Nice Early Data At EASL -- For MK-5172 & MK-8742 -- In Tougher Hep C Cases; FDA Clearance In 2016?

Yesterday, we analyzed the likely impact of the latest Phase II data on "easier" Hep C cases -- today, the tougher ones. And to be sure, even on these smallish n's, the data Merck made public in London -- at EASL overnight -- is impressive. [But remember, there are others out there, lurking, too.]

In conjunction with ribavirin, Merck's Hep C "cure" rates stay at or above 90 per cent -- both in prior non responders, and even in those with some advanced liver tissue scarring. This clearly means Merck will proceed to Phase III studies, and pencils in an FDA approval date of early to mid 2016, for Whitehouse Station (soon to be Kenilworth). That is my guess. [For the record, Merck itself is not allowed under FDA rules, to make such prognostications, but I can -- as I am unaffiliated.] And that is good news.

However, in the mean time, Gilead will have had this next gen Hep C market to itself -- at least until BMS and AbbVie arrive -- likely in mid to late 2015. So, that puts Merck as a likely fourth market entrant -- on the timelines as they now stand. And Merck will make money -- just nothing like the likely $15 billion Gilead's Solvadi^® will garner in 2015. Nothing like it. Perhaps a tenth of that (in peak year 2018) -- but with some obvious price competition, from AbbVie and others -- perhaps even Gilead. Do go read it all, though, for yourself. Here's a bit:

. . . .Viral suppression (HCV RNA levels less than 25 IU/mL) was demonstrated for treatment-naïve patients with cirrhosis, prior-null responder patients with and without cirrhosis and HIV/HCV co-infected patients by Treatment Week (TW)12. These levels were maintained at rates between 90 and 100 percent across patient subgroups through the completion of dosing and at the four-week treatment follow-up time point (FU4). . . .

Okay -- perspectives on departing HHS Secretary Sebelius will be a weekend post -- now, do go enjoy a stellar Friday, one and all! And so, "eventually, all things merge into one. . . and a river runs through it. . . ." I'll spend time on a quiet river this evening (albeit with steel and glass canyons, on either side -- as opposed to the Sawatch range). . . . as Spring is finally fully here. Sweet.