Merck Settles Vytorin Clinical Trials Data Lawsuit For US$688 Million
In what is claimed to be one of the top 25 securities class action settlements of all time, Merck & CO has settled investor claims that the company withheld negative data from clinical trials on Vytorin.
Investors believed that Merck & Co had failed to disclose important details about the clinical trials it was undertaking on Vytorin, a combination of the generic cholesterol drug Zocor and the newer medicine Zetia.
The New York Times reported that Merck announced it would settle lawsuits brought by pension funds and other shareholders whichasserted that the companies “had known for nearly two years that a clinical trial of the drug failed to show that it was any better than a statin drug at limiting the buildup of plaque in arteries, but they did not make the results public until 2008”.
The case revolves around the controversial ENHANCE trial of Vytorin comparing the drug to simvastatin alone in preventing the progression of atherosclerosis. The issue arose following delays by Merck in releasing the results of the trial, which led to accusations of attempts to bury unfavourable data. According to Forbes, the company was facing mounting pressure to release the data in early 2008 which showed the drug “did not reduce ultrasound readings of thickness in the neck artery any more than Zocor alone”.
This immediately led to a decline in annual sales of Vytorin and monotherapy Zetia (ezetimibe) from a level above US$5 billion in 2007. Doctors caring for patients with high cholesterol moved them onto other similar drugs, including Pfizer’s Lipitor and AstraZeneca’s Crestor.
This settlement means that the trial due to begin on in a couple of weeks will no longer go ahead. Merck’s executive vice president and 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.“We believe 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”.
Lawyers at Bernstein Litowitz Berger & Grossmann LLP, who co-led the five year battle over the results stated: “The combined $688 million in settlements is the second largest securities class action settlement in the Third Circuit, among the top 25 securities class action settlements of all time, and among the ten largest recoveries in a securities class action not involving a restatement”.
Merck persists in its efforts to prove that Vytorin can improve cardiovascular outcomes compared to simvastatin alone. Part of this is an IMPROVE-IT trial of 18,000 acute coronary syndrome patients. This data is expected to be released later in 2013 or even early 2014.