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mcbio

12/05/10 1:58 PM

#110101 RE: DewDiligence #109291

Re: TMC435/ACHN

TMC435 has not yet reported bona fide efficacy in phase-2b; rather, the phase-2b trials—PILLAR in the first-line setting (#msg-52204240) and ASPIRE in the second-line setting (#msg-56867553)—have completed 24 weeks of dosing in all arms. There are not yet any SVR data in either phase-2b trial, although the 24-week on-treatment data look quite good.

I don’t have an answer for you about phototoxicity. Medivir did not mention it on the webcast, and none of the analysts asked about it despite their extensive questioning about other aspects of the program.

In addition to the point about TMC435 being active against multiple HCV genotypes, has JNJ/Medivir indicated whether or not TMC435 is active against the relevant HCV mutations? ACH-1625 isn't active against multiple HCV genotypes and I don't believe is active against the relevant HCV mutations either, but I am thinking more in terms of ACH-2684 that is soon to enter the clinic and whether or not 2684 may have a potential advantage/differentiation angle compared to TMC435. (ACHN has indicated that 2684 is active against the relevant HCV mutations and is pan-genotypic.)