Oslo, Norway, April 20th, 2006.
PhotoCure ASA has received a non-approvable letter from the United States Food and Drug Administration (FDA) related to the Hexvix new drug application (NDA). FDA has requested additional analyses and information.
PhotoCure will, together with its US regulatory advisors, initiate a discussion with FDA to better understand the additional requirements necessary to obtain approval for Hexvix from the agency. This discussion will take place over the coming months.
PhotoCure is currently conducting a multicenter phase III clinical study for Hexvix in the EU/US. This study is not part of the initial application and may provide useful supplementary clinical data. This study is scheduled to be concluded in 2007.
Dr. Kjetil Hestdal, President and CEO of PhotoCure, comments: "We are disappointed with this initial decision by the FDA. However, we will continue our constructive dialogue with the agency with the aim to agree upon the actions that must be taken to address the deficiencies identified by the FDA."
Hexvix has previously been approved for the detection of bladder cancer in patients with known or suspected bladder cancer in 27 European countries.
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.