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EU Nod for Pfizer's Prevenar Label Expansion

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Pfizer Inc. (PFE - Free Report) recently announced that it has received EU approval for an expanded indication for its pneumococcal conjugate vaccine, Prevenar 13. With this approval, Prevenar 13 can now be used for the active immunization of adults 18 to 49 years of age for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae (S. pneumoniae).

Prevenar 13 was earlier approved in the EU for use in infants, young children and adolescents (6 weeks to 17 years old) and adults ≥50 years of age. However, with the new expanded label, Prevenar 13 can now be used in the EU for all patient populations starting from infancy.

We note that EU approval for use in children 6 to 17 years of age was received earlier this year. Prevenar 13 is approved and marketed in several countries including the US where it is known as Prevnar 13.

The US label includes approval for use in infants, young children and adolescents children (6 weeks through 17 years of age) and adults 50 years of age and above. Prevnar 13 is also approved in children (6 weeks through 5 years) for the prevention of otitis media caused by 7 of the 13 strains.

Pfizer reported Prevnar/Prevenar 13 sales of $3.7 billion in 2012, up 2%. Pfizer is currently conducting the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) in people ≥ 65 years of age.

The study has been designed to evaluate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia caused by the serotypes contained in the vaccine. Pfizer expects this event-driven study to complete in the second half of 2013.

Pfizer currently carries a Zacks Rank #3 (Hold). Pfizer recently lowered its earnings and revenue outlook for 2013 following the divestment of its stake in its former animal health business, Zoetis, Inc. (ZTS - Free Report) .

Companies that currently look well-positioned include Jazz Pharmaceuticals (JAZZ - Free Report) and Santarus, Inc. . While Jazz is a Zacks Rank #1 (Strong Buy) stock, Santarus carries a Zacks Rank #2 (Buy).

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