Merck & Co has agreed in principle to pay $688m to settle investor claims that it failed to disclose material details about a clinical trial of its combination cholesterol product Vytorin.
The company’s general counsel Bruce Kuhlik said in a statement that the settlement “avoids the uncertainties of a jury trial and will resolve all of the remaining litigation” in the case.
At the heart of the dispute was Merck’s controversial ENHANCE trial of Vytorin (ezetimibe plus simvastatin), which compared the combination to simvastatin alone in preventing the progression of atherosclerosis.
Merck took almost two years to publish the results of the study – which was completed in 2006 – leading to accusations that the company was trying to bury the data because it did not come out favourably.
When the findings were finally published in 2008, they showed that there was no significant benefit for Vytorin over simvastatin alone, a finding which immediately sparked a steady decline in annual sales of Vytorin and monotherapy Zetia (ezetimibe) from a level above $5bn in 2007.
Merck has always maintained that the delay was caused by difficulties in analysing arterial imaging data from the trial. Shareholders who bought stock in the company between 2006 and 2008 did not concur with that view, however, and claimed that they lost money when the results were finally published.
Under the terms of the settlement, Merck will pay $215m to resolve a lawsuit against Merck defendants and a further $473m to settle cases brought against Schering-Plough, which it took over in 2009. The payment “will have no impact on Merck’s 2013 results of operations”, said the company.
Merck continues to try to show that Vytorin can improve cardiovascular outcomes compared to simvastatin alone, and is in the final throes of the 18,000-patient IMPROVE-IT study in acute coronary syndrome patients, with data due to be reported later this year.
Meanwhile, the company is also trying to get a combination of ezetimibe with atorvastatin to market, and resubmitted a filing for the combination to the US FDA last month after being knocked back by the agency in March 2012.