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DewDiligence

11/03/13 3:22 PM

#169243 RE: ariadndndough #169241

Note: MRK’s PR today presents the HCV data on a per-protocol basis rather than an ITT basis; i.e., MRK’s calculation of the SVR12 rates in various cohorts excludes patients who dropped out.

This is not to say that MRK’s data aren’t excellent—they are; however, PP data have an upward bias relative to ITT data, and this should be taken into account when comparing MRK’s results to those of other studies.
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dewophile

11/03/13 3:53 PM

#169248 RE: ariadndndough #169241

Their Japan regimen is now on file out there and it shows good SVR but this is only good for GT1b (87% SVR in IFN intolerant and 81% SVR in prior non-responders



I'm hoping BMY can do well in japan despite SVR rates that seem on the surface to be a bit lower than those being reported in earlier stage trials for competing all oral regimens. First off these patients are somewhat harder to treat. even the interferon intolerant/ineligible patients (naives) tend to be older and more frail. Also I get the sense there must be a lot of demand for an all oral regimen and waiting another year for a combo that might yield another 5% in efficacy isn't going to make or break treatment decisions (I base this on the fact that telaprevir didn't sell well at all in japan* - presumably because the demographic is swayed towards older pts who can't take interferon and/or rib - which is one of the reasons why I don't think simeprevir will do all that well in japan despite it's early introduction relative to other follow on DAAs bc it is paried with I/R unless it gets significant off label use)

*sales were <100M for all of 2012, the first full year after telaprevir approval in japan