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THE US FDA GRANTS APATINIB ORPHAN DRUG DESIGNATION FOR TREATMENT OF GASTRIC CANCER
SALT LAKE CITY, USA, June 19 2017 — LSK BioPharma (LSKB, Company) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to apatinib for the treatment of gastric cancer. Apatinib, which has been approved and is marketed in China for patients with gastric cancer, is currently being investigated in a global phase 3 clinical trial sponsored by LSKB.
Orphan Drug Designation (ODD) can be awarded when the sponsor establishes that the drug product will be of significant clinical benefit to the intended orphan population. There are a number of incentives companies may receive when awarded this designation, including protocol assistance, scientific advice, and market exclusivity above and beyond patent expiration. Tax credits on clinical costs and exemptions from certain FDA fees are also available.
“We are encouraged by apatinib’s approval in China for gastric cancer and by our own clinical results to date,” said Dr. Sung Chul Kim, President, “We believe the US FDA’s and the European Union’s Orphan Drug Designation programs will assist the company in making apatinib available to gastric cancer patients worldwide, even in regions with lower incidence.”
Gastric (stomach) cancer is a disease in which cancer cells form in the lining of the stomach. It is often diagnosed at an advanced stage because of the lack of early signs or symptoms. In contrast to Asia, Eastern Europe, and South America, Gastric Cancer has a relatively lower incidence in the United States and Western Europe.