Oslo, Norway, April 21, 2009.
Photocure ASA announces today that Metvix® in combination with Aktilite® CL128, the LED based narrow band (630 nm) red light technology device, has been approved by Health Canada for the treatment of actinic keratosis (AK, pre-cancerous skin lesion) and superficial basal cell carcinoma (sBCC, skin cancer).
Galderma Canada Inc., an affiliate of Photocure's global licensing partner Galderma S.A., expects to launch Metvix and Aktilite during 2009. The application comprised data from pivotal studies conducted by Photocure and Galderma. In the pivotal studies on AK, 211 patients with multiple AKs in face or scalp were treated with Metvix Cream or placebo prior to illumination with Aktilite. Both studies showed significantly better response with Metvix compared to placebo at 3 months after treatment. The pivotal study for the sBCC indication included 196 patients treated with either Metvix or excision surgery. Three months after treatment the reduction in lesion count was nearly 90 % and similar for the two treatments. One year after treatment the cosmetic outcome was significantly better for the patients treated with Metvix compared to the patients who had surgical treatment. The results confirmed the excellent results seen in earlier phase III studies with Metvix.
Kjetil Hestdal, President and CEO of Photocure comments: "The approval of Metvix Cream in combination with Aktilite CL128 in Canada is an important approval for Photocure. We are looking forward to the launch of Metvix and Aktilite in this interesting market".
Metvixia(TM) is approved for the treatment of actinic keratosis in the US (Metvixia is the US trade name for Metvix). In EU/EEA Metvix is approved for treatment of actinic keratosis, Bowen's disease and basal cell carcinoma. Metvix is marketed by Photocure in the Nordic region, and by Galderma in the rest of the world.
Actinic keratosis (AK) is the most common premalignant skin lesion, frequently found on the hands, arms, head and other sun exposed areas. AK can develop into squamous cell carcinoma (SCC), which is an aggressive type of cancer that grows invasively into deeper layers of the skin and can spread and form metastases.
Basal cell carcinoma (BCC) is the most common malignant skin cancer. They are locally aggressive tumours that rarely metastasise (spread to other organs), but destroy surrounding tissue.
Bowen's disease (BD) is a pre-stage of SCC where the tumour has not spread, but has the potential to progress into invasive squamous cell carcinoma. It usually looks like a slow growing red, scaly patch.
Photodynamic therapy (PDT) is an effective, targeted treatment that destroys precancerous and cancer cells without harming surrounding tissue. Red light is used to activate a light sensitive substance that accumulates selectively in precancerous and cancer cells.
For further information, contact:
President and CEO Kjetil Hestdal
E-mail: kh@photocure.no
Mobile: +47 913 19 535
Office: +47 22 06 22 10
CFO Christian Fekete
E-mail: cf@photocure.no
Mobile: +47 916 42 938
Office: +47 22 06 22 10
www.photocure.com
Photocure has two proprietary pharmaceutical products on the market: Metvix®, for the treatment of sun-damaged skin and certain types of skin cancer, and Hexvix®, for the diagnosis of bladder cancer. In addition, the company has developed a proprietary light source, the Aktilite® lamp, which is used in combination with the Metvix cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products and technologies.
Photocure®, Metvix®, Hexvix® and Aktilite® are registered trademarks of Photocure ASA.