News Focus
News Focus
Replies to #84420 on Biotech Values
icon url

DewDiligence

05/10/10 8:01 PM

#95534 RE: genisi #84420

Attention investors in the HCV arena…

MRK holds its annual R&D Day presentation tomorrow (Tuesday) at 8:30 am ET:

http://www.merck.com/investors/events-and-presentations/home.html

For those who follow the HCV arena, there could be material updates on the Boceprevir, MK-7009, and MK-3281 programs.

I’ll be paying particular attention to what is said about MK-3281, a non-nuke where the abstract at the 2009 AASLD hinted at a possible safety issue. From #msg-42093301:

One patient discontinued due to an AE of myoclonus on study Day 2 of approximately 1.5 h in duration, preliminarily judged possibly-related to MK-3281 and rated of severe intensity.

Despite the severe intensity, this incident was tallied as an AE rather than an SAE.
icon url

DewDiligence

06/01/10 8:00 PM

#96598 RE: genisi #84420

MK-3281, MRK’s non-nucleoside polymerase inhibitor for HCV, is apparently defunct. There are three pieces of evidence:

• The entry at clinicaltrials.gov shows the status of the phase-1 trial as terminated, which means it was not completed as planned (http://clinicaltrials.gov/ct2/show/NCT00635804 ).

• The MK-3281 presentation at AASLD last fall noted that one patient in the phase-1 trial discontinued treatment for severe myoclonus that was judged to be “possibly drug-related” (#msg-42093301).

• MK-3281 was nowhere to be found at MRK’s annual R&D review on 5/11/10. (The webcast slides are at http://sec.gov/Archives/edgar/data/310158/000095012310047584/y84425exv99w1.htm .)

I consider this info material insofar as I had previously expected MRK to run its own all-oral HCV trial of Boceprevir + MK-3281. Now, MRK will have to look elsewhere if it wants to jump on the all-oral HCV bandwagon.