ALISO VIEJO, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE:VRX) today announced that results from the week-72 analysis 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, were presented at the American Association for the Study of Liver Disease (AASLD) 60th Annual Meeting in Boston. It is believed that taribavirin (TBV) may present an alternative therapy to ribavirin (RBV) for the treatment of hepatitis C by delivering similar efficacy to ribavirin but with significantly less anemia, which is the main treatment-limiting toxicity associated with ribavirin. The results were presented in an abstract entitled "Sustained Virologic Response Results for Weight-Based Taribavirin Versus Weight-Based Ribavirin, in Naïve Chronic Hepatitis C, Genotype 1 Patients", with an oral presentation given by Fred Poordad, M.D., Chief of Hepatology at the Center for Liver Disease and Transplant, Cedars-Sinai Medical Center, Los Angeles, CA and principal investigator in this study. "The final results of this Phase IIb study are promising, and imply that comparable efficacy can be achieved when compared to ribavirin," said Dr. Poordad. "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 that its use is associated with significantly less anemia in an evolving era of small molecule therapies, where anemia appears to be more problematic." The company has previously reported results from this Phase IIb trial exploring weight- based dosing of taribavirin at 20, 25 and 30mg/kg vs. weight-base dosed ribavirin 800-1400mg. The study consisted of 48 weeks of treatment with a 24-week post-treatment follow-up period. Consistent with previous reports, the viral response data continued to show comparable reductions in viral load for weight-based doses of taribavirin and ribavirin in a difficult-to-treat population of subjects infected with hepatitis C genotype 1 and end-of-study sustained virologic response rates were again comparable across the treatment groups. Relapse rates were identical for taribavirin 25mg/kg and weight-based doses of ribavirin. Importantly, the statistically significantly lower anemia rate for patients receiving taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm has been maintained at a rate similar to the end-of- treatment (week 48) throughout. Table: Efficacy/Safety (intent-to-treat) Phase IIb --------- TBV TBV TBV RBV 20 mg/kg 25 mg/kg 30 mg/kg 800-1400mg n=67 n=70 n=68 n=70 ------------------------------------------------------------------------- TW4 Undetectable(1) 11 (16.4%) 10 (14.3%) 11 (16.2%) 8 (11.4%) ------------------------------------------------------------------------- TW12 Undetectable(1) 28 (41.8%) 29 (41.4%) 17 (25.0%) 22 (31.4%) ------------------------------------------------------------------------- TW48 Undetectable(1) 30 (44.8%) 27 (38.6%) 23 (33.8%) 26 (37.1%) ------------------------------------------------------------------------- SVR Undetectable(1) 19 (28.4%) 19 (27.1%) 19 (27.9%) 19 (27.1%) ------------------------------------------------------------------------- Relapse Rate 10 (34.5%) 5 (20.8%) 3 (13.6%) 5 (20.8%) ------------------------------------------------------------------------- Anemia 48 weeks(2) 9 (13.4%)* 11 (15.7%)* 19 (27.9%) 23 (32.9%) ------------------------------------------------------------------------- (1) HCV RNA < 39 IU/mL (2) Anemia: hemoglobin < 10g/dL *P=400,000 IU/mL and 82.1 kg mean weight. Week 72 efficacy and safety results for the intention-to-treat (ITT) population are shown in the table above. About Valeant Valeant Pharmaceuticals International (NYSE:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology. More information about Valeant can be found at http://www.valeant.com/. FORWARD-LOOKING STATEMENTS This press release may contain forward-looking statements, including, but not limited to, statements regarding the potential for taribavirin in the treatment of hepatitis C, and the continuing role of ribavirin or taribavirin in the treatment of hepatitis C, Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of 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, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the U.S. Securities and Exchange Commission, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes. Contact: Laurie W. Little, Valeant Pharmaceuticals 949-461-6002 (Logo: http://www.newscom.com/cgi-bin/prnh/20081125/VALEANTLOGO) http://www.newscom.com/cgi-bin/prnh/20081125/VALEANTLOGO http://photoarchive.ap.org/ DATASOURCE: Valeant Pharmaceuticals International CONTACT: Laurie W. Little of Valeant Pharmaceuticals, +1-949-461-6002, Web Site: http://www.valeant.com/

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