EU Label Change for INTRON(R) A (interferon alfa-2b) Incorporates Long-Term Efficacy Data in Patients with Chronic Hepat

KENILWORTH, New Jersey, April 26 /PRNewswire/ --

-- Five-Year Follow-Up Data Demonstrate Sustained Viral Response Results in Long-Term Clearance of the Virus and Clinical 'Cure'

Schering-Plough Corporation (NYSE: SGP) today reported that the European Commission has adopted changes to the European Union (EU) label for INTRON(R) A (interferon alfa-2b) based on long-term efficacy data from a large, five-year follow-up study to evaluate the durability of sustained virological response (SVR)(1) in patients treated for chronic hepatitis C virus infection (HCV). This large study confirms that sustained loss of serum HCV RNA six months following the completion of treatment with nonpegylated interferon alfa-2b (with or without ribavirin) is a strong predictor of long-term clearance of the virus, providing resolution of the hepatic infection and clinical "cure" from chronic HCV. However, long-term clearance of the virus does not preclude the occurrence of hepatic events in patients with cirrhosis, including hepatocarcinoma.

"This large study involving more than 1,000 hepatitis C patients demonstrates that, even with close follow-up over a five-year period, patients who have achieved an SVR have essentially no evidence of clinical or virological disease," said John McHutchison, M.D., Duke University, and lead investigator of the study. "Recognition of this durability of response underscores the efficacy of interferon-based antiviral therapy. Furthermore, it may help motivate hepatitis C patients to seek treatment and provides physicians confidence that they are giving their patients a meaningful chance for a cure."

In the study, 1,071 patients were enrolled after completing prior treatment with nonpegylated interferon alfa-2b (with or without ribavirin). Of these, 492 patients achieved an SVR and only 12 relapsed during the follow- up period. In all, 446 patients completed at least five years of long-term follow-up. The Kaplan-Meier estimate for continued sustained response over five years for all patients in the study is 97 percent with a 95 percent Confidence Interval of [95 %, 99 %].

A similar long-term follow-up study with pegylated interferon alfa-2b (PEGINTRON(R)) is ongoing.

About Interferon Alfa-2b

Interferon alfa-2b is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets interferon alfa-2b (brand name INTRON A in most countries) for 16 major antiviral and anticancer indications worldwide. Schering-Plough also markets a longer-acting, once-weekly pegylated version of interferon alfa-2b called PEGINTRON (peginterferon alfa-2b), for use as monotherapy or in combination therapy with REBETOL(R) (ribavirin) for the treatment of chronic hepatitis C in patients with compensated liver disease who are at least 18 years of age.

Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.

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 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

    
    (1) SVR is the accepted criterion for assessing efficacy in HCV therapy
        and is defined as undetectable virus (HCV RNA) levels 24 weeks after
        the end of treatment.

Media: Robert Consalvo, +1-908-298-7409, or Gail Thornton, +1-908-298-5313, or Investors: Alex Kelly, +1-908-298-7436, both of Schering-Plough Corporation. NOTE TO EDITORS: Schering-Plough press releases are available on the company's Web site at http://www.schering-plough.com / Schering-Plough press releases are also available on PRNewswire's Web site at http://www.prnewswire.com/comp/777050.ht...