SciClone Pharmaceuticals Inc. said Tuesday that it will startPhase III trials in Taiwan of its lead compound, Zadaxin, asingle-drug treatment administered twice a week for 26 weeksto treat hepatitis B, in November.
The company expects results from the blind, randomized,controlled trial of 150 patients in mid-1993, said ThomasMoore, chief executive officer and chairman of the San Mateo,Calif., company (NASDAQ:SCLN).
The company also announced the formation of SciClone TaiwanPharmaceuticals Inc., which will be responsible for marketingSciClone's products in Asia.
"The formation of SciClone Taiwan and the start of trials therereally completes the company's network for Zadaxin in thatpart of the world," Moore said.
Asia has the largest concentration of the disease in the world --93 percent of the world's estimated 300 million cases. InTaiwan, 20 percent of the population, or 3 million people, havebeen infected with hepatitis B.
Taiwan's medical system offers a data base of hepatitis Bpatients extending back to the early 1980s.
SciClone expects the Phase III trial to cost more than $1million, but according to Moore, costs per patient aresignificantly lower in Taiwan than in the U.S. -- about $6,000per patient compared with $15,000 in the U.S.
Alpha 1 Biomedicals of Washington, D.C., produces the drug,which is a synthetic form of thymosin alpha 1.
SciClone said that thymosin alpha 1 clinical trials in the U.S. andItaly have shown the drug to be effective in haltingprogression of the disease and returning liver function tonormal in approximately 75 percent of the patients withchronic active hepatitis B.
Alpha interferon has also been widely tested in Asia fortreatment of hepatitis B, and industry sources expect $1.3billion in product sales for the drug in Japan alone over thenext year. But Moore doesnLt view it as a threat to SciCloneLsZadaxin. -- Michelle Slade
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