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 October 2014 the European Medicines Agency recommended approval for SCENESSE® under exceptional circumstances for 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) will host an investor teleconference on Wednesday October 29 at the following times: Melbourne: 18:00Singapore: 15:00Zurich: 08:00New York: 03:00 Investors can access the call by calling the numbers below and entering the conference PIN 758468# Country Number Australia +61 2 8417 2751 Austria +43 7 2088 1060 China +86 400 716 0165 France +33 9 7518 0198 Germany +49 89 2109 4210 Hong Kong +852 5808 0301 Italy                 +39 06 9926 8246 Netherlands +31 85 888 0207 Singapore                 +65 3158 5152 Switzerland +41 22 533 0940 UK +44 20 3026 6796 USA/Canada +1 877 724 3611 - 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 recommended for marketing authorisation under exceptional circumstance by the European Medicines Agency. 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) 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: 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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 2014-10-28

Australia’s Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) has announced that its drug SCENESSE® (afamelanotide 16mg) has received its first approval from the European Medicines Agency (EMA) to treat a disease caused by exposure to sunlight. The EMA’s Committee for Medicinal Products for Human Use (CHMP) voted in favour of marketing authorisation for SCENESSE® under exceptional circumstances for the rare genetic disorder erythropoietic protoporphyria (EPP). SCENESSE® is the first treatment ever to have been developed for EPP, a debilitating disorder which is clinically regarded as extreme intolerance to light and UV (phototoxicity). These patients suffer from intolerable pain, swelling, scarring and a state of distress which may result in hospitalisation. The first of five trials of SCENESSE® for EPP started in 2006, with Clinuvel pioneering the development of a new formulation of the drug, and designing and executing an entirely novel clinical program for EPP. SCENESSE® is the first drug developed by an Australian company and taken from novel molecule to marketing authorisation for a previously untreated disease. “Today’s EMA outcome is a landmark achievement by Clinuvel and all those who worked with this program for nearly a decade,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “My first thoughts go out to the EPP patients and families who have been asking us for the release of the drug for many years. “The life of a patient with EPP is one of social deprivation, punctuated by periods of second degree burns and unspeakable pain following exposure to daylight or bright indoor lighting. For a decade now my team remained motivated by the unique opportunity to provide a product that could be life altering for these patients,” Dr Wright said. An estimated 10,000 EPP patients are affected worldwide, 45% of whom live in Europe. In September 2014, the EMA announced that SCENESSE® was to be the first drug to be evaluated as part of a new and progressive European regulatory pilot program integrating patients’ and physicians’ clinical experiences with SCENESSE® in the CHMP’s decision process. The EC approval acknowledges the challenges of conducting clinical trials in rare and severe disorders and grants access to treatments for patients without alternative treatment.1 The European marketing authorisation covers 31 states.2 Clinuvel and the EMA have agreed to a comprehensive post-authorisation pharmacovigilance plan to follow up EPP patients long term. “Medical innovation requires an exceptional focus with a consistent strategy, passionate team and long term trust from patients and expert physicians worldwide. It is a privilege to have written pharmaceutical history for these patients. The EMA’s executive management is to be commended for its progressive vision and reform,” Clinuvel’s CEO, Dr Philippe Wolgen said. “The immediate goal now is to distribute the drug to Europe in the coming months, while we owe it to our American and Asia-Pacific patients to accelerate the regulatory submission and approval of SCENESSE®.” - End - Media enquiries Clinuvel Pharmaceuticals (Australia), Lachlan Hay +61 3 9660 4900 This email address is being protected from spambots. You need JavaScript enabled to view it. Monsoon (Australia), Emma Power, +61 3 9620 3333 This email address is being protected from spambots. You need JavaScript enabled to view it. Journalista (Europe/US), James Tout +44 207 232 4671 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 2014-10-26

