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Wyeth Submits European Marketing Authorization Application for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Young Children
Date:12/3/2008

COLLEGEVILLE, Pa., Dec. 3 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for approval to market its investigational 13-valent pneumococcal conjugate vaccine (PCV13) for infants and young children. Wyeth is seeking an indication for the prevention of pneumococcal disease (PD) caused by the 13 serotypes included in the investigational vaccine in infants and children from two months to five years of age. The review of the MAA will be coordinated by the EMEA for all 27 countries in the European Union, as well as Norway, Iceland and Liechtenstein.

PCV13 includes the 13 most prevalent pneumococcal serotypes associated with serious PD. Seven of these (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevenar* (Pneumococcal saccharide conjugated vaccine, adsorbed) - - 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 burden of remaining invasive disease. Both Prevenar (also known as PCV7) and PCV13 use CRM197 -- an immunological carrier protein with a 20-year history of use in pediatric vaccines.

"Today's submission is an important milestone for Wyeth and underscores the company's commitment to help protect current and future generations from serious pneumococcal disease," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "Since its introduction, Prevenar has had a substantial impact on public health, dramatically reducing the rate of invasive pneumococcal disease where it is routinely used. Our investigational 13-valent pneumococcal conjugate vaccine is designed to broaden protection, with the pot
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