Saturday, October 30, 2010

Okay -- The Next-Gen Hep C Race To Simply FILE NDA's, At FDA Is Called. . . What?

In what is plainly the work of corporate communications/spin-meister strategists, Merck included a paragraph in its Saturday press release indicating that it has begun filing the new drug application, or NDA with the FDA, "on a rolling basis," for Boceprevir®.


That's essentially the same as saying. . . we are getting ready to file. FDA won't review partial submissions. It never has. See 21 CFR "somethin' somethin'." [21 CFR Part 314.60(b)(1)-(4).]

This bit of breathy Merck prose is clearly in response to Vertex's Q3 earnings call this past week, in which it announced that it would be filing an NDA on Telaprevir® with FDA "in the coming weeks".

The only real news in the Merck statement is that Whitehouse Station is still committed to having a complete NDA package -- in the FDA's inbox -- by year end 2010.

It looks like Vertex will be at that point, within weeks.

. . . .Three Phase 3 studies, ADVANCE, ILLUMINATE and REALIZE will form the basis of the clinical portion of the telaprevir New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which is expected to be complete in the fourth quarter of 2010. . . .

What this all amounts to is very little, as FDA will certainly ultimately approve Telaprevir, as it is a cure for Hep C -- and will likely clear Boceprevir, as well -- despite its more troublesome side effects profile, for use in patients who show no response to Telaprevir. In the longer run, it will be the better efficacy of Telaprevir, coupled to its lower side effects profile, that will lead physicians to prescribe perhaps $4 billion worth of the drug, per year by about 2013, in the US alone -- in my opinion, of course.

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