Phase IV Programme for Metvix PDT in Non-Melanoma Skin Cancer

Main Category: Melanoma / Skin Cancer
Article Date: 19 Nov 2004 - 14:00 PDT

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Galderma today gave details of its extensive ongoing Phase IV clinical trial programme for Metvix� PDT involving more than 800 patients with non-melanoma skin cancer (NMSC) in 96 sites worldwide.

Details of the programme, composed of eight different studies, were released today at the 13th congress of the European Academy of Dermatology and Venereology (EADV) in Florence, and will add to the substantial data already available on Metvix�. In terms of evidence-based medicine among currently available NMSC treatments, Metvix� PDT is already the treatment with the most extensive comparative clinical evidence.

"This is an exciting series of trials", said Dr Pascale Soto, Head of the Phase IV Group at Galderma R&D, Sophia Antipolis. "NMSCs such as basal cell carcinoma (BCC) and actinic keratosis (AK) are common skin conditions caused by sun damage to the skin. Together these conditions represent a significant and growing healthcare burden for countries where the incidence is particularly high such as in Australia, Europe and in the US. This extensive Phase IV programme will give us the clearest picture yet of the efficacy of Metvix� PDT in the treatment of AKs and BCCs in a broad range of patients."

The studies will extend knowledge about the efficacy of Metvix� PDT against established methods of NMSC management such as surgery and cryotherapy. Although surgery and cryotherapy are effective, they can lead to scarring and discolouration, which is particularly problematic for patients who have multiple lesions on their face or other visible areas.

In contrast, Metvix� PDT is a highly selective and non invasive treatment. Metvix� PDT is very effective in treating AK and BCC but does not damage healthy surrounding skin, giving a superior cosmetic outcome compared with more invasive therapies.

Metvix�'s efficacy is also being studied in specific patient populations such as transplant patients and high risk patients.

The Phase IV programme is ongoing in 96 sites across the world. Countries involved in studies include Australia, Belgium, Germany, Italy, Spain, Switzerland and the UK.

The results of the first study in transplant patients are expected to be available in 2005.

For further information please contact:

Tara Breen
Hill & Knowlton
Tel: +44 207 413 3760
Mob: +44 7813 252673
Email: tbreen@hillandknowlton.com

Craig Haslop (Onsite at EADV)
Hill & Knowlton
Tel: +44 207 413 3516
Mob: +44 7971 884723
Email: chaslop@hillandknowlton.com

Metvix�

Metvix� is a novel skin cancer treatment that combines local application of a cream (Metvix�), which is selectively absorbed into the cancer cells, and illumination with a proprietary red light source (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 the treatment of 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 is responsible for the marketing and sales of Metvix in the rest of the world.

Galderma

Galderma is a 50/50 joint venture of L'Or�al and Nestl� and is a leading research-based pharmaceutical company dedicated to the development and marketing of novel prescription treatments for dermatological diseases. Devoted exclusively to dermatology, 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 850 medical sales representatives it reaches almost every dermatologist in the world. Sales in 2003 were 613 million euros.

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