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;
kevin.kingsbury@dowjones.com