European Medicines Agency CHMP approves novel drug for erythropoietic protoporphyria patients under exceptional circumstances (ART 14 (8) OF REGULATION (EC) NO 726/2004) EXECUTIVE SUMMARY SCENESSE® attains an historic breakthrough EMA approval for adult EPP patients extremely intolerant of light and UV Marketing authorisation in 31 European States Australian listed Clinuvel (ASX: CUV) has taken SCENESSE® from discovery to commercialisation SCENESSE® as the first drug for which patients’ and physicians’ clinical experiences were integrated EMA’s formal decision process Investor telephone conference-call Wednesday 29 October: 1800 Melbourne = 0900 Zurich = 0300 New York = 1500 Singapore. Details will be released to the ASX on Tuesday October 28. Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is proud to announce that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has voted in favour of marketing authorisation (MA) of Clinuvel’s drug SCENESSE® (afamelanotide 16mg) for adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is a first-in-class drug (belonging to a new drug category). EPP is a debilitating, rare genetic disorder clinically regarded as extreme intolerance to light and UV (phototoxicity). An estimated 10,000 EPP patients are affected worldwide, 45% of whom live within Europe. Clinuvel conducted five trials testing SCENESSE® in approximately 350 adult EPP patients across Australia, Europe and the USA. The first EPP patient received the drug in 2006. Clinuvel submitted its dossier for EMA evaluation on 6 February 2012. In September 2014, it was announced that the EMA - for the first time in its history - was incorporating patients’ and physicians’ clinical experiences with SCENESSE® in the CHMP’s decision process. EMA Decision On 23 October 2014 in its plenary session the CHMP voted in favour of marketing authorisation of SCENESSE®. This decision takes into account the challenges and limitations of conducting clinical trials in rare and severe disorders and allows access to treatment for patients without alternative medcine.1 Marketing authorisation is given for distribution of SCENESSE® across 31 European states.2 The CHMP’s decision will now be sent to the European Commission for formal ratification, expected within 67 days. Clinuvel and the EMA have agreed to a comprehensive post-authorisation pharmacovigilance plan to monitor patients’ safety long term. SCENESSE® will be distributed through academic and specialised centres. Comment “On behalf of the Board, I congratulate shareholders and patients, experts in the field and Clinuvel’s teams around the world,” Clinuvel’s Chair, Stan McLiesh said. “I have witnessed from our staff a decade long dedication and an enormous zeal which has come together for patients and all stakeholders in a marvellous outcome, one rarely accomplished in pharmaceutical development and which is now unique to Australia.” “Medical innovation requires an exceptional focus with a consistent strategy, passionate team and long term trust from patients, expert physicians and regulatory authorities worldwide,” Clinuvel’s CEO, Dr Philippe Wolgen said. “Today I am excited but mostly proud that Clinuvel overcame a number of hurdles from having identified an unmet clinical need and taken a molecule from discovery to final commercial product. I congratulate our Acting Chief Scientific Officer Dr Wright and his entire team for the extraordinary achievement.” “This outcome greatly impacts Clinuvel, our further operations and intrinsic value. The immediate goal is to distribute the drug to European patients in the coming months, while we owe it to our American and Asia-Pacific patient community to accelerate the regulatory process for them to gain access to SCENESSE®,” Dr Wolgen said. - End - Investor note: Clinuvel will host a teleconference with shareholders on Wednesday October 29 at 1800 Melbourne time. Details will be released to the ASX on Tuesday October 28. 1 According to Article 14(8) of Regulation (EC) No 726/2004. Further details of Approval under Exceptional Circumstances can be found on the EMA’s website at:  http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004883.pdf 2 The 28 EU member nations as well as Iceland, Liechtenstein and Norway. Investor enquiries Clinuvel Pharmaceuticals Ltd (Australia) +61 3 9660 4900   This email address is being protected from spambots. You need JavaScript enabled to view it. About SCENESSE® SCENESSE® is an injectable controlled-release implant formulation containing 16mg of afamelanotide, a novel molecule from a family of drugs known as melanocortins. SCENESSE® is the first melanocortin approved by a leading regulatory authority for the prevention of skin burns and symptoms in EPP. The drug provides anti-oxidative effects and activates the skin’s dark pigment, eumelanin, providing EPP patients with a biological barrier between their skin and the various wavelengths of light triggering phototoxic reactions. The clinical relevance of SCENESSE® is to facilitate patients to expose themselves to light and UV, preventing them from incurring the characteristic burns seen in EPP. SCENESSE® has been clinically trialled in over 900 patients, including 350 adult EPP patients. In October 2014 the European Medicines Agency recommended approval for SCENESSE® under exceptional circumstances. About erythropoietic protoporphyria (EPP) EPP is characterised by severe phototoxicity (absolute intolerance to light) of the skin resulting in intolerable pain, swelling, scarring and a state of distress. During phototoxic episodes patients experience long-term swelling of the exposed body surfaces such as the face, hands and feet. A severe reaction – triggered by exposure to light, particularly UV light – may result in hospitalisation. Patients do not respond to any analgesics or medication and following light exposure are typically unable to function. Due to the known risk to light and UV, patients often lead lifelong an isolated indoor life deprived of normal activities. 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 recommended for marketing authorisation under exceptional circumstance by the European Medicines Agency. 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) 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: 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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 2014-10-26

