Novel Cholesterol Uptake Inhibitor ZETIA® Approved In Japan

Main Category: Cholesterol
Also Included In: Clinical Trials / Drug Trials
Article Date: 23 Apr 2007 - 0:00 PDT

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The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved ZETIA® (ezetimibe), a novel cholesterol-lowering agent that inhibits the absorption of cholesterol in the intestines. ZETIA® will be co-marketed by Bayer Yakuhin Ltd. and Schering-Plough K.K. Japan. The drug is approved for use either as monotherapy or co-administered with a statin, for further reduction of LDL "bad" cholesterol.

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, 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® 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.

The total number of hypercholesterolemia patients in Japan, including those undiagnosed, is estimated to be approximately 30 million. It is believed that, of these, about 80% are untreated.

The co-marketing agreement regarding ZETIA® is part of Bayer's strategic pharmaceuticals alliance with Schering-Plough, which was announced in 2004. Bayer's primary care pharmaceutical products, such as the antibiotics Avelox® and Cipro®, the cardiovascular product Adalat® and also Levitra® are today marketed and distributed by Schering-Plough in the United States and Puerto Rico.

Bayer HealthCare

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. http://www.bayerhealthcare.com

Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. http://www.bayerscheringpharma.de

Forward-looking statements

This press release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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