Wyeth Provides Regulatory Update on Prevnar 13* in the United States
-FDA extends review time by 90 days-
Collegeville, Pa., August 11, 2009 - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced it received notice that the action date for the U.S. Food and Drug Administration's (FDA) review of the Biologics License Application (BLA) for Prevnar 13TM, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) has been extended from September 30, 2009, to December 30, 2009. In response to an FDA request, Wyeth submitted additional analytical method validation and specification information relating to physical/chemical properties of the product in late July. FDA considered this to be a major amendment and, as a result, they have elected to extend the review cycle for Prevnar 13 by 90 days. Prevnar 13 is under review for active immunization of infants and young children for the prevention of invasive disease and otitis media caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes.
"This is a significant application that is under priority review and we are working closely with the FDA on the review, including conduct of the pre-approval inspections," says Emilio Emini, Ph.D., executive vice president, Vaccine Research and Development, Wyeth Pharmaceuticals. "Priority review designation is given to products that, if approved, would be a significant therapeutic or public health advance. We continue to believe that our application supports the approval of Prevnar 13."
Prevnar 13TM is based on the scientific foundation of Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the standard in pneumococcal disease prevention for infants and young children. It contains the seven serotypes in Prevnar (4, 6B, 9V, 14, 18C, 19F and 23F), plus six additional serotypes (1, 3, 5, 6A, 7F and 19A) responsible for the greatest remaining burden of invasive disease. Prevnar has been available in the U.S. for more than nine years. It is currently available in 95 countries and more than 235 million doses have been distributed worldwide.
The Prevnar 13 submission is based on a clinical trial program of 13 core Phase 3 studies involving more than 7,000 infants and young children. To date, the company has submitted regulatory applications for Prevnar 13 in more than 50 countries spanning six continents, with filings in additional countries planned. In July, Prevenar 13*, as it is known outside the U.S., was approved in Chile for use in infants and young children.
About Pneumococcal Disease
Pneumococcal disease is complex and describes a group of illnesses all caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease 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 worldwide in children each year.
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 Prevnar 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 Prevnar 13. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. As with any vaccine, Prevnar 13 may not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.
Indication for Prevnar®
Prevnar® is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) are the strains that most commonly cause these serious diseases in children. The routine schedule is 2, 4, 6, and 12 to 15 months of age.
Prevnar® is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.
As with any vaccine, Prevnar® may not protect all individuals receiving the vaccine from serious invasive disease caused by S. pneumoniae. This vaccine should not be used for treatment of active infection.
Important Safety Information for Prevnar®
Ask your child's health care provider about the risks and benefits of Prevnar® and if Prevnar® is right for your child.
In clinical studies, the most frequently reported adverse events included injection site reactions, fever (≥38ºC/100.4ºF), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.
Risks are associated with all vaccines, including Prevnar®. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar® does not protect 100% of children vaccinated. Immunization with Prevnar® does not substitute for routine diphtheria immunization.
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 Prevnar 13 will receive regulatory approval in the United States or in other markets or will be commercially successful. 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.