Metvix application New Zealand

PhotoCure Submits Marketing Authorisation Application for Metvix® PDT Skin Cancer Treatment in New Zealand

PhotoCure ASA announced today the submission of a marketing authorisation application to the New Zealand 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, for the European Union, and in Australia. PhotoCure expects to receive marketing authorisation for Metvix® in Sweden in mid- 2001.

Metvix® PDT is an innovative skin cancer treatment that combines the local application of a cream (Metvix®), which is absorbed into the cancer cells, followed by activation of the drug through illumination with a proprietary red light source (Curelight). Metvix® PDT kills the cancer cells selectively and leaves the normal skin intact, thereby leaving the healed skin without scars or blemishes.

New Zealand and Australia are the two countries in the world with the highest frequency of BCC and pre-malignant AK. BCC is the most common form of cancer among Caucasians, with about two million cases documented annually worldwide. It is estimated that there are about 30,000 new cases of BCC in New Zealand each year. Although BCC is a type of skin cancer that rarely metastasizes, it spreads slowly just below the skin surface and can lead to significant complications. The most difficult lesions, “high risk” BCC lesions, are those which due to size, location (e.g. mid-face) or previous treatment may potentially lead to complications and poor cosmetic outcome associated with complex surgical procedures.

AK, also called “sun spots,” is the most commonly diagnosed pre-malignant skin condition. In New Zealand alone it is estimated that there are over 300,000 new cases of AK each year. Worldwide, 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.

“We believe Metvix PDT has significant commercial potential in the treatment of both skin cancer and pre-malignant skin lesions,” commented PhotoCure President and CEO Vidar Hansson. “We anticipate successful marketing clearance in New Zealand and look forward to the opportunity to expand our commercial base and generate revenues as we work towards regulatory approval in Europe, Australia and the US.”

PhotoCure last week announced positive results of a Phase III clinical trial comparing its Metvix® PDT treatment with surgery. The data suggest Metvix® PDT offers superior overall treatment of nodular BCC, demonstrating an initial cure rate comparable to surgery and a dramatic improvement in cosmetic outcome.

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 more information contact:

PhotoCure ASA
Attn. Vidar Hansson, CEO
Hoffsveien 48
0377 Oslo

Telephone: +47 22 06 22 10, Mobile: +47 90 73 78 72
Fax: +47 22 06 22 18