Philippines Appro For SciClone's Zadaxin

USA-based SciClone Pharmaceuticals has received approval to market its Zadaxin (thymosin alpha 1) as a treatment for chronic hepatitis B from the Philippines Department of Health Bureau of Food and Drugs. This is the second approval for the product, the first being in Singapore.

New drug applications for Zadaxin have already been filed in China, Hong Kong, India, Indonesia, Malaysia, Mexico and Cyprus. The company says it is also on track to file around 12 additional applications for the chronic hepatitis indication this year. SciClone also expects to receive the final results from a Phase III hepatitis B trial conducted in Taiwan later this year (Marketletter March 18), with the expectation of a regulatory filing to follow. The final results of a Phase III trial in the USA for the treatment of hepatitis C are expected early 1997.

The Philippines approval was based on clinical data from studies carried out in the USA and Europe, indicating that Zadaxin is safe and effective for patients suffering from chronic hepatitis B. It is licensed as a monotherapy, and is administered subcutaneously twice weekly for six months at a dosage of 1.6mg per injection. The BFAD estimates that there are more than 6.5 million carriers of the hepatitis B virus in the Philippines, of whom an estimated 10%-15% are chronic carriers of the disease.