PhotoCure obtains IND from the FDA for Hexvix®
PhotoCure ASA announced today that an Investigational New Drug application submitted to the US Food and Drug Administration (FDA) for its new photodiagnostic agent Hexvix® has been granted. As a result, PhotoCure is now in a position to start the final conclusive Phase III clinical studies in the US with Hexvix® for fluorescence cystoscopic detection of bladder cancer. These studies will start shortly.
A Phase III study, designed to compare Hexvix® to standard white light cystoscopie, will be started in the US as soon as possible. This study will be performed as a multicenter trial in collaboration with approximately 20 highly recognised hospitals across the US. This study, together with two other multicenter studies in Europe, where more than 30 leading hospitals across 9 countries are participating will provide the clinical data needed to support the product's planned regulatory submissions for the international marketing authorisation application.
Professor Vidar Hansson, PhotoCure's CEO and President, commented: "This is another important milestone in the development of our second pharmaceutical product, Hexvix®, particularly as it follows on so quickly from the recent European approval of our lead product Metvix®, for the treatment of actinic keratosis and basal cell carcinoma." He added, "The results from the Hexvix® clinical development programme so far have been very encouraging, and we are optimistic that we will get equally good results in our crucial Phase III studies. If these studies progress as we anticipate, we expect to submit applications for marketing authorisation of Hexvix® in the world's major pharmaceutical markets during the first half of 2003."
On a final note Hansson says: "The US market has over the last few years often turned out to represent half the world market for new pharmaceuticals, and it is therefore very positive that we already in the clinical testing phase establish a strong relationship with key opinionleaders on this continent."
Bladder cancer is the sixth most common malignant disease worldwide. In 1990, more than 50,000 new cases were reported in the US and 66,500 cases in Europe. Every year more than 2.5 million cystoscopies (bladder inspections) are performed in Europe and North America in order to diagnose or rule out bladder cancer. The commercial potential for Hexvix® fluorescence cystoscopy is therefore very promising.