Replies to post #71797 on Biotech Values

[DewDiligence]

Re: IFN use in HCV

…assuming the 85% [SVR rate] is achieved (a big IF), a percentage of failures will seek retreatment, and i would presume most would need an agent with novel MOA given resistance issues. it seems reasonable to think many of these failures will then go on an INF-based regimen.

Initially, an ifn-based regimen will be the only option (other than nothing at all) for second-line patients who failed a non-ifn cocktail in the first line. However, in due course we’ll probably see the adoption of a variety of oral HCV cocktails (as has happened in HIV), so that patients who failed one oral cocktail in the first line can try another oral cocktail in the second line.

In other words, the time window for IFN-Lambda and Locteron to pick up a bolus of second-line patients who failed a non-ifn cocktail in the first line could turn out to be relatively brief.

[DewDiligence]

Does interferon have a bright future in HCV? GILD, the world’s leading antiviral company, does not think so, evidently.

Instead of pursuing a phase-3 trial of GS9190 (GILD’s non-nucleoside polymerase inhibitor) in combination with peg-ifn and ribavirin, GILD has refocused the GS9190 program to pursue combination therapy with GS9256, GILD’s newly disclosed protease inhibitor. GILD is currently conducting drug-interaction studies of these two agents. Full-fledged efficacy studies of the GS9190+GS9256 combination are expected to begin in 1H10.

In other words, GILD now has an in-house all-oral HCV program to compete with Roche’s all-oral program that employs ITMN-191 from ITMN and RG7128 from VRUS. IDIX, which has in-house HCV drugs from the three main classes (nuke, non-nuke, PI) is also moving in this direction, although it remains far behind Roche and GILD.

Who are the main losers from all this? HGSI, Biolex, and ZGEN/BMY, IMO; these are the companies that have interferon-based HCV drug candidates.

(Source: GILD's 3Q09 CC today)