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

at taribavirin could replace ribavirin as a cornerstone in the treatment of hepatitis C, but with the advantage of less anemia," said J. Michael Pearson, chairman and chief executive officer. "These encouraging results, coupled with Schering-Plough's option agreement for a license in Japan, could offer new alternatives for patients suffering from this disease and we will continue to pursue additional licensing and partnering opportunities in order to maximize this compound's potential."

The most common adverse events during treatment were fatigue, nausea, flu-like symptoms, headache and diarrhea. The incidence rates for these adverse events among treatment arms were generally comparable except with respect to diarrhea, where incidence of diarrhea was approximately twice as common in patients receiving taribavirin compared to patients receiving ribavirin. However, the diarrhea was generally mild and not treatment limiting for taribavirin or ribavirin patients.

About Taribavirin

Taribavirin is an investigational compound that has not been found by the Food and Drug Administration (FDA) or any other regulatory agency to be safe or effective in the diagnosis, mitigation, treatment or cure of any disease or illness. It may not be sold or promoted in the United States unless and until approved for marketing by the FDA. Similar restrictions apply in other countries.

About Study 204

The Phase IIb trial is a U.S. multi-center, randomized, parallel, open-label study in 278 treatment-naive, genotype 1 patients evaluating taribavirin at weight-based doses of 20 mg/kg, 25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b. The control group was administered weight-based dose ribavirin (800/1000/1200/1400mg daily) and pegylated interferon alfa-2b. Overall treatment duration is 48 weeks with a post-treatment follow-up period of 24 weeks.

In the Phase I
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SOURCE Valeant Pharmaceuticals International
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