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Valeant Pharmaceuticals Reports Encouraging Final Results With Taribavirin Phase IIb Study
Date:6/1/2009

ALISO VIEJO, Calif., June 1 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals International (NYSE: VRX) today reported final results for its Phase IIb dose-finding clinical trial for taribavirin, a prodrug of ribavirin which is in development for the treatment of chronic hepatitis C in conjunction with a pegylated interferon. The study in treatment naive genotype 1 infected subjects was of standard design, consisting of 48 weeks of treatment with a 24-week follow-up period. It explored three weight-based doses of taribavirin: 20 mg/kg, 25 mg/kg and 30 mg/kg vs. ribavirin 800-1400 mg/day. Throughout the 72-week trial, all doses of taribavirin demonstrated comparable efficacy (sustained virologic response (SVR)) to ribavirin with consistently lower levels of anemia. In addition, relapse rates in the 25 mg/kg and 30 mg/kg arms were comparable with the ribavirin arm; supporting the premise that higher dose weight-based taribavirin may be as effective as weight based ribavirin. Valeant plans to present the full final data at the American Association for the Study of Liver Disease (AASLD) later this year.

"The final results of this Phase II study are promising and imply that comparable efficacy with taribavirin can be achieved when compared to ribavirin," stated Fred Poordad, M.D., Chief of Hepatology at the Center for Liver Disease and Transplantation, Cedars-Sinai Medical Center, Los Angeles, CA. "As is known for ribavirin, low doses are associated with a high relapse rate and, except for the lowest dose with taribavirin, relapse rates are also comparable to ribavirin. The safety of this ribavirin analog is of particular relevance in the evolving era of small molecule therapies as anemia appears to be more problematic."

"We are very pleased with the results from this dose finding study which confirms th
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SOURCE Valeant Pharmaceuticals International
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