Last month, Pfizer ($PFE) presented positive headline results from its massive Prevnar 13 trial, but the release was light on the details that could shape whether the data leads to an expanded recommendation. Now Pfizer has published a closer look at the data, and not everyone likes what they see.
While the initial release just said the trial met its primary and secondary objectives, the latest presentation discusses the underlying data. Participants who received Prevnar 13 had 46% fewer first episodes of community-acquired pneumonia (CAP), the factor Pfizer was tracking for its primary objective. The vaccine group also experienced 45% fewer first episodes of non-invasive CAP, and a 75% fall in invasive pneumococcal disease. Both declines were significant enough for the trial to meet its two secondary objectives.
Reuters reports J.P. Morgan analyst Chris Schott called the data "robust," while BMO Capital Markets' Alex Arfaei described it as "positive and better than our expectations." Both predict the data will lead to expanded use of Prevnar in adults, with Arfaei the more bullish of the two. The BMO analyst thinks adult sales of Prevnar could reach $4 billion by 2016. Last year sales of Prevnar 13 and its predecessor were $4.4 billion. Arfaei's forecast is based on the expectation that adult uptake of Prevnar will be strong outside the U.S. because smoking and other factors make these populations more vulnerable to pneumococcal disease.
The vaccine might prove a tougher sell in the U.S. where pneumococcal disease is less of a burden and herd immunity is a factor. The Netherlands introduced Prevnar 7 for kids in 2006--and last year reported a "sharp decline" in cases among non-vaccinated adults--but ISI Group analyst Mark Schoenebaum questioned how the data will translate to the U.S. "Advisory Committee on Immunization Practices discussion will be tough," Schoenebaum wrote in a note seen by Medical Marketing & Media.
- here's Reuters' article
- check out MM&M's take
- read Pfizer's release
- and the Dutch report (PDF)