VALEANT REPORTS DATA FROM PRADEFOVIR STUDY

Valeant Pharmaceuticals reported 24-week interim data from a Phase II study of its oral antiviral compound, pradefovir. Valeant is evaluating the safety and efficacy of pradefovir for the treatment of compensated chronic hepatitis B. Pradefovir is a pro-drug. It uses Metabasis' HepDirect technology, which enables higher concentrations of the drug in the liver, the primary site of hepatitis B viral (HBV) replication.

The Phase II study is an open-label, randomized, multiple-dose study with 242 patients enrolled at 21 sites in the U.S., Taiwan, Singapore and Korea. Approximately half of the patients had been previously treated ineffectively with other drugs and 70 percent of the patients were HBeAg positive. Patients that have been previously treated ineffectively are considered to be more difficult to treat.

The results indicate that pradefovir demonstrated a significant decline in HBV DNA, and have shown no evidence of nephrotoxicity. There were no serious adverse events related to treatment. No dose-related trends regarding safety were identified and no events resulted in a patient being withdrawn prematurely from treatment.