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How do I contact CLINUVEL?

Head to our Contact us page for full contact details.

Where can I apply to work for CLINUVEL?

Please see our Join the Team page for information on vacant positions.

What is SCENESSE® (afamelanotide 16mg)?

SCENESSE® (afamelanotide 16mg) is a first-in-class therapeutic developed by CLINUVEL, with the active ingredient (or INN) afamelanotide. Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH) which activates eumelanin of the skin, the dark pigment which is known to provide photoprotection (offering skin protection against light and UV radiation).

What conditions does CLINUVEL aim to treat with SCENESSE® (afamelanotide 16mg)? What are your ‘target indications’?

With its unique expertise in understanding the interaction of light and human skin, CLINUVEL has identified groups of patients with a clinical need for photoprotection and repigmentation. At present the Company is focused on the following indications:

  • Erythropoietic protoporphyria (EPP) – a rare genetic storage disorder that causes severe phototoxicity (anaphylactoid reactions and second degree burns).
  • Vitiligo – a pigmentary disorder.

How is SCENESSE® administered?

SCENESSE® is administered subcutaneously (underneath the skin) as a dissolvable implant approximately the size of a grain of rice. The procedure is only performed by trained healthcare professionals in recognised porphyria centres who will first determine patient eligibility for SCENESSE®, before deciding on implant timings and location of administration. For more information, please see the Summary of Product Characteristics (SmPC) for SCENESSE®.

Who is eligible for SCENESSE® administration?

SCENESSE® (afamelanotide 16mg) is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) in Europe. The innovative nature of the therapy in an orphan disorder, the lack of available scientific instruments to adequately measure the therapy, ethical considerations and the drug’s positive safety profile were some of the factors which led to the European marketing authorisation of SCENESSE®. For full information please see the Summary of Product Characteristics for SCENESSE® or contact your healthcare professional.

Is SCENESSE® (afamelanotide 16mg) suitable for children?

CLINUVEL has not tested SCENESSE® (afamelanotide 16mg) for human use under the age of 18. CLINUVEL intends to begin paediatric studies in the future to determine the safety and efficacy of for individuals under 18.

There are products being sold online that supposedly activate melanin in skin. Are these SCENESSE® (afamelanotide 16mg)?

No. SCENESSE® (afamelanotide 16mg) is often confused with illegal, untested and unregulated chemicals offered online for self-administration.

Products sold online as ‘melanotan’ are unlicensed unregulated chemicals which are wholly unrelated to CLINUVEL’s development program. The sale of ‘melanotan I’ ‘melanotan II’ or ‘jabbatan’ 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.

Peptides are sensitive molecules consisting of particular amino acids which need diligent and pure synthesis. During the decade of development of SCENESSE® various proprietary manufacturing processes have led to the current optimised product.

Is SCENESSE® (afamelanotide 16mg) available for prescription?

SCENESSE® (afamelanotide 16mg) has been approved for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) by the European Medicines Agency. The product is being made available only by prescription through expert centres for the treatment of EPP who have been trained and accredited by the company. CLINUVEL is working to make the drug available to all eligible EPP patients across Europe. At this time, it is not possible to provide access to the drug to patients with other disorders or outside of Europe and CLINUVEL recommends contacting your treating dermatologist for assistance.

SCENESSE® is currently being tested for its safety and efficacy in clinical trials for vitiligo, with a Phase II study underway in Singapore. The drug is not available for purchase for vitiligo anywhere in the world.

How many EPP patients are currently being treated by SCENESSE® (afamelanotide 16mg)

At present, over 150 EPP patients are been treated with SCENESSE®. CLINUVEL is working to make the drug available to all eligible EPP patients across Europe. To date more than 350 EPP patients have received SCENESSE®.

I’ve seen some photographs from your vitiligo clinical studies. What are these?

Two presentations have been given on clinical observations from CLINUVEL’s Phase II US vitiligo study, CUV102. These presentations can be accessed through http://www.clinuvel.com/en/vitiligo.
Results from this study were released in 2012, with follow-up results released in 2013. Data were published in the peer-reviewed journal JAMA Dermatology in 2014.

Clinical trials are ongoing to determine the safety and efficacy of SCENESSE® in vitiligo.

Will CLINUVEL run further trials in vitiligo? When will SCENESSE® be approved for use in vitiligo?

Clinical trials evaluating SCENESSE® as an adjunct therapy to narrowband UVB (NB-UVB) in generalised vitiligo were announced in 2010. The first of these trials was completed in late 2012, with results available on our website. We also published an in-depth Q&A on these trial results on our blog. A further, Phase II, study commenced in Singapore in 2014.

At present there are no timelines available for the drug’s commercial availability for vitiligo in any country; we must first conduct clinical trials to determine if the drug is safe and effective. Further trials are planned, but we are yet to announce the exact timing or location of these studies. This process takes time and we appreciate your patience 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.

What were the results from your first vitiligo studies?

Clinical trials evaluating SCENESSE® as an adjunct therapy to narrowband UVB (NB-UVB) in generalised vitiligo were announced in 2010. The first of these trials was completed in late 2012.

The initial study results evaluating SCENESSE® in certain vitiligo patients, have been encouraging. A summary of the results are available on our website, and the full study has been published in JAMA Dermatology. Further studies are underway and planned to determine the safety and efficacy of SCENESSE® for vitiligo.

Are you planning trials in other indications?

CLINUVEL is aware of the theoretical potential of its drug to treat additional indications.

Running clinical trials in multiple patient populations is an expensive and complex process, fraught with potential risk. CLINUVEL is currently focused on clinical indications with the highest unmet need, EPP and Vitiligo. Any updates to our clinical development will be announced to the ASX and emailed to our subscriber database.

What is photoprotection and how does SCENESSE® (afamelanotide 16mg) propose to 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. SCENESSE® (afamelanotide 16mg) provides a biological barrier of melanin between UV light and skin, which reflects and refracts damaging light rays.

Learn more about biomimicry and SCENESSE® (afamelanotide 16mg).

What is ‘regulatory and ethics approval’? How long does this process take?

Whenever a company or physician (a ‘sponsor”™) wishes to assess a drug in a clinical trial, it must seek approval from the governmental departments or agencies which regulate or control new drugs in a given country or jurisdiction, such as the FDA in the US or the TGA in Australia. This process varies from country to country, but generally requires the sponsor to present a clinical study protocol, which outlines the specifics of the study, and provide scientific rational for their planned trial. These documents must show that the necessary regulatory guidelines related to clinical trials are being followed in the trial protocol.

The relevant regulatory agency will review the study protocol and scientific rationale and determine whether the study should proceed. The protocol is also reviewed to ensure it meets Good Clinical Practice or GCP standard. This complete process often requires some negotiation between the sponsor, the physicians involved in the trial, and the regulator, to reach a satisfactory conclusion. Generally this process takes 1-3 months.

During or shortly after the regulatory approval process for the study protocol, the Ethics Committees at individual study sites will reviews the protocol to ensure it meets the ethical standards of the particular institute or hospital conducting the study.

What is vitiligo?

Vitiligo is a skin disorder in which the pigment producing cells of the skin (melanocytes) are absent or demonstrate lack of activity. As a result, lighter depigmented patches of skin (target lesions) appear in different parts of the body due the lack of melanin (pigment). The exact cause of vitiligo is unknown, but it is generally recognised that an autoimmune component plays a role in this disease.