Healthcare Industry News:  Bayer HealthCare 

Biopharmaceuticals Regulatory

 News Release - June 8, 2007

Schering-Plough and Bayer Healthcare Announce Availability of ZETIA in Japan, the First Cholesterol-Lowering Agent With a Novel Mechanism of Action Approved in Japan in 18 Years

Novel Cholesterol-Lowering Agent Works by Inhibiting Absorption of Cholesterol in the Intestine

KENILWORTH, N.J., June 8 (HSMN NewsFeed) -- Schering-Plough Corporation (NYSE: SGP ) and Bayer HealthCare today announced that ZETIAŽ (ezetimibe), a novel cholesterol-lowering agent that inhibits the absorption of cholesterol in the intestine, is now available in Japan for use in patients with hypercholesterolemia, familial hypercholesterolemia or homozygous sitosterolemia. ZETIA is the first new cholesterol-lowering medication with a novel mechanism of action since statins were introduced 18 years ago in Japan. ZETIA is marketed in Japan by Schering-Plough K.K. and Bayer Yakuhin Ltd., the country operations of Schering-Plough and Bayer HealthCare, respectively, in Japan. ZETIA can be used as a monotherapy and co-administered with a statin, for further reduction of low-density lipoproteins (LDL) or "bad" cholesterol.

ZETIA received marketing approval in Japan from the Ministry of Health, Labor and Welfare (MHLW) on April 18, and will become available on June 11 following National Health Insurance Reimbursement price listing on June 8. The total number of patients in Japan with high cholesterol, including those undiagnosed, is estimated to be approximately 30 million, which makes Japan the second leading country with patients with high cholesterol, following the U.S.

Schering-Plough, in collaboration with Merck, obtained FDA approval for ZETIA in 2002, and the medication has been approved in 90 countries worldwide. The cholesterol-management market is one of the largest worldwide, with total global sales of $34 billion and sales in the United States of $22 billion in 2006 (IMS Health). Schering-Plough, in collaboration with Merck, has developed and commercialized ZETIA for lipid management in the United States and the rest of the world (excluding Japan), where it is also marketed under the trade names EZETROL and ZIENT.

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. 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, 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.

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 Schering-Plough

Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

Schering-Plough disclosure notice: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to ZETIA and the potential market for this drug. 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 Part II, Item 1A. "Risk Factors" in the Company's first quarter 2007 10-Q.

Full prescribing information for ZETIA may be found by visiting http://www.zetia.com.


Source: Schering-Plough

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