ASIANET: SCHERING-PLOUGH K.K. STARTS PIVOTAL PHASE 3 HEPATITIS B STUDY
SCHERING-PLOUGH K.K. STARTS PIVOTAL PHASE 3 HEPATITIS B STUDY OF
SCICLONE'S ZADAXIN(R) THYMOSIN ALPHA 1 IN JAPAN
SAN MATEO, Calif., May 12 /PRNewswire/AsiaNet/-- SciClone Pharmaceuticals (Nasdaq: SCLN), announced today that Schering-Plough K.K. ("SPKK"), the Japanese subsidiary of Schering-Plough Corporation (NYSE: SGP), has started the pivotal Phase 3 hepatitis B study in Japan for the Company's lead product, ZADAXIN thymosin alpha 1. The study will involve 300 patients with chronic hepatitis B infection. It will be the largest randomized, double-blind clinical trial using thymosin alpha 1 to date.
"The launch of this trial in Japan is another significant milestone for SciClone and its shareholders," stated Donald R. Sellers, SciClone's President and Chief Executive Officer. "It represents the culmination of over five years of cooperative development and investment and the beginning of the final stage of the Japanese hepatitis B clinical program for ZADAXIN."
SPKK is SciClone's exclusive development and marketing partner for ZADAXIN in Japan. SciClone has retained Japanese manufacturing rights and can receive substantial milestone payments.
Chronic hepatitis B is one of the most common chronic infectious diseases in the world. The hepatitis B virus is much more infectious than HIV, the virus that causes AIDS. The World Health Organization estimates that there are approximately 2.6 million chronic carriers of the hepatitis B virus in Japan. Carriers of the hepatitis B virus have a 200-fold increased chance of developing primary liver cancer, the most common cancer in the world, and a significant number develop cirrhosis of the liver.
SciClone markets ZADAXIN, a drug that stimulates the immune system, in the People's Republic of China, the Philippines and Singapore for the treatment of hepatitis B. In the first quarter of 1998, ZADAXIN was approved in Kuwait and Peru for hepatitis B and in Argentina as an influenza vaccine adjuvant. In April 1998, SciClone acquired exclusive rights to ZADAXIN in Italy, Spain and Portugal, including a ZADAXIN marketing approval in Italy as an influenza vaccine adjuvant and a ZADAXIN marketing application in Italy as a treatment for non-small cell lung cancer. SciClone has 18 ZADAXIN hepatitis B marketing applications pending in Asia, Latin America and the Middle East. In the U.S. and Europe, SciClone is planning a pivotal Phase 3 hepatitis C study of ZADAXIN in combination with interferon.
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 at 800-996-7256.
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 size of the Japanese pivotal Phase 3 hepatitis B clinical trial. Actual events or results may differ from the Company's expectations and beliefs. In addition to the matters described in this release, future actions by the Food and Drug Administration or equivalent regulatory authorities in foreign countries, including the Japanese Ministry of Health and Welfare, 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.
SOURCE SciClone Pharmaceuticals, Inc.
-0- 05/12/98
/CONTACT: Shawn K. Singh, Senior Vice President of SciClone Pharmaceuticals, Inc., 650-358-3456/
/Company News On-Call: http://www.prnewswire.com or fax, 800-758-5804, ext. 775865/ /Web site: http://www.sciclone.com/
(SCLN SGP)
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