Merck Can't ACHIEVE Anything

What do you get when you combine a trial design that failed to show improved patient outcomes, two cholesterol-lowering drugs, and an FDA not-approvable letter? A clinical trial destined for cancellation.

Merck (NYSE: MRK  ) announced yesterday that it was cancelling its ACHIEVE (An Assessment of Coronary Health Using an Intima-Media Thickness Endpoint for Vascular Effects) clinical trial, after the study showed every sign of flopping badly.

ACHIEVE was testing MK-0524A -- formerly called Cordaptive, before the FDA nixed that name. The drug combines Merck's extended-release niacin with laropiprant, a novel flushing pathway inhibitor. The combo drug lowers bad cholesterol and raises good cholesterol without creating the flushed feeling that regular niacin causes in patients.

Like the Enhance trial, which tested its already-approved drug Vytorin, ACHIEVE was measuring the thickness of an artery to show that the drug could decrease the plaque buildup that leads to heart attacks and other ailments. Unfortunately, the patient population used in both the Enhance and ACHIEVE trials -- people with high cholesterol because of an inherited mutation -- are being treated much better today before entering the trial, compared to when a similarly designed trial for Pfizer's (NYSE: PFE  ) Lipitor succeeded. A lack of improvement on a "healthier" population looks considerably worse than Lipitor's improvement on a "less healthy" one did.

However, Merck and Schering-Plough (NYSE: SGP  ) argue that there is so little plaque in the arteries of the patients when they enter the trial that it's difficult to show an effect from cholesterol-lowering drugs.

Merck hasn't said why the FDA rejected MK-0524A. It's possible that the agency may require all companies to run a study showing that a cholesterol-lowering drug reduces the rate of cardiac events, such as heart attacks and other complications, before it will approve the drug for less needy patients. This seems to be the case for Isis Pharmaceuticals' (Nasdaq: ISIS  ) and Genzyme's (Nasdaq: GENZ  ) mipomersen. Along these lines, Merck has started a trial measuring cardiac events, but the results aren't expected until 2013.

Of course, it could be some minor factor keeping Merck from getting the agency's green light for MK-0524A. We just don't know yet.

In any event,competitors with cholesterol-lowering drugs already on the market, like AstraZeneca's (NYSE: AZN  ) Crestor and Abbott Labs' (NYSE: ABT  ) Niaspan, will get more time to enjoy the Enhance-d problems Merck has managed to ACHIEVE.

Pfizer is an Income Investor recommendation. See how dividend-paying stocks can offer both secure income and the opportunity for growth with a free 30-day trial subscription.

Fool contributor Brian Orelli, Ph.D., has been trying to figure out a pun for the word "orange" for the better part of his life. He doesn't own shares of any company mentioned in this article. Pfizer is also a recommendation of the Inside Value newsletter. The Fool's disclosure policy doesn't think puns are very punny.


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 651005, ~/Articles/ArticleHandler.aspx, 12/20/2014 3:03:22 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement