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

SUMMARY SCENESSE® Risk Management Plan infrastructure nearing finalisation EPP expert centre training commences this week Leatherhead, UK and Melbourne, Australia Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the commercial distribution of its drug SCENESSE® (afamelanotide 16mg) for erythropoietic protoporphyria (EPP) across Europe. SCENESSE® was granted marketing authorisation by the European Commission for adults diagnosed with EPP on December 22, 2014. A number of post-authorisation commitments were agreed with the European Medicines Agency (EMA) under a long-term risk management plan (RMP) for SCENESSE®. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is scheduled to complete the final review of commitments relating to the distribution of SCENESSE® in September 2015. POST-AUTHORISATION COMMITMENTSThe RMP requires that patients receiving SCENESSE® are monitored for long-term safety. This includes the establishment of a Centralised European EPP Disease Registry and a post-authorisation safety study (PASS) of all patients receiving SCENESSE®. PRAC is currently finalising its review of the Disease Registry. In accordance with relevant European legislation1 the Disease Registry is set up allowing trained physicians to enter anonymised medical information on the real-time use of SCENESSE®. Clinuvel is responsible for providing biannual safety reports to the EMA for the first 24 months following product release. An independent Governance Board and Data and Safety Monitoring Board oversee the management of the Disease Registry.EUROPEAN TRAINING OF EPP EXPERT PHYSICIANSAs part of its European regulatory commitments, Clinuvel is required to adequately train expert physicians and their professional staff prior to prescribing SCENESSE®.The first European EPP Expert Convention takes place on June 5 in Paris. In total 33 physicians from 23 different centres across 15 countries are represented. This convention will instruct expert physicians and specialists on the use of the Disease Registry and the administration of SCENESSE®. Clinuvel will host a number of these expert meetings concomitant with the European distribution of SCENESSE®.DISTRIBUTION OF SCENESSE® IN ITALY AND SWITZERLANDSpecial Access Schemes which started in 2010 allow the distribution of SCENESSE® in Italy and Switzerland.  A recent publication reported on the longer term follow up of 115 EPP patients from these programs.2 COMMENTARY“My team is putting all the required processes in place in accordance with the EMA’s principles and we have progressed our distribution of SCENESSE®,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “The extent of the interest shown in prescribing SCENESSE® for EPP has exceeded our expectations for today’s convention.” “It is a considerable undertaking to put in place the quality management systems and processes required by the EMA,” Clinuvel’s Director Clinical Affairs Dr Emilie Rodenburger said. “While EMA progress is taking longer than we wish for, our team is clearly excited by the approaching landmark of treating EPP patients.”“The past months have demonstrated clinical demand from EPP patients, especially from countries where Clinuvel had not been before,” Dr Rodenburger said.REFERENCES1 The European Convention on Human Rights, Article 8 of the Charter of Fundamental Rights of the European Union, and the Data Protection Directive 95/46/EC.2 Biolcati G, Marchesini E, Sorge F, Barbieri L, Schneider-Yin X and Minder E (2015). “Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria.” Brit J Dermatol. 172(6):1601-12. E-pub Dec 13, 2014. Available online: http://onlinelibrary.wiley.com/doi/10.1111/bjd.13598/pdf. - End - Media enquiries Lachlan Hay, Clinuvel (UK) Ltd. +44 1372 860 765    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. Investor enquiries   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 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 approved by the European Commission for treating adults with EPP. Headquartered 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 drug SCENESSE® (afamelanotide 16mg) for a range of clinical disorders with unmet need. 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 5, 160 Queen Street  T +61 3 9660 4900             www.clinuvel.com Melbourne, Victoria 3000F +61 3 9660 4999 Australia SCENESSE® Risk Management Plan infrastructure nearing finalisationEPP expert centre training commences this week

