Supply of SCENESSE® Unaffected by Coronavirus
CLINUVEL PHARMACEUTICALS LTD today communicated in response to a number of public queries that neither the drug substance nor the excipients of SCENESSE® (afamelanotide 16mg) are affected by the coronavirus.1 The coronavirus (COVID-19) is a class 1 viral fusion protein and is not affecting the supply chain or manufacturing of SCENESSE®.
THE CORONAVIRUS DISEASE (COVID-19)
COVID-19 is of significant concern to the worldwide community and the overriding focus of health authorities in all countries is to contain current and prevent new outbreaks and find an effective vaccine. CLINUVEL shares the community’s concern and supports the focus of the health authorities on the well-being of all people.
CLINUVEL is continuously reviewing its operations to assess ongoing supply of SCENESSE®. The synthetic peptide, afamelanotide, which is the active ingredient in SCENESSE®, is manufactured under current good manufacturing practice (GMP) conditions in the European Union and is supplied to a contract manufacturer under cold-chain transport in the USA. Other synthetic excipients of SCENESSE® are sourced within the United States. Quality control of the drug product entering the European Union involves further laboratory testing before formal release of the product and controlled distribution to hospitals treating adult patients with erythropoietic protoporphyria (EPP).
Based on the sourcing, manufacturing and controlled distribution in place for SCENESSE®, there are currently no consequences to CLINUVEL’s business operations within the European Economic Area or the United States which could be impacted by the COVID-19 outbreaks. The situation continues to be closely monitored.
“CLINUVEL is cognisant of worldwide concern about the spread of the coronavirus and its impact on the health of the community,” CLINUVEL’s Chief Scientific Officer, Dennis Wright said. “As part of our global pharmacovigilance and quality management systems, we have a duty to reassure the medical community. We can provide comfort to patients, physicians, and other stakeholders that the supply of SCENESSE® to those in need it is not impacted by the current coronavirus outbreak.”
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 can be found on CLINUVEL’s website at www.clinuvel.com.