Yesterday, Merck let it be known that it would partner with BMS — and its daclatasvir Hep C candidate, to compete in the next wave of treatments (likely all oral) for the disease that affects approximately 170 million people worldwide. Once infected with hepatitis C — and left untreated — patients often develop cirrhosis, liver cancer and ultimately, the need for a liver transplant. And so, the disease burden is vast — as is the correlative market opportunity.
However, nothing I’ve seen to date in this year 2013 would suggest that even Merck’s Phase II/III programs and partnerships will be able to significantly undercut Vertex’s current Incivek® lead. There are other promising candidates on the horizon (from other competitors), which may, perhpas as early a mid-2015 unseat Vertex, but it doesn’t appear that Merck has a bead on these candidates, at present.
In my experienced opinion, all Merck is poised to do, at the moment, is cannibalize a fair chunk of its own Victrelis® sales (another largely disappointing legacy Schering-Plough “second-in-classs” Hep C drug), come 2015 or 2016. Here is some of my earlier reporting on Vertex’s superiority in the Hep C space, at present. For now, Vertex is the lead dog.
Do go read it all, here — but this is the most-salient bit:
. . . .MK-5172 in combination with peginterferon alfa-2b and ribavirin (PR) was evaluated versus VICTRELIS® (boceprevir), 200 mg Capsules, in combination with PR in treatment-naïve, non-cirrhotic patients with HCV genotype 1. A total of 332 patients were enrolled and randomized to receive MK-5172 at 100, 200, 400 or 800-mg in combination with PR or boceprevir with PR. MK-5172 was administered for 12 weeks with PR, followed by an additional 12 or 36 weeks of PR therapy (depending on the HCV RNA levels at Treatment Week 4). . . .
“We continue to build upon our clinical experience of MK-5172 in chronic hepatitis C,” said Eliav Barr, M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. “The interim findings from this study provide clear direction for future larger trials designed to evaluate MK-5172 in novel all oral regimens for HCV. . . .”
By the way, the U.S. Centers for Disease Control and Prevention has recommended all baby boomers, defined by the agency as those born from 1945 to 1965, get tested for Hep C — a liver infection. Do stay tuned — we will keep you posted, but Vertex is rising again today, as the papers are being presented at the EASL. The EASL is an annual conference held by the European Association for the Study of the Liver, this year it is convening in Amsterdam