Merck Settles Lawsuits Over Vytorin

By: Tasnima Nabi, Staff Editor

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Merck & Co. will pay $688 million to settle two lawsuits filed in December 2008 over their patent-protected statin, Vytorin^®.  The suits state that Merck and Schering-Plough delayed releasing the results of their ENHANCE study to avoid a decrease in revenue.¹

Vytorin^® is a combination drug of simvastatin and ezetimibe.  ENHANCE was a trial conducted by Merck and Schering-Plough hoping to prove that the combination therapy of simvastatin and ezetimibe could prevent plaque buildup in arteries and prevent/reduce heart attacks and strokes, in addition to reducing low-density lipoprotein cholesterol levels.²  ENHANCE was a double-blind and randomized 24-month trial comprising of 720 patients diagnosed with heterozygous familial hypercholesterolemia.  The patients either took simvastatin 80 mg and ezetimibe 10 mg, or simvastatin 80 mg and a placebo.  The change in carotid intima-media thickening (cIMT) in each patient was measured.  After the two-year treatment, there was no statistically significant difference in carotid thickening between the two treatment groups.³  While patients treated with ezetimibe did show a larger reduction in LDL cholesterol levels, there were no differences in the occurrence of adverse effects or cardiovascular events.⁴

The results of ENHANCE were released on January 14, 2008.  Merck and Schering-Plough had completed the trial by April 2006, but failed to prepare and release data from the study on time.⁵  A class-action lawsuit was filed in December 2008 because Merck and Schering-Plough did not release information proving that Vytorin^® was not more effective at reducing plaque buildup than less-expensive generic drugs already on the market.

Merck has agreed to pay $215 million in a suit that involves its defendants and $473 million in a suit involving Schering-Plough defendants and added that the company acted responsibly.  Bruce N. Kuhlik, executive vice president of Merck, stated, “It is in the best interests of the company and its shareholders to put this matter behind us, and to continue our focus on scientific innovations that improve health worldwide.”⁶

SOURCES:

1. Thomas K. Merck Settles Suits Over Cholesterol Drug. NYTimes. 14 February 2013. Available at http://www.nytimes.com/2013/02/15/business/merck-settles-investor-suits-over-cholesterol-drug.html, Accessed February 16, 2013.
2. Johnson LA. Merck Settles Investor Suits on Cholesterol Drugs. U.S.News. 14 February 2013. Available at http://www.usnews.com/news/business/articles/2013/02/14/merck-settles-investor-suits-on-cholesterol-drugs, Accessed February 16, 2013.
3. Kastelein J, Akdim F, Stroes E, et al. Simvastatin with or without Ezetimibe in Familial Hypercholesterolemia. New England Journal of Medicine 358.14 (2008): 1431-443.
4. Hughes, S. ENHANCE results yield disappointment for ezetimibe. Theheart.org. 14 January 2008. Available at http://www.theheart.org/article/837243.do, Accessed February 16, 2013.
5. Berenson A. Drug Has No Benefit in Trial, Makers Say. NYTimes. 14 January 2008. Available at http://www.nytimes.com/2008/01/14/business/14cnd-drug.html, Accessed February 16, 2013.
6. Merck Resolves Securities Class-Action Lawsuits Related to ENHANCE Trial. Merck. 14 February 2012. Available at http://www.mercknewsroom.com/press-release/corporate-news/merck-resolves-securities-class-action-lawsuits-related-enhance-trial, Accessed on February 16, 2013.