Mountaineering put teams to the limits, those who strive for the ultimate success while managing risks in unpredictable environments. The parallel to de novo pharmaceutical drug development and commercialisation is indisputable. Of those that set out on the journey to find solutions and commercialise pharmaceutical drugs, approximately 7% succeed¹. CLINUVEL has ascended in the past, reaching the summit of regulatory approvals to distribute SCENESSE® (afamelanotide) for the treatment of erythropoietic protoporphyria (EPP) in 2014 in the European Union and 2019 in the U.S.A.
The challenge to subsequently establish a profitable business has been met with determination and fortitude by one united team, flanked by supportive stakeholders. In 2021, CLINUVEL began to develop new products and expand clinical programs to seek further regulatory approvals. In particular, the path to the treatment of vitiligo in the U.S.A. is well underway with recruitment of the first Phase III vitiligo study (CUV105) completed in May 2025.
The climate of the peak and its crevices test people and equipment and send many back to base camp. We continue to identify and manage adversities with a highly motivated group of professionals learning along each step, while cash reserves allow us for advancement, failures and adjustments protecting all from external funding for future growth. As stated over the past years, we are striving to build a diversified, sustainable biopharmaceutical based on a specialisation in melanocortins, potent peptides with an unstoppable drive to improve the wellbeing of patients.
We thank all those supporting CLINUVEL on this journey and as in the past, affirm our unwavering commitment to the continued success of our journey.