Clinuvel Pharmaceuticals

We are a global biopharmaceutical company committed to developing drugs for the treatment of a range of severe skin disorders.

Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe. In December 2014 the European Commission granted SCENESSE® marketing authorisation under exceptional circumstances for the prevention of phototoxicity in adult patients with EPP. Further trials of SCENESSE® are underway in the pigmentary disorder vitiligo.

Our website has been developed to help share our expertise on the interaction of light and human skin as well as provide a thorough overview of our global drug development programs.

Latest Company Announcements

Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its head office in Melbourne has relocated. The new address, which will also be the Company’s Registered Address, is: Level 5160 Queen StMelbourneVictoria, Australia 3000 All telephone and fax numbers remain the same. - End - 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 patient populations with a clinical need for photoprotection and another population with a need for repigmentation. These patient groups range in size from 5,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been granted marketing authorisation under exceptional circumstance by the European Medicines Agency for adults with EPP. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. For more information go to http://www.clinuvel.com.

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 2015-03-31

Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA: UR9; ADR: CLVLY) today announced that its drug SCENESSE® (afamelanotide 16mg) has featured in an editorial in the peer-reviewed Journal of Investigative Dermatology. The editorial – “An α-MSH analogue in erythropoietic protoporphyria” – reviews both Clinuvel’s program and the broader history of the bench to bedside development of α-MSH as a therapeutic drug. In their concluding remarks, the authors note that “[t]he approval of afamelanotide by the European Medicines Agency in late 2014 can be regarded as a breakthrough for α-MSH in clinical medicine.” SCENESSE® was approved under exceptional circumstances by the European Medicines Agency in December 2014 for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria. Reference Luger TA & Bohm M (2015). “An α-MSH analogue in erythropoietic protoporphyria”. J Inv Dermatol. 135:929-931. Full text online at  http://www.nature.com/jid/journal/v135/n4/full/jid201516a.html. - End - Media enquiries Lachlan Hay, Clinuvel Pharmaceuticals Ltd. +61 3 96604900   This email address is being protected from spambots. You need JavaScript enabled to view it. Nick Miles, Cabinet Privé de Conseils s.a. +41 22 321 4540   This email address is being protected from spambots. You need JavaScript enabled to view it. Ted Agne, The Communications Strategy Group Inc. +1 718 631 3117  This email address is being protected from spambots. You need JavaScript enabled to view it. 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 patient populations with a clinical need for photoprotection and another population with a need for repigmentation. These patient groups range in size from 5,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been granted marketing authorisation under exceptional circumstance by the European Medicines Agency for adults with EPP. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. For more information go to   http://www.clinuvel.com. Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide 16mg) for a range of UV-related and pigmentary skin disorders. 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: actual results may and often will differ materially from these forward-looking statements; 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; 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. Level 14 / 190 Queen Street             T +61 3 9660 4900             www.clinuvel.com Melbourne, Victoria 3000F +61 3 9660 4999 Australia

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 2015-03-19

Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its vitiligo program will feature in presentations to be given at this week’s American Academy of Dermatology (AAD) 73rd Annual Meeting in San Francisco. Data from Clinuvel’s vitiligo program will be reviewed and discussed by experts involved in the CUV102 and CUV103 clinical trials, where SCENESSE® has been used as a combination repigmentation treatment for darker skinned vitiligo patients. “We are seeing an increasing recognition of the need to treat vitiligo in practical dermatology, which is reflected in the number of presentations featuring Clinuvel’s program,” Clinuvel’s Director, Clinical Affairs, Dr Emilie Rodenburger said. “There are few public forums like the AAD which truly allow our thinking and data on the treatment of vitiligo to be presented to, and challenged by, a global audience of leading academics and practitioners. Given we’re the first pharmaceutical company to fully focus on the treatment of vitiligo, this feedback remains invaluable to our program.” The AAD meeting is the largest of its type anywhere in the world, with nearly 20,000 attendees from across the globe, and will run from March 20-24 Presentations – American Academy of Dermatology 73rd Annual Meeting, The Moscone Center San Francisco Grimes, P. What’s New in Vitiligo Therapy? March 21, 4:05pm, Room 3022. Hamzavi, I. Newer Systemic Treatments for Vitiligo. March 24, 11am, Room 2014. Hamzavi, I. Combinated therapies. March 24, 1.30pm, Room 120. Hamzavi, I. Overview and Vitiligo. March 24, 3.30pm, Room 120. Henderson, M. Vitiligo: What’s New? March 20, 11.30am, Room 2014. Lim, H. News on afamelanotide. March 24, 2pm, Room 120. - End - Media enquiries Lachlan Hay, Clinuvel Pharmaceuticals Ltd.  +61 3 96604900 This email address is being protected from spambots. You need JavaScript enabled to view it.  Nick Miles, Cabinet Privé de Conseils s.a. +41 22 321 4540 This email address is being protected from spambots. You need JavaScript enabled to view it.  Ted Agne, The Communications Strategy Group Inc. +1 718 631 3117  This email address is being protected from spambots. You need JavaScript enabled to view it. 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 patient populations with a clinical need for photoprotection and another population with a need for repigmentation. These patient groups range in size from 5,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been granted marketing authorisation under exceptional circumstance by the European Medicines Agency for adults with EPP. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. For more information go to  http://www.clinuvel.com. Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide 16mg) for a range of UV-related and pigmentary skin disorders. 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: actual results may and often will differ materially from these forward-looking statements; 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; 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. Level 14 / 190 Queen Street             T +61 3 9660 4900             www.clinuvel.com Melbourne, Victoria 3000F +61 3 9660 4999 Australia

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 2015-03-19

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Clinuvel Latest News

SCENESSE® featured in Nature Biotechnology

January's edition of Nature Biotechnology has featured Clinuvel's program with SCENESSE® (afamelanotide 16mg implant) in EPP patients. For more, head to this page (login required)....

Vitiligo Latest News

SCENESSE® vitiligo study results published in JAMA Dermatology

Results from Clinuvel's first Phase II study of SCENESSE® (afamelanotide 16mg) have been published in the peer-reviewed journal JAMA Dermatology. Access the article abstract Read Clinuvel's release Watch an interview with CUV102 investigator Dr Henry Lim...

Clinuvel Spotlight

Company History

The technology behind Clinuvel’s lead drug, SCENESSE® (afamelanotide 16mg), has been in research and development since the 1980s when a small team of scientists set out to investigate methods of preventing skin cancer in humans. Clinuvel licensed this technology and has spent over A$20million optimising the chemistry of afamelanotide (the active ingredient in SCENESSE...

Clinuvel Blog Posts

In 2010, Clinuvel announced that it would commence a clinical trial of a new drug for vitiligo. In late 2012 the first treatment results...

The biennial Porphyrins & Porphyrias conference is the only international meeting of global key opinion leaders on the group of...

Today, February 28, marks Rare Disease Day: an annual event to help highlight the effects of rare diseases on individuals, families and the...

Clinuvel Webcasts

What can vitiligo patients do? - Lee Thomas and Dr ...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

The future of vitiligo treatment - Lee Thomas and D...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

Vitiligo trials of SCENESSE® - Lee Thomas and Dr Ph...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

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