Clinuvel Pharmaceuticals Limited has obtained the EMEA status of small and medium enterprise (SME). This status provides incentives to Clinuvel during the preparation for its filing and commercialisation of afamelanotide in Europe. SME status is granted by the EMEA to assist eligible companies during the pre-marketing authorisation period, Scientific Advice, marketing authorisation application and inspection procedures.

In 2008 and 2009, afamelanotide was given Orphan Drug Designation (ODD) from the EMEA for the treatment of erythropoietic protoporphyria (EPP) and solar urticaria (SU). Afamelanotide is being developed as a photoprotective drug in three additional photodermatoses in phase-III and II trials. Clinuvel intends to file for registration of afamelanotide in Europe, Norway, Iceland and Liechtenstein ahead of other global markets in 2010.

Clinuvel’s CEO Dr Philippe Wolgen said, “Our activities are part of a continuum towards European market entry, and the reduced regulatory expenditure as a result of the award of SME status is most welcome. As a result of achieving SME status, we will benefit from a 90% fee reduction during the centralised procedure and GMP inspection fees of final product.”

Afamelanotide is an analogue of a-MSH, a peptide which activates the body’s natural ability to produce eumelanin, the dark pigment of the skin which is known to have photoprotective properties, thus providing skin protection against UV radiation (UVR). Increased pigmentation of the skin appears a few days after administration of afamelanotide and lasts up to two months.

Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of afamelanotide, its proprietary first-in-class photoprotective drug.