Mar 26 2007, 7:30 AM EST
News source: Business Wire
Merck & Co., Inc. (NYSE: MRK) announced today an agreement to commence development of an ezetimibe and atorvastatin combination product in collaboration with Schering-Plough Corporation.
Merck and Schering-Plough are the two parent companies of Merck/Schering-Plough Pharmaceuticals, a joint venture that was formed in 2000 to develop and market in the United States new prescription medicines in cholesterol management and respiratory disease. The cholesterol collaboration was expanded in 2001 and includes worldwide markets (excluding Japan). The joint venture/partnership also markets ZETIA(R) (ezetimibe) and VYTORIN(R) (ezetimibe/simvastatin) in the U.S. and these medicines are marketed as EZETROL and INEGY, respectively, in many countries outside the U.S.
"Everyone at Merck is delighted that we have entered into this agreement with Schering-Plough," said Richard T. Clark, president and chief executive officer of Merck & Co., Inc. "This agreement exemplifies Merck's Plan to Win by expanding our lead in cutting-edge science through investments in our own internal research as well as through external collaborations and is a logical next step for our very strong and successful partnership with Schering-Plough."
The development program is timed such that this combination product could be available at the time that patent exclusivity for atorvastatin expires in the U.S. and internationally.
The cholesterol-management market is one of the largest worldwide, with total worldwide sales of $32 billion (IMS Full Year 2006 Constant USD) and sales in the U.S. of $22 billion in 2006 (IMS Health).
"Based on the outstanding performance of VYTORIN and INEGY in markets around the world, the excellent LDL cholesterol efficacy and wide acceptance of the dual inhibition approach to the treatment of elevated cholesterol has clearly been established. The development of ezetimibe and atorvastatin is an extension of this approach," said Peter Loescher, president, Global Human Health, Merck & Co., Inc.
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, which work in the liver to reduce the production of cholesterol. In a multi-center, 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 10mg 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. 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 internationally.
Important information about ZETIA
ZETIA is a prescription medication and should not be taken by people who are allergic to any of its ingredients. When ZETIA is prescribed with a statin, it should not be taken by women who are nursing or pregnant or who may become pregnant, or by anyone with active liver disease. Statins should not be taken by anyone with these conditions. If you have ever had liver problems or are pregnant or nursing, your doctor will decide if ZETIA is right for you. Your doctor may do blood tests to check your liver before you start taking ZETIA with a statin and during treatment.
Due to the unknown effects of increased
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