Oslo, Norway, 28 July 2004
PhotoCure announces today that the U.S. Food and Drug Administration (FDA) has approved its novel product methyl aminolevulinate, presently called Metvix, for photodynamic treatment of actinic keratosis (sun-induced, pre-cancerous skin condition).
Approval to market the product in the United States is contingent on FDA's acceptance of a tradename other than Metvix, which is expected in several weeks. The Metvix tradename cannot be used due to similarity of an already existing tradename for another dermatology product.
Metvix works in combination with the CureLight lamp, PhotoCure's light source used in the clinical trials. As a result of the approval, PhotoCure is entitled to receive a milestone payment of EUR 3 million from Galderma, PhotoCure's sales and marketing partner outside the Nordic region.
The novel, non-invasive treatment offered by Metvix for pre-cancerous skin conditions combines the local application of cream (Metvix), selectively absorbed into abnormal cells, and illumination with a proprietary red light source (CureLight/Aktilite) to activate the drug.
Professor Vidar Hansson, President and CEO of PhotoCure ASA, commented: "The US approval marks an important milestone in Metvix's development. Metvix is now approved in 18 European countries, New Zealand and Australia in addition to the US".
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 precancerous conditions. The company develops products for internal cancer, skin cancer and other skin diseases. Metvix is developed for the treatment of basal cell carcinoma (skin cancer) and actinic keratosis (precancerous skin lesions). PhotoCure is responsible for sales and marketing of Metvix in the Nordic countries, while its licensee, the 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.
Galderma S.A is a 50/50 joint venture of L'Oréal and Nestlé and is a leading research-based pharmaceutical company dedicated to the development and marketing of novel prescription treatments for dermatological diseases. Devoted exclusively to dermatologist, the company focuses on treatment for disease areas including acne, rosacea, psoriasis, eczema, mycoses as well as life style conditions such as photoageing, alopecia, and pigmentary disorders. Galderma's major R&D center is located at Sophia-Antipolis in France and has a particular expertise in retinoids. The level of investment in R&D is the largest in the world exclusively devoted to dermatology. Differin®, the first new topical retinoid in 25 years launched world wide in 1995 for the treatment of acne, is derived from Galderma's R&D discovery program. Galderma has 33 fully owned subsidiaries and is present in more than 60 countries. Through its 1,000 medical sales representatives it reaches almost every dermatologist in the world. Sales in 2003 were Euro 615 million.
Metvix® 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 (CureLight/Aktilite) to activate the drug. Metvix is approved for pre-cancerous skin lesions (actinic keratosis, AK) and non-melanoma skin cancer (basal cell carcinoma, BCC) in most European countries, New Zealand and Australia, and for AK in the US. Market authorisation applications 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.
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.
PhotoCure, the PhotoCure logo, Aktilite, Metvix and Hexvix are trademarks or registered trademarks of PhotoCure ASA.
For further information, contact:
PhotoCure ASA
Attn. Vidar Hansson, CEO
Hoffsveien 48
NO-0377 Oslo
Norway
www.photocure.com
E-mail: vh@photocure.no
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 18Mobile: +47 90 73 78 72