Provectus Pharmaceuticals, Inc. (OTC: PVCT)’s leading anti-cancer agent - PV-10 - has received orphan drug designation from the USFDA for the treatment of metastatic melanoma.
An injectable formulation of Rose Bengal (also known as Provecta™) for the ablation of metastatic melanoma (an aggressive and often fatal form of skin cancer), PV-10 is currently under clinical development in Australia on metastatic melanoma patients.
The said Orphan Drug designation entitles Provectus to an exclusive PV-10 marketing rights in the United States for up to seven years ( in the event that Provectus become the first company to receive marketing approval for this therapeutic drug product) and allows Provectus to apply for a waiver from the USFDA of certain user fees required by the Prescription Drug User Fee Act (PDUFA).
According to Provectus CEO Craig Dees, Ph.D.:
Find more details from the press release."We are encouraged that the FDA has granted PV-10 orphan drug designation, which is the first in a list of regulatory benchmarks we are pursuing.
We are taking an aggressive but deliberate approach in working with the FDA and would like to make PV-10 available for metastatic melanoma patients, many of whom have very few options, as soon as the regulators will allow it.
For the moment, this orphan designation puts us first in line and, along with financial and regulatory benefits, will grant us market exclusivity, as long as we keep our trials on schedule and garner FDA approval as planned."
Comment Preview