The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) status to Noxopharm Ltd (ASX:NOX, OTC:NOXOF)’s CRO-67 pre-clinical drug candidate for the treatment of pancreatic cancer.
The award comes on the heels of further encouraging CRO-67 data that was presented at the American Association of Cancer Research Special Conference on Pancreatic Cancer last week.
Only two other Australian companies have received an ODD from the FDA this year, from a total of 260 issued.
The designation comes with various benefits, including tax credits for qualified clinical trials, exemption from user fees, and seven years of potential market exclusivity after approval.
The ODD status is critical to support the company’s development of the asset and its future commercial value as Noxopharm continues to build the data package needed for regulatory progression.
High-priority program
“For CRO-67 to achieve an ODD is a significant milestone in the development of the drug,” Noxopharm chief executive officer Dr Gisela Mautner said.
“In addition to financial benefits, the ODD will also strengthen our commercial position in a market that has seen very few new treatments over recent decades.
“Our pancreatic cancer program is a high priority, and we are committed to progressing its development as quickly as possible.
“Further studies are in the works, as are investigations into dosing and formulation.”
Pancreatic cancer has a very poor five-year survival rate of about 9% from the time of diagnosis and could become the second leading cause of cancer-related deaths in the US by 2040.