Replies to post #119733 on Biotech Values

[DewDiligence]

CHMP approves Prevnar 13 for adults age 50+:

http://www.reuters.com/article/2011/09/23/pfizer-idUSS1E78M0HQ20110923

Prevar/Prevar 13 will become PFE’s biggest franchise when Lipitor goes off-patent in a few months. (Enbrel is a bigger drug, but PFE shares Enbrel’s profits with AMGN.)

[DewDiligence]

FDA advisory panel endorses Prevnar 13 for adults age 50-infinity:

http://www.bloomberg.com/news/2011-11-16/pfizer-s-prevnar-13-wins-panel-backing-for-adults-50-and-older.html

The vote was 14-1 in favor, which is not surprising insofar as Prevnar 13 merely had to show comparable immune response to a very old drug from MRK called Pneumovax 23 (#msg-62901106).

Prevnar 13, which is already approved for children age 0.5-6.0, has a PDUFA date of 1/2/12 for the label expansion to adults. It was recently approved by Europe’s CHMP for the 50-infinity age group (#msg-67373824).

Within the next year or so, (when Lipitor will be off-patent everywhere), Prevnar/Prevnar 13 will likely become PFE’s biggest-selling franchise (#msg-62921065). It currently sells at an annualized rate of $4B, of which about half comes from the US, and approval in adults will almost certainly push sales to more than $5B. (Enbrel is a bigger drug, but PFE shares Enbrel’s sales and profits with AMGN.)