Data on PEG-INTRON(R) and REBETOL(R) Combination Therapy in Diverse Patient Populations to Be Presented at 2005 Digestive Disease Week (DDW) Meeting PEG-INTRON TO BE FEATURED IN 22 ORAL AND POSTER PRESENTATIONS KENILWORTH, N.J., May 12 /PRNewswire-FirstCall/ -- Important new data on PEG-INTRON(R) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy will be presented at the 2005 Digestive Disease Week (DDW) meeting at the McCormick Place Convention Center in Chicago, May 14-19. Researchers will report on the use of PEG-INTRON in treating hepatitis in diverse patient populations, including those with hard-to-treat forms of the disease. Comparative clinical data as well as retrospective analyses evaluating real-world treatment data with PEG-INTRON and Pegasys, the two approved forms of peginterferon, will be reported. Hepatitis C virus (HCV) is the most common blood-borne infection in America and the most common form of liver disease. It affects nearly 4 million people -- or one in 50 adults -- in the United States and 200 million people worldwide. Oral Presentations of PEG-INTRON Data Double-Dose Peginterferon Alfa-2b plus Weight-Based Ribavirin for Re- Treatment of African-American Non-Responders With Hepatitis C; J.B. Gross et al. Sunday, May 15, 11:15 - 11:30 am. S406B. Peginterferon Alfa 2-B Therapy for 8 Weeks in Acute Hepatitis C Genotypes 1 and 4: a Pilot Study; S. Kamal et al. Sunday, May 15, 10:30 - 10:45 am. S406B. Sustained Virologic Response (SVR) with PEG-Interferon-Alfa 2b / ribavirin Weight Based Dosing in Previous Interferon/ribavirin HCV Treatment Failures; Week 12 Virology as a Predictor of SVR in the EPIC3 Trials; T. Poynard et al. Sunday, May 15, 9:30 am - 9:45 am, S406A. Comparative Clinical Data and Retrospective Analyses with PEG-INTRON and Pegasys The Effect of Weight on Exposure in Hepatitis C: Peginterferon Alfa-2b and Peginterferon Alfa-2a; M. Silva et al. Poster presentation, May 15, 8:00 am - 5:00 pm. Hepatitis C Viral Load Declines with Peginterferon Alfa Therapy: Association with Interferon Alpha Gene Expression; M. Silva et al. Poster presentation, May 15, 8:00 am - 5:00 pm. Correlation of Immune Stimulation with Antiviral Response to Interferon Therapy in Hepatitis C Patients; M. Silva et al. Poster presentation, May 15, 8:00 am - 5:00 pm. Measurement of Interferon Alpha Receptor-Mediated Activity In Vitro by Stat Translocation: Implications of Differential Activity of Peginterferon Alfa-2b (12kda) and Peginterferon Alfa-2a (40kda); S. Bradshaw et al. Poster presentation, May 16, 8:00 am - 5:00 pm. Impact of Obesity on Degree of Liver Disease and Response to Therapy in Patients with Chronic Hepatitis C Genotype 1 Infection; K. Cesario et al. Poster presentation, May 16, 8:00 am - 5:00 pm. Predictors of Treatment Failure in Patients with Hepatitis C Genotypes 2 or 3 Infections; A.M. Qadri et al. Poster presentation, May 15, 8:00 am - 5:00 pm. Hematopoiesis Suppression with Different Pegylated and Nonpegylated Interferon-Alpha Regimens for Chronic Hepatitis C; M. Peck-Radosavljevic et al. Poster presentation, May 15, 8:00 am - 5:00 pm. A Descriptive Assessment of the Current Treatment Patterns for Hepatitis C in a Health Benefits Company Population; J. Whitworth et al. Poster presentation, May 15, 8:00 am - 5:00 pm. PEG-INTRON in Targeted Patient Populations Two Different Doses of Peginterferon alfa-2b and Ribavirin Combination Therapy in HIV/HCV Coinfected African-American Patients; G. Hammoud et al. Poster presentation, May 15, 8:00 am - 5:00 pm. 24 Weeks of Treatment with Peginterferon Alfa-2b 1.5 �g/kg/week Plus Ribavirin 800-1400 mg/day (p/r) in Patients Infected with Chronic Hepatitis C with Genotype 1 of Low Viral Load (lvlg1); S. Zeuzem et al. Poster presentation, May 15, 8:00 am - 5:00 pm. Treatment with Combination Peginterferon Alfa-2b and Ribavirin of Recurrent Hepatitis C In Liver Transplant Recipients Nonresponsive to Interferon Alfa-2b and Ribavirin; A. Samanta et al. Poster presentation, May 17, 8:00 am - 5:00 pm. Peginterferon/Ribavirin Treatment Compliance Rates in Methadone Maintenance Chronic HCV Infected Patients Compared to Interferon/Ribavirin Combination; D. Dimitroulopoulos et al. Poster presentation, May 16, 8:00 am - 5:00 pm. 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. PEG-INTRON is the only peginterferon approved for dosing according to patient body weight. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy that is designed to achieve an effective balance between antiviral activity and elimination half-life. REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog. Please see full prescribing information for PEG-INTRON and REBETOL available at http://www.schering-plough.com/. Important Information Regarding U.S. Labeling for PEG-INTRON and REBETOL WARNING Alpha interferons, including PEG-INTRON, 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 PEG-INTRON therapy. Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated. REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064. PEG-INTRON There are no new adverse events specific to PEG-INTRON as compared to INTRON A (interferon alfa-2b, recombinant) for Injection, 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/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia). The following serious or clinically significant adverse events have been reported at a frequency less than 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. In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG- INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL. REBETOL should not be used in patients with creatinine clearance less than 50 mL/min. SCHERING-PLOUGH DISCLOSURE NOTICE: This media alert contains "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including the market for PEG-INTRON and REBETOL combination therapy and the market for drugs to treat hepatitis C. Forward- looking statements relate to expectations or forecasts of future events and not to historical information. Schering-Plough does not assume the obligation to update any forward-looking statement. There are no guarantees about the market performance of PEG-INTRON and REBETOL combination therapy, Schering-Plough stock or Schering-Plough's business. Actual results may vary materially from forward-looking statements made here or in other Schering-Plough written or spoken communications due to many factors and uncertainties, which include the market acceptance of PEG-INTRON and REBETOL combination therapy, trade buying patterns, the introduction and performance of competitive products in the market, legislation that may impact the pricing/availability of PEG-INTRON and REBETOL combination therapy and other items. For further details about these factors and other risks and uncertainties that may impact Schering-Plough's forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's first quarter 2005 10-Q. 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. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com/. NOTE: Pegasys is a trademark of Hoffmann-La Roche Inc. See the Pegasys product insert for full prescribing information. DATASOURCE: Schering-Plough CONTACT: Media: Robert J. Consalvo, +1-908-298-7409, or Investors: Alex Kelly, +1-908-298-7436, both of Schering-Plough Web site: http://www.schering-plough.com/ Company News On-Call: http://www.prnewswire.com/comp/777050.html

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