Noxopharm (ASX:NOX) has announced that its lead oncology drug candidate Veyonda has been granted Orphan Drug Designation (ODD) by the US FDA for its use in the treatment of soft tissue sarcoma.
The ODD program has been established by the FDA to encourage companies to develop treatments for less common disorders. Noxopharm said receiving the ODD will speed up its commercial development plan for the US market.
Noxopharm CEO Dr Gisela Mautner said, “It is pleasing that the Noxopharm application for Orphan Drug Designation was approved so quickly. Considering that out of approximately 360 approved ODDs last year, only four went to Australian companies, demonstrates the high bar that is being set by the FDA. The 7-year period of market exclusivity is commercially extremely valuable, as it means that the FDA will not approve a subsequent drug for the same use within this timeframe.”
Dr Mautner continued, “The ODD will significantly increase the value proposition of Veyonda to potential purchasers or licensees by both lowering current development costs and by providing future competitive and financial advantages as Veyonda progresses through the clinical trial stages towards registration and approval for sale in the US. With the FDA orphan drug designation now secured for Veyonda, the Noxopharm team is excited to move our preclinical assets along the drug development process, while continuing to deliver on our clinical program plan.
“Noxopharm is currently conducting the CEP-2 trial into the treatment of soft tissue sarcoma in the United States (ASX Announcement 28 February 2022) and will keep the market informed as the study proceeds.”
