Biotech Values

[mcbio]

Re: ACHN 4Q08 Results

http://ir.achillion.com/events.cfm

I listened to the conference call and the main news is that ACH-1625, the unpartnered protease inhibitor, will be tested first in Europe, followed shortly by trials in the U.S. They expect to file the Clinical Trial Application in Europe in Q209 and the IND in the U.S. in Q309. 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. Also, ACHN noted that partnering discussions have begun for ACH-1625, but they will wait until proof of concept before partnering as the economics of a deal should of course be much better at that point assuming positive trial results. This makes sense since they do have the cash to get to that point.

Management didn't offer much up regarding ACH-1095, the NS4A antagonist partnered with Gilead, except to say that initial Phase I trials will lag that of ACH-1625 and could start in Q209 or possibly in Q309. Q309 would of course represent yet another delay in timeframe, which would not reflect well on management credibility to some degree in my book. 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.