Merck Combination Cholesterol Drug Fails to Meet Study Goals; Firm Doesn't Plan to Seek U.S. Approval
12/20/2012| 09:17am US/Eastern
By Tess Stynes
Merck & Co. (>> Merck & Co., Inc.) said its doesn't plan to seek U.S. Food and Drug Administration for a combination cholesterol treatment that aims to reduce the risk of cardiovascular events after the drug failed to meet primary goals in a large long-term study.
Shares were down 2.9% at $42.40 in premarket trading.
The pharmaceutical giant said it isn't recommending that health-care providers start new patients on the treatment--Tredaptive--an extended release combination of niacin and laropiprant. The company also plans to share the study results with health regulators in countries where it also is approved under the Tredaptive or Cordaptive brands.
"While we are disappointed in these results, we thank the investigators who have conducted the study and the patients who have participated in it," said Peter S. Kim, president, Merck Research Laboratories.
The study that compared extended-release niacin and laropiprant plus statin therapy versus statin therapy included 25,673 patients in Britain, Scandinavia and China considered at risk for cardiovascular issues that were followed for a median 3.9 years.
The study found that the combination drug along with statin therapy didn't significantly further reduce the risk of a combination of cardiovascular events such as nonfatal heart attacks, strokes or coronary-related deaths compared with just statin therapy. There also was an increase in nonfatal events in the group receiving Tredaptive.
Further analysis is under way and detailed study results are expected in the first quarter.
Write to Tess Stynes at Tess.Stynes@dowjones.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires