Posted: 6 October 2023
Innovative biotech company Noxopharm Limited (ASX:NOX) announces that the US Food and Drug Administration has granted Orphan Drug Designation (ODD) status to Noxopharm’s CRO-67 preclinical drug candidate, for the treatment of pancreatic cancer. The FDA grants ODDs for drugs designed to prevent, diagnose or treat rare diseases or conditions, and the designation comes with various benefits that include:
- Tax credits for qualified clinical trials
- Exemption from user fees (e.g. FDA application fees)
- Potential seven years of market exclusivity after approval
So far this year only two other Australian companies have received an ODD from the FDA, from a total of 260 issued.
CRO-67’s designation as an orphan drug supports the company’s development plan for the asset, and its future commercial value, as Noxopharm continues to build the data package that will be required for regulatory progression.
The designation comes shortly after further encouraging CRO-67 data was presented at the American Association of Cancer Research Special Conference on Pancreatic Cancer. The disease is set to become the second leading cause of cancer-related deaths in the US by 2040, and has a very poor five-year survival rate of about 9% from the time of diagnosis.
Noxopharm CEO Dr Gisela Mautner said: “For CRO-67 to achieve an ODD is a significant milestone in the development of the drug. 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.”
