CLINUVEL (ASX: CUV) has signed a distribution agreement for its drug SCENESSE treatment with Argentinian specialty pharmaceutical company Diligens Salud SA, part of the Scienza Group.
Under the terms of the agreement, Diligens will act as CLINUVEL’s exclusive distributor in Argentina, facilitating SCENESSE treatment for patients with erythropoietic protoporphyria (EPP) under reimbursed named-patient programs. The agreement provides for longer-term collaboration to seek formal marketing authorisation in Argentina.
SCENESSE is the only EPP treatment approved by global regulators, with over 17,000 doses administered to date.
Recognising the high unmet need in EPP, CLINUVEL has worked to expand patient access to SCENESSE, both within jurisdictions where the prescription pharmaceutical has received marketing authorisation and under early access, compassionate, and named-patient programmes.
In Latin America – where EPP has a prevalence of 1:200,000 individuals – CLINUVEL is working to navigate an evolving regulatory landscape and engaging with expertise on the ground to enable named-patient access.
Argentina’s Exception Regime for Access to Non-Registered Drugs – RAEM, enacted in 2019 – allows companies to import products approved in other jurisdictions to treat patients with unmet needs and is expected to be used by Diligens to treat the first EPP patients.
Through similar programs in Europe and North America, CLINUVEL has established reimbursed patient access prior to marketing authorisation, with data captured added to regulatory dossiers. Special access programs to treat Canadian patients, for example, led CLINUVEL to filing a formal marketing authorisation application with Health Canada, the outcome of which is expected in late 2025.
“At Diligens, we are deeply grateful to CLINUVEL for trusting us with the distribution of SCENESSE,” General Manager of Diligens Salud, Sebastián Roqueta said.
“This medication represents great hope and will significantly improve the quality of life for patients in our region. We are honoured to be part of this important step in healthcare, and we take on this challenge with the commitment and dedication that define us.”
