A corporate fact sheet on Clinuvel can be downloaded here (pdf format).
Investing in Clinuvel
How do I invest in Clinuvel in Australia?
How do I invest in Clinuvel in the USA or Europe?
How can I subscribe to Clinuvel's email updates?
Why is afamelanotide not currently available on the market?
When will afamelanotide be available on the market?
What is ‘photoprotection’ and how does afamelanotide provide ‘photoprotection’?
What conditions does afamelanotide aim to treat? What are your ‘clinical indications’?
Why don’t you use CUV1647 for your drug name anymore?
Could afamelanotide be used to treat Vitiligo or Rosacea? What about other pigment or UV-related disorders?
How is afamelanotide administered?
Is afamelanotide suitable for children suffering from the clinical indications?
Is afamelanotide safe to use?
Will afamelanotide give me a tan?
How can I register to take part in trials in Europe or Australia?
When will trials of afamelanotide begin in the USA?
How can I register to take part in trials in the USA?
When will Clinuvel open its US office?
I want to volunteer for a trial, but don’t currently suffer from one of the clinical indications, can I still participate?
Are you planning trials in other indications?
Counterfeit Products
There are products being sold online that supposedly activate melanin, are these afamelanotide?
Investing in Clinuvel
How do I invest in Clinuvel in Australia?
Clinuvel Pharmaceuticals Limited is listed on the Australian Securities Exchange (ASX) under the symbol CUV, Clinuvel does not issue stocks directly to investors. Please contact a financial advisor for more investing information.
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How do I invest in Clinuvel in the USA or Europe?
Clinuvel stock is available in the USA through ADRs listed with the Bank of New York Mellon with the symbol CLVLY. Clinuvel stock is available in Europe through the Xetra listing UR9. Clinuvel does not issue stocks directly to investors. Please contact a financial advisor for more investing information.
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How can I subscribe to Clinuvel's email updates?
Clinuvel maintains regular contact with our stakeholders via our email updates. These include ASX announcements, analyst reports and general news. Click here to subscribe.
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Afamelanotide
Why is afamelanotide not currently available on the market?
Afamelanotide is a photoprotective drug in a development phase and not currently available on the market. It is currently being tested for its safety and efficacy in clinical trials.
In ethical pharmaceutical drug development a rigorous clinical program needs to be followed to comply with the requirements of regulators worldwide. Drug development therefore is not a speedy process. It takes time.
Ensuring the safety and efficacy of afamelanotide is paramount to the program and Clinuvel is following an intensive clinical trial process in advance of pursuing regulatory approval and commercialisation to make this process as fast as possible.
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When will afamelanotide be available on the market?
Pharmaceutical products are legitimately required to be developed according to international regulatory standards and guidelines, whereby evaluation of safety in human use - short and long term - is the most critical parameter for drug approval. Certainly when it comes to novel drugs the regulatory rigor is stronger than in proven molecules and therapies. While Clinuvel maximises its chances to obtain regulatory approval, the company and its stakeholders need to abide by the regulatory timelines and review processes. Patience is a virtue in this process, and no pressure can accelerate this regulatory process.
At present Clinuvel is on track to file for registration for its photoprotective, afamelanotide, in Europe, Australia or Switzerland some time in 2010. Clinuvel is working hard to meet this target, however pharmaceutical development is not a linear process. Ensuring the safety and efficacy of the drug is Clinuvel’s primary concern and until these two endpoints are met, afamelanotide will continue to be trialed by Clinuvel.
At present it is not possible to speculate on a market date in the USA. By following Clinuvel’s clinical progress through the corporate website and the online mailing list, you will be kept abreast of any updates on this timeline.
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What is ‘photoprotection’ and how does afamelanotide provide ‘photoprotection’?
Put simply, photoprotection is protection from the damage caused by UV and visible light. Clinuvel’s work aims to provide photoprotection to patients who are most prone to UV and light related disorders of the skin. Afamelanotide provides a biological barrier of melanin between UV light and skin, which reflects and refracts damaging light rays. Click here for more information.
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What conditions does afamelanotide aim to treat? What are your ‘clinical indications’?
