PhotoCure- Marketing approval for Hexvix®
Oslo, Norway, 20 September 2004
PhotoCure has today received information from the Swedish regulatory authorities that the review for marketing approval for its novel imaging drug Hexvix is finished and formal notice will be given early this week.
Hexvix is approved for detection in patients with known or suspected bladder cancer. This product is the first on the market that improves cystoscopic diagnosis of bladder cancer. This marketing authorisation for Hexvix will pave the way for obtaining marketing authorisations for Hexvix in other EU/EEA member states.
Vidar Hansson, President and CEO of PhotoCure, states "PhotoCure is proud to have achieved marketing approval only 4 years after we started development of Hexvix. Compared to industry standards this is a remarkable achievement."
Bladder cancer is the sixth most common malignant disease worldwide. Approximately 5 million cystoscopies are performed in USA and Europe every year.
Hexvix imaging is an innovative and effective diagnostic method for all types of bladder cancer, in particular cancer lesions such as carcinoma in situ (CIS), which are difficult to see with normal white light cystoscopy but nonetheless highly malignant. Hexvix imaging is easy to use together with a normal cystoscopy. The detection is greatly improved and leads to a more accurate diagnosis with benefits for patients and society."Hexvix imaging provides major improvement to the diagnosis of bladder cancer compared to the golden standard techniques used today," says Professor Fred Witjes, University Medical Center Radboud, Nijmegen, The Netherlands. "This will be the new platinum standard for the diagnosis of bladder cancer, and lead to better treatment for the patients involved."