnesses, all caused by the bacterium
Streptococcus pneumoniae. Pneumococcal disease affects both
children and adults, and includes invasive infections such as
bacteremia/sepsis and meningitis, as well as pneumonia and otitis
media (middle ear infection). Following the inclusion of Prevnar(R)
into the routine pediatric immunization schedule in the United
States, there has been a 98 percent (95% CI: 97%-99%) reduction in
vaccine-type IPD and a 77 percent reduction in all IPD among
children younger than 5 years of age through 2005, compared with a
pre-licensure baseline. In addition, the incidence of disease
caused by the seven conjugate vaccine serotypes declined 55 percent
(95% CI: 51%-58%) among adults 50 years of age or older, an
unvaccinated group. The Centers for Disease Control and Prevention
has reported an increase in the incidence of IPD due to non-vaccine
serotypes in children younger than 5 years of age and in adults 40
years of age and older; it is unknown whether these effects would
be observed in other populations. Most recently, 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. In fact, serotype 19A has emerged as the
predominant invasive pneumococcal serotype in the United States.
Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria
CRM(197) Protein), 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 caused these serious diseases in children prior to
the introduction of the vaccine. The routine vaccination 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 (less than or equal
to 38°C/100.4°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. 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 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, 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 * Trademark DATASOURCE: Wyeth
Pharmaceuticals CONTACT: Media, Lili Gordon of Wyeth
Pharmaceuticals, +1-484-865-6671; or Douglas Petkus,
+1-973-660-5218, or Investors, Justin Victoria, +1-973-660-5340,
both of Wyeth
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