Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034

KENILWORTH, New Jersey, January 30 /PRNewswire/ -- Schering-Plough today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational oral hepatitis C protease inhibitor (SCH 503034), currently in Phase II clinical development for the treatment of chronic hepatitis C virus (HCV) infection.

The FDA granted Fast Track designation for the following reasons:

The proposed first indication for SCH 503034 is for treatment of HCV in patients with HCV genotype 1 virus who have not responded to combination therapy with pegylated interferon and ribavirin, the current standard of care, thus representing an unmet medical need.

SCH 503034 is an orally active inhibitor of the hepatitis C virus serine protease that inhibits HCV replication. This mechanism is distinct from those of current therapies, thus SCH 503034 represents a novel class of HCV inhibitor.

Fast Track designation allows FDA to expedite review of drugs and biologics for serious or life-threatening conditions and which demonstrate the potential to address unmet medical needs. An important feature of Fast Track designation is that it emphasizes the critical nature of close, early communication between the FDA and the sponsor company to improve the efficiency of product development.

Status of SCH 503034 Clinical Development

SCH 503034 has demonstrated potent antiviral activity and was well-tolerated, both as monotherapy(1) and in combination with PEGINTRON(R) (peginterferon alfa-2b),(2) in Phase I clinical studies in patients chronically infected with HCV genotype 1 who were nonresponders to previous therapy, including peginterferon and ribavirin combination therapy. Results of Phase I clinical studies with SCH 503034, including in healthy subjects,(3) were presented at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2005. HCV genotype 1 is the most common form of the virus worldwide and is considered the most difficult to treat successfully.

Phase II Study Ongoing

Based on the results of the Phase I clinical program and extensive preclinical safety and pharmacology studies, Schering-Plough is conducting a large, randomized Phase II dose-finding study involving 300 patients worldwide. This study evaluates the safety and efficacy of SCH 503034 in combination with PEGINTRON, with and without added ribavirin, for 24 or 48 weeks in patients with chronic HCV genotype 1 who were nonresponders to previous peginterferon and ribavirin combination therapy. The primary objective of this study is to determine the safe and effective dose range of SCH 503034 in combination with PEGINTRON in this patient population. A secondary objective is to explore whether or not ribavirin provides an additional benefit when combined with SCH 503034 plus PEGINTRON.

Additionally, an extensive preclinical and Phase I clinical development program is ongoing to support the potential broad utility of SCH 503034 in treating chronic hepatitis C.

About PEGINTRON

PEGINTRON and REBETOL (ribavirin) combination therapy for chronic hepatitis C was approved in the European Union in March 2001. The recommended dose in the EU for combination therapy is PEGINTRON 1.5 mcg/kg once weekly plus REBETOL 800-1,200 mg daily, adjusted to body weight. PEGINTRON had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.

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 is based in Kenilworth, N.J., USA, and its Web site is www.schering-plough.com.

References: 1. Zeuzem S et al. Antiviral 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), Abstract 67484, AASLD 2005. 2. Zeuzem S et al. Combination therapy with the HCV Protease Inhibitor, SCH 503034, Plus PEGINTRON in Hepatitis C Genotype-1 PEGINTRON Nonresponders: Phase Ib Results, Abstract 67627, AASLD 2005. 3. Zhang J et al. Single Dose Pharmacokinetics of a Novel Hepatitis C Protease Inhibitor, SCH 503034, in an Oral Capsule Formulation, Abstract 66787, AASLD 2005.

Web site: http://www.schering-plough.com