Clinuvel’s pioneering work aims to provide photoprotection, that is to assist those who suffer from three UV related skin disorders and two cancer related treatments. The five clinical indications that Clinuvel is currently testing afamelanotide for are:
- Erythropoietic Protoporphyria (EPP) - absolute sun intolerance, intolerable pain suffered when exposed to light by between one in 200,000 and one in 750,000 people. Afamelanotide is currently in Phase III trials in Australia, Switzerland and Europe for EPP.
- Phototoxicity associated with Photodynamic Therapy (PDT) for cancer – a debilitating photosensitivity to sunlight and artificial light (skin and eyes) that can last up to 90 days after PDT treatment.
- Polymorphous Light Eruption (PLE/PMLE) – likened to sun poisoning. Suffered by 10 -20% of Population. Afamelanotide is currently in Phase III trials in Australia and Europe for PLE.
- Actinic Keratosis (AK), a precursor to skin cancers and Squamous Cell Carcinoma (SCC) - non-melanoma skin cancers - in organ transplant patients. Organ transplant patients who are fair skinned are 65 to 100 times more likely to develop skin cancer on prescribed immune-suppressant medication following their transplant, compared to the general population. Afamelanotide is currently in Phase II trials in Australia and Europe for AK/SCC.
- Solar Urticaria (SU) – (acute) anaphylactic reaction to sun. In July 2009, Clinuvel announced results from Phase II trials in Europe for SU. You can view this announcement here.
For more information on each condition, click here.
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Why don’t you use CUV1647 for your drug name anymore?
In late 2008, Clinuvel’s drug in development was assigned an International Non-proprietary Name (INN) by the World Health Organisation (WHO). The INN, also known as the generic name, afamelanotide can now be used universally to describe the active pharmaceutical substance Nle4-D-Phe7 alpha-Melanocyte
Stimulating Hormone.
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Could afamelanotide be used to treat Vitiligo or Rosacea? What about other pigment or UV-related disorders?
Clinuvel is testing afamelanotide for the five clinical indications outlined above. Afamelanotide has not been tested for the indications of Vitiligo or Rosacea, and at present no clinical trials are planned for the foreseeable future. By subscribing to our database, you will receive company updates on any clinical trials. Drugs should only be used for specific disorders, after extensive trialing under clinical conditions, and under the supervision of a qualified healthcare practitioner.
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How is afamelanotide administered?
It is anticipated that afamelanotide will be administered by medical practitioners and delivered as a subcutaneous injection of a bioabsorbable implant that is approximately the size of a grain of rice. This type of underneath the skin administration allows the dosage of the drug to be carefully measured by the medical practitioners who prescribes it. Click here for more information.
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Is afamelanotide suitable for children suffering from the clinical indications?
Clinuvel has not tested afamelanotide for human use under the age of 18. As no clinical trials have been run in children, it is not possible to declare if the drug is suitable for their use. Clinuvel intends to begin pediatric studies in the future to determine if afamelanotide can assist individuals under 18, however no such research currently exists.
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Clinuvel’s focus in clinical trials is ensuring the safety and efficacy of afamelanotide. To date, no serious drug related events have been recorded in published studies using the afamelanotide implant. Clinuvel is continuing to trial the implantable product to prove the safety of its product under clinical conditions and strict supervision by medical experts.
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Will afamelanotide give me a tan?
Afamelanotide is a photoprotective drug, it is not a cosmetic tanning product.
It is a well known phenomenon that the general public ‘falls in love’ with a drug before it reaches approval. However, there is no foundation for the recreational use of afamelanotide as a self-injectable. Clinuvel’s proprietary drug is being administered by physicians for the purpose of medicinal photoprotection of the skin.
Clinuvel believes that afamelanotide has the potential to improve the quality of life of people worldwide who suffer from light related skin disorders and damage caused by UV radiation. We strongly support government and health care providers in their initiative to increase education about the dangers to UV-radiation and recommend that people follow their advice.
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Clinical Trials
How can I register to take part in trials in Europe or Australia?
Selection for clinical trials is not undertaken by Clinuvel but by the physicians at the clinical trial sites. You would need to contact these physicians regarding your suitability.
