Metvix® PDT approved in Australia
Oslo, Norway, 2 April 2003. PhotoCure has received formal approval in Australia of its marketing authorisation application (MAA) for the treatment of actinic keratosis (AK, an early form of skin cancer). Formal approval was issued by the Therapeutic Goods Administration (TGA) today following a recommendation by the Australian Drug Evaluation Committee (ADEC) in February 2003. With the highest frequency of sun-induced skin diseases in the world, Australia constitutes a very important market for Metvix® PDT. The approval is therefore a major milestone for PhotoCure. In September 2002, PhotoCure submitted additional clinical data to the TGA for Metvix® PDT in the treatment of basal cell carcinoma (BCC). This application is still pending.
PhotoCure ASA is a Norwegian listed company (Oslo Stock Exchange: PHO) that develops and sells pharmaceuticals and medical devices for photodynamic treatment of cancer and pre-cancerous conditions. The company develops products for internal cancer, skin cancer and other skin diseases. Metvix® PDT is developed for the treatment of basal cell carcinoma (skin cancer) and actinic keratosis (pre-cancerous skin lesions). PhotoCure is responsible for sales and marketing of Metvix® PDT in the Nordic countries, while global dermatology specialist, Galderma, is responsible for sales and marketing of Metvix® in the rest of the world. PhotoCure's second pharmaceutical product Hexvix® is developed for bladder cancer detection. A Marketing Authorisation Application (MAA) for Hexvix® is filed in Sweden and Phase III studies are ongoing in the US.
PCI Biotech AS, a subsidiary of PhotoCure ASA, is focused on the opportunities for photochemical internalisation (PCI) in drug discovery, development and delivery of novel cancer therapeutics.
Metvix® PDT is a novel skin cancer treatment that combines local application of a cream (Metvix®), selectively absorbed into the cancer cells, and illumination with a proprietary red light source (AktiliteTM) to activate the drug. Metvix® is approved for non-melanoma skin cancer (basal cell carcinoma, BCC) and pre-cancerous skin lesions, actinic keratosis (AK), in most European countries and New Zealand, while market authorisations are pending in other countries. PhotoCure ASA is responsible for marketing and sales of Metvix® in the Nordic countries, while Galderma S.A. is responsible for the marketing and sales of Metvix® in the rest of the world.
Basal cell carcinoma (BCC) is the most common form of cancer among Caucasians, with about two million cases annually worldwide. Although BCC is a type of skin cancer that rarely metastasises, it spreads slowly just below the skin surface and can lead to significant complications. The most difficult lesions are those that due to size, location (e.g. mid-face) or previous treatment may potentially lead to complications and poor cosmetic outcome. This type of lesions has normally required complex surgical procedures.
Actinic keratosis (AK), also called 'sun spots', is the most commonly diagnosed pre-cancerous skin condition. Worldwide, it is estimated that 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.
For further information, contact:
PhotoCure ASA
Vidar Hansson, CEO
Hoffsveien 48
NO-0377 Oslo
Norway
www.photocure.com
E-mail: vh@photocure.no
Telephone: +47 22 06 22 10
Mobile: +47 90 73 78 72
Fax: +47 22 06 22 18