SciClone Pharmaceuticals Inc. has filed a product licenseapplication (PLA) to market Zadaxin as a chronic hepatitis Btreatment in Singapore.
This synthetic form of thymosin alpha 1 is produced by Alpha1 Biomedicals of Washington, D.C.
SciClone (NASDAQ/NMS:SCLN) of San Mateo, Calif., choseSingapore for its first PLA filing because Asia in general hasthe largest concentration of hepatitis B cases in the world andSingapore in particular is considered a leader in health care.
"Singapore has some of the finest hospital facilities and medicalexpertise in the world," said Thomas Moore, SciClone'schairman and chief executive officer.
"If this application is approved, Singapore ... will serve as abeacon for other countries in the future treatment of hepatitisB," he said.
Of Singapore's population of about 3 million, some 250,000 arehepatitis B carriers. About 55 percent of carriers have chronicillness while the remaining 45 percent are asymptomatic. Thechronic disease often leads to cirrhosis of the liver and livercancer.
In Southeast Asia overall, there are about 40 million hepatitis Bcarriers.
SciClone conducted its Phase III Zadaxin trial in Taiwan andformed SciClone Taiwan Pharmaceuticals Inc. last fall to marketthis and future SciClone products in Asia.
The company said clinical trials conducted in the U.S. and Italyshowed that the drug restored normal liver function in about75 percent of patients with chronic active hepatitis B.
SciClone's stock was up 75 cents a share on Wednesday, closingat $13.75. -- Nancy Garcia
(c) 1997 American Health Consultants. All rights reserved.