Operating Review

Distribution of SCENESSE®

The key activities for FY2025, initiatives and plans in the distribution of SCENESSE® for EPP are detailed below:

Activity Review of FY2025 Plans - FY2026 and Beyond
Existing Regions of Distribution:
  • European Union
  • U.S.A.
  • Switzerland
  • Canada
  • Israel
  • Global growth in patient numbers and doses of SCENESSE® administered, now >18,500 implants in EPP.
  • North American Specialty Centers increased to 104 – 100 in the U.S.A. and 4 in Canada – as of 30 June 2025.
  • Over 100 U.S. insurers maintained.
  • Continued to treat patients in Canada under a special access scheme.
  • Submission to Health Canada for marketing authorisation, filed October 2024 and validated December 2024.
  • Until new indications are approved, the distribution of SCENESSE® for EPP is the driver of the revenues and cashflows of the business.
  • The focus is to maintain growth across patients, doses and treatment centres, whilst maintaining relationships with physicians and insurers.
  • Targeting 120 Speciality Centers in North America by the end of 2025.
  • Health Canada decision expected Q4 2025.
Access to New Jurisdictions
  • Colombia – efforts to identify EPP patients for treatment proceeded with partner, Valentech.
  • Argentina – a distribution agreement was signed in January 2025 with Diligens Salud SA.
  • Treatment of first patients in Colombia and Argentina is expected in 2026.
  • Access is planned to other jurisdictions.
Increased Dosage Frequency EU
  • Dosage – discussions progressed with the EMA to increase the recommended maximum number of doses of SCENESSE® per year in the EU. The drug’s European label currently includes a “recommended maximum” of four implants per annum compared to the FDA’s approval to allow treatment every two months, which translates to year-round photoprotection from six doses per annum. Approval of the EMA would harmonise the approved label of SCENESSE® across these jurisdictions.
  • The EMA’s decision on dosage frequency is expected in 2025.
Treatment of Adolescents
  • This initiative was advanced by the completion of study CUV052 which showed adolescents aged 12 to 17 years experienced similar safety and controlled-release profiles as adult EPP patients.
  • The results of CUV052 will be submitted to the EMA for consideration of the treatment of adolescent EPP patients in the first half of FY2026 – a cohort of adolescent and paediatric patients continues to receive treatment, fully reimbursed by health insurers, under the care of expert physicians in Europe.
Publications
  • Data on the experience of EPP patients was published during the past year:
    • Long-term safety and effectiveness data from the use SCENESSE® in EPP was presented to the European Academy of Dermatology and Venereology Spring Symposium in Prague, Czech Republic, in May 2025. Based on EPP patients treated in Italy since 2008, SCENESSE® treatment has resulted in positive clinical benefits, alleviating phototoxic symptoms.
    • The positive experience of a German cohort of EPP patients treated with SCENESSE® in the European post-authorisation safety study was published in March 2025 in the Photodermatology, Photoimmunology and Photomedicine journal.

Pharmaceutical Product Development & Clinical Programs

Clinical team restructured and clinical programs prioritised

In a welcome return to the Group, Dr Emilie Rodenburger was appointed Director, Global Clinical Affairs in April 2024. By August, she had redesigned the clinical affairs team, integrating clinical operations, medical monitoring, and data sciences into a streamlined structure capable of delivering on larger, more complex global programs. Dr Rodenburger’s journey – from building a foundation and honing her skills with peers to returning in a leadership capacity – perfectly embodies CLINUVEL’s values of growth and investment in talent.

The clinical program, spanning multiple conditions of the skin and brain, was prioritised in November 2024 to focus on programs which offered the highest probability of clinical and commercial success in more the immediate and largest addressable markets with the highest need. The Company is now focused on afamelanotide for porphyrias (EPP and VP) and vitiligo, and ACTH for a range of indications. The programs in DNA Repair (xeroderma pigmentosum), stroke, and Parkinson’s disease were suspended, with a commitment to finish the studies already commenced and to report on their results.

Key activities

The key activities for the year and plans for FY2026 and beyond are detailed below:

Activity Review of FY2025 Plans - FY2026 and Beyond
NEURACTHEL®
  • The development of instant and modified release formulations and work on manufacturing validation continued in FY2025.
  • An update on the status of NEURACTHEL® is planned by the end of 2025.
  • Targeting 2026 U.S. filing
Variegate porphyria (VP)
  • The results of the Phase II VP study, CUV040, were presented to the International Congress of Porphyrins and Porphyrias in Pamplona, Spain in September 2024. SCENESSE® was shown to reduce clinical symptoms and improve patients’ quality of life.
  • CUV053, a pivotal study on SCENESSE® for VP is planned to commence in 2026.
Vitiligo
  • Recruitment of patients for the Phase III study, CUV105 commenced October 2023 and completed May 2025, ahead of extended June 2025 completion date.
  • The study was fully recruited across 37 clinical sites spanning the U.S., Europe, and Africa.
  • The results of the Phase II pilot monotherapy study, CUV104, were announced in June. The study was conducted at the suggestion of regulatory authorities to assess the safety and efficacy of afamelanotide as a monotherapy in patients with darker skin types (Fitzpatrick IV–VI). The study results confirmed adjunct NB-UVB phototherapy is needed with SCENESSE® to activate repigmentation in vitiligo. Given this, no further studies are planned in afamelanotide as a monotherapy for vitiligo patients.
  • The last patient recruited to CUV105 will complete treatment in Q4 2025. After the follow-up period, data analysis and cleansing, results of the study will be available in the second half of 2026.
  • In the second half of 2025, CLINUVEL will liaise with regulators and seek their feedback on the progress of the study to date and subsequently finalise the design of the next Phase III study, CUV107.
  • The design and commencement of recruitment of CUV107 is planned by the end of 2025 / early 2026. There will be a one-year recruitment period, six-month treatment and follow-up periods. After data analysis and cleansing, results will be available.
  • Submission of the dossier to the FDA is expected to occur following completion of the clinical program.
Stroke
  • Results in the Phase II stroke study, CUV803 were announced in March 2025. Nine patients treated with PRÉNUMBRA® Instant tolerated the drug well and 8 out of 9 demonstrated functional improvement (at day 42), whilst 6 out of 9 showed radiological improvement or stability. These results are consistent with the previous CUV801 study and provide a solid basis for resuming the arterial ischaemic stroke program in the future.
  • The stroke and DNA repair programs were suspended in November 2024 to focus on EPP initiatives, the VP and vitiligo clinical programs, and the PhotoCosmetic product range.
DNA Repair
  • Study CUV151, evaluating the DNA-repair capacity of afamelanotide on the skin of healthy volunteers exposed to ultraviolet radiation, was presented at the British Association of Dermatologists 104th Annual Meeting, held in Manchester in July 2024. The RNA sequencing results indicate that critical genes expressed after UV-damage can be positively affected with afamelanotide treatment. For the general population, and particularly those with fair skin susceptible to sunburn, the results indicate that afamelanotide can reduce oxidative damage and inflammatory reactions after sun exposure and skin damage.

PhotoCosmetic Products

Activity Review of FY2025 Plans - FY2026 and Beyond
Protect Work on the PhotoCosmetic product range continued in FY2025:
  • Preparations have been made for the launch of the next generation “Protect” polychromatic product, CYACÊLLE Radiant.
  • Media outreach for launch of CYACÊLLE Radiant is planned for the second half 2025.
Preserve and Bronze
  • Formulation and manufacturing development work on M-lines, “Preserve” and “Bronze” continued.
  • Launch of the M-lines, “Preserve” and “Bronze” is planned for 2026.
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