GE Healthcare to distribute optical imaging agent for bladder cancer

10 January 2005

PhotoCure ASA of Norway has granted GE Healthcare exclusive global rights outside of the US and the Nordic region to market and distribute PhotoCure’s product Hexvix (hexaminolevulinate), an optical molecular imaging agent intended for the diagnosis and monitoring of bladder cancer. PhotoCure will be responsible for manufacturing and Nordic distribution of the product. The licensing agreement includes an exclusive option for GE Healthcare to market and distribute the product in the US.

Hexvix has received approval for the diagnosis of bladder cancer in a large number of European countries through the European mutual recognition procedure, with more expected in the near future. This product is not currently approved by the U.S. Food and Drug Administration (FDA). However, a New Drug Application (NDA) was submitted in June 2005 in the United States and if approved by the FDA it would be the first optical molecular imaging agent of its kind available to the US market. GE’s agreement includes access to other indications for the product currently under evaluation and testing by PhotoCure.

“This is a great match. With its focus, strong market position in imaging and successful track record of launching new products, GE Healthcare is the ideal partner for establishing Hexvix as a tool in the diagnosis of bladder cancer”, said Kjetil Hestdal, president and CEO, PhotoCure.

“We believe our partnership with PhotoCure will result in significant patient benefit in the diagnosis and management of bladder cancer,” said Daniel L. Peters, president of Medical Diagnostics at GE Healthcare. “This partnership underscores GE Healthcare’s commitment to addressing the unmet clinical needs of physician customers and to enhancing the quality of patient care through new approaches to the diagnosis and monitoring of disease.”

Optical imaging is an imaging modality with the potential to provide new applications in the prevention and treatment of bladder cancer as well as other diseases. Optical imaging uses light to illuminate superficial tissue — such as bladder tissue. By combining this technology with an optical molecular imaging agent, tumours might be targeted more accurately. Optical imaging may enhance the diagnostic abilities of urologists and allow for improved patient care.

“Fluorescent optical imaging is a core GE Healthcare competency and we have several applications of this technology in our Discovery Systems business, including the cellular analysis research tools and pre-clinical imaging systems we provide to our pharmaceutical customers for drug development,” said Peters.

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