Biotech Values

[DewDiligence]

Phase-3 safety study of Prevnar 13 in adults age 18-49 meets all endpoints:

http://finance.yahoo.com/news/pfizer-presents-phase-3-safety-113000881.html

This study supplements the immunogenicity study of Prevnar 13 in adults age 18-49, which reported a successful outcome in 2012 (#msg- 80280271)., and it should ensure FDA approval of Prevnar 13 for adults age 18-49. Inasmuch as Prevnar 13 is already approved for infants, children, adolescents, and adults age 50+, a label expansion to adults 18-49 would include everyone from an of six weeks to infinity.

Still, Prevnar 13 probably won’t become a big products for adults age 18-49 until the CDC endorses such use. CDC recently deferred making such a decision until PFE reports data from a large phase-4 efficacy study (#msg-72423498), which is expected to occur in mid 2015 (http://www.clinicaltrials.gov/ct2/show/study/NCT00744263 ). Curiously, all sites in this phase-4 study are in the Netherlands.

For background on why Prevnar 13 should eventually be a big-selling drug in young and middle-aged adults, please see #msg-80291688 and #msg-62921065.