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Thursday, 15 March 2012 11:00

Observations from Clinuvels vitiligo and EPP programs being presented at the American Academy of Dermatology

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SCENESSE® (afamelanotide 16mg implant) data and clinical reports to be discussed with global dermatology audience

Melbourne, Australia and Baar, Switzerland, March 15 2012

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that data and observations from the Company’s lead clinical trial programs for its novel drug SCENESSE® (afamelanotide 16mg implant) will be presented at a series of meetings centred on the American Academy of Dermatology (AAD) meeting in San Diego held from March 15-20.

Vitiligo: early US data, further encouraging observations
Repigmentation data and further clinical observations from Clinuvel’s open label Phase II US pilot trial of SCENESSE® in patients with vitiligo (CUV102) are being presented at both the Annual Meeting of the Photomedicine Society and the Skin of Color Society Symposium on March 15. SCENESSE® is being tested as a repigmentation therapy in combination with narrowband UVB light therapy in vitiligo, a pigmentary disorder affecting more than 45 million individuals.

Dr Oma Agbai, co-investigator for the CUV102 study at the Henry Ford Hospital, Detroit, Michigan, is presenting observations from all three US study sites and preliminary data from the Detroit cohort. Early observations from the CUV102 study were presented to the European Academy of Dermatology and Venereology (EADV) meeting in Lisbon in 2011. Dr Agbai’s presentation has been appended to this announcement.

Erythropoietic protoporphyria (EPP): clinical effects in longer term use
Dr Norbert Neumann of the Dusseldorf University Hospital will present data on the cutaneous effects of SCENESSE® in the rare disease erythropoietic protoporphyria (EPP) at the Annual Meeting of the Photomedicine Society. Dr Neumann is presenting data from 41 patients involved in Clinuvel’s Phase III studies of SCENESSE® in EPP (CUV017 and CUV029) and will focus on the safety profile, tolerability and overall efficacy of the drug in adult EPP patients. Attached is the abstract as published by the Photomedicine Society.

Prof Alex Anstey of the Aneurin Bevan Health Board, Newport, UK, is presenting on advances in diagnosis and management of erythropoietic porphyrias to the AAD meeting on March 16, including a brief discussion of his experiences with SCENESSE® in the European CUV029 study in EPP.

“The scientific advances made with the use of SCENESSE® in vitiligo are clinically remarkable and bode well for the future,” Clinuvel’s CEO, Dr Philippe Wolgen said. “The final results will give us a clear view of the utility of our drug. The presentation in EPP demonstrates the long term use of the drug; this report is consistent with clinical feedback obtained in other countries. We look forward to learn the US response from these sessions.”

The AAD Meeting is the largest dermatology event globally, attracting over 16,500 delegates in 2011.

Afamelanotide 16mg controlled-release formulation (SCENESSE®)
Afamelanotide, the active ingredient in SCENESSE®, is a linear peptide which activates eumelanin, the dark pigment, in skin. Eumelanin protects skin from light and UV radiation (photoprotection). SCENESSE® is administered underneath the skin as a dissolvable implant, approximately the size of a grain of rice, which activates eumelanin for a period of two months. In February 2012 Clinuvel filed a marketing authorisation application with the European Medicines Agency for EPP.

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A copy of Dr Agbai’s presentation has been appended (see pdf).

About SCENESSE® (afamelanotide)

SCENESSE® is a first-in-class therapeutic being developed by Clinuvel, with the generic name (or INN) afamelanotide. An analogue of α-MSH, afamelanotide is a linear peptide which activates eumelanin of the skin, the dark pigment which is known to provide photoprotective properties (offering skin protection against light and UV radiation). SCENESSE® is administered underneath the skin as a dissolvable implant approximately the size of a grain of rice. For more information on SCENESSE® go to http://www.clinuvel.com/en/scenesse.

SCENESSE® is a registered trademark of Clinuvel Pharmaceuticals Ltd.

About Clinuvel Pharmaceuticals Limited

Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been filed for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe and the US. For further information please visit www.clinuvel.com

Investor relations contacts:

Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900
Europe: Clinuvel AG, T: +41 41 767 45 45
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Media contact:

Lachlan Hay
Clinuvel AG
Baar, Switzerland
T: +41 41 767 45 45
a mailto:lachlan="" hay="" clinuvel="" com="" href="mailto:lt;p>Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following:</p> <ul> <li>actual results may and often will differ materially from these forward-looking statements;</li> <li>no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved;</li> <li>no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place</li> </ul>"

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