After reportedly reaching an agreement in principle, Merck has reached a settlement in which it will pay $688 million to resolve two class-action lawsuits over its cholesterol drug, Vytorin (ezetimibe/simvastatin).
Merck said it reached the agreement in principle with plaintiffs who alleged that drug makers Merck and Schering-Plough put off releasing the details of unfavorable clinical trial results, specifically from the ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) trial, said Cardiovascular Business.
ENHANCE involved 720 patients who were diagnosed with heterozygous familial hypercholesterolemia and who either received ezetimibe/simvastatin 10/80 mg or simvastatin 80 mg alone over a two-year period.
According to Cardiovascular Business, the plaintiffs were a group of investors who purchased securities issued by Merck and Schering-Plough between December 2006 and March 2008. The plaintiffs claim they suffered losses when the ENHANCE trial results were published in early 2008.
The lawsuits are pending in the U.S. District Court for the District of New Jersey against Merck and Schering-Plough, as well as some current and former officers and directors, said Cardiovascular Business. Merck and Schering-Plough jointly marketed Vytorin.
Under the proposal, Merck will pay $215 million to resolve the securities class action against the Merck defendants and $473 million to resolve the securities class action against the Schering-Plough defendants, said Cardiovascular Business, citing the proposed agreement. The agreement, which is subject to court approval, contains no admission of liability or wrongdoing.
Merck recorded a pre-tax and after-tax charge of $493 million, an anticipation of insurance recoveries and in connection with the settlement, Cardiovascular Business reported.
Meanwhile, we previously wrote that people who use statins such as Vytorin to lower their cholesterol may face a higher risk of developing age-related cataracts, according to a study published late last year in Optometry and Vision Science. According to the study, the association between statins and cataracts may be equal to the association with Type 2 diabetes, a known risk factor for age-relegated cataracts. That’s significant, because statin use is generally higher among Type 2 diabetics, compared to the general population. Statins, which are used to lower blood cholesterol levels, rank among the best selling drugs in the world.
Prior to that, we wrote that the U.S. Food & Drug Administration (FDA) warned that statins, including Vytorin, cannot only raise blood sugar levels, but may cause memory loss. The labels for the drugs were updated to include information about these possible statin side effects.