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Re: DewDiligence post# 190320

Thursday, 04/23/2015 11:39:56 AM

Thursday, April 23, 2015 11:39:56 AM

Post# of 252255
ABBV/ENTA GT4 NDA for 2-DAA Viekira regimen gets FDA priority review:

http://finance.yahoo.com/news/enanta-announces-u-fda-grants-121600402.html

The exact PDUFA date isn’t disclosed, but it should be during Oct/Nov 2015. GT4 represents 6% of the US HCV population, but its economic relevance for ENTA is greater than the 6% figure would suggest because ENTA’s royalty rate is based on 45% of the 2-DAA regimen’s sales (rather than 30% for the 3-DAA V-Pak).

In the EU, ABBV/ENDA’s 2-DAA regimen called Viekirax is already approved for GT4 patients (http://ir.enanta.com/phoenix.zhtml?c=147990&p=irol-newsArticle&ID=2008241 ).

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