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.
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
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.
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 www.valeant.com.
This press release contains 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, that are based on management's current expectations and involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to the clinical development of new products, regulatory approval processes, that results from week 60 in the phase IIb clinical trial are not necessarily predictive of the entire phase IIb trial or a phase III trial, and other risks as set forth under the caption Risk Factors in the company's most recent annual or quarterly report filed with the SEC, which factors are incorporated herein by reference. The company cautions the reader that these factors, as well as other factors described in its SEC filings, are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. The company also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this press release. The company undertakes no responsibility 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 firstname.lastname@example.org
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