Biotech Values

[DewDiligence]

FDA approves ABBV/ENTA’s 2-DAA regimen for GT4—several months before the PDUFA date:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455857.htm

This is the same 2-DAA regimen (ABT-450/ABT-267) for which ABVV/ENTA have GT4 approval in the EU and have a pending review for GT1b approval in Japan; however (unlike the EU and [proposed] Japanese labels), the FDA label includes use of ribavirin. ENTA receives a tiered double-digit royalty based on 45% (rather than 30%) of the gross sales.

GT4 represents about 6% of the US HCV market. The US brand name for the regimen is Technivie.

[An earlier version of this post said that the FDA label regimen did not include ribavirin.]