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Zadaxin

SciClone Pharmaceuticals, Inc.

Drug Names(s): thymosin alpha 1, thymalfasin

Description: ZADAXIN is a pure synthetic preparation of thymosin alpha 1, a substance which circulates in the blood naturally and is instrumental in the body's immune response to fight viral infections and certain cancers. ZADAXIN is easily and safely administered just under the skin twice a week. After administration, thymosin alpha 1 circulates at 50 to 100 times its normal level in the body. ZADAXIN has been approved for sale by the ministries of health in over 30 countries and is marketed in China and selected other countries outside the U.S. SciClone estimates that over 10,000 patients have used ZADAXIN in both clinical and commercial use, alone and in combination with anti-viral and anticancer drugs, without any reported significant ZADAXIN-specific side effects or toxicities.

Deal Structure: ZADAXIN was originally developed by SciClone.

In October 1996, the Company entered into an expanded and amended licenseand supply agreement with Schering-Plough K.K. (SPKK), giving SPKK exclusivedevelopment and marketing rights to ZADAXIN in Japan. Under the amendedagreement, the Company expects SPKK to continue development of ZADAXINmonotherapy for the treatment of hepatitis B and hepatitis C and to initiateinvestigation of the combination ZADAXIN plus SPKK's INTRON A (interferonalfa-2b) for the treatment of hepatitis C, with the parties sharing certaindevelopment expenses. SPKK will undertake the development, registration andmarketing of ZADAXIN in Japan. Contingent upon product approval, SciClone willreceive milestone payments.

In March 2000, SciClone licensed to Sigma-Tau, exclusive ZADAXIN development and marketing rights to include all countries in the European Union.

In March 2009, Merck & Co and Schering-Plough announced that their Boards of Directors have...See full deal structure in Biomedtracker

Partners: Sigma-Tau S.p.A. Merck & Co., Inc.


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