Hepsera

SAN FRANCISCO -- Valeant Pharmaceuticals International (NYSE:VRX) yesterday afternoon presented interim results from a Phase 2 study of its oral anti-viral compound, pradefovir mesylate, at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. Interim 24-week data show that the percentage of patients achieving undetectable HBV DNA (less than 400 c/mL) was significantly greater for patients receiving pradefovir compared to those receiving Hepsera (adefovir dipivoxil) at doses of 10mg, 20mg and 30mg QD. In addition, these data show that the pradefovir 30mg QD cohort achieved a 5.02 log10 drop in viral titers from baseline compared to a 3.66 log10 drop in the Hepsera group (p less than 0.001).

Pradefovir is a pro-drug of adefovir that was licensed from Metabasis Therapeutics. Pradefovir uses Metabasis' HepDirect(TM) technology that enables higher concentrations of the drug in the liver, the primary site of hepatitis B viral (HBV) replication.

"The 24-week interim results are excellent. These data suggest that pradefovir has the potential to be a 'best in class' option for those suffering from hepatitis B," said Kim D. Lamon, M.D., Ph.D., Valeant's president, research and development and chief scientific officer. "We continue to be encouraged by these interim results and look forward to pradefovir being highly competitive in this class of drugs."

The Phase 2 study is an open-label, randomized, multiple dose study with 242 patients enrolled at 21 sites in the United States, 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 who have been previously treated ineffectively are considered to be more difficult to treat. The Phase 2 study consists of five treatment groups: pradefovir -- 5, 10, 20 and 30 mg/day (QD), and Hepsera -- 10 mg/day (QD), with an overall treatment duration of 48 weeks.

The interim 24-week data indicate that pradefovir resulted in differences in the percentage of patients achieving undetectable HBV DNA summarized as follows:

As previously noted, the interim 24-week data indicate that pradefovir demonstrated a significant decline in HBV DNA summarized as follows:

The interim results have shown no evidence of nephrotoxicity. There were no serious adverse events related to treatment. The most frequently reported adverse events were similar across all treatment groups, including Hepsera. No dose-related trends regarding safety were identified and no events resulted in a patient being withdrawn prematurely from treatment.

Patient participation in the Phase 2 trial is expected to be completed early in 2006. Valeant has reviewed interim 24-week results from the Phase 2 trial with the Food and Drug Administration (FDA) and intends to initiate Phase 3 trials in mid-2006.

Pradefovir is an investigational compound that has not been found by the 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 its New Drug Application. Similar restrictions apply in other countries.

About Hepatitis B

Hepatitis B is a potentially fatal disease that can lead to complications such as cirrhosis and liver cancer. Approximately 2 billion people worldwide are estimated to have hepatitis B, with 350-400 million people estimated to be chronically infected. According to a recent study, the HBV market currently represents more than $1 billion in annual sales, and is expected to grow to over $2.8 billion by 2012.

About Valeant

Valeant Pharmaceuticals International (NYSE:VRX) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.

All trademarks are the trademarks or the registered trademarks of their respective owners.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant Pharmaceuticals, including funding and conducting clinical trials. These statements are based upon the current expectations and beliefs of Valeant Pharmaceuticals' 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 market conditions and other factors beyond Valeant Pharmaceuticals' control, adverse events that would require the clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of pradefovir is not advisable, the fact that Phase 2 interim clinical trial results may not be indicative of results from completed Phase 2 clinical trials, and that the results from completed Phase 2 clinical trials are not always indicative of those seen in Phase 3 clinical trials, and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission.

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