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Re: DewDiligence post# 109281

Friday, 11/19/2010 7:49:59 PM

Friday, November 19, 2010 7:49:59 PM

Post# of 252529
Re: Medivir/TMC435

Medivir did not even mention phototoxicity on their webcast, so this is presumably a non-issue.

But wasn't the trial referenced by ghmm in #msg-50267780 commenced presumably to address a potential/presumed phototoxicity issue?

Moreover, TMC435 works against all genotypes other than 3A, which is a consequential differentiation relative to Telaprevir and Boceprevir.

I did not realize TMC435 worked on multiple genotypes. That's a very big differentiation angle.

All told, TMC435 looks like the most promising of the “second-generation” PI’s.

As an ACHN long, I am clearly hoping that TMC435 stumbles somewhere along the way. But, I do have to give credit to Medivir for the data they have shown to date with TMC435. The fact that the drug works on multiple HCV genotypes, clearly has QD potential, and has shown good efficacy/safety data to date (I'll leave the question on phototoxicity open) makes me a little nervous as an ACHN long. Also, I'm guessing TMC435 is roughly two years ahead of ACHN's ACH-1625 since ACHN just recently commenced Phase 2a trials for 1625 and Medivir apparently just wrapped up Phase 2b trials and is about to move into Phase 3 trials. It also looks like TMC435 is active at much lower QD doses than what ACHN will be utilizing in the Phase 2a trials for 1625.

Notwithstanding all of those caveats, if any of the big pharmas are interested in licensing a 2nd gen HCV PI, I have to think that 1625 is still a legitimate potential option should Phase 2a trials prove successful given that TMC435 is presumably off the licensing table since its rights are owned by JNJ. And I imagine the HCV market is big enough to support two 2nd gen HCV PIs.

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