The agreement could help the companies gain a share of the large worldwide market for cholesterol-management treatments which is currently estimated at $32 billion by IMS Health.
The combination product would come available at the time that patent exclusivity for atorvastatin expires in the US and internationally.
“If approved, this new medicine should offer an advance for patients at risk for cardiovascular disease,” said Thomas Koestler, executive vice president and president, Schering-Plough Research Institute.
Schering-Plough and Merck have already collaborated successfully to develop and commercialize the products Zetia and Vytorin for lipid management. Zetia, which works in the digestive tract to inhibit the absorption of cholesterol, is complementary to the class of cholesterol-lowering agents known as statins, including Lipitor, which works in the liver to reduce the production of cholesterol.
In a clinical trial, the co-administration of atorvastatin with Zetia lowered LDL or bad cholesterol by an average of 53 to 61% from baseline across the dosing range compared to average LDL cholesterol reductions of 37 to 54% with Lipitor alone.