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FDA Approves New Indication For ZETIA(R), Merck & Co., Inc. (MRK) And Schering-Plough Corporation (SGP)'s Cholesterol Lowering Drug


6/9/2006 10:29:19 AM

WHITEHOUSE STATION & KENILWORTH, N.J.--(BUSINESS WIRE)--June 9, 2006--Merck/Schering-Plough Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved ZETIA® (ezetimibe) for use, along with diet, in combination with fenofibrate for the reduction of elevated total cholesterol and LDL "bad" cholesterol in patients with mixed hyperlipidemia, when diet alone is not enough. ZETIA is the first in a class of cholesterol-lowering agents that inhibits the intestinal absorption of cholesterol through a unique mechanism of action.

With this new indication, ZETIA offers patients with mixed hyperlipidemia another treatment option when it is prescribed in combination with fenofibrate. Fenofibrate is commonly used along with diet to treat hyperlipidemia and has proven efficacy in lowering triglyceride levels and increasing HDL "good" cholesterol. The use of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is studied.

Mixed hyperlipidemia is a metabolic disorder characterized by elevated LDL cholesterol, elevated triglycerides (a form of fat in the bloodstream), and reduced levels of HDL cholesterol.

"This is an exciting new development in the treatment of mixed hyperlipidemia. ZETIA and fenofibrate taken together offer complementary lowering of LDL and total cholesterol in patients with mixed hyperlipidemia," said Harold E. Bays, M.D., medical director, president of L-MARC Research Center, Louisville, KY.

Approval was based on the results from a clinical trial which showed that combination therapy of 10 mg of ZETIA co-administered with 160 mg of fenofibrate significantly reduced LDL cholesterol levels when compared to either treatment alone (p Less than 0.001). Patients in a 12-week study who were co-administrated ZETIA 10 mg and fenofibrate 160 mg (n=183) showed a 20 percent reduction in LDL cholesterol levels compared to a 6 percent reduction in LDL cholesterol levels with 160 mg fenofibrate as monotherapy (n=188) and a 13 percent reduction in LDL cholesterol levels with 10 mg ZETIA as monotherapy (n=185).

The study consisted of patients with mixed hyperlipidemia; 625 patients were treated for up to 12 weeks with 576 of these patients continuing treatment for up to an additional 48 weeks. The changes in lipid endpoints after an additional 48 weeks of treatment with ZETIA co-administered with fenofibrate or with fenofibrate alone were consistent with the 12-week data.

In this study, ZETIA co-administered with fenofibrate appeared to be well tolerated. For patients taking ZETIA and fenofibrate in whom gallstones (cholelithiasis) are suspected, physicians should perform gallbladder studies and consider alternative lipid-lowering therapy. While this study was not designed to compare how often infrequent events occurred, the rates for gallbladder removal (cholecystectomy) were 0.6 percent for fenofibrate alone and 1.7 percent for ZETIA and fenofibrate together.

ZETIA, along with diet, is indicated for use either by itself or together with statins or fenofibrate in patients with high cholesterol to reduce LDL cholesterol and total cholesterol when the response to diet and exercise has been inadequate. ZETIA, which works in the digestive tract, is complementary to the class of cholesterol-lowering agents known as statins, which work in the liver to reduce the production of cholesterol. ZETIA, alone or in combination with statins, has been proven to significantly improve LDL cholesterol levels. ZETIA, either alone or in addition to a statin or fenofibrate, has not been shown to prevent heart disease or heart attacks.

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 exposure to ZETIA in patients with moderate or severe hepatic insufficiency, ZETIA is not recommended in these patients. In clinical trials, there was no increased incidence of myopathy (muscle pain) or rhabdomyolysis (muscle breakdown) associated with ZETIA; however myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs. There are no adequate and well-controlled studies of ZETIA in pregnant women. ZETIA should not be used in pregnant or nursing women unless the benefit outweighs the potential risks.

When ZETIA was co-administered with a statin, consecutive elevations in liver enzymes, more than three times the upper limit of normal, were slightly higher than those with the statin alone (1.3 percent vs. 0.4 percent). These elevations were generally asymptomatic and returned to baseline after discontinuation of therapy or with continued treatment. When ZETIA was co-administered with fenofibrate, consecutive elevations in liver enzymes more than three times the upper limit of normal, were 2.7%, and 4.5% in patients treated with fenofibrate alone. Caution should be exercised when initiating ZETIA in patients treated with cyclosporine, particularly in patients with severe renal insufficiency, due to increased blood levels of ZETIA.

In clinical trials, most frequent side effects for ZETIA alone vs. placebo included: back pain (4.1 percent vs. 3.9 percent), arthralgia (3.8 percent vs. 3.4 percent), and fatigue (2.2 percent vs. 1.8 percent); for ZETIA plus statin vs. statin or placebo alone: back pain (4.3 percent vs. 3.7 percent vs. 3.5 percent), abdominal pain (3.5 percent vs. 3.1 percent vs. 2.3 percent), and fatigue (2.8 percent vs. 1.4 percent vs. 1.9 percent).

About Merck/Schering-Plough Pharmaceuticals

Merck/Schering-Plough Pharmaceuticals is a joint venture between Merck & Co., Inc. and Schering-Plough Corporation formed to develop and market in the United States new prescription medicines in cholesterol management. The collaboration includes worldwide markets (excluding Japan). ZETIA is marketed as EZETROL in more than 50 nations outside the U.S.

Merck forward-looking statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

Schering-Plough disclosure notice

The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to ZETIA and EZETROL and the potential market for these medications. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's 2005 10-K.

Full prescribing information and patient product information for ZETIA® is attached.

ZETIA® is a registered trademark of MSP Singapore Company, LLC.


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