Pfizer's Prevnar 13 meets all endpoints in pivotal Ph III trials on over 50s

Global drugs behemoth Pfizer (NYSE: PFE) says that the data from its two pivotal Phase III immunogenicity and safety trials of pneumonia vaccine Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) in adults aged 50 years and older met all study endpoints.

These studies provide the clinical foundation for the regulatory filings that have been submitted in the USA, the European Union and more than a dozen other countries. The results were presented yesterday at the 21st European Congress of Clinical Microbiology and Infectious Diseases and the 27th International Congress of Chemotherapy (ECCMID/ICC) in Milan, Italy.

The firm’s pneumonia vaccines Prevnar and Prevnar13 had combined sales of $996 million in the first quarter of this year (The Pharma Letter May 4), up a massive 248%, and Prevnar 13 is approved for use in children up to the age of six. Pfizer has submitted supplemental applications seeking regulatory approval to expand the use of Prevnar 13 to adults aged 50 years and older in more than 40 countries around the world with additional submissions planned. According to analysts polled by Bloomberg, the vaccine could generate sales of $5.5 billion a year by 201.f