Replies to post #109289 on Biotech Values

[DewDiligence]

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.

[DewDiligence]

JNJ/Medivir present 24w TMC435 data from phase-2b ASPIRE study in second-line HCV. This PR has a little more color than JNJ/Medivir’s PR on the same study issued in Nov 2010 (#msg-56867553):

http://finance.yahoo.com/news/Medivir-Week-24-Interim-prnews-1150859088.html?x=0&.v=2

In this Week 24 interim analysis, treatment-experienced patients who failed peginterferon and ribavarin treatment achieved significantly greater virologic response rates following treatment with TMC435-containing regimen at all doses, compared with placebo. Results demonstrated that the TMC435 150 mg dose group showed the highest response, particularly in prior null responders. In this 150 mg dose group, HCV RNA levels were undetectable at week 24 for between 82% and 91% of the patients.

150mg was the highest dose tested.

The following sentence—particularly the “statistically relevant” phrase— could signify a less than pristine safety profile for TMC435 in this dataset.

Results also showed that there was no statistically relevant difference in safety and tolerability between the TMC435 and placebo treated groups.

The link above has the full data table.

Please see #msg-56933047 and #msg-60078852 for overviews of the phase-2b and phase-3 programs, respectively.