Nation's Top Medical Centers Seek Participants for Largest Study Comparing Leading Hepatitis C Treatments

May 13, 2004

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: http://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:

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

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

For information about hepatitis, visit

http://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

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

http://www.idealstudy.com

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May 13, 2004