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) is pleased to announce the appointment of Mr Willem Blijdorp as a Non-Executive Director of the Company. Mr Blijdorp’s appointment comes as Clinuvel prepares the commercial distribution of SCENESSE® for the rare disease erythropoietic protoporphyria (EPP) throughout the European Union. Mr Blijdorp is the founding member, majority shareholder and a current supervisory Director of B&S International NV, a privately owned Dutch group focused on the wholesale and international trading of luxury and fast moving consumer goods and pharmaceutical products. He managed B&S International for 27 years as CEO and remains actively involved in the company’s expansion strategy, helping it to become one of the largest trading houses globally with a compounded annual growth rate of 10% for the past decade. Being recognised for his expertise in merger and acquisitions and leadership, in 2014 Mr Blijdorp was awarded the Ernst & Young Entrepreneur of the Year in the Netherlands. "I’m delighted to welcome Willem Blijdorp to Clinuvel as a Non-Executive Director," Clinuvel’s Chair, Mr Stan McLiesh said. "Clinuvel is transforming from an R&D to a commercial entity, and the Company needed to add relevant expertise to its Board. Willem is a long-standing supporter of Clinuvel and brings a wealth of commercial skills to the Board which will prove invaluable as we advance the commercialisation of SCENESSE® and follow-on products." - End - Media contact: Lachlan Hay, Clinuvel Pharmaceuticals Ltd Lachlan.Hay@Clinuvel.comAbout 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.comMelbourne, Victoria 3000    F +61 3 9660 4999Australia

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 2015-01-20

Commercial distribution in preparation for European EPP patients Clinuvel Pharmaceuticals Ltd (ASX:CUV; XETRA-DAX: UR9; ADR: CLVLY) announced today that the European Commission has ratified the recommendation of the European Medicines Agency (EMA), granting marketing approval under exceptional circumstances to Clinuvel’s breakthrough drug SCENESSE® (afamelanotide 16mg). Clinuvel is now allowed to market SCENESSE® for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) across the 31 EMA counties1. EPP is defined as the most severe clinical form of light and sunlight intolerance, often described as anaphylaxis to indoor and outdoor light sources. EPP patients are characterised by a lifelong fear of light, leading to a reclusive existence starved of daylight. “Our objective has long been to provide EPP patients who are chronically deprived of light with a meaningful therapy to enable them to lead a normal existence free of impediment or psychological encumbrance,” Clinuvel’s CEO, Dr Philippe Wolgen said.  “Now the Clinuvel teams will focus on accelerating distribution of SCENESSE® while continuing to reach agreements with individual and collective insurers to provide national coding for a completely new pharmaceutical treatment.” “We are the first drug developer in a novel field of medicine providing these patients the ability to lead a disease-free and normal existence, without fear of severe burns and scarring, in accordance with the EU’s Charter of Fundamental Rights,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “The persistent strong demand from European and US EPP patients indicates that SCENESSE® is, for the first time, providing patients an opportunity to fully participate in society and lead a life without handicap.” Clinuvel will first focus on rolling out SCENESSE® in the eight countries across Europe where EPP clinical trials were conducted, with other countries to follow thereafter. Discussions are underway with government bodies and reimbursement authorities to enable patient access through expert national reference centres for porphyrias. “Since the landmark opinion from the EMA two months ago the Company has been preparing for commercialisation in key markets in Europe,” Dr Wolgen said. “EPP patients are particularly light deprived and are at risk of burns during the spring and summer months. Clinuvel aims to facilitate access to the drug to as many of the known EPP patients as possible in 2015, and much will depend on the administrative duties with Competent Authorities and payors in each European country.” “I take the opportunity to publicly commend the two EMA rapporteurs and their teams for seeing through a challenging dossier and for their support in bringing pharmaceutical innovations to the European markets. On occasions our teams have challenged the EMA but we need to acknowledge the vision and their leadership when it comes to supporting novel developments in medicine,” Dr Wolgen said. As part of the exceptional circumstances approval, Clinuvel is establishing a post-marketing program to monitor ongoing patient safety and efficacy, including the establishment of patient and disease registries. A Phase IV pharmacokinetic study in 12 EPP patients (CUV052) will also be conducted according to the Pharmacovigilance Plan developed by Clinuvel and the EMA. In line with article 14(8) of Regulation (EC) No 726/2004, Clinuvel will submit a Periodic Safety Update Report to the EMA to comply with the Company’s obligations as part of the marketing authorisation under exceptional circumstances. - End - 1 28 European Union member states plus Iceland, Liechtenstein and Norway. Media contact: Lachlan Hay, Clinuvel Pharmaceuticals Ltd +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 (vitiligo) of the skin. 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 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.

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 2014-12-22

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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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