Oslo, Norway, 30 November, 2001.
PhotoCure ASA announces today that its European marketing applications for Metvix® PDT, to treat actinic keratosis (AK, pre-cancerous skin lesions) and basal cell carcinoma (BCC, skin cancer), have been approved across Europe.
Metvix® PDT was granted marketing authorisation in Sweden in June this year and the application was submitted to remaining EU/EEA countries through the European Mutual Recognition Procedure in August. National marketing authorisation for Metvix® PDT will be issued for Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Luxemburg, Norway, Spain, and the UK, upon agreement with individual countries. This process takes at least 30 days and will be followed with price and reimbursement application in the different countries.
Professor Vidar Hansson, PhotoCure's CEO and President, comments, "This recognition of the Swedish approval will allow PhotoCure to provide a new and beneficial treatment to both AK and BCC patients in major European countries." He adds, "This represents an important step forward in our ambitions for global marketing and sale of Metvix® PDT."
Three countries (Portugal, France and the Netherlands) were ready to accept the documentation on AK, however, they required additional clinical information on BCC beyond the data in the phase II trial that formed the basis for the application. PhotoCure intends to submit a new application to these countries.
PhotoCure has completed a Phase III multi-centre trial for Metvix® PDT for the treatment of BCC in Australia, a key market due to the high incidence of sun-induced skin diseases, and has also submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Metvix® PDT for the treatment of AK.