Metvix Applications in Europe
PhotoCure ASA announced the submission of marketing authorisation applications to the health authorities of 16 EU/EEA countries for Metvix® PDT (photodynamic therapy) for the treatment of actinic keratosis (AK, pre-cancerous skin lesions) and basal cell carcinoma (BCC, skin cancer) where traditional therapies are considered less suitable.
These applications follow the granting of marketing authorisation in Sweden which was received on the 15th June 2001 and are submitted through the European Mutual Recognition Procedure. Under this procedure, PhotoCure is requesting each of the countries concerned to recognise the Swedish Authority's approval of Metvix® PDT. Following a validation phase, the review process will start on 29th of August and will last for a total of 90 days. A marketing authorisation may then follow in each country that has recognised the Swedish authorisation.
Professor Vidar Hansson, PhotoCure's CEO and President, commented, "Metvix® PDT is now another step closer to commercialisation in Europe and is the first topical PDT treatment to be approved on the European continent". He added, "We are very pleased to be able to file these applications in Europe so shortly after we gained the approval in Sweden".
Metvix® PDT is an innovative skin cancer treatment that combines the local application of Metvix® cream to the skin, which is then absorbed into cancer cells. The drug is activated through illumination using a proprietary red light source called Curelight. Metvix® PDT kills the cancer cells selectively and leaves the normal skin intact, thereby healing the skin without causing scars or blemishes.
BCC is the most common form of cancer among Caucasians, with about two million cases documented annually worldwide. 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 to treat are those which due to size, location (e.g. mid-face) or a previous unsuccessful treatment using another method, can potentially lead to complications and poor cosmetic outcome because of the associated complex surgical procedures.
AK, also known as 'sun spots', is the most commonly diagnosed pre-malignant skin condition. Worldwide, about 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.
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 were 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 was 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.