CLINUVEL PHARMACEUTICALS LIMITED (ASX: CUV; ADR LEVEL 1: CLVLY; Börse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives.
CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP).
CLINUVEL’s mission is supported by a clear vision, with principal values and strategic plans to support the advance of the business towards a diversified and sustainable pharmaceutical group. Since the commencement of commercial distribution of SCENESSE® (afamelanotide 16mg), in Europe from June 2016 and in the USA from April 2020, CLINUVEL has generated annual revenues growth to record seven years of consecutive annual profit. The balance sheet is strong with no bank debt and sufficient accumulated cash reserves to finance its expansion. From this position of strength, CLINUVEL is expanding the product range and clinical program to develop treatments for a range of conditions of the skin and brain with unmet needs.
Like any business, CLINUVEL faces a range of risks to the achievement of its objectives, but it has a track record of successfully innovating a first-in-class treatment therapy for adult patients who experience an acute phototoxic reaction to light. CLINUVEL is translating its technology to the non-pharmaceutical sector through a range of PhotoCosmetic products to provide healthcare solutions to targeted audiences of the general population.
CLINUVEL has an experienced Board of Directors and management team with dedicated and committed staff to effectively implement its plans in the ensuing years.
CLINUVEL’s American Depositary Receipt (ADR) listing (CLVLY) is sponsored by the Bank of New York Mellon. BNY-Mellon provides comprehensive information on their website covering ADRs and how they work for investors, which may be of interest. The stock CLVLF is not a company-sponsored Depositary Receipt (DR), rather it is a broker sponsored DR. Therefore, it is the individual broker’s responsibility to ensure the DR is backed by a purchase of the ASX listed CUV share in Australia. We encourage you to contact your broker for more information on investing.
CLINUVEL maintains its Australian Securities Exchange (ASX) shareholder registry with Computershare. ASX Shareholders can access the Company’s share registry with Computershare online and view their Security Holdings (Account Details, Balances, Communication Details) and Shareholding Records. For all enquiries related to your ASX shareholding with CLINUVEL, contact:
Within the USA, CLINUVEL shares can be purchased through the Bank of NY Mellon’s Level 1 American Depositary Receipt (ADR) program under the ticker code CLVLY. For more information on ADRs, log onto the Bank of NY Mellon’s ADR investors website here.
If an ADR holder wishes to vote on resolutions of meetings of the Company, it is recommended they either cancel their ADRs and acquire CUV or transfer their ADRs to CUV and hold the underlying security as an ordinary share. ADR holders should seek advice on this action from their broker and/or financial advisor.
Alternatively, an ADR holder would need to discuss their intention to vote with their broker which would need to be facilitated on a best endeavours basis through the Bank of New York Mellon, noting this may be on a fee for service basis.
As a Level 1 sponsored ADR program, and consistent with market practice of other ASX-listed companies with similar Level 1 sponsored ADR programs, the Company does not disseminate proxy notices to ADR holders. The Company remains at arms-length to the capacity of Bank of New York Mellon to process individual proxy forms from ADR holders.
All releases of information to the Australian Securities Exchange covering company news and financial results can be found on the CLINUVEL website. CLINUVEL also sends regular Email Updates on its progress, as well as published announcements and analyst reports.
SCENESSE® (afamelanotide 16mg) is authorised in the European Union and United Kingdom (UK) as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain-free light exposure in adult EPP patients with a history of phototoxicity. The product is only available by prescription from trained and accredited EPP Expert Centres in Europe, the UK, Switzerland and Israel, and Specialty Centers in the USA and Canada.
If you wish to access SCENESSE®, please speak to your healthcare professional.
SCENESSE® (afamelanotide 16mg) is contract manufactured in the USA to CLINUVEL’s specifications, with a secondary manufacturing partner in Europe to finalise the product for release within the European Union.
CLINUVEL is on a path to expand and diversify the business.
CLINUVEL plans to grow its commercial operations globally. This encompasses growth in existing countries of distribution and work to gain market access to distribute SCENESSE® (afamelanotide 16mg) in new jurisdictions where there are patients living with EPP.
