All patients included in PhotoCure’s phase III study on pre-cancerous skin lesions (Actinic Keratosis) in Australia

A total of 210 patients have been included in PhotoCure’s phase III study for pre-cancerous skin lesions (Actinic Keratosis) in Australia. The study takes place in 9 different centres and the investigators are enthusiastic about the method. Australia has the highest incidence of Actinic Keratosis in the world and it is estimated that a total of 2 million new cases arise each year in the country. Actually, 40% of all Australians above the age of 40 have Actinic Keratosis. The high incidence of this disease is due to the fact there are many fair skinned persons living under the strong Australian sun.

The study completes the formal clinical program for Metvix® in Actinic Keratosis in Australia and will be followed by submission of a registration file for Marketing Approval. Such approval is required for marketing of Metvix® in this area.

“We are very pleased to perform our first phase III study in Australia and work together with so many enthusiastic and competent investigators”, says President and CEO Vidar Hansson.

PhotoCure expects to release the results from this study by 1st quarter 2001. The study in Australia is a supplement to two phase III studies for Actinic Keratosis completed earlier this year in Europe, where PhotoCure has applied for Marketing Authorisation for Metvix for Actinic Keratosis. Patient inclusion is still ongoing in PhotoCure’s phase III study for Actinic Keratosis in USA.

Oslo 8th of September 2000