Oslo, Norway, 8 July 2003
PhotoCure ASA (Oslo, Norway) and Karl Storz GmbH & CO. KG (Tuttlingen, Germany) have signed a formal collaboration agreement for the development and commercialisation of PhotoCure's photosensitizing product, Hexvix®, and Karl Storz' D-light system. The two products will be tested together for the diagnosis of bladder cancer with the objective of obtaining marketing authorisation for both the products in the USA.
Karl Storz has a world wide presence and is a leading manufacturer of advanced endoscopes, instruments and equipment for use in minimal invasive surgery, including urology. Over the past fifty years, the company has introduced several innovative products around the world. The D-light system is already approved in Europe and through the collaboration with PhotoCure, the company is aiming to obtain marketing authorisation in the USA, based on data from the clinical trials that the two companies are conducting together.
Through former collaboration, the two companies have completed the European regulatory application for Hexvix®, based on clinical trials performed in 28 leading urology clinics in Europe. A comprehensive program is now ongoing in the USA and Canada, including 19 leading urology clinics. The NDA (New Drug Application) for Hexvix® and the PMA (Premarket Approval Application) for the D-light system will be submitted next year. Following approval of Hexvix® and the D-light system in the USA, there will be a period of exclusive marketing collaboration between the two companies.
Sybill Storz, president and CEO of Karl Storz, comments: "This collaboration is important for Karl Storz, with regard to the commitment we have towards our customers in the urology market and for our strive for continuous technology innovation."