The Food and Drug Administration (US FDA) has informed Photocure that the new drug application (NDA) for Hexvix for detection of non-invasive papillary bladder cancer may be approved pending approval of the PMA for the Karl Storz photodynamic diagnosis system and final agreements between Photocure and US FDA on labelling, and post-marketing commitments. The photodynamic diagnosis system is the blue light cystoscopy system that will be used with Hexvix on the US market. Photocure expects the pending issues to be agreed with US FDA within the first half year of 2010.

Hexaminolevulinate is marketed under the name Hexvix in EU. The name to be used in US is currently being discussed with the US FDA.

Photocure submitted the NDA on 30 June 2009 and achieved a priority review in August 2009. The NDA includes data from one pivotal and four supportive phase-3 studies. The pivotal phase-3 study in 814 patients showed a significantly improved detection (p=0.001) of non-invasive papillary bladder cancer using Hexvix cystoscopy compared to standard white light cystoscopy in patients with suspicion of non-invasive papillary bladder cancer. The improved detection was followed by a significant reduction (p= 0.026) in recurrence at nine months. All supportive phase-3 studies confirmed the improved detection using Hexvix.

GE Healthcare licensed the global marketing and distribution rights for Hexvix from Photocure in 2006. Photocure will, according to the License Agreement with GE Healthcare, receive a milestone payment when the NDA and the PMA for the medical device is approved. The medical device is the blue light cystoscopy system from Karl Storz GmbH. This system is currently under a PMA review by US FDA.

Kjetil Hestdal, president and CEO of Photocure commented, “We are pleased that US FDA acknowledge the medical need for improved detection of bladder cancer. We believe this new product will result in significant patient benefit in the diagnosis and management of bladder cancer. In Europe Hexvix has already been used by over 57, 000 patients since approval in 2005. We look forward to US FDA’s approval and the subsequent launch by GE Healthcare on the US market.”

Photocure develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.