The 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 FDA on labeling, 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 FDA within the first half of 2010, said the company.

Hexaminolevulinate is marketed under the name Hexvix in EU. The name to be used in US is currently being discussed with the FDA. The company claims that it has 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 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 reduction in recurrence at nine months. All supportive phase 3 studies confirmed the improved detection using Hexvix, said the company.

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 FDA.