Wyeth Receives Positive Opinion from European Regulators for its 13-valent Pneumococcal Candidate Vaccine for Infants and Young
September 25 2009 - 11:08AM
PR Newswire (US)
COLLEGEVILLE, Pa., Sept. 25 /PRNewswire-FirstCall/ -- 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 the world." 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
worldwide. 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. Pneumococcal Disease 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 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 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 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. *Trademark DATASOURCE: Wyeth Pharmaceuticals CONTACT:
Media, Lili Gordon, +1-484-865-6671, or Douglas Petkus,
+1-973-660-5218, or Investors, Justin Victoria, +1-973-660-5340,
all of Wyeth Web Site: http://www.wyeth.com/
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