Category Archives: Q3 2008 SEC Form 10-Q truth-telling no omissions contin

End of Vytorin/Zetia? Merck Decides to Switch Cholesterol Horses — the Return of "Cordaptive"?

Again, in keeping with the meme of getting more news out (in this case, more bad news for Schering-Plough’s joint venture with Merck) prior to Q3 earnings on Tuesday/Wednesday, we learned after market-close tonight (via an AP item) that Merck is going to revive, and expand, its efforts to seek FDA approval for its “next generation” cholesterol management drug candidate (Merck was seeking to call it “Cordaptive“, but the FDA had earlier nixed that, as well) — after most-recently receiving a non-approvable letter from the FDA — the Friday after the Merck 2008 Q1 earnings release conference call. Here’s a snippet from the Linda Johnson/AP item on it:

. . . .Merck & Co. is expanding an already-large study of an experimental cholesterol drug — rejected this spring by U.S. regulators — to get results sooner so it can move up its second bid for approval.

The drug, known as MK-0524A, combines the B vitamin niacin and a drug called laropiprant to limit the facial flushing caused by niacin. It was rejected in April by the Food and Drug Administration, which said it wanted results of a major international trial known by the acronym THRIVE before ruling again, Merck spokesman Ron Rogers said Friday.

The study, run by Oxford University in England, began in May 2006 and was to end in 2013. In a statement, the university’s Clinical Trial Services Unit said it would expand the number of patients included from 20,000 to 25,000. . . .

There can be no doubt that this is a reflection on the Schering-Plough/Merck joint venture — as Merck released this news through a spokesman — without issuing a press-release to trumpet it.

Yep — this development was apparently shared entirely orally with the AP writer.

Fascinating.

Advertisements