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Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers
Collegeville, Pennsylvania (ots/PRNewswire) -
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes included in the vaccine. The vaccine includes six new serotypes (1, 3, 5, 6A, 7F and 19A) in addition to the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in PREVNAR(R), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), also known as PCV7.
"While the incidence of pneumococcal disease has been substantially reduced since our introduction of PREVNAR in the United States, pneumococcal disease remains a health threat to children, specifically as emerging strains, such as 19A, become more prevalent," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "With that in mind, we are very pleased that the FDA has granted Fast Track designation to our investigational 13-valent vaccine for pediatric use."
Fast Track designation is designed to facilitate review of products that address serious or potentially life threatening conditions for which there is an unmet medical need. With Fast Track designation, Wyeth plans to submit the biologics license application on a rolling basis as sections of the application are completed, enabling the FDA to begin review sooner.
The Company expects to complete its U.S. filing for pediatric use of the vaccine in the first quarter of 2009. Wyeth is also exploring opportunities to accelerate the timing of pediatric filings of the vaccine in the rest of the world from its current target of the first quarter of 2009. Wyeth's investigational 13-valent pneumococcal conjugate vaccine is being studied in Phase 3 global clinical trials in both infants and adults.
Wyeth recently has achieved significant success in bringing new products to market. In the first quarter of 2008 alone, Wyeth obtained three new product approvals in the following therapeutic areas: major depressive disorder, Hemophilia A and opioid-induced constipation.
According to the World Health Organization (WHO), pneumococcal disease is the number one vaccine-preventable cause of death in children younger than 5 years of age. Due to the significant burden of pneumococcal disease and demonstrated vaccine efficacy, WHO recommends the priority inclusion of PCV7 in national childhood immunization programs worldwide. WHO notes that once other pneumococcal vaccines offering broader protection become available, countries can assess whether it would be helpful to switch to these vaccines.
Pneumococcal disease affects both children and adults and is a leading cause of illness and death worldwide. Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae and describes a group of illnesses, including invasive infections, such as bacteremia/sepsis and meningitis, as well as pneumonia and upper respiratory tract infections, including otitis media.
Important Safety Information about PREVNAR
In clinical trials (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 PREVNAR. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. PREVNAR does not provide 100 percent protection against vaccine serotypes or protect against nonvaccine serotypes.
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. These risks and uncertainties include, without limitation, 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; 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; economic conditions including interest and currency exchange rate fluctuations; 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, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. 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.
Web site: http://www.wyeth.com
ots Originaltext: Wyeth Pharmaceuticals
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Media, Lili Gordon, Wyeth Pharmaceuticals, +1-484-865-6671, or Doug
Petkus, Wyeth, +1-973-660-5218; or Investors, Justin Victoria, Wyeth,