Frequently Asked Questions
About CLINUVEL
About CLINUVEL
CLINUVEL PHARMACEUTICALS LTD is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic, skin, and systemic disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development initially has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide.
The CLINUVEL Group works to translate scientific concepts and breakthroughs into commercial products.
We are determined in our desire to excel scientific research and development, building on our global expertise to deliver lifelong care and novel products for patients and consumers.
The CLINUVEL Group places much emphasis on its People and Environment as central to all of the Group’s working practise. CLINUVEL Group focuses its research and development on genetic metabolic and diseases not yet addressed, aiming to deliver innovative medical solutions for complex problems.
Innovating novel solutions for unmet patient and healthcare needs.
- People & Environment – being aware of the environment we work in and the people we work with and help
- Technology – striving to create and develop technologically advanced products to add value beyond existing offerings
- Approach – being innovative, optimistic and focussed
- Respect & Appreciation – being sincere, respectful, responsible and appreciative of people
- Knowledge Building & Sharing – sharing our expertise and continuously growing our knowhow for scientific breakthroughs.
CLINUVEL is headquartered in Melbourne, Australia with operations in Europe, the USA and Singapore.
CLINUVEL’s Board of Directors comprises:
- Mr. Willem Blijdorp (Non-Executive Chair);
- Dr. Philippe Wolgen (Chief Executive Officer);
- Mrs. Brenda Shanahan (Non-Executive);
- Dr. Karen Agersborg (Non-Executive);
- Mrs. Susan Smith (Non-Executive); and
- Prof. Jeffrey Rosenfeld (Non-Executive).
For more information on our Directors, please read the People page of CLINUVEL’s website or CLINUVEL’s Annual Report, also accessible on this website.
Information about the Company’s corporate governance (including links to the Company’s corporate governance policies and charters) can be found on the Corporate Governance section of CLINUVEL’s website. Click here to view the 2021 Corporate Governance Statement.
CLINUVEL’s prudent and thorough approach to risk management and environmental, social and governance criteria is explained here.
Investing in CLINUVEL
CLINUVEL’s mission is supported by a clear vision, with principal values and strategic plans to support and progress the business. Performance in the commercial phase of the business is positive with a well-developed pipeline to develop existing and new products to treat people with severe genetic, skin and systemic disorders. 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 and is proud of its successful distribution of SCENESSE® (afamelanotide 16mg) in Europe and the USA. 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 primary listing is on the Australian Securities Exchange (ASX) under the ticker code CUV. A secondary listing is through the XETRA-DAX (Frankfurt) under the ticker code UR9. The stock can also be purchased in the USA through a sponsored Level 1 American Depository Receipt (ADR) with the symbol CLVLY. CLVLY is issued at a ratio of 1 ADR: 1 Ordinary Share of CUV. The ADR is part of the Nasdaq International Designation and the Bank of New York Mellon provides depositary services. ADRs are traded on the over-the-counter securities market in the USA.
CLINUVEL does not issue stock directly to investors. Please contact a financial advisor for more information on investing.
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 Depository 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.
If an ADR holder wishes to vote on resolutions of meetings of the Company, it is recommended they cancel their ADRs and hold the underlying security as an ordinary share. To cancel ADRs and have the security issued as an ordinary share, ADR holders should seek advice 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 endeavors 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.
If an ADR holder wishes to vote on resolutions of meetings of the Company, it is recommended they cancel their ADRs and hold the underlying security as an ordinary share. To cancel ADRs and have the security issue as an ordinary share, ADR holders should seek advice 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 endeavors 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.
CLINUVEL’s financial year end is 30 June.
CLINUVEL’s independent auditor is Grant Thornton Australia Limited.
Annual Reports can be found on the CLINUVEL website here. Holders of the ASX listed stock may choose to receive a printed copy of the Annual Report by changing their preferences with Computershare.
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.
Historical data for CLINUVEL shares can be found on the Share Price page of CLINUVEL’s website here.
The results can be found on the Announcements page of CLINUVEL’s website here.
CLINUVEL announces its cash flow quarterly, as well as filing annual and half year reports. A calendar of key scheduled releases can be found on the Announcements Calendar page of CLINUVEL’s website here.
