(Reuters) - Merck & Co on Monday said long-awaited data from an 18,000-patient trial suggest the company will not have to write down the value of its blockbuster Zetia and Vytorin cholesterol drugs.
“The company has determined that the Zetia and Vytorin intangible assets are not impaired,” the No. 2 U.S. drugmaker said on Monday in a regulatory filing, noting its assessment was based on having seen “unblinded” data from the huge study.
Merck’s statement suggests that the study, meant to determine whether Zetia can prevent heart attacks, strokes and deaths, proved favorable to its $2.5 billion-a-year drug. A related Merck drug, Vytorin, pairs Zetia with Merck’s statin Zocor (simvastatin), and has annual sales of $1.5 billion.
Pam Eisele, a Merck spokeswoman, said the company had no further comment on the trial results, or their likely financial impact on Zetia and Vytorin.
Merck almost a decade ago began the study, called IMPROVE-IT, to determine whether adding Zetia to simvastatin is better at preventing heart attacks, deaths and strokes than simvastatin alone.
Trial results are slated to be unveiled on Nov. 17 in Chicago, at the annual scientific sessions of the American Heart Association. Merck earlier this year warned that it might have to write down the value of Zetia and Vytorin if the study did not prove Zetia provided an incremental benefit to patients.
Zetia, which prevents absorption of “bad” LDL cholesterol in the intestines, was approved by U.S. regulators in 2002 based on its ability to lower cholesterol 25 percent beyond reductions seen with simvastatin alone. Statins work by reducing the liver’s production of cholesterol, and can cut LDL levels by 50 percent or more.
No previous studies have ever proven conclusively whether Zetia or Vytorin actually improve patient outcomes.
Despite longstanding doubts about Zetia’s effectiveness, many doctors have prescribed it and Vytorin on the assumption that Zetia’s demonstrated ability to further lower cholesterol will lead to better patient outcomes.
Shares of Merck were down 1 percent in afternoon trading on the New York Stock Exchange.
Reporting by Ransdell Pierson in New York; Editing by Lisa Shumaker