CLINUVEL is expanding its product and clinical development program. The Company is committed to continue to develop new melanocortin product formulations and to conduct clinical studies in a wide range of indications, including variegate porphyria, vitiligo, xeroderma pigmentosum, and arterial ischaemic stroke.
The product and clinical program can be reviewed here. Strategic Updates I – VI can also be reviewed on this website. Annual Report 2023, available on this website, provides a comprehensive overview of the Company’s activities in FY2023 and plans into 2024 and beyond.
The execution of these plans will transform CLINUVEL into a diversified, sustainable pharmaceutical group, based on the provision of multiple products to treat multiple patient groups and geographies.
CLINUVEL’s Research, Development & Innovation (RD&I) Centre is located in Singapore and is operated by the fully owned subsidiary VALLAURIX PTE LTD. A bespoke, expanded RD&I Centre was opened in August 2020 and has development and analytical laboratories. CLINUVEL also partners with expert clinical and academic centres on clinical studies worldwide.
SCENESSE® (afamelanotide 16mg) is CLINUVEL’s proprietary first-in-class photoprotective drug. It is authorised in the European Union, United States and Australia for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
SCENESSE® (afamelanotide 16mg) is also being assessed as a potential treatment for a range of other indications including variegate porphyria, vitiligo, xeroderma pigmentosum and arterial ischaemic stroke. Information on these indications can be found here. Other indications are planned in the future.
SCENESSE® (afamelanotide 16mg) has been approved in the European Union for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is also approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. More information on the use of the drug in EPP can be found here. The drug is only available by prescription from trained and accredited Expert Centres.
CLINUVEL’s stated goal is to register SCENESSE® (afamelanotide 16mg) for those patients most severely affected by UV and light and those living with vitiligo. SCENESSE® (afamelanotide 16mg) is authorised in the European Union for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. These approvals were granted after years of research and development and extensive application and review processes with the European Medicines Agency and the US Food and Drug Administration. CLINUVEL has plans to obtain approval from appropriate authorities to distribute SCENESSE® in other regions and countries of the world.
In contrast, products sold online and elsewhere as ‘melanotan’ are unlicensed unregulated chemicals which are wholly unrelated to CLINUVEL’s development program. The sale of ‘melanotan’ for human use is illegal in most countries. Due to the unlicensed nature of the ‘melanotan’ products, they may pose a serious threat to human health and under no circumstances does CLINUVEL recommend their purchase or use.
At present SCENESSE® (afamelanotide 16mg) is not authorised for the treatment of vitiligo. Clinical trials evaluating SCENESSE® in vitiligo were announced in 2010, with the first of these trials completed in late 2012 and results are available on our website. Follow up results were subsequently announced in September 2013. A subsequent Phase II study, conducted in Singapore, commenced in May 2014, with preliminary results released in December 2015. Full results from the Singaporean Phase II vitiligo study were released in December 2018. Results of these studies can be accessed on our website.
A clinical trial further evaluating SCENESSE® as an adjunct therapy to narrowband UVB (NB-UVB) in generalised vitiligo is underway, with a focus on darker skinned patients (with Fitzpatrick skin types IV to VI).
Details of our vitiligo program can be found in the vitiligo section of our website. Further updates will be provided as the program advances.
A clinical development program to confirm the ability of SCENESSE® to protect skin from photodamage and repair DNA damaged by ultraviolet and high energy visible light. More information can be found here.
In October 2020, CLINUVEL announced world first pilot Phase IIa study (CUV801) to evaluate SCENESSE® (afamelanotide 16mg) in patients suffering from arterial ischaemic stroke (AIS). The focus was on patients who were ineligible to receive standard therapy (IVT/EVT), and in stroke affecting the M2 segment or higher, where there is a great unmet medical need. Results from CUV801 can be accessed here. The second study (CUV803) is underway using the liquid formulation of afamelanotide, PRÉNUMBRA® Instant. More information can be found here.
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