PhotoCure - National Marketing Authorisation for Metvix® PDT issued in Germany

Oslo, 6 March 2002.
PhotoCure ASA announces today that the company has received the national German marketing authorisation from Bundesinstitute für Arzneimittel und Medizinprodukte or BfArM. The marketing authorisation is a result of the fact that the German Authorities as one of 13 European countries by the end of November 2001 recognised the Swedish Drug Authorities' decision to approve Metvix® PDT. By issuing the national marketing authorisation, BfArM has accepted the German translation of the product information and the patient information.

Germany is the fourth European country to issue national marketing authorisation, after Sweden, Norway and Iceland. Marketing authorisation has also been granted in New Zealand. Metvix® PDT is launched in Sweden and the Swedish National Social Insurance Board (Riksförsäkringsverket) has approved a reimbursed price of SEK 1,300 per tube of Metvix®. The Norwegian Authorities has recently approved a price of NOK 1,100 per tube and reimbursement application is being prepared.

Applications for market authorisation are pending in Australia, USA and Switzerland. PhotoCure has licensed the rights to marketing and sale of Metvix® PDT to Galderma S.A. outside the Nordic area.