Enanta Pharmaceuticals Inc (ENTA)

[NY1972]

Dewophile predicted a label similar to what olysio got for MRK. Will know if his analysis is worth a bar of gold in a week.


2. above 800,000 IU/mL, the virologic failures were all over the map. one at 948k, 3 between 1-2M iu/ml, 3 between 2-4M, 3 between 4-6M, 3 w VL>6M. So unlike havoni's 8 week trial where they only saw a break point post hoc above 6M baseline VL (constituting the minority of patients), MRK will forever be dogged in the marketplace with a lower efficacy for GT1a, which will be especially pronounced for the majority of GT1a patients who don't have low viral loads. I also think this adds regulatory risk since these pts as i mentioned likely have SVRs below 90%. Recall 8 weeks of Harvoni for pts with VL >6M had 91% SVR and the label only allowed consideration of 8 weeks below this level, so what are they to do with MRK?

3.directly from the paper: "NS5A RAVs were identified at baseline in 19 of 154 (12%) GT1a-infected patients. SVR12 was achieved in 11 of 19 (58%) of these patients compared with 133 of 135 (99%) patients without baseline NS5A RAVs". I'm not sure how readily available and cost effective screening for baseline NS5A RAV is, but if approved they could get tagged with a label similar to what olysio got, strongly urging testing and treating with another regimen if someone has these at baseline (one difference though Q80K is more common than these NS5A resistant variants, but in this study 12% pts had it - in GILD's ION study it was 18%, so not exactly uncommon either). Of note GILD's TE cohorts (but not naives) showed some correlation w these RAVs, but not nearly as severe as MRK. ABBV failures had higher rates of basleine RAV to NS5A, but again correlation not nearly as strong as MRK (probably due to the 3rd agent in ABBV's case).

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