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Treatment for Keratosis

U.S. New Drug Application Approval Expected for Metvix

OSLO, Norway, June 17, 2004--The US Food and Drug Administration (FDA) officially informed PhotoCure that it intends to finish its review of Metvix (methyl aminolevulinate), for the treatment of pre-cancerous lesions (actinic keratosis, AK), no later than July 27, 2004.

PhotoCure's first New Drug Application was submitted for Metvix for the treatment of actinic keratosis and is previously deemed approvable by the FDA. Prior to approval of Metvix, a cream that works in conjunction with the light source CureLight, the FDA requested a safety update on the Metvix product. This safety update was submitted to the FDA in May 2004. The FDA and PhotoCure have previously agreed on labelling for the Metvix product. Therefore, PhotoCure anticipates that final approval of Metvix will be issued by end of July 2004.

About PhotoCure ASA
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 filed 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) and non-melanoma skin cancer (basal cell carcinoma) in most European countries, New Zealand and Australia. 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.

Actinic keratosis (AK), also called 'sun spots', is the most commonly diagnosed pre-cancerous skin condition. Worldwide, it is estimated that about 20 million cases of AK occur each year. Early and effective treatment of AK is important as, if left untreated, a certain number of these lesions may progress to squamous cell carcinoma, an aggressive and potentially life-threatening type of skin cancer.

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Posted: June 2004

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