- Media release - The first new pharmaceutical drug invented and developed for an untreated disorder by any Australian company has received regulatory approval from the European Medicines Agency (EMA). SCENESSE® (afamelanotide 16mg) treats the debilitating genetic disorder porphyria (EPP), or absolute intolerance to sunlight. The fear of lifelong burns requires EPP patients to lead an indoor, isolated existence avoiding any form of light. SCENESSE® is the first treatment ever to have been developed for EPP. EPP is characterised by an extreme risk of severe burns (phototoxicity) of the skin resulting in intolerable pain, swelling, scarring and a state of distress. A severe reaction – triggered by exposure to light, particularly sunlight – may result in hospitalisation. Since 2006 Australian company Clinuvel Pharmaceuticals has invented, developed and tested SCENESSE®. The drug – the first approved from a new family of drugs known as melanocortins – acts as an anti-oxidant and activates melanin in skin, providing patients with a biological barrier between their skin and the various wavelengths of light triggering phototoxic reactions. Clinical trials in 350 adult EPP patients have shown the drug to be well tolerated, to reduce the incidence and severity of reactions, and to dramatically improve patients’ quality of life. “The life of a patient with EPP is one of social deprivation, punctuated by periods of second degree burns and unspeakable pain following exposure to daylight or bright indoor lighting,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “For a decade now my team remained motivated by the unique opportunity to provide a product that could be life altering for these patients.” The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that SCENESSE® be approved under exceptional circumstances (EC) after announcing in September that SCENESSE® was the first drug in a European pilot program incorporating patients’ and physicians’ clinical experiences in the regulatory decision process. The EC approval acknowledges the challenges of conducting clinical trials in rare and severe disorders and enables access to treatments for patients without alternative treatment.1 An EC authorisation will enable Clinuvel to market SCENESSE® for EPP across the 31 EMA states.2 As part of the EC approval, Clinuvel and the EMA have agreed to a comprehensive post-authorisation pharmacovigilance plan to follow up patients long term. “Medical innovation requires an exceptional focus with a consistent strategy, passionate team and long term trust from patients and expert physicians worldwide. It is a privileged to have written pharmaceutical history for these patients,” Clinuvel’s CEO, Dr Philippe Wolgen said. “The immediate goal now is to facilitate access for European patients in the coming months, while we owe it to our American patients to accelerate the submission of the SCENESSE® dossier to the US FDA.” - End - 1 According to Article 14(8) of Regulation (EC) No 726/2004. Further details of Approval under Exceptional Circumstances can be found on the EMA’s website at   http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004883.pdf 2 The 28 EU member nations as well as Iceland, Liechtenstein and Norway. Media enquiries Journalista (US/Europe)James Tout+44 207 232 4671   This email address is being protected from spambots. You need JavaScript enabled to view it. Clinuvel Pharmaceuticals Ltd (Australia)Lachlan Hay+61 3 9660 4900   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,andhasbeenrecommended for marketing authorisation under exceptional circumstances by the European Medicines Agency. 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) 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: 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 Melbourne, Victoria 3000             T +61 3 9660 4900             www.clinuvel.com

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 2014-10-24

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Clinuvel Latest News

Afamelanotide mentioned in EMA release

Clinuvel's drug SCENESSE® (afamelanotide 16mg) has been mentioned in a press release issued by the European Medicines Agency. To read the release, click on the following link: Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use...

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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