PhotoCure - Hexvix® approved in 26 European countries

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Oslo, Norway, 2 March 2005.


PhotoCure ASA announces today that Hexvix has been approved for the diagnosis of bladder cancer in 26 EU/EEA countries through the European Mutual Recognition Procedure.


The recognition of the approval issued in Sweden in September 2004 is the result of a 90-day approval procedure in the following 26 EU/EEA countries:


Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, United Kingdom.


National marketing authorisations in each of the 26 countries will be issued following the approval of the Hexvix product information for doctors and patients in the local language.


Hexvix is approved for the detection of bladder cancer in patients with known or suspected bladder cancer, and will be the first product on the market that improves cystoscopic diagnosis of bladder cancer. The unanimous approval of Hexvix throughout Europe reflects the need for improvement in bladder cancer diagnosis.


Dr. Kjetil Hestdal, President and CEO of PhotoCure, comments: "Our team has once again made an outstading effort, getting Hexvix approved only three years after the first clinical trials. Our new product has a great market potential, and PhotoCure will now focus on launch preparations in the Nordic countries and establishment of partnerships for marketing and sales in other markets."


Bladder cancer is the third most common malignant disease 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 Imaging 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. It is in particular effective for carcinoma in situ (CIS), a highly malignant cancer that is difficult to see with standard white light cystoscopy. Hexvix gives a more accurate diagnosis than current standard methods and will therefore provide health economic benefits.


At the first regulatory approval of Hexvix in September 2004, Professor Fred Witjes, Radboud University Nijmegen Medical Centre, Netherlands, stated: "Hexvix Imaging provides major improvement to the diagnosis of bladder cancer compared to the gold standard techniques used today. This also significantly improves patient care, and I am convinced that urologists will use this method once it becomes available on the market."

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