CLINUVEL and Valentech enter SCENESSE LATAM partnership

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CLINUVEL (ASX:CUV) has announced it has entered a strategic partnership with rare disease specialists Valentech Pharma to introduce SCENESSE (afamelanotide) as a treatment for erythropoietic protoporphyria (EPP) patients in Latin America.

CLINUVEL said it will work with Valentech to enable EPP patient treatment access in Latin America through both special access programs and regulatory pathways.

Valentech will adhere to CLINUVEL’s global risk management programs to monitor the use of SCENESSE in EPP. The partnership's further terms have not been disclosed.

EPP is an inherited disorder that causes debilitating phototoxic reactions when patients are exposed to visible light.

In Latin America, EPP affects 1 in 200,000 individuals. CLINUVEL’s SCENESSE is the world’s first and only therapy approved for treating EPP, with the drug authorised by global regulators. SCENESSE protects EPP patients from light and UV, preventing phototoxic reactions.

"We are honoured to focus our efforts on providing support for those with erythropoietic protoporphyria,” Valentech’s CEO, Mr Gabriel Muñoz.

“This devastating condition demands effective solutions to improve the lives of patients and their families. Through our collaboration with CLINUVEL, we aim to bring much-needed relief and hope to our region. This initiative leverages our expertise in severe and orphan diseases, reaffirming our dedication to bringing life-changing therapies to those in need.”

“Since the safety profile of the drug has withstood the test of time, two decades of patient use, we are comfortable in expanding patient access to Latin America,” said CLINUVEL’s vice president for commercial affairs, Antonella Colucci. “In Valentech we have found an experienced partner who understands the unique challenges of EPP and CLINUVEL’s approach to granting patient access.”