Replies to post #31944 on Biotech Values

[DewDiligence]

> VRTX CC – A couple of the questions were aimed at getting the VRTX folks to admit they were angling for approval based on P2 results, but they didn't get too far except for an acknowledgement that it was a possibility. Assuming the product stability data is done by early '08, they could file at that time based on P2, or wait for P3 data and file in late '08.<

VRTX is smartly playing this both ways: the official guidance is that they do not expect to submit the NDA based on phase-2, but (wink, wink) the guidance for the timing of the NDA submission—mid 2008—is such that it would be impossible for the submission to be based on phase-3.

[DewDiligence]

>This delay by VRTX may be why IDIX has made the coinfected cohort a priority for NM283. A good move, IMO, since coinfected patients are such a large chunk of the market.<

That’s part of the reason, IMO; another part of the reason is that IDIX is hedging in case the treatment-refractory setting does not pan out.

[mskatiescarletohara]

VRTX-GOFISH-Coinfected patients.

VRTX rarely mentions their strategy for the HIV-coinfected cohort and also that the analysts don't seem to be interested.

VRTX wants to treat HCV effectively first, as most physicians who treat coinfected patients wish to treat the HCV condition effectively while patients are on HAART and I think you nailed the reason below. I don't think analysts will get excited about treating coinfected patients until a candidate can be proven to be administered with other HIV nukes safely without causing SAEs. This population is difficult to treat and the studies have high drop out rates due to SAEs.

I suppose they want to see the results of ritonavir addition before they initiate trials in coinfected patients

Ritonavir is one of the more widely prescribed protease inhibitors and is linked to hepatotoxicity in coninfected patients. Physicians have to be very careful in treating HCV in patients on HAART therapy because of the potential of harmful toxicities arising from the interactions between the cocktails.

IDIX has made the coinfected cohort a priority for NM283.

I read recently HCV advocates are anxious for IDIX and VRTX to test their drugs in coinfected patients, I wasn't aware that IDIX has now added a coinfected cohort. Coinfected patients desperately need new options for treating HCV, just as all patients who suffer from HCV exclusively.

but they didn't get too far except for an acknowledgement that it was a possibility.

IMO, VRTX/JNJ are gambling on the FDA reviewing the Phase II data package before accepting an NDA for accelerated approval, the FDA very well could accept the data for review on acclerated basis for naive patients and potentially approve based on 24 week data from one of the pivotals. After, the pivotals are complete and data complete, the FDA would then grant traditional approval. The FDA has treated approved several HIV candidates in this manner, it would be a first to my knowledge for an HCV candidate.

katie....