Healthcare Industry News: hepatitis C
News Release - March 14, 2007
Valeant Pharmaceuticals Initiates Taribavirin Phase 2b Clinical Study
ALISO VIEJO, Calif.--(HSMN NewsFeed)--Valeant Pharmaceuticals (NYSE:VRX ) today announced that it has begun enrolling patients in a Phase 2b clinical study for its antiviral compound, taribavirin, an oral nucleoside (guanosine) analog, for the treatment of chronic hepatitis C in conjunction with a pegylated interferon. The Phase 2b is a multi-center, randomized, parallel, open-label study in 260 treatment-naive, genotype 1 patients and will evaluate taribavirin at 20 mg/kg, 25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b. There also will be a control group comprised of ribavirin (800/1,000/1,200/1,400 mg daily) and pegylated interferon alfa-2b."Our analysis of the VISER studies has convinced us that taribavirin should be dosed based on the patient's weight to achieve efficacy equal to that of ribavirin," said Timothy C. Tyson, president and chief executive officer. "We are hopeful that this Phase 2b study will provide us with sufficient information to establish the path for registration of taribavirin for the treatment of hepatitis C."
Valeant will perform analyses of the study data after all patients have reached the week 12 time point which is the primary endpoint of the study. The results at week 12 are typically predictive of a full 48-week treatment course. Based on the 12-week data, the company will decide whether to begin another Phase 3 study at a more appropriate dose than used in the VISER studies. Additionally, if the week 12 data are encouraging, the company intends to continue the current study for a full 48-week treatment course with a post-treatment follow-up at week 72. The 12-week results are expected to be available and be released by the end of the year.
"It is important to continue studying taribavirin in combination with pegylated interferon for hepatitis C naive patients," said Fred Poordad, M.D., Chief of Hepatology at the Center for Liver Disease and Transplant, Cedars-Sinai Medical Center. "The development of this antiviral compound could be of great benefit due to its potential to reduce the anemia seen with conventional peginterferon and ribavirin therapy, which can negatively impact dosing and the chance of clearing virus."
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 FDA has approved a New Drug Application. Similar restrictions apply in other countries.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX ) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including, but not limited to, statements regarding the company's Phase 2b program 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, and other risks detailed from time to time in the company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2005. 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.
Source: Valeant Pharmaceuticals
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