Again — almost a full year before the complete disclosure of ENHANCE (at ACC, on March 31 to April 1, 2008) — way back on April 19, 2007, according to the complaint, here is what CEO Hassan had to say in response to a question, on the dearth of ENHANCE updates — from analyst Tim Anderson (then at Prudential) — quoting from the bottom of page 45, now:
. . . .122. Defendant Hassan began deliberately downplaying the importance of ENHANCE and discrediting its results as early as April 2007, if not earlier, including, for instance, on the Company’s April 19, 2007 first quarter 2007 earnings conference call. Tim Anderson, an analyst at Prudential Equity, asked Hassan, “Your first big kind of quasi-outcomes trial is coming up on VYTORIN, which is ENHANCE, and I have not heard you talk much about that despite that trial and all those results almost being in hand. It seems like they could be fairly important to [the] VYTORIN franchise. I’m wondering if you are at all worried about the outcome of this trial in terms of what it shows?” Hassan replied:
First, I think we’ve already discussed on previous occasions that the data analysis is ongoing for the ENHANCE trial. That as you know is a surrogate market trial in a very special population with very special doses. There is a much larger trial called the IMPROVE-IT trial which is more of an outcomes trial. So one has to look at the overall mix of the data. The overall regression curve in terms of LDL, lower LDL, is better, is being proven in numerous studies, so we are pretty confident about the overall pattern of data for VYTORIN.
In this statement, Hassan made a vague reference to the fact that the ENHANCE study involved “a very special population.”. . .
Why did he do that, on the very same day — in the very same public conference-call in which he also announced the spectacular 48 percent quarterly sales growth garnered by Vytorin/Zetia?
The answer to that question will likely be very illuminating — in Mr. Hassan’s deposition (read: under oath). Buckle-up.