Wyeth to seek FDA approval for new formations of Prevnar

7/1/2008

MADISON, N.J. Wyeth is working on a new form of its infant and child pneumonia and blood infecting vaccine Prevnar for adults, according to Reuters.

Prevnar now protects against seven strains of streptococcus pneumoniae. The current seven-valent vaccine prevents against strains of the bacterium that cause about 80 percent of pneumococcal infections, and that the new formulation will greatly close the gap, according to Emilio Emini, Wyeth’s head of vaccine research and development.

Wyeth’s new 13-valent formulation, in late stages of development, is designed to protect against an additional six strains of the bacterium. Early next year, the company plans on asking the Food and Drug Administration to approve the more-protective form of Prevnar for infants and young children, and to seek approval in early 2010 to market it to adults age 50 or older.

According to Emini, one of the most important things about the improved vaccine would be that, it would protect against infection with the 19a strain of the bacterium, which has been increasing in incidence and has been becoming more resistant to treatment with antibiotics.

The drug already has sales of about $2.5 billion per year and the approval for adults could provide as much as another $1.5 billion in potential sales, according to research firm Cowen and Co.

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