KENILWORTH, N.J., Nov. 7 /PRNewswire-FirstCall/ -- Important new data on Schering-Plough's investigational oral protease inhibitor in development for treating hepatitis C virus (HCV) infection will be presented for the first time at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) at the Moscone West Convention Center, San Francisco, Calif., November 11-15, 2005.
Study investigators will report Phase I clinical study results with protease inhibitor SCH 503034 capsules, both as monotherapy and in combination therapy with PEG-INTRON(R) (peginterferon alfa-2b), in patients with chronic hepatitis C genotype 1 who were nonresponders to previous therapy, including previous peginterferon combination therapy. Currently, there are no products approved for treating patients who failed previous therapies, representing an area of great unmet medical need.
Investigators also will present final results of major clinical studies with PEG-INTRON and REBETOL(R) (ribavirin, USP) combination therapy in patients with HCV, as well as results of large-scale prospective and retrospective analyses of "real-world" treatment data with PEG-INTRON combination therapy. Pharmacoeconomic analyses of the cost-effectiveness of PEG-INTRON combination therapy also will be presented.
In total, 67 abstracts involving Schering-Plough hepatitis therapies will be presented at AASLD, including eight oral presentations.
Hepatitis C is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 4 million people -- or one in 50 adults -- in the United States and 200 million people worldwide.
HCV Protease Inhibitor (SCH 503034)
Oral Presentations
Anti-Viral Activity of SCH 503034, a HCV Protease Inhibitor, Administered as Monotherapy in Hepatitis C Genotype-1 (HCV-1) Patients Refractory to Pegylated Interferon (Peg-IFN-a), Zeuzem S. et al. Presidential Plenary I, Moscone West General Session Room, Monday, Nov. 14, 8:45 - 9:00 am.
Combination Therapy with the HCV Protease Inhibitor, SCH 503034, plus PEG-INTRON in Hepatitis C Genotype-1 PEG-INTRON Nonresponders: Phase Ib Results, Zeuzem S. et al. Parallel Session 29, Moscone West Rooms 3016/3018/3020, Tuesday, Nov. 15, 11:45 - 12:00 pm.
Poster Presentations
Single Dose Pharmacokinetics of a Novel Hepatitis C Protease Inhibitor, SCH 503034, in an Oral Capsule Formulation, Zhang J. et al. Moscone West Exhibit Hall, Monday, Nov. 14, 8:00 am - 6:30 pm.
SCH 503034, a Mechanism-Based Inhibitor of Hepatitis C virus (HCV) NS3 Protease Suppresses Polyprotein Maturation and Enhances the Antiviral Activity of Interferon alfa-2b (INF), Malcolm B.A. et al. Moscone West Exhibit Hall, Monday, Nov. 14, 8:00 am - 6:30 pm.
Modeling of Hepatitis C Viral Dynamics During Combination Therapy with Peginterferon alfa-2b (PEG-INTRON) and the NS3 Protease Inhibitor SCH 503034, Malcolm B.A. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
PEG-INTRON and REBETOL Combination Therapy
Oral Presentations
Weight-Based Ribavirin Dosing (WBD) Increases Sustained Viral Response (SVR) in Patients with Chronic Hepatitis C (CHC): Final Results of the WIN-R Study, a US Community Based Trial, Jacobson I. et al. Parallel Session 33, Moscone West General Session Room, Monday, Nov. 14, 3:00 - 4:45 pm.
Double-Dose Peginterferon Alfa-2b with Weight-Based Ribavirin Improves Response for Interferon/Ribavirin Nonresponders with Hepatitis C: Final Results of "RENEW", Gross J. et al. Parallel Session 08, Moscone West General Session Room, Sunday, Nov. 13, 6:00 - 6:15 pm.
Poster Presentations
PEG-INF alfa-2b (1.5 mcg/kg/wk) + ribavirin (800-1400 mg daily) is Significantly More Effective than PEG-INF alfa-2b (1.0 mcg/kg/wk) + ribavirin (800-1400 mg daily) in men with G1 and women with G2/3: Final Results of a Prospective, Randomized, Controlled Trial, Flamm S.L. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
Efficacy of PEG-IFN Alfa-2b vs. PEG-IFN Alfa-2a + Ribavirin Regimens in Treatment-Naïve Chronic HCV Patients: A Cumulative Meta-Analysis of Retrospective Data from 6 Clinic Sites, Almasio P. and the HCV Meta-Analysis Working Group. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
PEG-INTRON Prospective Optimal Weight-Based Dosing Response Program (POWER): Preliminary Results, Abadir N. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
A Pharmacoeconomic Analysis of the Registration Trials: Peginterferon Alfa-2a plus Ribavirin versus Peginterferon Alfa-2b plus Ribavirin for Treatment of Genotype 1 Chronic Hepatitis C, Kamal A. et al. Moscone West Exhibit Hall, Saturday, Nov. 12, 2:00 - 8:00 pm.
Cost-Effectiveness of Peginterferon Alfa-2b plus Ribavirin for Chronic Hepatitis C in HIV/HCV Co-Infected Patients, Wong, J.B. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
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(R) 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 Corporation 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's Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, related to 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 Schering-Plough's forward-looking statements 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 uncertainties. 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 third quarter 2005 10-Q.
Schering-Plough CorporationCONTACT: Media: Robert J. Consalvo, +1-908-298-7409, +1-908-295-0928, onsite, or Gail Thornton, +1-908-298-5313, Investors: Alex Kelly,+1-908-298-7436, all for Schering-Plough Corporation
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