Sunday, October 31, 2010

More Hep C: TMC 435 Shows High Promise -- But Likely Not FDA-Approvable Much Before 2015

Adam Feurstein, writing for, has done a nice job of summarizing the next-gen Hep C "state of the play" -- as to the most important candidates in Boston, at the big liver conference.

Because there will still be some patients who won't respond to Telaprevir®, or Boceprevir®, J&J (via a The Medicines Company-researched drug candidate, thus the TMC nomenclature) is advancing a powerful alternate candidate, still about four years away from market, to follow in Telaprevir's wake:

. . . .In addition to partnering with Vertex on Telaprevir, Johnson & Johnson is developing its own Hep C drugs, including TMC435. A phase IIb study being presented Monday shows that between 79% and 86% of patients treated with TMC435 and standard of care responded well enough to stop all therapy after 24 weeks.

This interim result for TMC435 looks better than the 58% and 65% of telaprevir-treated patients who were able to stop therapy after 24 weeks, except that J&J used a more liberal definition of response, which inflates its numbers.

Patient treated with higher doses of TMC435 also reported increases in certain liver enzymes levels, raising safety concerns about the drug. . . .

So, the Vertex juggernaut in Hep C may only last for about five years -- but that will certainly be "enough" -- enough to clearly label Ex-Schering-Plough CEO Fred Hassan's Boceprevir as primarily a second-line "me too" candidate. We'll keep you informed.

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