Oslo, Norway, 30 June 2005: PhotoCure ASA announces today that a New Drug Application (NDA) has been submitted to the US Food and Drug Administration (FDA) for Hexvix for use in bladder cancer diagnosis during cystoscopy.  

Dr Kjetil Hestdal, President and CEO of PhotoCure, comments: "This is a major step towards obtaining marketing authorisation for Hexvix in the US, the largest single market worldwide. The NDA is submitted only four years after the development was initiated."

The NDA is based on the same phase III studies that formed the basis for the European approval of Hexvix. The application concerns carcinoma in situ (CIS), which is a highly malignant superficial bladder cancer with high recurrence and progression rates. The efficacy and safety of Hexvix have been documented in three clinical phase III studies in Europe and the US/Canada. The studies show that Hexvix detects 23% more patients with CIS than current methods.

In developing this innovative technology, PhotoCure has collaborated with Karl Storz Endoscopy-America (KSEA) in the US on clinical studies in which Hexvix was used in combination with the Karl Storz D-Light Imaging System for performing blue-light cystoscopy. In addition, KSEA will submit a premarket approval (PMA) application for the Karl Storz D-Light System in the US.

Key clinical investigator Dr H. Barton Grossman, Professor at M. D. Anderson Cancer Center comments: "Among cancer patients, US health care expenditure is highest in patients with bladder cancer. Therefore, new diagnostic methods and treatments are highly needed to improve the management of these patients."

Bladder cancer is the third most common malignant cancer worldwide, with approximately four million cystoscopies performed in the USA and Europe every year. Patients have a good prognosis if diagnosed early and treated adequately. Hexvix is an innovative and effective diagnostic method that can be used for all types of bladder cancer, and will be used as a supplement to current standard methods. Hexvix gives a more accurate diagnosis than current methods and will therefore provide health economic benefits.