SciClone Pharmaceuticals Inc. announced Thursday that it hasfiled a product license application (PLA) with the Departmentof Health in Hong Kong for approval to market Zadaxin fortreating chronic hepatitis B infection and as a vaccine adjuvantin immunocompromised patients.
When approved, SciClone plans to manage the drug'sdistribution through its Asian Pacific headquarters in HongKong.
Zadaxin is a synthetic form of the naturally occurring peptidethymosin alpha 1, which SciClone (NASDAQ:SCLN) has licensedfrom Alpha 1 Biomedicals Inc. (NASDAQ:ALBM). SciClone of SanMateo, Calif., has the rights to commercialize the productworldwide except in the U.S., Canada, Europe, Israel and Korea.(The two companies are currently in arbitration proceedingsregarding some details of that licensing agreement.)
Hepatitis B virus (HBV) infection is a major public healthproblem throughout Southeast Asia, with an estimated 40million carriers. In Hong Kong, for instance, it's estimated that10 percent of the territory's 5.8 million people carry the virusand as many as 250,000 individuals are chronically infected.And in the Republic of Singapore, where SciClone receivedapproval to market Zadaxin in September, there are anestimated 250,000 HBV carriers, 55 percent of themmanifesting a chronic illness.
The company's stock gained $1.13 a share on Thursday, closingat $26.13.
-- Jennifer Van Brunt Senior Editor
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