Patient Access

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.

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®.

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.

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.

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.

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.

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