Tuesday, April 23, 2013

Come 2016 Or So, Merck's MK-5172 Is Likely To Cannibalize Some Of Merck's Victrelis® Sales -- But Not Vertex's Incivek® Sales

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


Anonymous said...

The structure you have for MK5172 is not correct (the structure you have drawn, the acid, is the starting material for the last step) and should instead be an acylsulfonamide. Furthermore, although I agree with your assessment that MK5172 may not be a game changer in the HCV field, but it won't be because Incivek is a great compound (MK5172 is vastly superior in terms of both potency as well as genotype and mutant coverage) but because most of the HCV patients will already be well served by the time MK5172 is on the market.

Condor said...

I hear you, Anon. -- and thanks for the chemistry lesson(!).

My point was more that in the presnetly-approved FDA regimens, Incivek is king.

MK-5172 is a good candidate -- but it looks to me as though Gilead's next gen Hep C candiate will be on the market for close to a year and a half, before MK-5172 reaches an FDA filing date. It is likely to obsoleted by the Gilead candidate, which is two years ahead of it, in the development cylce. That is the way I should have laid out my point -- more preciseley -- above.

So -- in my opinion, the next one and a half years belong to Vertex, and the next four or so look to belong to Gilead -- in the Hep C market in the US, at least.

As ever, we shall see. Do stop back; and thanks for commenting. Now, as to your opening observation on chemical structures, I'm going to go check the PubChem database, to see what it shows as the final molecule for MK-5172. Presumably, Merck itself submitted that model to the database. And I guess I'll trust that they MRL knows what it is they are making, and testing, here.

Namaste, friend!

Condor said...

Okay -- take a look here -- and at the new post.

I think mine matches PubChem.

I guess it is possible that PubChem's is wrong. But that seems unlikely -- I've shown it as a simple line drawing, in my graphic in the next post, to make the comparison easier. Thoughts?


Condor said...

My post is up. Do let me know what you think.


Anonymous said...

Spot on! The NS5b nucleoside inhibitor that Gilead obtained from Pharamasett is going to be hard to beat. Its use in combination with the NS5a inhibitor from BMS gave spectacular results. However, by itself, or in combination with what Gilead has in-house, the results are less impressive. All to say that, yes, with so many exciting compounds reaching the end of their clinical development cycle, it is hard to see a scenario where Merck would get a bigger slice of the HCV market than they have now at the moment.