On December 7, 2020 Biofrontera Pharma GmbH and Galenica AB signed an exclusive license and supply agreement for the marketing of both Ameluz® and BF-RhodoLED® in Sweden, Norway, Denmark, Finland and Iceland. Galenica AB hereby receives exclusive distribution rights for the Nordic regions, whereby Biofrontera will supply Ameluz® to Galenica.
Biofrontera will be responsible for the marketing authorization as well as manufacturing and quality control, while Galenica will handle all aspects of commercialization, local registration and reimbursement in the Scandinavian countries. Both companies will collaborate on regulatory compliance regarding drug safety (pharmacovigilance). Galenica is now working towards the reintroduction of the products in Denmark, Sweden and Norway and their initial launch in Finland and Iceland by the middle of next year. In addition, Galenica has a right of first refusal for commercialization in the Baltic States.
Ronnie Wallin, CEO of Galenica AB: “Due to the increasing number of cases as well as the growing attention, sun-induced skin cancers today are a major cause for visits to dermatologists. We are therefore very pleased to be able to offer this excellent drug for the treatment of actinic keratosis and basal cell carcinoma to dermatologists in our region.”
Prof. Dr. Hermann Lübbert, CEO of Biofrontera AG, commented: “We are particularly pleased to have a new strong partner on our side, who will again successfully commercialize Ameluz® in the Scandinavian countries.”
In 2011, the prescription drug Ameluz® received a centralized EU marketing authorization from the European Commission, which since then has repeatedly been expanded. Ameluz® is approved for use in photodynamic therapy (PDT) of mild to moderate actinic keratoses, field cancerization, and superficial and nodular basal cell carcinomas. Ameluz® is approved for the use in conventional PDT with a special red-light lamp as well as for daylight PDT. Ameluz® is the only PDT drug worldwide that is approved for the treatment of field cancerization, i.e. continuous surfaces with actinic keratoses and other sun damage, and is not restricted to the treatment of individual keratoses only.