CLINUVEL commenced commercial distribution of SCENESSE® (afamelanotide 16mg) in June 2016. CLINUVEL has reported the following net profit after tax (in Australian currency) in recent financial years:
- A$ 7.114 million in 2016/17;
- A$13.224 million in 2017/18; and
- A$18.134 million in 2018/19; and
- A$16.647 million in 2019/20.
CLINUVEL has paid an unfranked dividend in each of the last four financial years. It declared a first unfranked dividend in 2017/18 of A$0.02 per share to acknowledge the long-term support of all investors who enabled the development of CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) since the Company listed on the Australian Securities Exchange in 2001. An unfranked dividend of A$0.025 per share was declared in relation to the each of the 2018/19, 2019/20 and 2020/21 financial years.
Questions on CLINUVEL's Business
SCENESSE® (afamelanotide 16mg) is authorised in the European Union 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 and Specialty Centers in the USA.
SCENESSE® (afamelanotide 16mg) is distributed in the European Union under an approved European risk management plan to accredited erythropoietic protoporphyria (EPP) Expert Centres. In the USA, the product is distributed through trained and accredited Specialty Centers. The product is only available by prescription. For further information, please speak to your doctor.
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 growth and expansion path.
CLINUVEL plans to grow its commercial operations globally. In October 2020, SCENESSE® was approved by the Australian Therapeutic Goods Administration (TGA) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). We also progress with applications for approvals to distribute SCENESSE® (afamelanotide 16mg) in other countries for patients living with EPP.
CLINUVEL is expanding its research and development program. The Company is committed to continue both clinical and non-clinical development for the application of SCENESSE® (afamelanotide 16mg) in different indications such as vitiligo and xeroderma pigmentosum. The latter as the first step in the DNA Repair Program announced in September 2020.
A new indication, arterial ischaemic stroke, was announced in October 2020 and we continue efforts to clinically evaluate the safety and efficacy of SCENESSE® as a treatment for the large number of stoke patients who lack therapeutic alternatives.
A liquid injectable form of afamelanotide, PRÉNUMBRA®, was announced in July 2020 for new indications to be announced. Research and development of topical applications for the prevention and treatment of skin conditions is also underway.
The execution of these plans will transform CLINUVEL into a diversified pharmaceutical company providing treatments to multiple patient groups and geographies.
The Strategic Update of October 2020 provides more information on the Group’s strategy and the research and development pipeline. The pipeline can also be accessed here.
CLINUVEL’s Research, Development & Innovation Centre is located in Singapore and is operated by the fully owned subsidiary VALLARUIX PTE LTD. The new RDI Centre was opened in August 2020 and has biological and analytical laboratories. CLINUVEL also partners with expert clinical and academic centres on clinical studies worldwide.
CLINUVEL has a pipeline of products in clinical and non-clinical development. The novel product SCENESSE® (afamelanotide 16mg) is being evaluated in adult patients with the pigment loss disorder, vitiligo and the rare genetic disorder, variegate porphyria. Development work is underway to arrive at a dose of afamelanotide suitable for paediatric use, intended for first use in erythropoietic protoporphyria (EPP) patients.
SCENESSE® (afamelanotide 16mg) is authorised in the European Union for the prevention of phototoxicity in adult patients with EPP. SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity.
PRÉNUMBRA®, a liquid dosage form of afamelanotide provides dosing flexibility as part of the life-cycle management of afamelanotide to address clinical needs in critical disorders. CLINUVEL is advancing PRÉNUMBRA® as a potent haemodynamic (acting on blood vessels) and anti-oncotic (counteracting fluid formation in tissues) therapeutic agent, initially in adult patients. PRÉNUMBRA® will be evaluated in a number of critical disorders with vascular anomalies and oedema (fluid formation) – where corticosteroids and other anti-inflammatory drugs have not been successful, cause drug dependency or severe side-affects.
The innovative DNA Repair Development Program aims to confirm that intervention with SCENESSE® causes elimination of DNA damage (photoproducts) and regeneration of DNA. SCENESSE® has been proven to protect skin from light (photoprotection) and shown to repair DNA damage and thus, play a role in reducing skin cancer. SCENESSE® will first be used to treat xeroderma pigmentosum (XP), a rare genetic life-threatening and mutating disorder. The clinical stage commenced with the treatment of a patient with XP-C, the most prevalent of eight forms of XP. Following confirmation of the safety of SCENESSE® in this highest risk population, a pilot study and parallel control study in healthy volunteers will be undertaken.
