Wyeth's Prevenar 13* Receives First Approval
July 14 2009 - 8:00AM
PR Newswire (US)
-Chile Grants First Approval of Prevenar 13 for the Prevention of
Pneumococcal Disease in Infants and Children- COLLEGEVILLE, Pa.,
July 14 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division
of Wyeth (NYSE:WYE), announced today that the Chilean Ministry of
Health, MINSAL (Ministerio de Salud), has become the first
government agency to approve Prevenar 13* Valent, (Pneumococcal
Conjugate Vaccine 13 Valent (Diphtheria CRM(197) Protein)) for
infants and young children. Prevenar 13 Valent is approved for
active immunization of children aged 6 weeks through 5 years for
the prevention of invasive pneumococcal disease, as well as
pneumonia and otitis media (middle ear infection) caused by 13
pneumococcal serotypes. Pneumococcal disease (PD) 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 in children each year. Prevenar 13, which builds on the
scientific foundation of Prevenar* (Pneumococcal Saccharide
Conjugated Vaccine, Adsorbed), is designed to provide the broadest
serotype coverage of any pneumococcal conjugate vaccine. Prevenar
13 contains 13 serotypes, seven of which (4, 6B, 9V, 14, 18C, 19F
and 23F) are included in Prevenar and six additional serotypes (1,
3, 5, 6A, 7F and 19A) associated with the greatest remaining burden
of invasive disease. Notably, serotype 19A is prevalent in many
regions of the world and is often associated with antibiotic
resistance. "The approval of Prevenar 13 in Chile is the first of
many regulatory decisions we anticipate receiving around the world
this year," says Emilio Emini, Ph.D., Executive Vice President,
Vaccines Research and Development, Wyeth Pharmaceuticals. "We
believe that Prevenar 13 is an important milestone in Wyeth's
ongoing commitment to public health in the fight against serious
pneumococcal disease worldwide." The routine immunization schedule
for Prevenar 13 Valent in Chile is at ages 2, 4, 6, and 12 to 15
months, and the vaccine can be administered at the same time as
other regularly administered childhood vaccines. Children who have
already initiated a vaccination program with Prevenar* can
transition to Prevenar 13* Valent at any point in their dosing
schedule to help protect them from the six additional disease
serotypes included in Prevenar 13 Valent. Children aged 7 months
through 5 years should follow the appropriate dosing schedule for
their age group. There is no information about the
interchangeability of Prevenar or Prevenar 13 Valent with any other
pneumococcal conjugate vaccine that does not contain protein
carrier CRM(197). Wyeth expects Prevenar 13 Valent will be
commercially introduced in Chile later this year. The Company
initiated its global pediatric filings in late 2008 and, to date,
has submitted regulatory applications for Prevenar 13 in more than
50 countries spanning six continents and has been granted priority
review in the U.S., Canada, Australia and South Africa. Prevenar 13
is also being studied in global Phase 3 clinical trials in adults,
with regulatory submissions expected in 2010. About 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. Important Safety Information
for Prevenar 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 Prevenar
13. Hypersensitivity to any vaccine component, including diphtheria
toxoid, is a contraindication to its use. As with any vaccine,
Prevenar 13 may not provide 100% protection against vaccine
serotypes or protect against nonvaccine serotypes. Important Safety
Information for Prevenar* In clinical studies (n=18,168), the most
frequently reported adverse events included injection site
reactions, fever (greater than or equal to 38 degrees Celsius/100.4
degrees Fahrenheit), 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 decision to administer Prevenar should be based on
its efficacy in preventing invasive pneumococcal disease. 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. 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
Prevenar 13 will be commercially successful or will receive
regulatory approval in other markets such as the United States and
the European Union. 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, Lili Gordon of Wyeth
Pharmaceuticals, +1-484-865-6671, or Douglas Petkus of Wyeth,
+1-973-660-5218; or investors, Justin Victoria of Wyeth,
+1-973-660-5340
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