Emerging C. Diff. Franchise: Could Merck Have Avoided About $270 Million In R&D Expenses?

It has been more-than occasionally said that one clear mark of truly-revolutionary scientific innovation is that it seems intuitively obvious -- once the innovation is fully-revealed. File the below story under that heading.

First the back story: it seems that in the Spring of 2009, Merck Research Laboratories agreed to pay up to about $250 million to in-license a Medarex Phase II candidate based on the quite-promising antibodies for C. Diff. Since then, it is likely that MRL has spent another $20 million or more on that development program.

But Merck isn't the only major pharma with the potential for egg on its research face, here. Not to be outdone, Sanofi had already made a costly bet on a vaccine against clostridium difficile -- and in all probability spent much more than MRL on its own program. To my eye, however, it looks as though this "low-tech" approach is achieving response rates that equal or exceed those seen in the more-formal Phase II antibody trials conducted by Medarex.  And with 3 million cases per year, the burden of the disease here is staggering. So too would be the benefit from an inexpensive, reliable and low tech cure.

True enough, the "ick" factor should not be underestimated as a potential dampener/barrier to patient acceptance -- but for sufferers who've seen no improvement from other approaches, I suspect this approach will be worthy of a shot. And it makes sense -- if C. Diff. appears in the gut/colon when other antibotics knock out the "good" bacteria strains that keep C. Diff at bay -- then a re-introduction of "good" bacteria, via a donated stool sample, ought to do the trick. From a Bangor, Maine news outlet, overnight, then -- a bit -- but do go read it all:

. . . .For patients hit hardest by the bacterium Clostridium difficile, getting a “stool transplant” could become a standard treatment within just a few years. Just as blood banks and sperm banks are now commonplace, stool banks may soon dot the landscape.

About 3 million Americans are infected annually with the bacterium — also known as C. diff — which spreads mainly through hospitals, nursing homes and doctors’ offices. . . .
Costly treatments from Merck & Co and other drugmakers, and a vaccine from Sanofi, are on the horizon. But growing numbers of gastroenterologists are more excited about the use of human stool transplants, which in experimental settings have consistently cured 85 percent to 90 percent of patients who have had multiple episodes of C. diff.

“Until recently, fecal transplants have been on the fringes of mainstream medicine,” said Dr. Cliff McDonald, an epidemiologist with the U.S. Centers for Disease Control and Prevention. “It could become the primary mode of therapy within a year or two for patients with multiple recurrences. . . .”

We will keep you informed, but this -- if one can get past the "ick" factor -- bears the mark of scientific genius: it seems so completely obvious, once someone explains it.

Even so, I doubt it will ever reach the status of blood and bone marrow donation -- as a "public-good" program. But I could be wrong about that, too. FYI -- here is my 2009 backgrounder on the MRL in-licensed program.