Photocure Submits Metvixia NDA to FDA
OSLO, Norway, 28 June 2007- Photocure ASA announces today that the Supplement to the New Drug Application (NDA) for Metvixia and Aktilite CL 128 has been submitted to the US Food and Drug Administration (FDA) for the treatment of actinic keratosis (AK), a pre-cancerous skin lesion.
The submission is a supplement to the previously approved NDA for Metvixia (Metvixia is the US trade name). The current supplement comprises data from two new pivotal and three supportive phase 3 studies to document the efficacy of Metvixia in combination with the new lamp developed by Photocure, the 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 confirm the excellent results seen in earlier phase III studies with Metvix PDT
Photocure expect the first response from FDA to the application after 10 months, in May 2008.
Actinic keratosis affects more than 10 million Americans.
Kjetil Hestdal, President and CEO of Photocure comments: "The filing of this supplement is a major step towards accessing the largest pharmaceutical market in the world with Metvix PDT. With the implementation of the new treatment guidelines for AK we have great expectations for Metvix PDT in the US. "
Metvix PDT is approved in the EU/EEA for treatment of actinic keratosis, Bowen's Disease and Basal Cell Carcinoma.
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 cancer cells without harming surrounding tissue. Red light is used to activate a light sensitive substance that accumulates selectively in cancer cells.
For further information, contact: President and CEO Kjetil Hestdal E-mail: firstname.lastname@example.org Mobile: +47 913 19 535 Office: +47 22 06 22 10
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.
Posted: June 2007