Clinuvel’s melanin stimulant headed for U.S. trials
This article was originally published in The Rose Sheet
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.
You may also be interested in...
How Realistic Is Injectable Tan/Sun Protection? UK Cracks Down On Illegals
UK regulators are warning consumers not to use Melanotan, an "injectable tan" being sold illegally online; however, a product in development by Australian firm Clinuvel raises the question of whether self-tanner and sun protection marketers could face competition down the road from such an injectable
Finance Watch: Canaan, Regeneron Reveal New Funds For Start-Ups
Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to $1bn-plus. Also, incubators plan to grow over the next decade and in recent financings Avenzo raised $150m and Nvelop launched with $100m.
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.