Singapore, Nov 30, 2009: Australia's Clinuvel Pharmaceuticals has obtained the European Medicines Agency (EMEA) status of small and medium enterprise (SME). This status provides incentives to Clinuvel during the preparation for its filing and commercialization of afamelanotide in Europe.

SME status is granted by the EMEA to assist eligible companies during the pre-marketing authorization period, scientific advice, marketing authorization 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 percent fee reduction during the centralized procedure and GMP inspection fees of final product.”