Oslo, Norway, 3 December 2004. The US Food and Drug Administration (FDA) has reviewed PhotoCure's amendment, submitted in June 2004, to the marketing application (NDA) for Metvix® (methyl aminolevulinate) for the treatment of skin cancer (Basal Cell Carcinoma). FDA concludes that the current data submitted was insufficient for approval of the proposed indication. PhotoCure is now evaluating the requirements set out by FDA. These requirements include further clincal phase III studies and may take up to 2 years. The alternatives will be discussed with FDA.  The FDA has previously reviewed Metvix for treatment of pre cancerous skin lesions (Actinic Keratosis), where an approval was obtained in July 2004. The approved trade name for Metvix in the United States is Metvixia(TM). Vidar Hansson comments: "I am surprised and disappointed by this decision by FDA. We strongly believe that the current scientific data supports our application and look forward to improve our documentation in collaboration with FDA."

PhotoCure ASA is a Norwegian listed company (Oslo Stock Exchange: PHO) that develops and sells pharmaceuticals and medical devices for photodynamic treatment of cancer and precancerous conditions. The company develops products for internal cancer, skin cancer and other skin diseases. Metvix is developed for the treatment of basal cell carcinoma (skin cancer) and actinic keratosis (precancerous skin lesions). PhotoCure is responsible for sales and marketing of Metvix in the Nordic countries, while its licensee, the global dermatology specialist, Galderma, is responsible for sales and marketing of Metvix in the rest of the world. PhotoCure's second pharmaceutical product Hexvix is developed for bladder cancer detection. A Marketing Authorisation Application (MAA) for Hexvix is approved in Sweden and Phase III studies are ongoing in the US.

Metvix® is a novel skin cancer treatment that combines local application of a cream (Metvix), selectively absorbed into the cancer cells, and illumination with a proprietary red light source (CureLight/Aktilite) to activate the drug. Metvix is approved for pre-cancerous skin lesions (actinic keratosis, AK) and non-melanoma skin cancer (basal cell carcinoma, BCC) in most European countries, New Zealand and Australia, and for AK in the US. Market authorisation applications are pending in other countries. PhotoCure ASA is responsible for marketing and sales of Metvix in the Nordic countries, while Galderma S.A. is responsible for the marketing and sales of Metvix in the rest of the world.

PhotoCure, the PhotoCure logo, Aktilite, Metvix and Hexvix are trademarks or registered trademarks of PhotoCure ASA.

For further information, contact:

Kjetil Hestdal, President and CEO 
E-mail: kh@photocure.no
Mobile: +47 913 19 535
Office: +47 22 06 22 10

Christian Fekete, CFO 
E-mail: cf@photocure.no
Mobile: +47 916 42 938
Office: +47 22 06 22 10

www.photocure.com