MEDIA RELEASE PR35387
Wyeth's Prevenar 13* Receives First Approval
COLLEGEVILLE, Pa., July 14 /PRNewswire-AsiaNet/ --
-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
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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