Replies to post #117089 on Biotech Values

[genisi]

I think it's very very likely that Boceprevir will be approved but its label is unlikely to include null responders.

[DewDiligence]

Re: Telaprevir vs Boceprevir

Do you think Boceprevir will get rejected? After reading thru the all the HCV posts, it seems like MRK took a shortcut with their def. of null responder, which could come back to haunt them…

MRK’s non-standard definition of a null responder has no consequence whatsoever with respect to FDA approval in the first-line setting. However…

…in the second-line setting, Boceprevir may end up with a more restrictive FDA label than Telaprevir. In practice, this could cause Boceprevir to be relegated to a third-line agent for patients who were treated with SoC in the first line and Telaprevir + SoC in the second line. Since Telaprevir has an impressively high SVR rate in the second-line setting (#msg-54315761), there will not be many patients in the third-line setting for Boceprevir to capture.

In summary, MRK’s taking shortcuts in the second-line setting (and using non-standard definitions to try to mask these shortcuts), will not stop Boceprevir from being approved, but it may compromise the commercial uptake of the product. My wild guess is that, all told, Telaprevir will outsell Boceprevir by about 4:1.