Schering-Plough Announces ZETIA Approved In Japan For Treatment Of High Cholesterol

Schering-Plough
Corporation (NYSE: SGP) today announced that Schering-Plough K.K., the
company's country operation in Japan, has received marketing approval for
ZETIA(R) (ezetimibe), a novel cholesterol-lowering agent that inhibits the
absorption of cholesterol in the intestine. ZETIA is approved in Japan for
use in patients with hypercholesterolemia, familial hypercholesterolemia or
homozygous sitosterolemia. ZETIA can be used as a monotherapy and co-
administered with a statin, for further reduction of LDL "bad" cholesterol
in patients with hypercholesterolemia, familial hypercholesterolemia or
homozygous sitosterolemia. ZETIA will not become available in Japan until
National Health Insurance Reimbursement price listing.


"ZETIA has achieved worldwide recognition for its unique mechanism of
action in lowering LDL cholesterol levels. The ezetimibe molecule
represents an important innovation by Schering-Plough's scientists," said
Robert J. Spiegel, M.D., chief medical officer and senior vice president of
medical affairs, Schering-Plough Research Institute (SPRI). "ZETIA offers
an advance for Japanese patients at risk for cardiovascular disease, and
provides a new option in the physician's armamentarium for the treatment of
elevated LDL cholesterol," Spiegel added.



Schering-Plough 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). The total number of hypercholesterolemia patients in Japan,
including those undiagnosed, is estimated to be approximately 30 million.



ZETIA will be co-marketed in Japan with Bayer Yakuhin Ltd., a global
pharmaceutical company with a large expertise in cardiovascular disease-
related products. 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).



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. ZETIA is also marketed under the trade name EZETROL
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 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 schering-plough.



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, 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 I, Item 1A. Risk Factors in the
Company's 2006 10-K.


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