ADEC RECOMMENDS METVIX MARKETING AUTHORIZATION EXTENSION.

PhotoCure ASA, Oslo, Norway, has announced that the Australian Drug Evaluation Committee (ADEC) has recommended extension of the current marketing authorization for Metvix to include the treatment of basal cell carcinoma (BCC, the most common type of skin cancer). According to the ADEC recommendation, Metvix is indicated for use in the primary treatment of BCC where surgery is considered inappropriate. The approval is subject to finalization of the Product Information to the satisfaction of the TGA (Therapeutic Goods Administration). Approval for use in Aktinic Keratosis (AK or pre-malignant skin lesions) was granted in April 2003.

Australia constitutes a very important market for PhotoCure, as this is the country with the highest frequency of sun-induced skin diseases in the world. BCC is the most common cancer affecting Western industrialized countries, representing 40% of all cancers. The incidence of new cases is increasing by 5% per year in the USA and Australia.

Since most BCCs occur on sun-exposed areas such as the face and scalp, it has long been recognized that there is a clear medical need for an effective, non-invasive technique that will not leave scars.

Prof. Vidar Hansson, CEO of PhotoCure ASA, welcomes the good news. He commented: "This is a great step forward, not only for PhotoCure, but for the many patients with skin cancer in Australia."

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 pre-cancerous 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 (pre-cancerous skin lesions). PhotoCure is responsible for sales and marketing of Metvix in the Nordic countries, while 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 Authorization 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 (AktiliteTM) to activate the drug. Metvix is approved for non-melanoma skin cancer (basal cell carcinoma, BCC) and pre-cancerous skin lesions, actinic keratosis (AK), in most European countries and New Zealand, while market authorizations 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.

Basal cell carcinoma (BCC) is the most common form of cancer among Caucasians, with about two million cases annually worldwide. Although BCC is a type of skin cancer that rarely metastasises, it spreads slowly just below the skin surface and can lead to significant complications. The most difficult lesions are those that due to size, location (e.g. mid-face) or previous treatment may potentially lead to complications and poor cosmetic outcome. This type of lesions has normally required complex surgical procedures.

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.

For more information, visit http://www.photocure.com.