PhotoCure ASA has submitted its second marketing authorisation application (MAA) for Metvix PDT for the treatment of basal cell carcinoma (BCC), a non-melanoma skin cancer. The marketing application was made to the Health Authorities in Sweden who will act as the Reference Member State in the European Mutual Recognition Procedure, leading to EU-wide approval. PhotoCure ASA submitted its first MAA for Metvix PDT for treatment of pre-cancerous skin lesions, actinic keratosis (AK) in May 2000.

This second MAA, for the treatment of BCC, is the result of PhotoCure's continuous development of Metvix PDT as an efficacious and cosmetically beneficial new treatment, which will provide health care professionals with a further option to treat a broader range of patients. This new documentation provides support for Metvix PDT in patients with BCC where traditional treatments carry the risk of complications and a poor cosmetic outcome.

"This application is a major milestone for PhotoCure and we are proud to have developed the first pharmaceutical product for this indication. We are confident that Metvix PDT will become an important treatment option for these patients allowing them to reduce the need for costly and advanced reconstructive surgery," said CEO Vidar Hansson.

BCC accounts for approximately 80 percent of non-melanoma skin cancers. There are over 1.7 million cases of BCC each year in Europe, the U.S. and Australia, and the incidence of the disease has grown at 5 percent per annum in the last decades. BCC is a locally invasive, slowly spreading tumour of the basal cell layer of the epidermis. The overall metastasis rate is very low, but if the tumour is not adequately treated initially, it may become more difficult to cure.

Furthermore, the location of BCC has significant influence on its prognosis. The lesions that occur in the centre of the face tend to be more invasive and destructive, with greater risk of recurrence, and are more difficult to treat effectively. BCC on the nose is considered to be the location with highest risk and the most common location of recurrence. Patients with a primary BCC have a 47 percent chance of developing a second primary lesion within 3.5 years indicating the need for good follow-up in these patients.

PhotoCure ASA is a Norwegian listed company founded in 1993. PhotoCure ASA's mission is to develop and sell pharmaceuticals and medical devices based on proprietary photodynamic technologies. The company is developing products for skin cancer and other skin diseases, internal cancer, gene therapy and cancer vaccines.

PhotoCure has completed final registration studies (phase III) with its first products, Metvix and Curelight for actinic keratosis (pre-cancerous skin lesion), and filed its first application for European marketing approval in May 2000. Pivotal clinical trials for basal cell carcinoma (BCC) are ongoing. PhotoCure's second pharmaceutical product, Hexvix, is currently in clinical phase II for bladder cancer detection.