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Argentina Grants Extended Approval For Zadaxin (Thymalfasin) For Hepatitis B And C SAN MATEO, CA -- August 7, 2000 -- SciClone Pharmaceuticals announced that Zadaxin® (thymalfasin), its lead immunotherapy, has received expanded marketing approval in Argentina for the treatment of both hepatitis B and hepatitis C. Zadaxin previously was approved in Argentina as a vaccine adjuvant for patients with weakened immune systems. SciClone said it will follow the same strategy of expanded approval in Italy, Mexico and South Korea, where Zadaxin also is approved as a vaccine adjuvant, as well as in certain future markets. "This expansion of indications is typical of our regulatory strategy for Zadaxin in many markets," said Donald R. Sellers, SciClone's President and Chief Executive Officer. "While Zadaxin is best known as a drug for hepatitis and cancer, in several countries the vaccine adjuvant indication, which results from immune system stimulation, has proven and will prove the quickest route to market. Our goal is always to get Zadaxin on the market in the most expedient fashion and then expand to the fullest range of approved indications." The hepatitis B and hepatitis C viruses are highly infectious and prevalent. The World Health Organization estimates that approximately 350 million people worldwide are long-term carriers of hepatitis B and 170 million people worldwide are chronic carriers of hepatitis C. In Argentina, over 400,000 people are infected with hepatitis B and over 800,000 are infected with hepatitis C. Up to 40 percent of people with acute hepatitis B and the majority of patients with hepatitis C infection show no symptoms. Many people chronically infected with hepatitis B or hepatitis C will progress to liver cirrhosis and liver failure, from which they will eventually die. People with chronic hepatitis B and hepatitis C infection have a significantly higher chance of developing primary liver cancer than those not infected. Zadaxin is approved for sale in 20 countries, principally for the treatment of hepatitis B and hepatitis C and as a vaccine adjuvant for patients with weakened immune systems. Related Links: Zadaxin (thymalfasin) and SciClone Pharmaceuticals. E-mail this page to a friend or colleague! To print, use this version