Biotech Values

[mcbio]

ACHN @ Lazard (11/18/09)

The ACH-1625 program appears to be running ahead of the original schedule—the phase-1b monotherapy study is expected to be completed by the end of 2009 (vs the original guidance of 1Q10). If the results are good, ACHN will undoubtedly strive to disseminate the top-line data at the JPM conference in January.

ACHN announced today at the Lazard conference that they expect to gather data from the Phase 1b trial of ACH-1625 in top-line form near the end of this year and announce the results very early next year. So, presumably that means disseminating top-line data at the JPM conference in January. Management did issue a caveat that there could be a slight delay if they decide to add an additional cohort to the Phase 1b trial. I didn't get the impression that they actually intended to do this additional cohort though. Management indicated that they expect to present the full data release for the Phase 1b trial at EASL in April 2010.

Separately, management very clearly indicated that ACHN is willing to move forward on its own into Phase 2 with ACH-1625 if they are unable to strike the right partnering deal. They implied that the company has the funds to do that because a Phase 2 trial won't be as expensive as a Phase 3 trial. If it were ultimately play out this way, I would expect there would be dilution as I don't see how they have sufficient cash right now to conduct the Phase 2 study without some further dilution. I trust that this will be a moot point though if the data from the Phase 1b is good.

Finally, in looking at potential disadvantages of HCV PIs ahead of ACH-1625, management noted that TMC-435 compares most favorably to ACH-1625 but a presentation slide implies that TMC-435 causes billirubin elevation and has potential phototoxicity issues. Do you or anyone know if this is accurate? It's on slide 16 of the presentation. See: http://www.wsw.com/webcast/lz6/achn/