As 2005 drew to a close, avenues were limited and prospects were at a bare minimum; this point in time marks the birth of CLINUVEL, the Company as we know it today. Twenty-five years wasted on execution and intellectual property; a new reset was needed.
Fast forward, and the October 2019 approval of SCENESSE® (afamelanotide 16mg) by the US Food and Drug Administration (FDA) has been a catalyst to ‘unlock the door’ for CLINUVEL to justify expansion of its research and development (R&D) programs in melanocortins. The regulatory endorsement of the concept of systemic photoprotection and use of melanocortins has followed decades of unsuccessful attempts. The emphasis on the safety of SCENESSE® provides the basis to translate CLINUVEL’s technology to multiple technologies, new formulations, and new indications.
The 2021 financial year saw an expansion in R&D as part of the overall strategy to make CLINUVEL’s proven technology available for more patients with unmet medical needs, as well as broader targeted groups at high risk from exposure to ultraviolet and high energy visible light.