Earlier this week, Gilead’s sofosbuvir received a unamimous approval recommendation — from the FDA’s Advisory Committee. That likely means in about six to nine weeks, the drug could be on-market, in the US. Gilead will revolutionize the Hep C drug field. That much is nearly certain, now. [This thesis jibes with my April 2013 predictions, as well.]
We also learned this week that the quarterly sales of Vertex’s Incivek® have plunged, primarily because most Hep C patients who are not acutely afflicted are now “warehousing“. That is, they are not even starting on the current generation of either Incivek or Merck’s Victrelis®, because it is given in combination with interferon (and thus causes moderate to severe flu-like symptoms in many patients). It is also an injection regimen, as opposed to a pill. And many, many patients hate needles.
So — while these interim results on MK-5172 are quite encouraging, Merck will likely be a little too late to the game — and once the estimated three million or so “warehoused” non-acute Hep C patients are likely cured by Gilead, Merck’s role, as I said here before, when finally MK-5172 arrives, will be largely as a clean up, secondary player. That’s my S.W.A.G. (scientific wild arse guess), at least. Here’s a bit, from Reuters — do go read it all:
Gilead Sciences is widely seen as being in the lead with a safe and effective all-oral combination, with Bristol-Myers-Squibb and AbbVie close behind.
Gilead last week won an approval recommendation from a U.S. Food and Drug Administration advisory panel for its highly regarded sofosbuvir.
Some analysts believe the market for all-oral hepatitis C treatments could reach $20 billion as many more people get tested for the virus, given the very high cure rates, shorter treatment durations and tolerable side effects. . . .
I do think Merck has a solid candidate here — but just like legacy Schering-Plough’s “Fast” Fred Hassan (with Victrelis, then known as boceprevir), in 2008 through 2012, Merck will be too late to the party — unless a major off-target effect emerges in the commercial rollout of Gilead’s new regimen. That’s my $0.02.