Replies to post #89755 on Biotech Values

[DewDiligence]

Roche has no rights to VRUS’ HCV candidates other than RG7128.

[DewDiligence]

Is GILD’s GS9190 a serious drug candidate?

[This is a repost of a prior message on this board that contained several typographical errors and was probably posted when I hadn’t had an adequate amount of coffee.]


GILD reported more trouble with its HCV non-nucleoside polymerase inhibitor, GS9190, on the 4Q09 CC this week.

Background: GS9190 is about two years behind its original schedule because a QT-prolongation problem was encountered in phase-1 even at the lowest dose (#msg-24268443). Subsequently, GILD reported that the QT-prolongation issue was “manageable” by lowering the dose further (#msg-26220678); then, in Oct 2008, GILD told investors that GS9190 did not cause a QT-prolongation problem after all (#msg-32919311).

A year later (Oct 2009), GILD announced that GS9190 would not be advanced into phase-3 in conjunction with interferon and ribavirin, but rather would be tested in an all-oral regiment with GILD’s newly disclosed PI called GS9256 (#msg-42717806). However, before these two drugs could be combined in a phase-2 efficacy study, a drug-drug-interaction study was needed to ascertain the proper dosing.

Fast forward to this week: on the 4Q09 CC, GILD said the DDI study showed that GS9256 boosts the effective dose of GS9190, which could lead to unacceptable QT-prolongation!

In other words, GILD has come full circle on the QT-prolongation issue. After dickering with GS9190 for more than three years, GILD still doesn’t have what it considers an acceptable regimen for testing.

Bottom line: I’m finding it hard to take the GS9190 program seriously. I consider this bullish for IDIX and the other companies pursuing HCV nukes and non-nukes.

[DewDiligence]

GILD HCV Update from 1Q10 CC

• GILD has three HCV drugs in phase-1 trials that they will not discuss for competitive reasons. (These are in addition to GILD’s two known HCV drug candidates: the non-nuke, GS9190, and the PI, GS9256.)

• Enrollment is “brisk” in GILD’s all-oral phase-2a trial of GS9256 + GS9190 with and without ribavirin. Preliminary data is expected in 2H10.

• GILD says they are still “assessing the data” to determine what to do with the GS91900+SoC program but, as previously noted, I don’t think this program is viable (#msg-46036072).