Oslo, Norway, 18 June 2001. PhotoCure ASA announced today that it has received its first marketing authorisation for Metvix® PDT (Photodynamic Therapy) in Sweden. The Swedish authorities have approved Metvix® PDT for the treatment of actinic keratosis (AK) and basal cell carcinoma (BCC) in patients where traditional therapies are considered less suitable. The treatment is particularly useful for AK and BCC lesions in cosmetically sensitive areas, such as the face and scalp.
The quality of data package submitted by PhotoCure for Metvix® PDT is reflected in the speed in which the approval was granted for two indications in one year.
Metvix® PDT's approval is the most important milestone PhotoCure has achieved to-date. The strength of PhotoCure's development capabilities is evidenced by the fact that it has only taken four and half years since the Company started full-scale development of Metvix® PDT until gaining its first approval. PhotoCure's global development has involved 100 clinical centers and more than 2,000 patients in Europe, USA and Australia.
"Photodynamic therapy with Metvix® provides major benefits to the patients compared to current therapies" says Professor Lasse Braathen, Chairman, Department of Dermatology, Inselspital, Bern, Switzerland. "This new method has the potential to become the treatment of choice for the patients where optimal results, including excellent cosmetic outcome, are required."
PhotoCure expects to start selling Metvix® PDT, which comprises Metvix® cream and the light source, Curelight, through its own salesforce in Sweden during the second half of 2001. The Company intends to market Metvix® PDT in the Nordic region itself but is currently negotiating with potential marketing partners who will market the product in the world's other major pharmaceutical markets.
The Swedish approval of Metvix® PDT is the first step in gaining a pan European approval for this novel treatment regime. This will be followed by applications for Metvix® PDT for the treatment of BCC and AK in the other countries of the European Union as well as in Iceland and Norway, through the 90 days mutual recognition procedure.
"We are proud to have reached this very important milestone for PhotoCure's development. The fact that we have gained our first product approval after only four and a half years highlights the quality and hard work of the Company's development team", commented PhotoCure President and CEO Vidar Hansson. "This approval marks the beginning of PhotoCure's commercialisation of Metvix® PDT and we are confident that the clinical benefits that it delivers to both BCC and AK patients will enable the product to achieve significant sales".