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Re: DewDiligence post# 119733

Wednesday, 11/16/2011 6:38:53 PM

Wednesday, November 16, 2011 6:38:53 PM

Post# of 257262
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.)

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