Biotech Values

[DewDiligence]

ACH-1625 vs TMC435:

…in looking at potential disadvantages of HCV PIs ahead of ACH-1625, management noted that TMC435 compares most favorably to ACH-1625 but a presentation slide implies that TMC435 causes bilirubin elevation and has potential phototoxicity issues. Do you or anyone know if this is accurate?

The claim about elevated bilirubin is true (see below). You probably noticed that ACHN’s webcast slide citing the differentiating features of TMC435 had a question mark after the word phototoxicity, which presumably means that this is not a claim by ACHN, but rather is just speculation.

From Medivir’s TMC435 PR at the 2009 AASLD (#msg-43361309):

Four out of five patients completed triple therapy to Day 28, where one patient discontinued treatment after 14 days due to an increase in serum bilirubin (grade 4). This patient already had elevated bilirubin (direct and indirect) levels at study entry. Bilirubin levels decreased after treatment discontinuation and there were no increases in alanine aminotransferase or aspartate aminotransferase.