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February 15, 2013
Merck Finally Settles Over Vytorin
You may remember that Merck and Schering-Plough took a lot of fire for the way that they released the clinical data for one of the key Vytorin trials (ENHANCE). The numbers were delayed for months, and when they were finally released, they were. . .problematic for the drug. And for the companies' stocks.
The institutional shareholders did not take that one well; and a number of them filed suit. This week it was announced that Merck has settled for $688 million, while admitting no wrongdoing. This settles the suit, but it isn't going to settle anyone's nerves, as Matthew Herper rightly observes:
Merck admitted no liability or wrongdoing in the decision, and continues to believe its handling of the study was proper. But the settlement could make investors nervous anyway. One of the reasons Vytorin has never recovered (sales of the pill are $1.5 billion, $1 billion less than before the results were released, but that partly reflects a price increase) is that Merck’s other clinical trials, so far, have never again compared Vytorin to Zocor to look for differences in real cardiovascular problems like heart attack and stroke. Instead, the other big trial of Vytorin compared it to placebo in patients who had a heart valve that did not close fully.
But Merck is doing that big Vytorin versus Zocor study, a giant clinical trial called IMPROVE-IT. Results have been delayed several times, and probably won’t come until next year. But the company has said that the independent board that is monitoring the results of the trial will meet in March. They could decide to stop the trial if it has already proved more effective, if Vytorin appears more dangerous than Zocor, or if there is no hope that Vytorin will prove more effective.
I doubt that the trial will be stopped, but at this point I'll be surprised if it yield enough strong data to vindicate Vytorin, either. The delays seen in the trial so far make that look like a very outside chance. My guess is "beneficial effect, but not as much as you'd want", which won't satisfy anyone.
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