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VALEANT BEGINS CLINICAL DEVELOPMENT OF VIRAMIDINE IN JAPAN.


Valeant Pharmaceuticals International Valeant Pharmaceuticals International is a pharmaceutical company with activities spanning the drug discovery pipeline from target identification through clinical trials and commercialization.  (NYSE NYSE

See: New York Stock Exchange
:VRX VRX Virtual Resources Executive
VRX Voice Receive Mode
), Costa Mesa, Calif., 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 in Tokyo. The company is developing Viramidine, a nucleoside (guanosine guanosine /gua·no·sine/ (gwah´no-sen) a purine nucleoside, guanine linked to ribose; it is a component of RNA and its nucleotides are important in metabolism. Symbol G. ) 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 “Todai” redirects here. For the restaurant called Todai, see Todai (restaurant).

The University of Tokyo (東京大学
 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 It may never be fully completed or, depending on its its nature, it may be that it can never be completed. However, new and revised entries in the list are always welcome.

This is an alphabetical list of people who have or had the infectious disease 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 Chronic liver disease is a liver disease of slow process and persisting over a long period of time, resulting in a progressive destruction of the liver.

It includes amongst others:
  • Cirrhosis of the liver
  • Alcoholic liver disease
  • Chronic hepatitis C
, 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 ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon  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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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

(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.
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Publication:Worldwide Biotech
Geographic Code:1USA
Date:Sep 1, 2005
Words:506
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