ASIANET: SCICLONE AND SCHERING-PLOUGH K.K. RECEIVE JAPANESE APPROVAL TO START THE PIVOTAL PHASE 3 HEPATITIS B STUDY FOR ZADAXIN (R) THYMOSIN ALPHA 1 IN JAPAN
"We are very pleased to be in the final phase of clinical testing in Japan, the world's largest market for viral hepatitis therapies," said Donald Sellers, President and Chief Executive Officer of SciClone.
SPKK is SciClone's exclusive Japanese development and marketing partner for thymosin alpha 1. SciClone has retained Japanese manufacturing rights and can receive substantial milestone payments.
ZADAXIN, SciClone's lead product, is approved and marketed for treatment of chronic hepatitis B in the People's Republic of China, the Philippines and Singapore. SciClone has filed for approval to market ZADAXIN for this indication in 18 additional countries.
Chronic hepatitis B is the second most common chronic infectious disease worldwide. The World Health Organization estimates that there are approximately 2.6 million chronic carriers of the hepatitis B virus in Japan.
In November 1997, SciClone announced that SPKK started the Japanese Phase 2 hepatitis C clinical program for ZADAXIN.
SciClone Pharmaceuticals, Inc. is an international biopharmaceutical company that acquires, develops and commercializes specialist-oriented drugs for treating chronic and life-threatening diseases, including hepatitis B, hepatitis C, cystic fibrosis, cancer and immune system disorders.
Press releases and corporate information from SciClone Pharmaceuticals, Inc. are available on the Internet at www.sciclone.com and by fax at800-996-7256.
The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties, including, without limitation, those associated with the initiation and success of the Japanese pivotal phase 3 hepatitis B clinical trial. Actual events or results may differ from the Company's expectations and beliefs. Factors which may affect the actual results achieved by the Company include future actions by the FDA, or equivalent regulatory authorities in foreign countries, including the Japanese Ministry of Health and Welfare, results of pending or future ZADAXIN clinical trials, as well as risk factors listed from time to time in SciClone's SEC filings and reports, including, but not limited to, its Annual Report on Form 10-K.
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