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First of Two Global Phase III Studies Initiated for Viramidine in Hepatitis C
Robert W. O'Leary, Valeant Pharmaceuticals' Chairman and Chief Executive Officer, commented, "Our clinical data have allowed us to begin Phase 3 clinical trials for Viramidine after 12 weeks of our 72-week Phase 2 program. Our evaluation has led us to decide to further increase our total research and development expenditures in 2004 to between $85 million and $95 million to accelerate the clinical trials for Viramidine while continuing to support other discovery and development programs."
Valeant Pharmaceuticals has initiated the first of two global Phase 3 studies for Viramidine that will be conducted at approximately 80 sites with approximately 1,000 patients in each study. Global patient enrollment in the first study, known as VISER1 (VIramidine's Safety and Efficacy vs. Ribavirin), has commenced, and the company expects to complete enrollment in 2004.
The second Viramidine Phase 3 study, known as VISER2, is now scheduled to commence by mid-2004 with investigator meetings in the U.S., Europe and Australia. Patient enrollment in the second study is expected to begin shortly thereafter. Valeant also noted that the accelerated schedule for Viramidine may or may not accelerate the timetable for submission for approval.
The studies will compare Viramidine and ribavirin, each in conjunction with a pegylated interferon. The company has selected PEG-INTRON, a pegylated interferon marketed by Schering-Plough, for use in its first study, and has now added Pegasys, marketed by F. Hoffmann-La Roche, for use in its second study.
The Phase 3 studies are designed to treat patients for either 24 or 48 weeks, depending on viral genotypes, take patients off therapy for an additional 24 weeks, and then determine the percentage of patients with undetectable virus in their blood, as well as the incidence of anemia during the course of the entire 72-week study period.
Valeant Pharmaceuticals is continuing its Phase 2 study of Viramidine and has completed that study's 24-week treatment evaluation of safety and efficacy. Valeant intends to present the 24-week data from the Phase 2 study at the 39th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany in April 2004, and additional data at the Digestive Disease Week (DDW) Conference in New Orleans in May 2004.
Source: Valeant Pharmaceuticals