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Valeant Pharmaceuticals to Initiate Clinical Development of Viramidine(R) in Japan; Valeant Forms Hepatitis C Advisory Board in Japan

Posted on: Monday, 25 July 2005, 09:01 CDT

Valeant Pharmaceuticals International (NYSE:VRX) today announced plans to initiate the development of Viramidine(R) in Japan following the first meeting of the company's hepatitis C Japanese advisory board, which was held Monday evening in Tokyo. The company is developing Viramidine, a nucleoside (guanosine) analog, in oral form for administration in combination with pegylated interferon for the treatment of chronic hepatitis C in treatment-naive patients. Valeant is currently conducting two pivotal Phase 3 trials for Viramidine in major markets around the world.

"Japan represents the world's second largest hepatitis C market, with an estimated 2.3 million people infected," Valeant's president and chief executive officer, Timothy C. Tyson, said. "Our hope is that Viramidine's potentially improved safety profile could be of great benefit to hepatitis C patients in Japan, especially when you consider that many physicians believe that Japanese patients tend to be more prone to developing anemia. We remain confident in Viramidine's potential and look forward to presenting the results of the first of two global Phase 3 trials in the first half of 2006."

Dr. Masao Omata, Professor and Chair, Department of Gastroenterology, University of Tokyo has been selected to chair the advisory board. Valeant is partnering with one of the largest contract research organizations in Japan and plans to initiate pharmacokinetic studies later this year.

About Hepatitis C

There are an estimated 2.3 million people with hepatitis C virus in Japan and approximately 25 percent of those who are chronically infected have been diagnosed.(1) Hepatitis C is the leading cause in Japan of chronic liver disease, cirrhosis, and hepatocellular carcinoma, which is associated with more than 30,000 deaths there annually.

A recent report estimated the hepatitis C market in Japan to be approximately $370 million and projected the market to grow to nearly $2.5 billion by 2013.(2) With the approval of Peg-Intron and Rebetol combination therapy in Japan in late 2004, sales of ribavirin increased from $18.9 million in the period of January 2004 to June 2004, to $55.6 million in the same period of 2005.(3)

Viramidine 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 a New Drug Application. Similar restrictions apply in other countries.

About Valeant

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

Viramidine is a registered trademark of Valeant Pharmaceuticals International or its related companies. All other 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 our ability to fully enroll clinical trials for Viramidine in Japan within the company's estimated timeline or at all and to obtain approval to launch the product in Japan. 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 clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Viramidine is not advisable, and the risk factors and other cautionary statements discussed in Valeant Pharmaceuticals' filings with the U.S. Securities and Exchange Commission.

(1) Decision Resources, Inc., April 2004, based on research done in United States, France, Germany, Italy, Spain, United Kingdom and Japan.

(2) Decision Resources, Inc., April 2004, based on research done in United States, France, Germany, Italy, Spain, United Kingdom and Japan.

(3) IMS Health, June 2005.

Source: Business Wire

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