2015/01/26

Golden Biotechnology Corporation, a company developing a new drug for cancer, announced that it has been granted the Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) Office of Orphan Products Development for Antroquinonol, the company’s lead drug candidate. Antroquinonol received the Orphan Drug Designation in treatment of pancreatic cancer.(FDA Designation Request #14-4608).

Under the Orphan Drug Act, the U.S. FDA may grant Orphan Drug Designation to a drug intended to treat rare diseases, generally those which affect fewer than 200,000 individuals in the USA. With the Orphan Drug Designation being granted, the incentives GoldenBiotech will receive include a 7-year marketing exclusivity, Tax credits (up to 50% of clinical development costs), Exemption/Waiver of application (filing) fees, and OOPD assistance during the development process.

“Orphan Drug Designation from the FDA allows us to pursue an accelerated pathway for development of Antroquinonol so we can deliver new drug treatments for the patients in desperate need,” said Liu Sheng-Yung, CEO of GoldenBiotech. “GoldenBiotech is also pursuing the Orphan Drug Designation for Antroquinonol in various indications in coming years.”

In addition to the treatment of Pancreatic Cancer, GoldenBiotech has already started Phase II clinical trials in the USA to evaluate the use of Antroquinonol (trade name Hocena®) for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is estimated that both GoldenBiotech’s new drugs for Pancreatic Cancer and NSCLC will be introduced by the end of 2016. The approval of these drugs represents a major public health accomplishment toward treating this life-threatening disease.