To: TokyoMex who wrote (1983 ) 3/25/1998 1:13:00 AM From: Charles J Respond to of 34592
To All, FYI One you may want to track. SciClone Receives Approval to Market ZADAXIN(R)Thymosin Alpha 1 in Kuwait For the Treatment of Hepatitis B SciClone's Third Market Approval in 1998 SAN MATEO, Calif. March 24 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN -news) today announced that it has received approval from the Ministry of Health in Kuwait tomarket its lead product, ZADAXIN(R) thymosin alpha 1, for the treatment of hepatitis B. Kuwait's approval was based on clinical data from studies conducted in the U.S., Europe and Asia demonstrating ZADAXIN to be safe and effective for patients suffering from hepatitis B. ''We are extremely pleased to receive approval to market ZADAXIN in Kuwait. The drug approval process in Kuwait is stringent and exacting, reflecting the approval process in the Middle East generally,'' said Donald R. Sellers, SciClone's President and Chief Executive Officer. ''It is significant that with this approval ZADAXIN has now been approved in each of the three primary regions we have targeted for ZADAXIN hepatitis B sales -- Asia, Latin America and the Middle East. Collectively, these regions represent most of the potential hepatitis B market worldwide.'' This ZADAXIN marketing approval is SciClone's first in the Middle East. SciClone currently markets ZADAXIN in three Asian countries -- the People's Republic of China, the Philippines and Singapore -- for the treatment of hepatitis B. In February 1998, ZADAXIN was approved in two Latin American countries -- Argentina and Peru -- as an influenza vaccine adjuvant and for treatment of hepatitis B, respectively. SciClone has 15 ZADAXIN NDAs pending in Asia, Latin America and the Middle East. SciClone's exclusive Japanese partner, Schering-Plough K.K.(SPKK), a subsidiary of Schering-Plough Corporation (NYSE: SGP - news), recently received government approval to commence a pivotal Phase 3 study of ZADAXIN as a monotherapy for hepatitis B. In late-1997, SPKK started a Phase 2 study of ZADAXIN as a monotherapy for hepatitis C, as required in Japan for approval of the drug for hepatitis C. SPKK also is working to satisfy requirements to begin a clinical program to study the use of its interferon and ZADAXIN as acombination therapy for hepatitis C. In the U.S. and Europe, SciClone is planning a pivotal Phase 3 study of ZADAXIN in combination with interferon for hepatitis C.