The big drugmaker may encounter its third negative study result within two years for Vytorin and Zetia which, along with Zocor, is a component in the expensive cholesterol pill. The latest trial is scheduled to be presented this coming Monday at the American Heart Association meeting, and pits Merck’s drugs against Abbott Labs' Niaspan,Bloomberg News notes.
The results are likely to show that Niaspan unclogged arteries better than Vytorin, according to Leerink Swann analyst Seamus Fernandez and Wells Fargo Advisors analyst Larry Biegelsen, Bloomberg writes. If so, Vytorin and Zetia revenue may be reduced by $800 million yearly, or 20 percent, Fernandez forecasts. Since January, sales have declined $480 million, or 14 percent, to about $3 billion.
A win by Niaspan may discourage more docs from prescribing Vytorin and Zetia. “The longer Zetia goes with a series of trials that are not favorable, the more questions get raised about whether it is a good choice,” Steve Nissen, chief of cardiology at the Cleveland Clinic, tells Bloomberg. The study “is another major test for Vytorin and Zetia, which have come under a lot of criticism regarding whether or not they are, in fact, effective.”
Speculation on the outcome began in July after researchers halted the trial about four months early. While they said safety wasn’t an issue, they didn’t give a reason for stopping the study, Bloomberg reminds us, adding that the Abbott-funded trial began in November 2006, and was expected to enroll 400 patients.
Merck and Schering-Plough, which jointly marketed Vytorin, have scrambled to promote their drugs after a scandal over their Enhance clinical study in early 2008. The study, which was completed two years earlier but not publicized, showed the expensive Vytorin pill lowered cholesterol better than Zocor (which, by then, was available as a cheaper generic). But it failed to show better results in preventing plaque build-up in arteries. Vytorin sales plunged amid the controversy (back story here and here).
3 Comments
If Arbiter 6 - HALTS was stopped for the reasons most suspect, it might be a good idea for Merck to quietly "fold the tent", on the IMPROVE-IT study. That result won't be available until early 2013, in all likelihood, now. [It hasn't even reached the half-way marker, yet.]
By 2013, the game in this market will already be over. And IMPROVE-IT is a very large, very expensive study -- the aim of which is to show an actual cardiovascular-risk benefits, from taking Vytorin.
In short, it might be time for Merck to stop re-arranging the deckchairs on Titanic. She's sailed, mate.
Namaste
Whytorin indeed? Ezetimibe has not been proven to do anything but lowering cholesterol through the inhibition of absorption. many questions remain. What else does it inhibit the absorption of? Is that good or bad? Does it do anything for atherosclerosis? Does it prevent cardiovascualr events? Is it safe? What about cancer? Sorry, but I can't use this drug on faith. The time has come to see some real data. And plaeas don't let me wait another 4-5 years until IMPROVE-IT is done - if ever!
Okay -- earlier today, Merck CEO Dick Clark commented, for Reuters, on how well-prepared his team is/will be to answer the likely science challenges a negative outcome in Arbiter 6 - HALTS might bring.
[That's why I post this here. . . .]
But CEO Clark also fielded questions about his ultimate successor at New Merck, as by the end of 2010, he'll be approaching mandatory retirement age, there. . . .
All of which has led me -- perhaps immodestly so -- to show-off my decidedly old-skool GIF-animation skillz, in creating a visual satire (which of course, Ed, you are free to use, anywhere -- and in any fashion). Shucks -- it is public domain, by my declaration. Take and re-post, freely.
Do understand, though -- it is satire.
I'll post the URL for the stand-alone .gif animation file -- if anyone asks, in a later comment, for easy downloading.
Namaste, and 'night, all. . . .