2011 Announcements

Patients diagnosed with erythropoietic protoporphyria (EPP) receiving SCENESSE® (afamelanotide) were able to expose skin to direct sunlight without burns and pain and recorded an improved Quality of Life. Melbourne, Australia and Baar, Switzerland, December 20, 2011 Key results Patients receiving afamelanotide reported significantly less pain associated with phototoxicity (median pain score 6.0, p=0.035). Patients on active drug experienced half as many phototoxic reactions (p=0.044). Afamelanotide enabled patients to experience significantly more direct sunlight exposure without pain (10 AM-3 PM, p=0.005). For the majority of study days, patients treated with afamelanotide were able to spend up to seven times longer in…

In organ transplant patients who experience a high rate of skin cancers and co-morbidity, no significant safety concerns were seen during first 12 months of consecutive use of SCENESSE®. Melbourne, Australia and Baar, Switzerland, December 15, 2011 Executive summary Blinded interim analysis of safety data from 12 months of treatment in OTR study No major safety concerns were identified in this population Treatment was well tolerated with the most frequent adverse events being abdominal pain, fatigue, headaches, nausea and vomiting, mostly mild in severity. Final efficacy and safety results due by end of 2012. Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX:…

Appendix 3B - New issue announcement, application for quotation of additional securities and agreement. For further details see the attached PDF.

Four Appendix 4Y (Change of Director's Interest Notice) documents have been lodged with the ASX. For further details see the attached PDF.

Appendix 3B & Lapse and Forfeit of Unlisted Conditional Performance Rights. For further details see the attached PDF.

Clinuvel's 2011 Annual General Meeting (AGM) was conducted on Wednesday November 9 in Melbourne, Australia. For further details see the attached PDF.

A PDF copy of the 2011 CEO presentation from Clinuvel's Annual General Meeting can be downloaded from the link below.

Protection granted for novel formulations of new class of melanin activating drugs Baar, Switzerland and Melbourne, Australia, November 8 2011 Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the United States Patent and Trademark Office (USPTO) has granted Clinuvel pivotal patent protection for the delivery of melanocortins as photoprotective agents in transdermal formulations. Clinuvel has two melanocortin drugs in development (afamelanotide and CUV9900), both of which are analogues of the naturally occurring hormone alpha-Melanocyte Stimulating Hormone (alpha-MSH). Patent 20110263508 grants Clinuvel exclusive rights for compositions of alpha-MSH analogues and transdermal delivery systems and methods of inducing…

Analyses from US confirmatory study demonstrate a dramatic improvement in Quality of Life from SCENESSE® (afamelanotide 16mg) in the ‘orphan’ disease erythropoietic protoporphyria (EPP) Melbourne, Australia and Baar, Switzerland, November 3, 2011 Executive summary EPP patients who received afamelanotide (active drug) were able to spend more time in direct sunlight between 10 AM and 3 PM and 10 AM and 8 PM (p=0.036, p=0.025). Photoprovocation on the back and hand in a subset of patients showed a significant treatment effect up to Day 60 (p=0.019 to p=0.045, depending on the study day and body site tested). Afamelanotide significantly improved patients’…