PhotoCure ASA has submitted a marketing authorisation application to the Australian authorities for Metvix® PDT (Photodynamic Therapy) for the treatment of “high risk” basal cell carcinoma (BCC), and actinic keratosis (AK). This marketing application follows applications filed in Sweden as the first step in a European approval procedure for the same indications.
Actinic keratoses, also called “sun spots” are the most frequent pre-malignant skin condition. Up to 50% of the population in Australia above 40 years of age have at least one AK. Worldwide, it is estimated that about 20 million cases of AK occur each year. Because AKs may progress to squamous cell carcinoma, which is an aggressive, even life-threatening type of skin cancer, it is important to treat AK’s effectively.
About two million new cases of BCC occur worldwide every year making this the most common form of cancer among Caucasians. BCC is a type of skin cancer which rarely metastasizes, but which spreads slowly just below the skin surface. If it is left without adequate treatment it may become very difficult to treat. The most difficult, “high risk” BCC lesions are those which are located in the mid-face, or which have become very large, so that the patients are at high risk of complications and poor cosmetic outcome due to the complex surgical procedures that are required to treat these lesions.
Metvix® PDT is an innovative skin cancer treatment which combines the local application of a cream (Metvix®) followed by activation of the drug through illumination with a red light (Curelight). Metvix® PDT kills the cancer cells selectively and leaves the normal skin intact, thereby leaving the healed skin without scars or blemishes.
Australia is the country in the world where these sun induced skin diseases occur most frequently. PhotoCure has performed important parts of the clinical testing of Metvix® PDT in Australia, and has built up strong relationships with leading researchers in the field, thus contributing considerable local experience and expertise to the Australian marketing authorisation application.
“This application is a major milestone for PhotoCure, since Australia represents an extremely important market for Metvix® PDT” says CEO Vidar Hansson.
PhotoCure ASA is a Norwegian listed company founded in 1993. PhotoCure ASA's mission is to develop and sell pharmaceuticals and medical devices based on proprietary photodynamic technologies. The company is developing products for skin cancer and other skin diseases, internal cancer, gene therapy and cancer vaccines. Metvix® and Curelight is developed for the treatment of basal cell carcinoma (skin cancer) and actinic keratosis (pre-cancerous skin lesions). PhotoCure's second pharmaceutical product, Hexvix®, is currently undergoing clinical trials for bladder cancer detection. PCI Biotech AS is established as a subsidiary of PhotoCure ASA to develop and commercialise new transfection technologies for the research market as well as products in oncology and gene therapy.
For further information, please contact
PhotoCure ASA
Attn. Vidar Hansson, CEO
Hoffsveien 48
0377 Oslo
Norway
www.photocure.com
E-mail: vh@photocure.no
Telephone: +47 22 06 22 10
Fax: +47 22 06 22 18