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Re: DewDiligence post# 169229

Saturday, 05/24/2014 3:54:53 PM

Saturday, May 24, 2014 3:54:53 PM

Post# of 257266
EMA may be considering ABBV/ENTA’s 2-DAA regimen of ABT-450 + ABT-267 (w/o ABT-333 or ribavirin) for GT1b (and GT4*) patients (h/t ‘jq1234’):

https://twitter.com/jq1234t/status/469857759916478464/photo/1
http://t.co/s9feCvTvT6

This is the same 2-DAA regimen where ABBV is conducting phase-3 trials in Japan for GT1b and GT2 (#msg-95444387).

In Europe, ABBV/ENTA’s 2-DAA regimen may be approvable for treatment-naïve GT1b patients without cirrhosis, based on data from the PEARL-1 phase-2 study where the SVR12 rate was 95% (#msg-93662501, #msg-93659700).

Although ABBV/ENTA’s 2-DAA regimen will presumably be priced at a discount to the 3-DAA regimen, the royalty rate for ENTA will be higher on the 2-DAA regimen (because ABT-450 comprises a larger portion of the regimen’s value) and the absolute royalty payable to ENTA per sales dollar ought to be at least as high for the 2-DAA regimen as for the 3-DAA regimen.

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*GT4 is mainly a Middle East strain, but it has a prevalence of 5-15% in France and Spain.

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