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Valeant Pharmaceuticals Highlights Taribavirin Phase IIb 60-Week Data Presentation at EASL

http://finance.yahoo.com/news/Valeant-Pharmaceuticals-prnews-15017959.html

›Thursday April 23, 2009, 5:00 pm EDT

ALISO VIEJO, Calif., April 23 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE: VRX ) today announced that results from the week-60 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, was presented today at the European Association for the Study of Liver (EASL) 44th Annual Meeting in Copenhagen, Denmark.

The results were presented in an abstract entitled "Efficacy And Safety of Weight-Based Regimens of Taribavirin or Ribavirin, Given With Peginterferon Alfa-2b, At 12 Weeks After Treatment (SVR12) In Naive Patients With Genotype 1 Chronic-Hepatitis C", 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 company previously reported week 12 and 48 results from this Phase IIb trial. The study consists of 48 weeks of treatment with a 24-week post-treatment follow-up period during which period the week 60 results were collected from the arms receiving 20mg/kg and 25mg/kg taribavirin and the ribavirin control arm. Similar to the week 12 and 48 results, the 60-week viral response data continue to show comparable reductions in viral load for weight-based doses of taribavirin and ribavirin in a difficult-to-treat population of subjects infected Hepatitis C genotype 1. At the end of week 60, 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).

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) 29 (43.4%) 21 (30%) 20 (29.4%) 23 (32.9%)
SVR12
Undetectable(1) 19 (28.4%) 17 (24.3%) 14 (20.6%) 15 (21.4%)
Anemia SVR12(2) 10 (14.9%)* 11 (15.7%)* 19 (27.9%) 23 (32.9%)

(1) HCV RNA < 39 IU/mL
(2) Anemia: hemoglobin < 10g/dL
*P<0.05 vs. RBV

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.

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.

About Study 204

In the Phase IIb study (previously disclosed as Study 204), 278 treatment naive, genotype 1 patients were randomized with the following patient demographics: mean age 48.8 yrs, 61.1% male, 30% African-American or Latino, 80.7% viral load 400,000 IU/mL and 82.1 kg mean weight. Week (TW) 60 efficacy and safety results for the intention-to-treat (ITT) population are shown in the table above.

About Valeant

Valeant Pharmaceuticals International (NYSE: VRX - News) 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 www.valeant.com.‹