COLLEGEVILLE, Pennsylvania, July 14 --
- Chile Grants First Approval of Prevenar 13 for the Prevention of Pneumococcal
Disease in Infants and Children-
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
SOURCE: Wyeth Pharmaceuticals
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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