The Swiss Agency for Therapeutic Products issues positive...

The Swiss Agency for Therapeutic Products issues positive opinion on Clinuvel’s photo protective drug following Europe’s EMEA Orphan Designation on 4th March
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is very pleased to announce that its photo protective drug CUV1647 has been granted Orphan Drug Designation (ODD) by Swissmedic, the central Swiss supervising authority for therapeutic and medicinal products. The orphan designation is for the preventative treatment of erythropoietic porphyrias (metabolic blood disorders).

This represents the second orphan designation of CUV1647 as a photo protective drug for the treatment of light-related skin disorders. This announcement follows on from the European Medicines Agency (EMEA) grant of two ODDs to Clinuvel on 4th March 2008 for erythropoietic porphyrias EPP and CEP.

The designated diseases, erythropoietic porphyrias, are classified as severe and rare genetic diseases with no effective preventative therapy other than avoiding sun and light, by spending life indoors.

CUV1647 will be the first drug offering preventative treatment for phototoxic reactions associated with the erythropoietic disorders. This group of patients is unable to expose themselves to ambient light and UV.
Subject to successful completion of Clinuvel’s current Phase III EPP trials due in 2009, Clinuvel will seek marketing authorization from Swissmedic and the registration of CUV1647. This will be the final regulatory step before the start of sales in Europe.

Clinuvel’s CEO, Dr Philippe Wolgen said:
“Achievement of Orphan Drug Status in Switzerland is a key milestone for Clinuvel and follows the recent approval by the EMEA for Europe. The acknowledgement by both EMEA and Swissmedic, within two consecutive months, highlights the severity of erythropoietic diseases and recognises the potential value of CUV1647 as a preventative therapy to such patients. Switzerland will be an important market for Clinuvel”.