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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

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February 15, 2013

Merck Finally Settles Over Vytorin

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Posted by Derek

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.

Comments (3) + TrackBacks (0) | Category: Cardiovascular Disease


COMMENTS

1. anonymous on February 16, 2013 9:50 AM writes...

For those who have friends / loved ones at the "new Merck", pray that Vytorin has at least equivalent (and far more preferably, superior) effects on CV outcomes than Zocor. If not, it will be a bloodbath (for Merck employees, that is).

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2. anonymous 2 on February 18, 2013 10:10 AM writes...

@ Anonymous-As an XMerck, not a day go by when I think of my friends and others at Merck. I was fully dedicated scientist and gave it all, as were others then as in now at Merck! Sitting at a distance gave me a real clarity on the scientific/management structure and comprehend how screwed they are! They let go of us with some excuse(s) and yet it is business as usual for them and seems to me that no lessons were learned. Same mistakes are repeated even after 5 years of leaving. And now, we hear that they have signed a deal with Lycera (http://www.lycera.com/news-2013-02-12.php) a small spinoff company based in Michigan. What is even more confounding is that the CEO of Lycera is Kathleen Metters and she along with other cohorts, f@#@#d not only the Montreal site but did an encore at Rahway! Talking of “quid pro qo!” I say good luck to all.

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3. Anonymous on April 2, 2013 9:25 PM writes...

Merck under Vagelos and Scolnick was the premier drug discovery company. Management has destroyed the culture of discovery through politicizing the process. Perlmutter is a refreshing cange but will most likely require a complete revamp of the present management. Interesting to see that the true discoveries are now being performed at biotechs.

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