Category Archives: Boceprevir Schering Plough Hep C Phase II Phase III Ver

Some More Detail on the "Horse Race" to Phase III for Next-Gen Hep C Drug candidates. . . .

[UPDATED 11:00 AM EDT — Adam Feurstein at The Street has gotten this story exactly backwards. Exactly. That is my view; that is also the view of several of the more-learned Wall Street analysts, as well (from Feurstein’s piece, at the end):
. . . .Cowen & Co. analyst Rachel McMinn views Monday’s [Vertex] selloff as an overreaction to expected news. She reiterated her outperform raring [sic] on Vertex.

“We believe that yesterday’s [Vertex] sell off was driven by an over-reaction to two-week old information. Timelines for commercial launch of. . . . telaprevir (late 2010/early 2010) are unchanged, and we see 50% upside relative to the market on the basis of this timeframe. While probability of an early 2009 FDA approval is low, we see 100% upside relative to the market under this scenario over the next 6-12 months. . . .”


Some mindless stock-boosters, over at Yahoo!, set me to digging more deeply (background, from my earlier post on Vertex‘s candidate, here) into what Schering has actually disclosed about its next generation Hep C Drug candidate — and, what I found is actually rather comical:

. . . .A phase III protocol has been submitted to the FDA and the company is waiting for concurrence from the FDA prior to beginning phase III clinical trials. . . . Schering-Plough is also working through the complex chemical synthetic process to build additional qualified clinical supplies for the phase III clinical trials. . . .

That was from Schering-Plough’s April 21, 2008 Investor FAQs (from the bottom of page 1, to top of page 2, of the PDF file).

Next, in June 2008 (no exact date available), Schering updated its “Product Pipeline Chart” (PDF file), adding this text:

“. . . .Phase II

. . . .Boceprevir

In May 2008, Schering-Plough announced that it is initiating two Phase III studies with boceprevir in patients chronically infected with hepatitis C virus (HCV) genotype 1. The compound will remain in Phase II until patient dosing commences in the Phase III trial. . . .

That quote comes from the top of page 2, first column of text, of the “Pipeline” PDF file.

Read together, it is very-likely that FDA has not yet signed off on the SGP Phase III study design. I mean, seriously — if FDA had cleared Schering’s Phase III study designs, wouldn’t Schering have very-directly said so?

Perhaps more importantly, it is also increasingly clear that Schering-Plough is having some difficulty (as a matter of physical chemistry) manufacturing adequate supplies of this drug candidate to even begin dosing the Phase III patients — re-read this, from April 2008: . . .working through the complex chemical synthetic process to build additional qualified clinical supplies for the phase III clinical trials. . .

And, that line would actually dove-tail with the odd “asterisked” disclosure on page 1 of the June 2008 “Pipeline” sheet — about staying in Phase II, until “dosing commences” for the Phase III group.

It is almost humorous: the oft’ befuddling-fog — over at Schering Plough Resaerch Institute — of only-positive-information. . . . magically becomes as clear as a crisp mountain morning, if one reads about, around, over and through its myriad, disparate disclosures on any given topic. . . . long enough, hard enough and with a truly independent eye.