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Schering-Plough News Release

Nation's Top Medical Centers Seek Participants for Largest Study

Comparing Leading Hepatitis C Treatments

Schering-Plough Sponsors IDEAL Study to Determine Best Treatment For

Most Common Blood-borne Infection in America

KENILWORTH, N.J., May 13 /PRNewswire-FirstCall/ -- Medical centers,

hospitals, clinics and other treatment sites across the country are

actively enrolling Americans with the hepatitis C virus (HCV) in a

nationwide study that will for the first time determine which of the

two FDA-approved pegylated interferon therapy regimens offers

patients the best chance to eliminate the virus. The regimens being

compared are PEG-INTRON® (peginterferon alfa- 2b/Schering

Corporation) versus PEGASYS (peginterferon alfa-2a/ Hoffmann-La

Roche, Inc.), both used in combination with ribavirin.

Hepatitis C, a potentially fatal virus that infects the liver, blood

and other tissues, is the most common blood-borne infection in

America, and is the leading cause of liver transplantation in the

United States, according to the National Institutes of Health.

Approximately 4 million Americans, or about one in every 50 adults,

are now infected with HCV,(1) compared to 900,000 Americans with HIV.

A total of 2,880 patients at up to 100 U.S. sites will join the IDEAL

study, which stands for Individualized Dosing Efficacy vs. flat

dosing to Assess optimaL pegylated interferon therapy. The study is

led by co-principal investigators G. McHutchison, M.D., FRACP,

Medical Director, Liver Research, Duke University Medical Center, and

Mark S. Sulkowski, M.D., assistant professor of medicine in the

Division of Infectious Diseases, s Hopkins University School of

Medicine.

IDEAL study sites currently open to patient enrollment can be

identified via zip code search on the study's Web site:

www.idealstudy.com. Patients are encouraged to check the Web site on

an ongoing basis as additional study sites will be opening enrollment

in the coming weeks and will be added to the Web site at that time.

Unlike some clinical studies, where patients receive either active

drug or placebo, all participates in the IDEAL study will receive

active treatment at no cost.

" The IDEAL Study offers an excellent opportunity to collect more data

on hepatitis C treatment, " said Alan Brownstein, president and chief

executive officer of the American Liver Foundation. " Treating HCV is

a long and arduous process. To give people the best chance for

success in the future, we need more information. "

The IDEAL study will compare the efficacy and safety of

individualized weight-based dosing with PEG-INTRON and REBETOL®

(ribavirin, USP) to PEGASYS, which is administered as a flat dose to

all patients regardless of individual body weight, and COPEGUS

(ribavirin, USP) dosed either at 1,000 mg or 1,200 mg daily, in U.S.

patients chronically infected with hepatitis C, genotype 1. Genotype

1 is the most common worldwide, the most difficult to treat

successfully and accounts for about 70 percent of HCV infection among

Americans. PEG-INTRON is a form of interferon alfa-2b that has been

chemically " pegylated " so it is retained in the body longer than

standard interferon, thereby providing for once weekly

administration. PEGASYS is a pegylated form of interferon alfa-2a.

IDEAL is sponsored by Schering-Plough Research Institute (SPRI) and

is being conducted to respond to questions raised by the hepatitis C

medical and patient communities.

" These two treatment regimens have never before been directly

compared in a study of this magnitude, " said J. Spiegel, M.D.,

senior vice president of medical affairs and chief medical officer,

Schering-Plough Research Institute. " We are confident that the

results of this large head-to- head study between PEG-INTRON and

PEGASYS will help doctors and patients determine the therapy that

offers them the best chance for achieving a sustained virologic

response. "

About IDEAL

Combination therapy with pegylated interferon, which boosts the

body's immune system, and ribavirin, an oral antiviral agent, is

today's standard of care when treating chronic HCV. Approximately 50

to 60 percent of individuals who are treated with this combination

therapy clear the hepatitis C virus from their bodies.

