GE prepares blue light special for Europe

Optical imaging has lumbered along for decades, employed by specialists of body areas typically accessible through a natural opening. Only modest improvements, such as CCD chips for recording analog images, have been made until recently. The development of fluorescent imaging agents promises to uncork new diagnostic potential in optical imaging. Among the first to benefit may be GE Healthcare.

The company in mid-January struck a deal with Norwegian firm PhotoCure to distribute its blue-light-sensitive optical dye, called Hexvix, for use in the diagnosis and monitoring of bladder cancer. The deal assigns distribution rights to GE for all markets except those in the Nordic region, where PhotoCure plans to sell the product directly. With European Union approval of Hexvix already in hand and PhotoCure manufacturing the agent, all GE needs to launch its planned marketing program is the paperwork transferring the right to market this agent in the EU, which could be done by fall 2006. GE expects its European marketing program to be in full swing by year's end. The next step may be transatlantic.

The deal with PhotoCure includes an exclusive option for GE to distribute the agent in the U.S., according to Kathleen Deardorff, vice president of global marketing for medical diagnostics at GE Healthcare. The company has not yet exercised that option, but Deardorff expects this would happen if the agent passes regulatory muster.

FDA approval of Hexvix as a diagnostic agent for bladder cancer could be handed down by the end of 2006, she said. (PhotoCure submitted a new drug application in June 2005.)

GE's efforts surrounding Hexvix only hint at the firm's overall strategy to build a business in optical imaging. Applications addressing colorectal, esophageal, and cervical cancers are in the crosshairs of GE marketing strategists. Each will be approached by combining specific imaging agents and endoscopes. Deardorff declined to comment on when GE might expand into these areas, although the company's agreement includes access to other indications for Hexvix currently under evaluation and testing by PhotoCure. GE also has an R&D program actively looking into optical imaging.

Fluorescent optical imaging is a core competency at GE Healthcare, according to Deardorff. GE incorporates optical technology in cellular analysis research tools and preclinical imaging systems. These instruments are sold mostly to pharmaceutical customers to assist in drug development.

When marketing Hexvix as a diagnostic agent for bladder cancer, GE plans to collaborate with the many makers of cystoscopes. Deardorff said the company will send representatives on sales calls alone and with salespeople from cystoscope manufacturers.

Urologists will be their primary targets. These specialists are the main users of cystoscopes, which are inserted through the urethra to scope the bladder for signs of pathology. The uncomfortable but tolerable procedure uses a flexible cystoscope to inspect tissue and a rigid one to biopsy tissues. Blue-light cystoscopes, already approved in Europe, use Hexvix to enhance the diagnostic process.

Hexvix, after being instilled into the bladder, combines selectively with cancer cells growing in the superficial tissue. This causes the cancer to fluoresce and, thereby, appear more clearly during blue-light cystoscopy.

"Being able to improve the visualization and detection of superficial bladder tumors will help urologists design the appropriate treatment regimen and resect these tumors," Deardorff said.

Multicenter research used to support the application for European approval of Hexvix demonstrated that fluorescence cystoscopy identifies about 30% more patients with the aggressive form of superficial bladder cancer than white-light cystoscopy. Its use is recommended by the European Association of Urology in guidelines released in September.

If approved by the FDA, Hexvix would be the first optical imaging agent for bladder cancer on the U.S. market. Bladder cancer ranks fourth and eighth in men and women, respectively, in global mortality due to cancer. Incidence is expected to increase with rising industrialization, an aging population, and the pursuit of risky lifestyle factors, such as tobacco use.