Schering-Plough Receives U.S. Marketing Approval for INTRON(R) A Pediatric Use in Chronic Hepatitis B

MADISON, N.J., Aug. 25 /PRNewswire/ — Schering-Plough Corporation (NYSE: SGP) today announced that INTRON(R) A (interferon alfa-2b, recombinant) for injection has received marketing approval from the U.S. Food and Drug Administration for the treatment of chronic Hepatitis B in pediatric patients 1 year of age or older. INTRON A is the only interferon currently marketed in the United States for the treatment of chronic Hepatitis B in adults.

“This new indication extends the benefits of INTRON A therapy for the treatment of chronic Hepatitis B to an important patient population,” said Jonathan R. Spicehandler, M.D., president of Schering-Plough Research Institute. “Schering-Plough’s ongoing clinical studies using INTRON A in various indications continue to demonstrate the value of this biologic agent and expand its therapeutic utility.”

Chronic Hepatitis B is a highly infectious liver disease that can lead to cirrhosis, liver cancer and death. In the United States, Hepatitis B is transmitted through exposure to infected blood and blood products, sexual contact and from infected mothers to their infants. Although there are currently no reliable data on the Hepatitis B pediatric population in the United States, in 1994 approximately 1,200 new cases of Hepatitis B were reported in the 1-to-19-year age group, according to the Centers for Disease Control and Prevention.

The benefit of INTRON A therapy for pediatric patients with chronic Hepatitis B was demonstrated in a controlled study with 149 patients ranging from 1 year to 17 years of age. In the study, patients treated with INTRON A received 3 million international units (IU)/m2 administered subcutaneously three times a week for one week, then were escalated to 6 million IU/m2 of INTRON A three times a week for a minimum of 16 weeks up to 24 weeks, compared with untreated patients. Treated patients had a significantly better response (24 percent) at 24 weeks of follow up compared with untreated patients (10 percent), as defined by a loss of serum markers (HBV-DNA and HBeAg) that indicate hepatitis viral replication. All but one of the treated responders remained HBV-DNA and HBeAg negative and had a normal serum ALT 12 to 24 months after completion of treatment.

Adverse events most frequently reported by patients in this study included flu-like symptoms, gastrointestinal system disorders, nausea and vomiting. The majority of side effects resolved upon dose modification or dose discontinuation.

INTRON A is a recombinant version of a naturally occurring alpha interferon, having both antiviral and immunomodulatory effects. In addition to chronic Hepatitis B, INTRON A is marketed in the United States for the treatment in adults of chronic Hepatitis C, hairy cell leukemia, AIDS-related Kaposi’s sarcoma, condylomata acuminata (venereal warts), and as adjuvant therapy for malignant melanoma and in combination with chemotherapy for non- Hodgkin’s lymphoma. INTRON A is also marketed in the United States in combination with REBETOL(R) (ribavirin, USP) Capsules as REBETRON(TM) Combination Therapy. INTRON A is marketed in 82 countries for 16 major indications.

The most common side effects associated with INTRON A therapy are flu-like symptoms, such as fever, headache, myalgia, rigors and asthenia. Other frequently occurring side effects are nausea, alopecia, abdominal pain, depression, musculoskeletal pain and somnolence. As with other interferons, very infrequent reports of suicidal behavior (ideation, attempts and completed suicides) have been associated with treatment.

Schering-Plough Research Institute is the pharmaceutical research and development arm of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.

SOURCE: Schering-Plough Corporation