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

A copy of Dr Wolgen's presentation from the 2014 AGM can be downloaded via this link.

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 2014-11-28

3 November 2014* Dear Shareholders, The EMA’s approval of SCENESSE® (afamelanotide 16mg) on 23 October was an historic event for all stakeholders, most of all for the EPP patients who have been awaiting the therapy. The reactions from physicians and patients the past week have been overwhelming and emotive. Both groups expressed a sense of reprieve and state of euphoria; the long journey has had an impact on all. I am delighted that our teams have persisted and been able to make SCENESSE® available to all European EPP patients. I also readily admit that the conduct of the orchestra at times had been harder than ever anticipated, given the new domain of our technology. I often think about the people and families who all supported and remained in the five trials and who have been instrumental to the successful development.   We have witnessed that the positive effects of the EMA’s approval have caused immediate ripples. Research groups have congratulated us as Clinuvel’s regulatory achievement has now given additional credence to their own independent research on melanocortins. Some divisions have been working for three decades on MC-receptor binding, some on topics related to MITF expression and transcription factors to better understand the signaling and biology of the melanocyte, the primary target cell of SCENESSE®. In seeing a first in class product commercially approved, these scientific communities are indirectly receiving acknowledgement for the family of melanocortins currently being researched. We forecast that the numerous interactions between Clinuvel and the EMA would lead to a convergence of knowledge for both actors. It eventually led to a novel approach in the context of drug development. Owing to the combination of the specific characteristics of erythropoietic protoporphyria (EPP; the tested indication) and impact of our novel drug we had opened a sui generis regulatory review. The communication between our teams and the European agency about rationale, need, relevance, and impact of treatment versus risk led to a lengthy process of information exchange. I laud Dr Wright’s team and all staff who have overcome the many hurdles along the long way. Equally I must congratulate the EMA’s executive management in London for the reform and progressive thinking about European drug development. The patient organisations in Europe and the US, and the porphyria specialists, deserve an ovation for their involvement. In transitioning from a research to a commercial entity, clinical considerations and commercial value will be balanced. In the recent shareholder conference call I alluded to the fact that we are drastically restructuring Clinuvel to meet our growth requirements. One of our activities at present is to attract new skilled talent needed for the next chapter. Expectations from all stakeholders are high, and our Board of Directors remains aware that we will always be balancing and trying to serve disparate interests. At the Annual General Meeting on 28 November we will briefly review the European regulatory process and then look forward to the FDA’s filing and expectations. We will also discuss the commercial roll out of SCENESSE® in Europe and the commercialisation processes being built for success. Now that Clinuvel has been able to meet the tallest of all challenges and has laid the foundation, our next and immediate focus is on realising enterprise value mid- and long-term. After a decade of equity investments flowing from the selected institutional and professional investors the Board’s and management’s next task is to adjust its business plan. Years ahead of the EMA vote the Clinuvel Board and external advisors prepared for the two possible regulatory outcomes. With last week’s outstanding result we now look at what is best for the Company, shareholders and, mostly, patients. The Clinuvel Board wishes thank, on behalf of all patients, the financial sponsors who have provided direct financial support and shared the long term vision for SCENESSE® (listed in alphabetical order): The Agersborg family, Mr Alter, Mr Ashok, Mr Calvert-Jones, Cayros Capital, Diamond Network, Chartport, Cycladic Capital, the Ender Group, the European Investment Fund, Fidelity Investments, the Freedman Foundation, Mr James, the Jonen family, Mr Mitchell, Mr Najib, Mr Naphtali, the Otter family, the Riefler family, Mr Stanley, Mr Watkinson, the Wennmann family office, Mr Wilkie, the Wood family, and all those we have not yet been able to reach, wished to remain anonymous, or who we inadvertently may not have listed. Yours respectfully, Philippe Wolgen Managing DirectorClinuvel Pharmaceuticals Ltd *This letter has replaced an earlier version which included an unintentional error.

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 2014-11-02

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

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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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