FDA Says No To Application For Potential Lipitor/Zetia Combo

The Food and Drug Administration has turned away a new-drug application which would combine cholesterol treatments Zetia and Lipitor, saying additional data are needed.

Lipitor is the world's best-selling prescription drug, but Pfizer Inc. (PFE) is facing a landscape in which its cash cow will lose patent exclusivity in two years. Zetia, part of a joint venture between merger partners Merck & Co. (MRK) and Schering-Plough Corp. (SGP), has seen weaker sales since a study last year raised questions about the safety and effectiveness of the drug.

The update on the potential Lipitor/Zetia combination was disclosed in Merck's third-quarter report, filed Monday with the Securities and Exchange Commission. The company said the combined drug is an investigational medication to treat dyslipidemia, a disorder affecting cholesterol.

However, the FDA refused to file the new-drug application, saying it "has identified additional manufacturing and stability data that are needed." As a result, Merck "is assessing the FDA’s response in order to determine a new timetable for filing."

Merck and Schering said in 2007 they hoped to launch a new product combining Zetia with Pfizer's cholesterol agent after Lipitor lost patent protection.

-By Kevin Kingsbury; Dow Jones Newswires; 212-416-2354; [e-mail]