CLINUVEL’s Research, Development & Innovation Centre, VALLAURIX PTE LTD is currently evaluating new molecules, including CUV9900 and VLRX001, for use in various formulations for patients with severe genetic and skin disorders, as well as developing topical products for patient use.
CLINUVEL has a range of patents to protect SCENESSE® with expiry dates ranging from 2026 to 2033.
A clinical development program to confirm the ability of SCENESSE® to protect and repair DNA damaged by ultraviolet and high energy visible light. More information can be found here.
In October 2014, the European Medicines Agency (EMA) approved an exclusive marketing period for SCENESSE® (afamelanotide 16mg) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) in the European Union. This was ratified by the European Commission in December 2014. As an orphan designated product, the period of exclusivity in the European Union is ten years.
The market exclusivity may be extended by a further two years for an orphan-designated condition when the results of specific studies addressing the paediatric population are acceptable and completed in a fully compliant paediatric investigation plan. If there is no extension to the original period, expiry of the exclusivity period in the European Union will be December 2024.
The US Food and Drug Administration (FDA) approved SCENESSE® (afamelanotide 16mg) to increase pain-free light exposure in adult EPP patients with a history of phototoxicity in October 2019. As an orphan drug, the period of exclusivity in the USA is seven years from approval. This period ends October 2026 and can be extended by two years to October 2028 upon acceptance by the FDA of a paediatric treatment for EPP.
Any new, alternative treatment for EPP would be expected to obtain regulatory approval from the EMA to distribute in Europe and the FDA to distribute in the USA, with an obligation to substantiate the efficacy and safety attributes of the treatment. This would need to be based on clinical research and Phase II and III studies.
It is important to note that SCENESSE® is a complex formulation, not easily replicated and is also patent protected for a period beyond the expiry of the exclusive marketing period. CLINUVEL has also built a distribution network of accredited porphyria centres in Europe, where physicians prescribe SCENESSE® as part of their consultative relationship with EPP patients. CLINUVEL has also reached agreements on the reimbursement of the cost of SCENESSE® with insurers in each of the countries in which it distributes SCENESSE®. Any new pharmaceutical business seeking to treat EPP patients would need to do the same.
In October 2020, CLINUVEL announced that it would commence a pilot Phase IIa study (CUV801) to evaluate SCENESSE® (afamelanotide 16mg) in patients suffering from arterial ischaemic stroke (AIS) who are ineligible to receive standard therapy (IVT/EVT), and in stroke affecting the M2 segment or higher, where there is a great unmet medical need. More information can be found here.
Questions on CLINUVEL's Treatments
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® is administered as an injectable controlled release implant by a trained healthcare professional. More information on the use of SCENESSE® in EPP can be found here.
SCENESSE® (afamelanotide 16mg) is also being assessed as a potential treatment for a range of other indications including vitiligo, xeroderma pigmentosum and arterial ischaemic stroke. Information on these indications can be found here. Other indications are planned in the future.
For insight into how SCENESSE® (afamelanotide 16mg) works, please refer to the SCENESSE® section of the website.
CLINUVEL’s drug 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.
For information on the safety profile of SCENESSE® (afamelanotide 16mg), please see this document.
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 further evaluating SCENESSE® as an adjunct therapy to narrowband UVB (NB-UVB) in generalised vitiligo are planned following the approval of SCENESSE® in the USA for patients with erythropoietic protoporphyria.
All details of our vitiligo program can be found in the vitiligo section of our website. Updates are posted to our Facebook. You can also view a brief introductory video explaining our vitiligo program on our YouTube Channel.
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 from these studies can be accessed on our website.
The clinical trial process takes time and we appreciate the patience of persons with vitiligo while the Company progresses its program. If you are interested in participating in clinical research, it is best to speak with your treating dermatologist first – they are best placed to evaluate your suitability for any study. At present there are no open clinical trials and it is not possible to purchase the drug for vitiligo anywhere in the world, nor can we provide any estimate on when these may become available.
In February 2020, CLINUVEL requested a Type C Guidance meeting with the US Food and Drug Administration (FDA) to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data
package necessary to support a supplemental New Drug Application (sNDA) filing for SCENESSE® in vitiligo. The FDA has responded and confirmed a meeting date of 29 April 2020. The meeting was held and CLINUVEL is continuing to liaise with the FDA and working to complete the study design.
Further updates will be provided as the development of SCENESSE® as a treatment for vitiligo progresses.