Tuesday, March 12, 2013

I Am Adding 6 MORE Months To The IMPROVE-IT "Countdown Clock" (At Left Margin). . .

It will now complete in September of 2014 -- and results won't be known until near the end of the year 2014. And it may even be after that, as I've always said -- it may take months to discern what small effect is there, among the 18,000 patients.

I will take a moment to point out that ever since mid-2008, I alone have been reporting that there was no way legacy Schering-Plough could get definitive outcome results as early as Ex-CEO "Fast" Fred Hassan was telling Wall Street. And that was before the trial had to be "super-sized" (increasing the patient count to over 18,000), in order to see a statistically-significant outcome. [Here is the clinicaltrials.gov webpage for the IMPROVE-IT study, with a listing of the background history -- including changes to the trial design, at least as to the n studied.]

So, back when everyone inside Schering-Plough was predicting a 2011 read-out of IMPROVE-IT, I prepared the graphic at right, and started my 2014 countdown clock, at left.

On the Yahoo! stock chatboards, I took some abuse for these views -- and I welcomed it then, just as I am laughing now.

Why? Because, in my opinion, the effects to be seen (or not seen) in IMPROVE-IT (rate of CV events) are going to be very small -- if they exist at all. We need to see about 5,250 clinical endpoints (CV events) in the population of about 18,000 patients -- then we will see whether the Vytorin® treatment arm fared better than the overall population. Was the rate of strokes, heart-attacks, and other CV events reduced to a statistically-significant level, in patients taking Merck's drug? That is the question of the day.

So, honestly, I am laughing at the traders in the NASDAQ premarket this morning who are bidding Merck up five percent, due to this news. If it appears in late 2014, the effect seen in favor of Vytorin will be very small. Not worth a five percent pop, on a $50 billion per year company, today.  That's silly.

Let's see where the NYSE settles in at open. In the mean time, here's a bit of the Bloomberg story:

. . . .Vytorin, with $1.7 billion in sales last year, combines a generic cholesterol drug with Merck’s cholesterol drug Zetia, which generated $2.6 billion in revenue. Investors have been watching the trial after researchers found in 2008 that Vytorin may not provide a heart benefits.
The announcement “suggests no safety issues,” said Mark Schoenebaum, an analyst with ISI Group in New York, in a note to clients. “If Zetia, Vytorin were unsafe, would you be comfortable waiting another 18 months to look at the data?”. . . .
Again, as I have repeatedly-said, I do believe a null- or nearly-null-result in IMPROVE-IT is priced into Merck's stock at this time -- so a small pop would be logical, if a small effect is seen in favor of Vytorn, after the study is published. But anyone who thinks this is going to be a category killer, post IMPROVE-IT -- is, frankly, delusional. Just my $0.02.

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