Replies to post #75065 on Biotech Values

[DewDiligence]

ACHN CC: They mentioned one reason for starting in Europe is that they won't be as constrained clinically as compared to the U.S. E.g., the 3-day limitation of the initial U.S. trials is not a European standard so they will test beyond 3 days in the initial European trials.

Another benefit to starting in Europe: there is less competition, compared to the US, from clinical trials of other HCV protease inhibitors.

Management also noted that ACHN and GILD continue to do extensive preclinical work on 1095 just to ensure that none of the safety problems that plagued the prior NS4A antagonist exist in the new compound. There was no indication that there have been any potential preclinical safety issues, but no one specifically posed that question during Q&A. I'm starting to wonder if there may be some kind of issue though given the possibility of yet another delay in starting the Phase I trial. [i/]

I, too, don’t like the feel of this latest delay for additional preclinical testing. By “protesting too much” that there was not a safety problem with ACHN-1095, ACHN made me think that such a problem may indeed have cropped up.

[DewDiligence]

Management also noted that ACHN and GILD continue to do extensive preclinical work on 1095 just to ensure that none of the safety problems that plagued the prior NS4A antagonist exist in the new compound. There was no indication that there have been any potential preclinical safety issues, but no one specifically posed that question during Q&A. I'm starting to wonder if there may be some kind of issue though, given the possibility of yet another delay in starting the Phase I trial.

You should’ve trusted your instincts! Also see the bottom of #msg-36600712, where I noted that ACHN management “protested too much” about there being no problem with the drug on the 4Q08 CC.

Good luck.