PEG-INTRON and REBETOL combination therapy is the most-prescribed

treatment for chronic hepatitis C worldwide, with more than 300,000

patients having received this treatment since its introduction in

2001.

All participants will be treated with an active study medication for

up to 48 weeks, with follow-up by a physician for an additional six

months.

How to Participate in IDEAL

To enroll in the IDEAL study, people must be diagnosed with chronic

hepatitis C, genotype 1, not have received any prior treatment for

hepatitis C and be between the ages of 18 and 70.

To identify a study center near you, consult the study's Web site:

www.idealstudy.com. The list of institutions actively enrolling

patients will be updated on the Web site as additional sites open for

enrollment or as patient enrollment at specific institutions is

completed.

IDEAL Study Locations (by city):

Akron, OH Hartford, CT Pittsburgh, PA

andria, VA Hershey, PA Plymouth, MN

Atlanta, GA* Houston, TX* Portland, ME

Baltimore, MD* Indianapolis, IN Portland, OR

Baton Rouge, LA Kansas City, MO* Providence, RI

Birmingham, AL Lancaster, PA Richmond, VA

Boston, MA* Lexington, KY Rochester, MN

Bradenton, FL Lincoln, NE Royal Oaks, MI

Bronx, NY Long Beach, CA Sacramento, CA*

Burlington, MA Los Angeles, CA Salt Lake City, UT

Burlington, VT Louisville, KY San , TX

ton, SC Madison, WI* San Diego, CA

Charlotte, NC Manhasset, NY San Francisco, CA

Charlottesville, VA Marietta, GA Shreveport, LA

Chicago, IL Miami, FL* St. Louis, MO*

Cincinnati, OH Milwaukee, WI Syracuse, NY

Cleveland, OH* Minneapolis, MN* Tucson, AZ

Columbia, MO Mobile, AL Valhalla, NY

Dallas, TX* Nashville, TN Washington, DC

Detroit, MI New Orleans, LA* Wellington, FL

Downers Grove, IL New York, NY*

Durham, NC Norfolk, VA

Falls Church, VA Orange, CA

Farmington, CT Pasadena, CA

Florham Park, NJ Philadelphia, PA*

*indicates multiple study participants in this city

PEG-INTRON and REBETOL Combination Therapy

PEG-INTRON and REBETOL combination therapy is indicated for the

treatment of chronic hepatitis C in patients with compensated liver

disease who have not been previously treated with interferon alpha

and are at least 18 years of age.

WARNING

REBETOL monotherapy is not effective for the treatment of chronic

hepatitis C virus infection and should not be used alone for this

indication. (See WARNINGS.)

The primary toxicity of ribavirin is hemolytic anemia. The anemia

associated with REBETOL therapy may result in worsening of cardiac

disease that has lead to fatal and nonfatal myocardial infarctions.

Patients with a history of significant or unstable cardiac disease

should not be treated with REBETOL. (See WARNINGS, ADVERSE REACTIONS,

and DOSAGE AND ADMINISTRATION.)

Significant teratogenic and/or embryocidal effects have been

demonstrated in all animal species exposed to ribavirin. In addition,

ribavirin has a multiple-dose half-life of 12 days, and so it may

persist in nonplasma compartments for as long as 6 months. Therefore,

REBETOL therapy is contraindicated in women who are pregnant and in

the male partners of women who are pregnant. Extreme care must be

taken to avoid pregnancy during therapy and for 6 months after

completion of treatment in both female patients and in female

partners of male patients who are taking REBETOL therapy. At least

two reliable forms of effective contraception must be utilized during

treatment and during the 6-month post-treatment follow-up period.

(See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS-Information for

Patients and Pregnancy Category X.)

