GE Healthcare has held the licence to market, sell and distribute Hexvix since 2006. GE Healthcare continues to have the highest confidence in the product, but since urology is not a core business area for the company, Photocure has renegotiated the global licensing agreement enabling it to license the marketing rights for Hexvix to Ipsen and to commercialise the product directly in the US.
Stephen Lightfoot, COO, Medical Diagnostics, GE Healthcare said:
"We have had a successful collaboration with Photocure and are proud to have launched Hexvix/Cysview and to have worked with the product over the last six years. Urology is not a core business area for GE Healthcare and we believe a company that is dedicated to urology will be better placed to enable Hexvix to reach its full market potential and benefit more patients."
About HexvixHexvix/Cysview ((hexaminolevulinate hydrochloride) for intravesical solution), is the first approved drug-device procedure for improved detection of bladder cancer. It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect non muscle invasive bladder cancer, as an adjunct to white light cystoscopy. Clinical data show an up to 30% increase in detection of the malignant cells in the bladder as compared to the white light system, bringing the total detection rate to 96% [3,4]. Hexvix also showed a 32% increase in detection of carcinomas in situ, where tumor cells have not yet penetrated in deep tissues, but carry high risk of progression . It is the first product in a new diagnostic class known as photodynamic diagnostic (PDD) agents. The product is used in combination with a blue light cystoscopy system. Blue light cystoscopes are broadly available across Europe, where there are an estimated 800 systems currently placed. In the US there are currently only a few systems available. Karl Storz has submitted a supplement to the approved PMA to the FDA for an improved blue light system. This system is similar to the model sold in Europe. Karl Storz estimates that FDA will respond to this application in the fourth quarter 2011. In November, 2010, clinical results from a follow up of recurrence in patients with Non Muscle Invasive Bladder Cancer were published . Results, based on both EU and US clinical data, showed a long term benefit of the use of Hexvix compared to patients who received white light cystoscopy alone. The number of patients who have experienced recurrence of their bladder cancer is significantly lower, and the time it takes before the recurrence occurs is longer when they had Hexvix-guided fluorescence cystoscopy, although this has not yet been approved by the relevant regulatory authorities. Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women in the US. More than 70,000 people in the US were diagnosed with cancer of the bladder in 2009, with an estimated 14,000 people dying from the disease, according to the National Cancer Institute. In Europe, bladder cancer is the seventh most common type of cancer in men and the fourteenth in women . Each year in Europe, approximately 36,500 men and 13,000 women die due bladder cancer (Ferlay et al., 2001).It is notoriously difficult to detect. The most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy. Important Risk and Safety Information about Cysview (hexaminolevulinate HCl)
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