PhotoCure ASA announces today that its European marketing applications for Metvix, for treatment of actinic keratosis (AK, precancerous skin lesions) and basal cell carcinoma (BCC, skin cancer), have been approved through a repeated European Mutual Recognition procedure in the Czech Republic, Estonia, Latvia, Lithuania, Poland, Portugal, the Slovak Republic and the Netherlands.
The new approvals follow the submission in June 2004, to 8 EU countries, of an updated application containing additional clinical data on the BCC indication. National marketing authorisation in each country will be issued following the approval of Metvix product information for doctors and patients in the local language.
Metvix is now approved for marketing for precancerous skin lesions and skin cancer in 26 European countries, Australia and New Zealand, and for precancerous skin lesions in the US. Galderma, PhotoCure’s marketing partner for Metvix, has already initiated launches of Metvix in Germany, the UK, Belgium, Switzerland, New Zealand and Australia.
Professor Vidar Hansson, PhotoCure’s CEO and President, comments, “We are pleased that Metvix is now approved in 8 additional European countries. We are approaching the situation whereby Galderma will make Metvix available to patients all across Europe.”