Schering-Plough Corporation (NYSE: SGP) announced that it has entered into an agreement with Merck & Co., Inc. to commence development of an ezetimibe and atorvastatin combination product.
“This important new combination therapy reflects the growing potential of ezetimibe,” said Fred Hassan, chairman and chief executive officer of Schering-Plough.
“Given the size of the worldwide market in which this product would compete, we believe the combination of ezetimibe with atorvastatin could be an important contributor to Schering-Plough’s future,” Hassan said.
The cholesterol-management market is one of the largest worldwide, with total global sales of $32 billion (IMS full year 2006 constant USD) and sales in the United States of $22 billion in 2006 (IMS Health).
The development program is timed such that this combination product could be available at the time that patent exclusivity for atorvastatin expires in the United States and internationally.
Through an existing joint venture, Schering-Plough and Merck have already collaborated successfully to develop and commercialize ZETIA(R) (ezetimibe) and VYTORIN(R) (ezetimibe/simvastatin) for lipid management in the United States and the rest of the world (excluding Japan), where the products in some countries are also marketed as EZETROL and INEGY, respectively.
“Ezetimibe was discovered by Schering-Plough Research Institute and represents an important innovation by Schering-Plough’s scientists,” said Thomas P. Koestler, Ph.D., executive vice president and president, Schering- Plough Research Institute (SPRI). “If approved, this new medicine should offer an advance for patients at risk for cardiovascular disease. This international collaboration, which already successfully draws upon the strengths and experience of both companies in world markets, creates the opportunity to develop yet another new option in the physician’s armamentarium for the treatment of elevated LDL cholesterol, utilizing our proprietary compound ezetimibe,” Koestler added.
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 atorvastatin, which work in the liver to reduce the production of cholesterol. In a multi-center, randomized, double-blind, placebo-controlled 12-week clinical trial in 628 patients with high cholesterol, the co-administration of atorvastatin (10 mg, 20 mg, 40 mg, 80 mg) with ZETIA 10 mg lowered LDL “bad” cholesterol by an average of 53 to 61 percent from baseline across the dosing range compared to average LDL cholesterol reductions of 37 to 54 percent with atorvastatin alone. ZETIA, either alone or in addition to a statin, has not been shown to prevent heart disease or heart attacks.
ZETIA is indicated, along with a healthy diet, for use either by itself or together with statins in patients with high cholesterol to reduce LDL cholesterol and total cholesterol when the response to diet has been inadequate. ZETIA is also marketed under the trade name EZETROL internationally. It is also available in a once-daily tablet with Zocor (simvastatin), a Merck statin and marketed under the brand names VYTORIN in the United States and INEGY and VYTORIN internationally.