Clinuvel Pharmaceuticals (ASX:CUV, XETRA-DAX:UR9; ADR:CLVLY) has received orphan-drug designation from the U.S. Food and Drug Administration for the active ingredient of its Hailey-Hailey Disease treatment.
The designation is the second to recognise the potential of afamelanotide in its proprietary drug SCENESSE® to treat the rare disease.
Orphan-drug designation is granted for drugs that have the potential to diagnose or treat rare conditions, defined as those affecting less than 200,000 individuals in the U.S.
This entitles Clinuvel to technical assistance throughout the development process for HHD, potential fee reductions and tax credits, and seven years’ market exclusivity if approved for marketing by the FDA.
SCENESSE had earlier this week received received an orphan designation from the European Medicines Agency.
Hailey-Hailey Disease, also known as familial benign chronic pemphigus, is a genetic disorder that causes outbreaks of rashes and blisters in the skin.
Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.