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.
Apatinib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Apatinib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, apatinib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma, which holds the global rights (ex-China), has partnered development and marketing in South Korea with Bukwang Pharmaceutical Co., Ltd. The Company is currently conducting a global Phase 3 clinical trial of apatinib in 3rd line gastric cancer patients. Apatinib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating apatinib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.
About LSK BioPharma
LSKB is a privately-held biopharmaceutical company based in Salt Lake City, Utah. The Company specializes in clinical development of promising targeted therapies for unmet medical needs in cancer. LSKB is developing two proprietary drug candidates; apatinib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors and a selective BTK/JAK3 inhibitor with the potential to treat hematologic malignancies and rheumatoid arthritis as an immunosuppressive agent. LSKB can be found on the web at www.lskbiopharma.com.
Contact: Angie Price firstname.lastname@example.org