Executive Summary

Melbourne, Australia firm Clinuvel Pharmaceuticals says FDA has granted Investigational New Drug status to its photoprotective afamelanotide drug, allowing it to initiate clinical trials in the U.S. A synthetic version of a naturally occurring hormone that controls melanin levels in human skin, Clinuvel's drug has achieved positive interim results in Switzerland in a Phase III trial involving subjects with a severe genetic skin disorder causing absolute intolerance to sun, according to a recent statement. The substance is in clinical studies in Europe and Australia for four other UV-light-related indications, and there is speculation that Clinuvel eventually could pursue the drug's use in healthy populations for aesthetic purposes; the company previously has reported that the tan associated with its product lasts for roughly three months (1"The Rose Sheet" Nov. 24, 2008, p. 4). In late 2008 UK regulators took action to stem the sale of similar, unlicensed Melanotan products promising an "injectable tan" due to potentially serious side effects. This year Clinuvel aims to "finalize" initial data related to afamelanotide use in cancer patients undergoing photodynamic therapy; it also intends to brand and settle on a trade name for its drug that currently goes by "CUV1647.