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Re: DewDiligence post# 182052

Monday, 09/22/2014 2:41:05 PM

Monday, September 22, 2014 2:41:05 PM

Post# of 257268
ENTA—If the decision were up to me, I would decline to opt in for US profit sharing on the ABT-493/ABT-530 program. It’s a close call, but opting in is unduly committal, IMO, to a program that appears to be less economically compelling than either ABBV/ENTA’s 3-DAA global program or ABBV/ENTA’s 2-DAA Japan program (ABT-450/ABT-267 for GT1b and GT2).

I reached this opinion after considering the designs of the phase-2b dose-finding trials for ABT-493/ABT-530 (#msg-106413637), which indicate that there is a lot of work to be done to fine-tune this regimen for multiple genotypes.

Reminder: If ENTA does not opt in for US profit sharing on ABT-493/ABT-530, ENTA will receive a $40M milestone from ABBV for FDA approval, $40M in additional milestones for ex-US approvals, and double-digit royalties on worldwide sales of the ABT-493 portion of the 2-DAA regimen (#msg-104670740).

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