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| |  ZADAXIN Thymosin Alpha 1 Launched in the People's Republic of China SAN MATEO, Calif., Dec. 4, 1996 -- SciClone Pharmaceuticals, Inc. (Nasdaq: SCLN), an international biopharmaceutical company, announced today that it has launched ZADAXIN(R) thymosin alpha 1 in the People's Republic of China as a treatment for chronic hepatitis B. The launch commenced after clinical data from the Company's multicenter hepatitis B clinical trials in China were presented by Professor Wang Bao-en, President of the Chinese Society of Hepatology at the biennial National Meeting of Liver Diseases in Wuhan, China on November 16 - 19, 1996. More than 650 Chinese liver specialists attended the presentation by Professor Wang who presented data on a total of 150 Chinese hepatitis B patients treated with ZADAXIN at 13 medical centers throughout China. Patient response rates were defined as those patients whose hepatitis B virus DNA ("HBV DNA") and hepatitis B e-antigen ("HBeAg") levels were undetectable after six months of treatment. HBV DNA is a measure of hepatitis B viral load while HBeAg, a protein synthesized by the hepatitis B virus, is a sign of viral replication. Elimination of HBV DNA and HBeAg are important goals of therapy when treating chronic hepatitis B. Professor Wang reported on a total of 96 patients who received ZADAXIN as a monotherapy for six months (1.6 mg subcutaneously, 2x a week) and on a total of 54 patients who received the combination of ZADAXIN (1.6 mg subcutaneously, 2x a week) and alpha interferon (3 million units intramuscularly, 3x a week) for six months. There were no significant side-effects reported during the trials. At the conclusion of treatment, the results were as follows:
Professor Wang commented "ZADAXIN(R) thymosin alpha 1 as a monotherapy is a safe and effective treatment for hepatitis B and combining it with the only other approved treatment for hepatitis B, alpha interferon, could bring even further improved response." "We are extremely encouraged by the response of the Chinese liver specialists to the data supporting ZADAXIN, and we have begun our first shipments into this important market," said Donald R. Sellers, president and chief executive officer of SciClone Pharmaceuticals. He added, "We will begin our launch in our other approved markets, Singapore and the Philippines, very shortly. These are exciting times for the Company as we begin to launch our first product, particularly with more pending ZADAXIN marketing approvals anticipated." The Chinese Ministry of Health estimates there are more than 120 million carriers of the hepatitis B virus in China, of whom approximately 12 million are currently estimated to have chronic active hepatitis. The Philippines Bureau of Food and Drug estimates there are more than 6.5 million carriers of the hepatitis B virus in the Philippines, of whom approximately 650,000 are estimated to have chronic active hepatitis. The Singapore Ministry of Health estimates there are more than 250,000 carriers of the hepatitis B virus in Singapore, of whom approximately 100,000 are estimated to have chronic active hepatitis. ZADAXIN, SciClone's lead product, is a synthetically produced immunomodulator that the Company believes stimulates the immune system's disease-fighting properties. SciClone has pending new drug applications for permission to market ZADAXIN in several Asian countries and expects to file additional ZADAXIN new drug applications in foreign markets shortly and throughout 1997. The Company anticipates having filed and/or approved ZADAXIN new drug applications in approximately 25 countries over the course of the next year. The statements made in this press release contain certain forward-looking statements, including statements regarding the acceptance of thymosin alpha I by physicians, the receipt of additional thymosin alpha 1 filings or approvals and the efficacy of thymosin alpha 1 therapy, that involve a number of risks and uncertainties. Actual events or results may differ from the Company's expectations. In addition to the matters described in this release, future actions by the Food and Drug Administration or equivalent regulatory authorities in foreign countries, results of pending or future clinical trials, as well as the risk factors listed from time to time in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K, may affect the actual results achieved by the Company. SciClone Pharmaceuticals is an international biopharmaceutical company engaged in the acquisition, development and commercialization of pharmaceuticals worldwide. SciClone's focus is on therapeutics for diseases that are chronic and life-threatening, including hepatitis B and C, immune system disorders and cancer.
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