Collegeville, Pennsylvania (ots/PRNewswire)
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that the European Medicines Agency's (EMEA) Committee for
Medicinal Products for Human Use (CHMP) has issued a positive opinion
for the company's pneumococcal conjugate vaccine, Prevenar 13*
(Pneumococcal Polysaccharide Conjugate Vaccine [13-valent Adsorbed]).
The CHMP recommends approval of Prevenar 13 for active immunization
of children aged 6 weeks to 5 years for the prevention of invasive
pneumococcal disease, as well as pneumonia and otitis media (middle
ear infection) caused by 13 pneumococcal serotypes. The CHMP's
opinion for Prevenar 13 will now be forwarded to the European
Commission and a final decision is expected in the coming months.
"The CHMP's positive opinion brings us one step closer to
providing infants and young children in Europe with the broadest
serotype coverage of any pneumococcal conjugate vaccine," says Emilio
Emini, Ph.D., Executive Vice President, Vaccine Research and
Development, Wyeth Pharmaceuticals. "Prevenar, our currently
available vaccine, has both proven clinical efficacy and documented
effectiveness, which has resulted in a significant public health
benefit. Prevenar 13 builds on the scientific foundation of Prevenar
and, if approved, will provide coverage for the 13 most prevalent
pneumococcal-disease causing serotypes, including serotype 19A, which
has emerged as a serious public health threat in Europe and around
Prevenar 13 is designed to provide the broadest serotype coverage
of any pneumococcal conjugate vaccine. The vaccine contains the seven
serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in Prevenar
(Pneumococcal Saccharide Conjugated Vaccine, Adsorbed) -- the global
standard in pneumococcal disease prevention in infants and young
children -- plus six additional serotypes (1, 3, 5, 6A, 7F and 19A)
responsible for the greatest remaining burden of invasive disease.
Both Prevenar and Prevenar 13 use CRM197 -- an immunological carrier
protein with a 20-year history of use in pediatric vaccines.
Available in Europe since 2001, Prevenar is currently available in 97
countries and more than 265 million doses have been distributed
To date, the company has submitted pediatric regulatory
applications for Prevenar 13 in more than 50 countries spanning six
continents. Prevenar 13 has been approved in two countries, with
Chile being the first in July 2009. Prevenar 13 is also being studied
in global Phase 3 clinical trials in adults, with regulatory
submissions expected in 2010.
Important Safety Information for Prevenar 13
In clinical studies, the most commonly reported adverse reactions
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 component, including diphtheria toxoid, is a
contraindication to its use.
As with other vaccines, the administration of Prevenar 13 should
be postponed in subjects suffering from acute, febrile illness.
However, the presence of a minor infection, such as a cold, should
not result in the deferral of vaccination.
The use of Prevenar 13 should be determined on the bases of
official recommendations, taking into consideration the impact of
invasive disease in different age groups as well as the variability
of serotype epidemiology in different geographic areas. Prevenar 13
does 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 C/100.4 degrees F), 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
non-vaccine 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.
According to the World Health Organization (WHO), pneumococcal
disease is the leading cause of vaccine-preventable death worldwide
in children younger than 5 years and is estimated to cause up to 1
million deaths worldwide in children each year.
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 acute otitis media.
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, haemophilia, oncology, vaccines and nutritional
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
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 the
European Commission will grant final approval to Prevenar 13 or that
Prevenar 13 will be commercially successful or receive regulatory
approval in other markets such as the United States. 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
commercialisation 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 31
December, 2008, which was filed with the Securities and Exchange
Commission on 27 February, 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.
ots Originaltext: Wyeth Pharmaceuticals
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