Oslo, Norway, 19 December, 2001.
PhotoCure ASA, a leader in photodynamic therapy (PDT), today announced that it has signed an exclusive global licensing agreement with Galderma S.A. for Metvix® PDT, PhotoCure's new approved treatment for certain cancerous and pre-cancerous dermatological conditions. The agreement gives Galderma the exclusive right to market both the Metvix® cream and PhotoCure's activating light sources outside of the Nordic region. Galderma, which is a joint venture between Nestlé and L'Oréal, is the only global company exclusively dedicated to providing dermatological treatments.
Under the terms of the agreement, PhotoCure will, in addition to royalties, receive 12 million Euro upon signing and a further 18 million Euro as milestone payments linked to market authorisations and launch in certain key markets. PhotoCure will also receive further significant milestone payments from Galderma based on the global sales performance of Metvix® for sales exceeding 25 million Euro per year as well as payments for the manufacture of the light sources and the Metvix® cream. Regardless of sales, PhotoCure is entitled to receive significant guaranteed amounts in royalties and milestone payments during the five years following marketing approval of Metvix® in the US.
Following an initial period, Galderma will assume the responsibility for the manufacturing of Metvix®, while PhotoCure will continue to receive payments for the supply of the active ingredient, methyl aminolevulinate (MAL).
PhotoCure will continue to be responsible for marketing authorisation applications in the EU, US, Australia and New Zealand where Metvix® has already been filed, while applications submitted to other countries will be managed by Galderma. Metvix® is already approved for basal cell carcinoma (BCC), and pre-cancerous skin lesions or actinic keratoses (AK) in 14 European countries.
Under certain conditions, PhotoCure has granted Galderma the right to market Metvix® for additional indications. For such indications where PhotoCure and Galderma agree on a development plan, Galderma will fund 75% of the development costs. PhotoCure will also receive further milestone payments and royalties if Metvix® receives regulatory approval for new indications.
"Metvix® is a great opportunity for Galderma and will allow the us to expand into an area of major interest to dermatologist world wide, and Galderma intends to invest significant resources in the marketing of this product. The incidence of BCC and AK is increasing due to more sun exposure and an ageing population, says Xavier Yon, Galderma's President and CEO."
Professor Vidar Hansson, PhotoCure's CEO and President comments, "We see today's agreement as the most significant step so far in the commercialisation of our lead product, Metvix® PDT. This partnership with Galderma allows us to make Metvix® available to patients globally and to move closer towards our goal of becoming a worldwide leader in photodynamic therapy. We are very happy to partner with Galderma, the most focused and dedicated company in dermatology, and we look forward to working with them."
PhotoCure ASA is a Norwegian listed company with the mission to develop and sell pharmaceuticals and medical devices based on proprietary photodynamic technologies. The company develops products for skin cancer and other skin diseases, internal cancer, gene therapy and cancer vaccines. Metvix® PDT is approved 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 phase III 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.
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 2001 will reach 585 million Euro.
Metvix® PDT is an innovative skin cancer treatment that combines the local application of a cream (Metvix®), which is selectively absorbed into the cancer cells, followed by activation of the drug through illumination with a proprietary red light source (Curelight). Metvix® PDT kills cancer cells and leaves the normal skin intact, thereby leaving the healed skin without scars or blemishes. Metvix® is approved for non-melanoma skin cancer, basal cell carcinoma (BCC) and pre-cancerous skin lesions, actinic keratosis (AK), in most European countries, while market authorisations are pending in the US, Australia and New Zealand.
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 associated with 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 more information contact:
PhotoCure ASA
Attn. Vidar Hansson, CEO
Hoffsveien 48
0377 Oslo
Norway
www.photocure.com
E-mail: vh@photocure.no
Telephone: +47 22 06 22 10
Fax: +47 22 06 22 18
Mobile: +47 90 73 78 72
Galderma S.A.
Attn. Xavier Yon, CEO
Tour Europlaza - La Défense 4
20, avenue André Prothin
F-92927 La Defense Cedex
France
www.galderma.com
E-mail: xavier.yon@galderma.com
Telephone: +33 1 58 86 45 46
Fax: +33 1 58 86 45 01