Biotech Values

[DewDiligence]

TMC435 update: Medivir did not even mention phototoxicity on their webcast, so this is presumably a non-issue. They did talk a lot about bilirubin, but they characterized the elevations seen in some patients as mild and transient, even for patients who remained on treatment.

In the aggregated phase-2b data, the rates of AE’s and discontinuations for patients in the TMC435+SoC arms were similar to the rates for patients in SoC control arms. TMC435 may be better tolerated than Telaprevir (less rash) and Boceprevir (no anemia, no EPO used).

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

Medivir and JNJ are mimicking the trial designs used for Telaprevir; e.g. in the phase-2b TMC435 trial in the second-line setting called ASPIRE (the subject of #msg-56867553), all patients will receive 48 weeks of treatment as in the Telaprevir REALIZE study (#msg-54152015).

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