Metvixia(TM) and Aktilite® CL128 approved by FDA
Oslo, Norway, 27 June 2008: Photocure ASA announces today that Metvixia(TM) in combination with Aktilite® CL128, the LED based narrow band (630 nm) red light technology device has been approved by US Food and Drug Administration (FDA) for the treatment of actinic keratosis (AK), a pre-cancerous skin lesion.
The supplement to the NDA for Metvixia (Metvixia(TM) is the US trade name) submitted 28 June 2007, comprised documentation on the new medical device Aktilite CL128 developed by Photocure as well as data from two new pivotal and three supportive phase 3 studies to document the efficacy of Metvixia in combination with Aktilite CL 128. In the pivotal studies 211 patients with multiple AKs in face or scalp were treated with Metvixia Cream or placebo prior to illumination with Aktilite. Both studies showed significantly better response with Metvixia compared to placebo at 3 months after treatment. The results confirmed the excellent results seen in earlier phase 3 studies with Metvixia photodynamic therapy (PDT).
Actinic keratosis affects more than 10 million Americans.
Kjetil Hestdal, President and CEO of Photocure comments: "The approval of Aktilite CL128 in combination with Metvixia Cream in the US, the largest pharmaceutical market in the world is a major achievement for Photocure. With the implementation of the new treatment guidelines for AK where PDT is recommended as first line therapy, we have great expectations for Metvixia PDT in the US. Galderma is well prepared and will be able to launch shortly after the approval."
Metvixia PDT (known as Metvix® outside the United States and France) is approved in the EU/EEA 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 keratoses (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 ASA is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer.
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.