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FDA Grants Priority Review Status to Prevnar 13 Marketing Application
Date:5/7/2009

-- Candidate vaccine designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease --

COLLEGEVILLE, Pa., May 7 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) granted priority review to the company's Biologic License Application (BLA) for Prevnar 13*, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein), which was submitted on March 31. Priority review designation is given to products that, if approved, would be a significant therapeutic or public health advance. Based on this designation, Wyeth expects a regulatory decision within six months.

Wyeth is seeking an indication in the U.S. for Prevnar 13 for the prevention of invasive pneumococcal disease (IPD) and otitis media caused by the 13 serotypes included in the investigational vaccine in children aged two months through five years. Seven of these serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar(R), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein) - the current global standard in PD prevention in infants and young children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest remaining burden of invasive disease. Both Prevnar 13 and Prevnar use CRM(197) - an immunological carrier protein with a 20-year history of use in pediatric vaccines.

"Since its launch in 2000, our 7-valent pneumococcal vaccine, Prevnar, has significantly reduced the incidence of pneumococcal disease among infants and young children in the United States. Recently, however, disease due to pneumococcal serotypes not found in Prevnar, particularly serotype 19A, have increased in prevalence in many regions of the world, and are a significant public health con
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SOURCE Wyeth Pharmaceuticals
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