Valeant Pharmaceuticals Advances Funding For Viramidine Clinical Trials
COSTA MESA, Calif., Jan. 28 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals today provided an update on its clinical program for the development of its antiviral compound, Viramidine(TM), a nucleoside (guanisine) analog, in oral form for the treatment of hepatitis C. In addition, the company announced that it will increase its investment in research and development to support an accelerated schedule for progressing development of Viramidine.
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.
The company will host a conference call to discuss this announcement today, January 28, 2004 at 6:00 a.m. Pacific time. The dial-in number to participate live on this call is (877) 295-5743, confirmation code 5217501. International callers should dial (706) 679-0845, confirmation code 5217501. A replay will be available approximately two hours following the conclusion of the conference call through midnight on Wednesday, February 4, 2004, and can be accessed by dialing (800) 642-1687, confirmation code 5217501.
The company will also Web cast the call live over the Internet, which will be hosted in the investor relations section of its corporate Web site at http://www.valeant.com/ . Participants should allow approximately five to ten minutes prior to the call's start time to visit the site and download any streaming media software needed to listen to the Internet Web cast. An online archive of the Web cast will be available following the end of the live call in the Web cast archive portion of the investor relations section at http://www.valeant.com/ .
Valeant Pharmaceuticals International is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets a broad range of pharmaceutical products. More information about Valeant can be found at http://www.valeant.com/ .
This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant Pharmaceuticals, including funding and conducting clinical trials and expected research and development expenses. These statements are based upon the current expectations and beliefs of Valeant Pharmaceuticals' management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties include market conditions and other factors beyond Valeant Pharmaceuticals' control, the company's success in identifying and enrolling patients in the clinical trials program, the absence of adverse events that would require the clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Viramidine is advisable, and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission.
For further information, please contact: Jeff Misakian of Valeant Pharmaceuticals, +1-714-545-0100, ext. 3309.Valeant Pharmaceuticals
CONTACT: Jeff Misakian of Valeant Pharmaceuticals, +1-714-545-0100,ext. 3309
Web site: http://www.valeant.com/