ZETIA (ezetimibe) Named Cardiovascular Compound of the Year at 2004 Pharmaceutical Achievement Awards

Main Category: Cardiovascular / Cardiology
Article Date: 15 Aug 2004 - 0:00 PDT

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ZETIA (ezetimibe) was named the "Cardiovascular Compound of the Year" at the third annual Pharmaceutical Achievement Awards held earlier this week in Boston.

ZETIA is the first in a class of cholesterol-lowering therapies that works by blocking cholesterol absorption in the intestine. Clinical studies have demonstrated that adding ZETIA to a statin provides significant additional LDL cholesterol-lowering efficacy through dual inhibition of cholesterol production in the liver and absorption in the intestine. ZETIA, along with diet, is indicated for use either by itself or together with statins in patients with high cholesterol to reduce LDL ýýýbadýýý cholesterol and total cholesterol when the response to diet and exercise has been inadequate.

The Pharmaceutical Achievement Awards recognizes innovation and individual achievement in a number of categories including: Scientific Achievement, Worldwide Health and Community Involvement, Drug Product R&D; Pharmaceutical Businesss and Drug Product Research and Development.

"We are very happy to continue to receive recognition for the unique attributes of ZETIA and how it provides doctors and patients with an important treatment option for managing high cholesterol," said Rick Veltri, M.D., Group Vice President, Worldwide Clinical Development, Schering-Plough Research Institute.

ZETIA, discovered by scientists at Schering-Plough Research Institute and developed jointly with Merck Research Laboratories, is marketed by the Merck/Schering-Plough Pharmaceuticals Joint Venture. Since its introduction in November, 2002, more than 10 million prescriptions for ZETIA have been written and it is one of the fastest growing products in the lipid lowering market. The once-daily tablet of ZETIA 10 mg was approved in the United States in October 2002 and is also available in several countries in Europe, where it is marketed under the name EZETROL, and throughout the world.

About ZETIA

ZETIA is the first in a class of cholesterol-lowering agents that inhibits the intestinal absorption of cholesterol through a unique mechanism of action. ZETIA is complementary to the class of cholesterol-lowering agents known as statins, which work in the liver to reduce the production of cholesterol. ZETIA has been proven to significantly reduce LDL cholesterol levels. The effects of ZETIA, either alone or in addition to a statin, on the risk of cardiovascular morbidity and mortality have not been established.

Important information about ZETIA

ZETIA is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. When ZETIA is used with a statin, liver function tests should be performed at the start of therapy and after that in accordance with the label for that statin. Liver function tests are not required when ZETIA is used alone. 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 or rhabdomyolysis 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. The safety and effectiveness of ZETIA with fibrates have not been established; therefore, co-administration with fibrates is not recommended.

For monotherapy, the most frequent adverse events reported with greater incidence than placebo, regardless of causality, were back pain (4.1 percent vs. 3.9 percent) and arthralgia (3.8 percent vs. 3.4 percent). In co-administration with a statin, the most frequent adverse events reported with greater incidence for ZETIA plus statin versus statin or placebo alone, regardless of causality, were back pain (4.3 percent vs. 3.7 percent vs. 3.5 percent, respectively) and abdominal pain (3.5 percent vs. 3.1 percent vs. 2.3 percent, respectively).

About Merck/Schering-Plough Pharmaceuticals

Merck/Schering-Plough Pharmaceuticals is a joint venture between Merck & Co., Inc. and Schering-Plough Corporation formed in May 2000 to develop and market in the United States new prescription medicines in cholesterol management. The collaboration was expanded in December 2001 to include worldwide markets (excluding Japan). 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 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 businesses, particularly those mentioned in the cautionary statements in Item 1 of our Form 10-K for the year ended Dec. 31, 2003, and in our periodic reports on Form 10-Q and Form 8-K (if any) which the company incorporates by reference.

SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including the market for ZETIA. Forward-looking statements relate to expectations or forecasts of future events and not to historical information. Schering-Plough does not assume the obligation to update any forward-looking statement. There are no guarantees about the market performance of ZETIA, Schering-Plough stock or Schering-Plough's business. Actual results may vary materially from forward-looking statements made here or in other Schering-Plough written or spoken communications due to many factors and uncertainties, which include the market acceptance of ZETIA, trade buying patterns, the introduction and performance of competitive products in the market, legislation that may impact the pricing/availability of ZETIA and other items discussed in Schering-Plough's Securities and Exchange Commission filings, including the 2004 second quarter 10-Q.

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