The clinical trials that Clinuvel is currently conducting for afamelanotide are in specific patient groups and only for those patients suffering from one of the outlined clinical indications. As with all clinical studies there are strict inclusion and exclusion criteria for participating patients and only patients with designated diseases who meet these criteria are eligible for entry. By subscribing to our database, you will receive company updates on any clinical trials and the conditions of participation.
Anonymity is a key requirement for trial participation. By contacting Clinuvel, you may disqualify yourself from possible trial participation.
More information on Clinuvel's confirmatory EPP trials is available on the ClinicalTrials.gov website.
More information on Clinuvel’s AK/SCC trials with organ transplant recipients is available on the ClinicalTrials.gov website.
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When will trials of afamelanotide begin in the US?
Clinuvel commenced a clinical trial program in the US in mid 2009.
Clinuvel will make the results of its first US trial (CUV028) public in Q1 of 2010.
The company has filed in November for permission to start its program in EPP in the US by April 2010 and is currently awaiting FDA approval to replicate its EU program in the US. Clinuvel will work closely with all physicians and specialist in the field of porphyria to organise and conduct successful US trials.
Conducting trials in orphan indications in the US is more demanding than in EU or Australia. Identification of patients willing to participate and organisation of the clinical trial by the company has required much preparation time.
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How can I register to take part in trials in the US?
In January 2009, afamelanotide was allowed IND status by the Food and Drug Administration (FDA) to commence clinical trials in the USA on humans. Clinuvel intends to begin trials in its clinical indications in 2010 and is awaiting regulatory approval to continue its program. Enrolment in these trials will be open only to those patients suffering from one of the clinical disorders Clinuvel is testing.
Clinuvel does not recruit patients directly. Anonymity is a key requirement for trial participation. By contacting Clinuvel, you may disqualify yourself from possible trial participation.
Patients suffering from one of the indications are advised to discuss trial candidacy with their dermatologist or physician who can contact a relevant trial site. Once trials have been confirmed, trial site information will become available.
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When will Clinuvel open its US office?
Clinuvel is awaiting approval of the expansion of its US clinical program for EPP to mirror that of the EU and Australia. Resources towards a US team will only be made available when the FDA approval is granted; thus far a minimal team is retained.
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I want to volunteer for a trial, but don’t currently suffer from one of the clinical indications, can I still participate?
At present Clinuvel is only looking for trial volunteers in the clinical indications listed on the site. Although we have conducted ‘healthy’ trials from time to time to test the efficacy or safety of afamelanotide, we are no longer seeking volunteers for such trials.
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Are you planning trials in other indications?
Clinuvel is aware of the theoretical potential of its drug to treat additional indications. At present, the company’s focus is on the five indications outlined on this website. Running clinical trials in multiple patient populations is an expensive and complex process, fraught with potential risk. To provide the best possible path to market for afamelanotide, Clinuvel has identified five indications and will focus on these at the present time. Any updates to our clinical development will be announced to the ASX and emailed to our subscriber database.
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Counterfeit products
There are products being sold online that supposedly activate melanin, are these afamelanotide?
No. Afamelanotide is often confused with illegal, untested and unregulated chemicals offered online for self-administration.
The confusion lies in that vendors present injectable tanning products as afamelanotide. In reality both the molecule and formulation of afamelanotide have been optimised and altered and is not related to counterfeit products offered nowadays as Melanotan I and II.
Peptides are sensitive molecules consisting of particular amino acids which need diligent and pure synthesis. During the decade of development of afamelanotide various proprietary manufacturing processes have led to the current optimised product.
Clinuvel’s formulation titrates the available quantities of afamelanotide in the human body whereby maximum and minimum dosing has been carefully evaluated over the years. At picomol quantities, afamelanotide is targeting specific skin cells to activate the process of biochemical photoprotection. Afamelanotide has no effect on other organs or the brain. Afamelanotide does not cause increased weight loss or libido.
It is a well known phenomenon that the general public ‘falls in love’ with a drug before it reaches approval. However, there is no foundation for the recreational use of afamelanotide as a self-injectable. Clinuvel’s proprietary drug is being administered by physicians for the purpose of medicinal photoprotection of the skin.
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