[MOL] FDA Granted orphan drug status to Zadaxin........for the treatment [01852] Medicine On Line


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[MOL] FDA Granted orphan drug status to Zadaxin........for the treatment of hepatocellular carcinoma....



SAN MATEO, CA -- March 22, 2000 -- SciClone Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status to Zadaxin(R) (thymalfasin), SciClone's lead immunotherapy, for the treatment of hepatocellular carcinoma, the most common and deadliest form of liver cancer worldwide. Orphan Drug Status provides for U.S. marketing exclusivity for seven years upon marketing approval, as well as significant tax benefits and exemptions from FDA application fees.

"This is another green light for our Zadaxin U.S. clinical development program in cancer," said Donald R. Sellers, SciClone's President and Chief Executive Officer. "There is a growing body of data that shows enormous potential for Zadaxin in cancer. Liver cancer is an ideal first cancer target for us because it is a primary fatal endpoint in the progression of hepatitis B and hepatitis C, diseases Zadaxin is currently treating successfully in numerous countries worldwide."

Hepatocellular carcinoma (HCC) is the most prevalent malignant disease in the world, killing up to 1,250,000 people each year. HCC accounts for more than 80 percent of all primary liver tumors. Worldwide, there are approximately 1,000,000 new cases each year. In the U.S., the American Cancer Society estimates approximately 14,000 new cases of liver cancer, including up to 6,000 cases of HCC, and 13,000 deaths each year. There is a strong association between HCC and chronic hepatitis B and C. The most common non-surgical treatment alternative for HCC is transcatheter arterial chemoembolization (TACE).

SciClone's U.S. phase two liver cancer trials, which are planned to begin in the third quarter of 2000, will be based on the same protocols as a previous study in Italy combining ZADAXIN immunotherapy with TACE. In that pilot study, the combination resulted in a statistically significant increase in survival compared to a matched historical group receiving TACE alone. Patients receiving the combination also showed an increase in peripheral blood immune cells, which are fundamental in the destruction of cancer cells. No additional side effects, often a limiting factor for combination therapies in cancer, were observed from the addition of Zadaxin.

Many patients with cancer and chronic infectious diseases have an impaired immune system. Zadaxin significantly enhances the immune system's ability to recognize and destroy cancerous and infected cells. Zadaxin immunotherapy is in late-stage development for cancer and viral hepatitis worldwide. Zadaxin now is approved for marketing in 19 countries, principally for treatment of hepatitis B and hepatitis C. SciClone has filed for Zadaxin marketing approval in 18 additional countries.

SciClone Pharmaceuticals is a global biopharmaceutical company that develops and commercializes novel medicines for treating a broad range of the world's most serious diseases. The Company has focused its current product development and commercialization activities on cancer, hepatitis B, hepatitis C, drug-resistant tuberculosis and cystic fibrosis.

Related Links: Zadaxin (thymalfasin) and SciClone Pharmaceuticals.





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