Oslo, 18 December 2002.
Today PhotoCure ASA submitted a marketing authorisation application (MAA) for Hexvix® fluorescence cystoscopy (visual inspection of the bladder) in Sweden. Hexvix® fluorescence cystoscopy enables better diagnosis of all types of bladder cancer compared to currently available diagnostic methods. This is the first application for marketing authorisation for Hexvix® in any country, and it will pave the way for obtaining market authorisations for Hexvix® in all EU/EEA member states. The clinical studies included in this application have been performed at 20 leading university hospitals across Europe.
Professor Vidar Hansson, President and CEO of PhotoCure comments: "Hexvix®, our second pharmaceutical product, has passed an important milestone on the way to commercialisation in Europe. Hexvix® has a significant market potential due to a large unmet medical need in the diagnosis of bladder cancer and we are very proud to be able to file this application several months earlier than planned."
Hexvix® fluorescence cystoscopy is an innovative and effective diagnostic method for bladder cancer, in particular for the detection of flat cancer lesions such as carcinoma in situ (CIS). CIS lesions are highly malignant and early detection is an important factor for the prognosis of the patient. Hexvix® solution is instilled in the bladder, and after 60 minutes the bladder is inspected with standard white light, followed by Hexvix® fluorescence cystoscopy. A significant and clinically relevant improvement over the use of standard cystoscopy was demonstrated in the clinical studies, both for 'flat' lesions, such as CIS and dysplasia, and for small papillary lesions. The ease of implementing Hexvix® fluorescence cystoscopy as a supplementary diagnostic method to standard cystoscopy and its favourable safety profile ensures adaptability to current standard procedures.
The fact that Hexvix® fluorescence cystoscopy, as an adjunct to the already existing methods, detects 29% more patients with CIS lesions than standard cystoscopy, is compelling clinical evidence that Hexvix® is an efficacious and clinically important product. More accurate and earlier detection of bladder cancer results in better patient management and thus clear benefits for the patient.