PhotoCure is submitting European marketing authorisation application for Metvix®

PhotoCure ASA is today submitting its first Marketing Authorisation Application (MAA) for Metvix® for treatment of precancerous skin lesions, actinic keratosis (AK). As the first step to obtain Marketing Authorisation for Metvix® in Europe, the MAA is submitted to the Health Authorities in Sweden as the Reference Member State in the European Mutual Recognition Procedure.

This MAA is the results of PhotoCure's 3 to 4 years of pre-clinical, chemical, pharmaceutical, and clinical research and development of Metvix® photodynamic therapy (PDT). The documentation is based on clinical experience from almost 2000 patients that have been treated with Metvix® PDT. The clinical studies show that Metvix® PDT gives high and similar efficacy as other treatment options, however, Metvix® PDT has superior cosmetic results.

"The application is a major milestone for us and we are proud to have reached this according to our timelines and within budgets. This is our first indication for Metvix® and should hopefully be followed by an application for treatment of basal cell carcinoma", says CEO Vidar Hansson. He continuos: "It is only about three year since we started our development of our Metvix® product for both actinic keratosis and basal cell carcinoma, and the first patent application for this product was filed as late as 1995."

PhotoCure ASA is a Norwegian development stage pharmaceutical company founded in 1993. PhotoCure ASA is engaged in the research and development of novel therapeutics and diagnostics and related medical devices based on proprietary photodynamic therapy (PDT) technologies. PDT is a two step process involving the application of a drug known as a photosensitiser followed by controlled exposure to a selective light source which activates the drug. All of the company’s products are based on proprietary technology from the Norwegian Radium Hospital, the largest comprehensive cancer centre in Northern Europe. PhotoCure has completed final registration studies (phase III) with its first products, Metvix® and Curelight in Europe for actinic keratosis (pre-cancerous skin lesion) and pivotal clinical studies (phase III) in non-melanoma skin cancer (basal cell carcinoma, BCC) are ongoing. The shares of the company are on certain conditions accepted for listing on the main list on the Oslo Stock Exchange.

Oslo, Norway 2nd of May 2000.