Ann: SCENESSE European Orphan Drug Designation for VP, page-10

More great news for Clinuvel, and yes why indeed not price sensitive? A quick search below comes up with 4 concrete examples of Orphan Drug Designation being granted and EACH ONE IS MARKET SENSITIVE as marked by the ASX. I could go on because there are plenty more but why the inconsistency. So what does Orphan Drug status do, it usually means tax credits for trials, a market exclusive period and less or no fees throughout the drug approval process.

Mesoblast MSB 15/02/24, Neuren NEU 3/9/21, Noxopharm NOX 4/10/23, Argenica AGN 15/11/23 All market sensitive but not CUV 29/4/24?

In my opinion this is very likely to be added as a label extension for the already approved and safe drug. Clinuvel did mention payors will reimburse for this terrible disease and the following statements in todays release are quite positive:

"The Committee for Orphan Medicinal Products (COMP) recognised the chronically severe nature of skin
symptoms in VP, the high unmet need, lack of alternative therapies, and afamelanotide’s potential as a VP
treatment.

The EMA considered clinical evidence from the CUV040 study – an open-label six-month study of six adult VP
patients – to be a sufficient proof-of-concept to enable a positive opinion on the ODD application for
SCENESSE®. The Agency reviewed the study endpoints and results on disease severity, ability to expose to
light, and quality of life as a potential clinical benefit for VP patients."


All IMO DYOR