Clinuvel Pharmaceuticals : First US Patients to be treated with SCENESSE®

SCENESSE^® SAVINGS PROGRAM

CLINUVEL has established the SCENESSE^® Savings Program for American EPP patients. Individual applications, made according to the terms and conditions of the Program, will allow support on a case by case basis. EPP patients with commercial or private health insurance may be eligible, depending on the terms of each insurance policy. EPP patients will be able to register online and enrol into the SCENESSE^® Savings Program, as well as register interest through a designated call center.²

COMMENTARY

'Novel drugs and molecules must be subjected to an extensive and rigorous clinical journey taking more than a decade to be able to demonstrate safety and efficacy and ultimately receive regulatory approvals,' CLINUVEL's Director of Clinical Affairs and Compliance, Dr Linda Teng said. 'It's not a pathway which can be accelerated at risk of patient health. The SCENESSE^® controlled release formulation, administered by trained healthcare professionals, gives comfort that patients are receiving the approved dose, one which has been given to more than 1,400 patients to date. Importantly, our systems enable compliance with global rules on quality and pharmacovigilance to monitor the safety of the innovative product.
'Despite the COVID-19 pandemic affecting the globe, the Specialty Centers are still able to offer treatment and the first EPP patients will receive SCENESSE^® in the coming days. We have been working intensively with the FDA and the Centers over the past several months to get to this point. Our team is immensely proud that, after more than a decade of hard work, the treatment is finally available to our patients,' Dr Teng said.

^{1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product, including the approved prescribing information, can be found on CLINUVEL's website at www.clinuvel.com.}

^{2 Further details and terms and conditions are available from www.scenesse.com. This site is intended for US residents only.}