InvestorsHub Logo
icon url

pollyvonwog

04/23/15 9:12 AM

#190321 RE: DewDiligence #190320

ABBV just reaffirmed $3b run rate by Q4
icon url

DewDiligence

04/23/15 11:39 AM

#190349 RE: DewDiligence #190320

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 ).