Oslo, Norway, 18 October 2001.
Today PhotoCure hosted a "world launch symposium" for Metvix® in Stockholm, Sweden. Metvix® is the first photodynamic therapy (PDT) regime to be approved anywhere in the world for the treatment of skin cancer.
In the symposium invited speakers presented the Metvix® clinical data that has been generated by PhotoCure during the last three years. PhotoCure has conducted clinical studies in Europe, US and Australia on a total of 3000 patients with either basal cell carcinoma or actinic keratosis.
Sweden is the first country to approve Metvix®. Sweden was chosen by PhotoCure as the reference country for its Metvix® European marketing authorisation application under the mutual recognition procedure. Earlier this year PhotoCure also filed approval applications for Metvix® in Australia, New Zealand and most recently in the US.
In addition, two weeks ago it was announced that the Swedish National Social Insurance Board (Riksförsäkringsverket) has approved a reimbursement price for Metvix® cream, thus making the product available to patients under the Swedish reimbursement scheme. The decision by the Swedish authorities to reimburse Metvix®, supports the fact that it represents an important new treatment option for both basal cell carcinoma and actinic keratosis.
Professor Vidar Hansson, PhotoCure's CEO and President, commented, "This launch is the beginning of a new era in dermatology, as there is now an approved method available to dermatologists for the treatment of skin cancer which leaves the patients without scars. The launch of Metvix® also represents the start of a new era for PhotoCure. Until now we have been a development company, but our decision to market Metvix® PDT ourselves in the Nordic region means that we are becoming a full-scale pharmaceutical company. We are currently looking for commercial partners for Metvix® outside the Nordic area."
Metvix® PDT is an innovative treatment for pre-malignant skin lesions and skin cancer that combines the local application of Metvix® cream to the skin, which is then absorbed into pre-malignant or malignant cells. The drug is activated through illumination using a proprietary red light source called CureLight.
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 25,000 new cases of BCC in Sweden each year and the corresponding figure in Europe is 500,000. 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 known as "sun spots", is the most commonly diagnosed pre-malignant skin condition. Worldwide, more than 20 million cases of AK occur each year. Early and effective treatment of AK is important as if it is left untreated a certain number of these lesions may progress to squamous cell carcinoma, an aggressive and potentially life-threatening type of skin cancer.