Alpha interferons, including PEG-INTRON and INTRON A, may cause or

aggravate fatal or life-threatening neuropsychiatric, autoimmune,

ischemic and infectious disorders. Patients should be monitored

closely with periodic clinical and laboratory evaluations. Patients

with persistently severe or worsening signs or symptoms of these

conditions should be withdrawn from therapy. In many but not all

cases these disorders resolve after stopping therapy with PEG-INTRON

or INTRON A. (See WARNINGS, ADVERSE REACTIONS.)

PEG-INTRON

There are no new adverse events specific to PEG-INTRON as compared to

INTRON A, however, the incidence of some (e.g., injection site

reactions, fever, rigors, nausea) were higher. The most common

adverse events associated with PEG-INTRON were " flu-like " symptoms,

occurring in approximately 50% of patients, which may decrease in

severity as treatment continues. Application site disorders were

common (47%), but all were mild (44%) or moderate (4%) and no patient

discontinued, and included injection site inflammation and reaction

(i.e., bruise, itchiness, irritation). Injection site pain was

reported in 2% of patients receiving PEG-INTRON. Alopecia (thinning

of the hair) is also often associated with alpha interferons

including PEG-INTRON.

Psychiatric adverse events, which include insomnia, were common (57%)

with PEG-INTRON, but similar to INTRON A (58%). Depression was most

common at 29%. Suicidal behavior including ideation, suicidal

attempts, and completed suicides occurred in 1% of patients during or

shortly after completing treatment with PEG-INTRON. PEG-INTRON is

contraindicated in patients with autoimmune hepatitis and

decompensated liver disease.

The following serious or clinically significant adverse events have

been reported at a frequency <1% with PEG-INTRON or interferon alpha:

Severe decreases in neutrophil or platelet counts, hypothyroidism,

hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic

colitis, development or exacerbation of autoimmune disorders

including thyroiditis, RA, systemic lupus erythematosus, psoriasis,

pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and

pneumonia, some resulting in patient deaths), urticaria, angioedema,

bronchoconstriction, anaphylaxis, retinal hemorrhages and cotton wool

spots.

Renal failure patients should be closely monitored for signs and

symptoms of interferon toxicity and PEG-INTRON should be used with

caution in patients with creatinine clearance <50 mL/min. Patients on

PEG-INTRON therapy should have hematology and blood chemistry testing

before the start of treatment and then periodically thereafter.

DISCLOSURE NOTICE: The information in this press release includes

certain " forward-looking " statements concerning, among other things,

the future prospects of the company's products. All forward-looking

statements are subject to substantial risks and uncertainties. The

prospects of the company's products may be adversely affected by

general market and economic factors, competitive product development,

product availability, current and future branded, generic and OTC

competition, market acceptance of new products, the regulatory review

process in the United States and foreign countries for new products

and indications, existing manufacturing issues and new manufacturing

issues that may arise, timing of trade buying and patent positions.

Actual results may differ from forward-looking statements and

Schering-Plough undertakes no obligation to update the forward-

looking statements. For a discussion of other risks and uncertainties

that may impact forward-looking statements, see the company's past

and future Securities and Exchange Commission filings, including the

company's 2003 10-K.

Schering-Plough 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

more than 30,000 people around the world.

For more information about Schering-Plough, visit the company's Web

site at www.schering-plough.com.

For more information about PEG-INTRON, visit www.pegintron.com.

For information about hepatitis, visit www.hepatitisinnovations.com.

PEGASYS and COPEGUS are trademarks of Hoffmann-La Roche Inc. See

PEGASYS and COPEGUS product inserts for information on these products.

(1)

http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm#A

SOURCE Schering-Plough Corporation

05/13/2004

CONTACT: Media - J. Consalvo, +1-908-298-7409, or Investors -

, +1-908-298-7450, or W. DeBerardine, +1-908-298-7437,

or Janet M. Barth, +1-908-298-7417, all of Schering-Plough

Web site: http://www.schering-plough.com

http://www.idealstudy.com

(SGP)

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