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 2015-06-05

Singaporean subsidiary VALLAURIX completes preliminary evaluation of VLRX001 SUMMARY Clinuvel expands pipeline with VLRX001 targeting skin disorders First therapeutic target: vitiligo (depigmentation disorder) as maintenance therapy following SCENESSE® (afamelanotide 16mg) Innovation is the result of collaboration between Clinuvel and the international research community Proprietary technology of VALLAURIX PTE LTD, a majority-owned Clinuvel subsidiary Recent clinical research has demonstrated a renaissance in the demand for novel melanocortin molecules Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA: UR9; ADR: CLVLY) today announced that its Singaporean subsidiary VALLAURIX PTE LTD has successfully completed initial in-vitro development of VLRX001, an innovative melanocortin analogue. VLRX001 is an addition to Clinuvel’s product pipeline alongside CUV9900 and SCENESSE® (afamelanotide 16mg), which was recently granted marketing authorisation by the European Commission for the rare disease erythropoietic protoporphyria (EPP). CLINICAL USEFormulation work will focus on the development of VLRX001 for topical self-administration by patients. The transdermal product will initially be evaluated as adjuvant maintenance therapy in the depigmentation disorder vitiligo. SCENESSE® is currently being evaluated as a subcutaneous medicinal product for repigmentation in vitiligo patients. Clinuvel published its first vitiligo results in 2012/13. RATIONALE FOR INNOVATIONThe VLRX001 development work was undertaken through Clinuvel’s majority owned Singaporean subsidiary, VALLAURIX and has leveraged the knowledge gained from long term experience with the clinical use of SCENESSE®. It has long been acknowledged that melanocortins have a ubiquitous application in medicine. A renaissance in the demand for novel melanocortin molecules has been seen in clinical research, with more than 400 peer reviewed publications on the use of melanocortins over the past 24 months. KNOWHOW AND INTELLECTUAL PROPERTYLong term collaboration between Clinuvel’s scientific teams and research groups at prestigious institutes and universities led to the innovation of VLRX001. VALLAURIX was able to harness the knowhow in melanocortins from IP and data generated in pharmacology studies and clinical use of SCENESSE® by Clinuvel’s global teams. Overall, the development of VLRX001 is part of Clinuvel’s life cycle management of its portfolio of products to ensure long term use and value of its technology and assets. Patent applications on VLRX001 have been filed in the commercially relevant jurisdictions. Clinuvel will hold all rights to the final product and indications through VALLAURIX. Formulation work will commence this year. VLRX001 is the second novel molecule to be evaluated by VALLAURIX. The first, CUV9900, has been developed as the first reference standard for evaluating pharmacological properties such as binding affinity, potency and cellular signalling. NOVEL PHARMACOLOGYVLRX001 is an addition to the family of melanocortin analogues which provoke increased and prolonged cellular activity. It contains a specific peptide sequence, designed to make it less susceptible to degradation than physiologic (natural) alpha-melanocyte stimulating hormone (α-MSH). COMMENTARY“Many biotech and pharmaceutical companies commence the development of novel products but the complexity of human biological response and regulatory pathway see many of these fail along the road,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “It is a privilege to be part of a team which has delivered success through SCENESSE®. “With VLRX001 we now have a logical follow-on product which we hope will act synergistically and be complementary to SCENESSE® in the treatment of vitiligo, a disease which is notoriously difficult to treat and deserves a range of therapeutic approaches,” Dr Wright said. “Over the past year the management of Clinuvel have successfully transformed the Company from being an R&D house with a prospective regulatory outcome, to one with a commercial product lending its validation to second generation technology with wide applications,” Clinuvel’s Chairman, Mr Stan McLiesh said. “It has been Clinuvel’s key objective to retain the proprietary rights to the new technology. “Our scientific and commercial progress stems from many years of interaction and dialogue with physicians and patients, and our teams have consistently taken a staunch approach to the opinions of global experts. I am certain that the corollary of Clinuvel’s work will result not only in clinical worth but in sustained shareholder value even in Australia, a market still lacking full appreciation of its biotech companies,” Mr McLiesh said. CLINUVEL'S PIPELINE [See PDF announcement] REFERENCES Bohm M et al (2006). Melanocortin Receptor Ligands: New Horizons for Skin Biology and Clinical Dermatology. J Inv Dermatol. 126:1966-1975. Graham A, Westerhof W & Thody AJ (1999). The Expression of α-MSH by Melanocytes is Reduced in Vitiligo. Annals NY Acad Sci. 885:470-473. Lim, HW et al (2015). Afamelanotide and Narrowband UV-B Phototherapy for the Treatment of Vitiligo. JAMA Dermatol. 151(1): 42-50. E-Pub Sept 17, 2014. Luger TA & Bohm M (2015). An α-MSH Analog in Erythropoietic Protoporphyria. J Inv Dermatol. 135:929-931. ` Luger TA & Brzoska T (2007). Alpha-MSH related peptides: a new class of anti-inflammatory and immunomodulating drugs. Ann Rheum Dis. 66 (Suppl 3):iii52-55. Biolcati G et al (2014). Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. Br J Dermatol. E-Pub Dec 13. - End - Media enquiries Lachlan Hay, Clinuvel (UK) Ltd. +44 1372 860 765    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. Investor enquiries   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 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 approved by the European Commission for treating adults with EPP. Headquartered 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 drug SCENESSE® (afamelanotide 16mg) for a range of clinical disorders with unmet need. 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 5, 160 Queen Street  T +61 3 9660 4900             www.clinuvel.com Melbourne, Victoria 3000F +61 3 9660 4999 Australia

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 2015-05-05

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

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Clinuvel Latest News

EPP, SCENESSE® featured on NBC's Dateline

On Sunday June 14, 2015, NBC's Dateline program featured a full episode on children living with rare disorders who are most acutely affected by exposure to UV and light (particularly sunlight) as well as the use of SCENESSE® (afamelanotide 16mg) in adults with EPP. US users can access the full program via the NBC website (this content is geoblocked). Excerpts are avai...

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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