Rebetol Approved for Use in Treating Pediatric Patients With Hepatitis C

July 31, 2003

KENILWORTH, N.J., July 31 /PRNewswire-FirstCall/ -- Schering-Plough

Corporation (NYSE:SGP) today announced that the U.S. Food and Drug

Administration (FDA) has granted marketing approval to REBETOL®

(ribavirin, USP) Oral Solution and Capsules for use in the treatment of

pediatric hepatitis C.

" REBETOL combination therapy with INTRON A represents the first and only

therapy approved in the United States for treating hepatitis C in children, "

said J. Spiegel, M.D., senior vice president of medical affairs and

chief medical officer, Schering-Plough Research Institute. " For more than a

decade, Schering-Plough has been the leader in developing new treatments for

chronic hepatitis C. We remain committed to developing innovative therapies

to meet the needs of patients with hepatitis C and other serious diseases. "

In the pediatric population, REBETOL is indicated for use in combination

with INTRON® A (interferon alfa-2b, recombinant) Injection for the

treatment of chronic hepatitis C in patients 3 years of age and older with

compensated liver disease previously untreated with alpha interferon. For

these patients, individualized combination therapy is recommended, with

REBETOL dosed according to patient body weight and INTRON A dosed according

to patient size measured in body surface area. The recommended duration of

therapy is 24 weeks for pediatric patients with genotype 2/3 virus and 48

weeks for pediatric patients with genotype 1 virus.

The New Drug Application (NDA) for REBETOL for pediatric use was submitted

to FDA in January 2003 and received priority review. Priority review status

is granted to drugs that, if approved, would address unmet medical needs and

represent significant advances over existing treatments. It is estimated

that less than 200,000 children in the United States are infected with the

hepatitis C virus.

Schering-Plough also noted that FDA has granted orphan-drug designation to

REBETOL for the treatment of chronic hepatitis C in pediatric patients.

REBETOL Oral Solution represents a new formulation of ribavirin, USP.

REBETOL Capsules are approved in the United States for use in combination

therapy with INTRON A for the treatment of chronic hepatitis C in patients

with compensated liver disease previously untreated with alpha interferon or

who have relapsed following alpha interferon therapy. REBETOL Capsules also

are indicated in combination with PEG-INTRON® (peginterferon alfa-2b,

recombinant) Injection for the treatment of chronic hepatitis C in patients

with compensated liver disease who have not been previously treated with

interferon and are at least 18 years of age.

Some 4 million Americans are infected with the hepatitis C virus (HCV) and

approximately 70 percent of infected patients go on to develop chronic liver

disease, according to the Centers for Disease Control and Prevention (CDC).

Hepatitis C infection contributes to the deaths of an estimated 8,000 to

10,000 Americans each year and this toll is expected to triple by the year

2010, according to the CDC. The CDC has reported that HCV-associated

end-stage liver disease is the most frequent indication for liver

transplantation among adults. It is predicted that direct U.S. medical costs

to treat HCV-related disease will exceed $13 billion for the years 2010

through 2019, according to a study published in the American Journal of

Public Health.

Source: Schering-Plough Corporation

July 31, 2003