Monday 30th November 2009
Melbourne, Australia
The European Medicines Agency (EMEA) grants Clinuvel SME status
Small medium enterprise status ahead of regulatory filings of afamelanotide
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is pleased to announce
today that it 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.

http://www.clinuvel.com/resources/cmsfi ... 130SME.pdf