Replies to post #174296 on Biotech Values

[DewDiligence]

Re: ENTA questions

QUESTION 1: I was wondering what you think the inherent value of ENTA's future HCV pipeline is. For example, ABT-493/ABT-530 combo…

The biggest potential upside from the ABT-493 + ABT-530 combination is that it may work for any HCV genotype rather than GT1 only. If it pans out, this combination would have an edge relative to GILD’s Sovaldi + Ledipasvir, which doesn’t work in GT3.*

The other advantages you enumerated for ABT-493 + ABT-530—including, for instance, longer-running patent protection compared to ABBV/ENTA’s 3-DAA regimen—are also significant. However, one major benefit to ENTA that you neglected to mention is that the royalties (or profit share if ENTA opts in) will be larger when ENTA’s drug (ABT-493 in this instance) is part of a 2-DAA regimen rather than a 3-DAA regimen.

QUESTION 2: What is likelihood in your mind that FDA denies GILD’s 8-week tx for non-cirrhotics based on lower SVRs and their concern it could lead to resistance?

Great question. I think a likely outcome is that the FDA label permits 8-week dosing for treatment-naïve non-cirrhotic patients but also cites 12-week dosing as an option for such patients, leaving the choice up to the patient and physician.

Note that the EMA may have its own view on 8-week dosing.

If a denial for this happens, [would it] adversely affect GILD’s pricing/labeling strategy of using that shorter regimen to gain the cost savings that the public wants…?

If the FDA were to reject 8-week dosing outright, it would actually make GILD’s pricing strategy simpler, IMO, by allowing GILD to treat all GT1 patients at the same price. Under the single-duration framework for GT1, the price for 12w of Sovaldi + Ledipasvir would presumably be lower than the price for 12w of Sovaldi + Ledipasvir under the dual-duration framework, but the aggregate revenue for GILD from all GT1 patients would probably be larger.

QUESTION 3: Any timeline on when phase-1 might be done with EDP-788?

According to clinicaltrials.gov, the phase-1 trial is expected to complete in Jun 2014 (http://www.clinicaltrials.gov/ct2/show/NCT01999725 ). Regards, Dew

*GILD is testing the Sovaldi + GS-5816 combination in phase-2 trials for GT1 and GT3 patients to see if it can be the hoped-for single regimen that works in all genotypes.