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).