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 SAN MATEO, Calif., Nov. 17 /PRNewswire/ -- SciClone Pharmaceuticals Inc. (NASDAQ: SCLN) today announced that it has filed a Product License Application (PLA) with the Department of Health in Hong Kong for approval to market Zadaxin(TM) thymosin alpha 1 to treat chronic hepatitis B and as a vaccine adjuvant in immunocompromised patients.
 Like other parts of Asia, hepatitis B is a major disease in Hong Kong, where approximately 10 percent of the territory's 5.8 million people carry the virus. It is estimated that as many as 250,000 people in Hong Kong could be affected with the chronic form of the disease, the major indication for which SciClone has filed for approval. SciClone plans to manage the distribution of Zadaxin through its Asian Pacific headquarters, located in Hong Kong.
 "The filing in Hong Kong is a significant event for SciClone as the company proceeds with its plan to bring Zadaxin to the many people suffering from chronic hepatitis B in the Asia-Pacific region," said Thomas E. Moore, SciClone's chairman and chief executive officer. "We are also pleased to be involved in Hong Kong, which is one of the world's most prosperous economic regions, with a per capita income of approximately $16,000, compared to $14,910 in the United States."
 As previously announced, SciClone recently received marketing approval from the Ministry of Health of the Republic of Singapore for Zadaxin to treat chronic hepatitis B and plans to introduce the drug in Singapore next March.
 Hepatitis B is a widespread, highly contagious virus that affects an estimated 300 million carriers worldwide. Approximately 90 percent of the world's hepatitis B is contained within the countries where SciClone has market exclusivity. Currently, the only FDA-approved treatment for hepatitis B is alpha interferon, which is accompanied by a number of side effects. To date, in studies with thymosin alpha 1, there have been no reported side-effects in more than 1,000 patients treated and the drug has demonstrated superior efficacy.
 SciClone Pharmaceuticals Inc. is engaged in the development and marketing of pharmaceuticals on a worldwide basis. The company's primary focus is on the development of therapeutics for infectious diseases including hepatitis B, C cancer and immune system disorders that are life-threatening and place major cost burdens on the world's healthcare system.
 Hong Kong General Statistics
 -- Population: 5.8 million
 -- Main language: English and Chinese
 -- Per capita income: $16,000 (vs. the U.S. at $14,910)
 -- Infant mortality per 1,000 live births: 5 (vs. U.S. at 10)
 -- Life expectancy: 78 years (vs. 75.5 in the U.S.)(A)
 How does the healthcare system in Hong Kong operate?
 The healthcare system in Hong Kong provides a range of medical and health services that is comparable to the United States. Healthcare costs vary depending upon the medical care facility visited. Government subsidized medical care is provided on a limited basis, such as to young children, and some employers offer employer-subsidized healthcare programs. Government hospitals provide satisfactory care at reasonable cost, and additionally, there are large hospitals groups managed by charitable organizations that are more expensive than government hospitals, but less expensive than Hong Kong's private hospitals, where costs often exceed those in the United States.
 How are drugs reimbursed in Hong Kong?
 Drugs provided (at low cost) by the government hospitals are most often low cost generics that are bought by the government on a tender system. Other more expensive drugs are bought by the government on an "as and when needed" basis. Most medicines in Hong Kong are distributed to the public by "dispensing doctors," including leading specialists as well as general practitioners that diagnose and dispense in their own surgery. There are very few pharmacies in Hong Kong that actually dispense prescription drugs.
 Why is SciClone seeking approval for Zadaxin in Hong Kong?
 The company's current focus is to obtain marketing approval for Zadaxin in the countries within its territory where hepatitis B is a major concern and a cost burden on the healthcare system. SciClone has licensing rights for Zadaxin in all countries worldwide with the exception of the United States, Canada, Europe, Israel and Korea. Approximately 90 percent of the world's hepatitis B is contained within the countries where SciClone has market exclusivity.
 When do you expect Zadaxin will be approved for marketing in Hong Kong?
 According to the IFPMA Compendium 1987 (International Federation of Pharmaceutical Manufacturers Associations), the average time for approval to be given to an application for product registration in Hong Kong is 6-8 months.
 What is Zadaxin(TM) and how does its work?
 Zadaxin is SciClone's lead compound and trade name for thymosin alpha 1. Zadaxin is a chemically synthesized version of thymosin alpha 1, which is a naturally occurring peptide produced primarily by the body's thymus gland. Thymosin has been shown to be centrally involved in regulating the development and function of T cells and promotes the production of interferons and interleukins, key components that the body's immune system uses to combat disease.
 (A) Statistics from the Hong Kong Economic and Trade Office, San Francisco.
 -0- 11/17/93
 /CONTACT: Michelle E. Slade, manager of corporate communications of SciClone Pharmaceuticals, 415-358-3456/

CO: SciClone Pharmaceuticals Inc. ST: California IN: MTC SU:

TM-SG -- SF009 -- 5506 11/17/93 12:42 EST
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Publication:PR Newswire
Date:Nov 17, 1993

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