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PhotoCure - British Journal of Urology Publishes Paper on Hexvix(R)


3/18/2011 10:13:11 AM

Oslo, Norway 18 March 2011: Photocure (OSE: PHO), a Norwegian pharmaceutical company specialising in dermatology and cancer, announces the publication of a paper on Hexvix® in the peer-reviewed British Journal of Urology (BJU). This publication demonstrates that Hexvix®-guided cystoscopy (Hexvix®), as an adjunct to conventional white-light cystoscopy, improves the detection of bladder cancer and reduces the rate of recurrence as compared to white-light cystoscopy alone. Hexvix is the first approved drug for diagnosis of bladder cancer. Hexvix enhances detection of bladder cancer and enables doctors to carry out more effective tumor removal.

The publication is based on a prospective, randomised clinical trial in 233 patients which was conducted by Photocure in two centres in Denmark. Patients were randomized to either standard white-light transurethral resection of the bladder (TURB) or standard white-light TURB followed by Hexvix. In this study, lesions identified with standard white-light cystoscopy and TURB were removed prior to the Hexvix guided cystoscopy and TURB.

The results of the trial demonstrate that Hexvix identified lesions (including residual tumors) that were not detected with white light alone in 49% of the patients. It also demonstrated that the improved detection of lesions resulted in a significant reduction in tumour recurrence within 12 months.

In the study, 31% of patients who had Ta or T1 tumors at inclusion experienced recurrence with Hexvix-guided cystoscopy compared to 47% with white-light cystoscopy (p=0.05), a relative reduction in recurrence of 36%. Additionally, the recurrence free interval was significantly longer for patients in the Hexvix arm (p=0.02).

“This study demonstrates that Hexvix-guided cystoscopy improves the detection and resection of non-muscle invasive bladder cancer when compared to white-light cystoscopy alone, and that these improvements lead to a reduction in the tumour recurrence after 12 months of follow up” states Gregers Hermann MD, F.E.B.U., Frederiksberg Hospital, principal investigator.

Bladder cancer has the highest rate of recurrence of all cancer types. This results in a very high prevalence of disease which requires patients to return for regular follow-ups and treatment.

The results of this study confirm the results from a large prospective international study published in the Journal of Urology in November 2010. This is the second study to demonstrate that the improved detection of non-muscle invasive bladder cancer with Hexvix cystoscopy leads to a reduction of the bladder cancer recurrence.

For further information, please contact:

Photocure President & CEO Kjetil Hestdal Tel: + 47 913 19 535, Email: kh@photocure.no CFO Christian Fekete Tel: + 47 916 42 938, Email: cf@photocure.no

Capital MS&L Mary Clark, Justine Lamond and Hollie Vile Tel: +44 (0)20 7307 5337, Email: Photocure@capitalmsl.com

About Photocure ASA

Photocure ASA is a worldwide leader in photodynamic therapy. Listed on the Oslo Stock Exchange (OSE: PHO), Photocure develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications. The company strives to solve unmet needs by developing new and innovative solutions based on its patented Photocure Technology™. Photocure markets and sells its own products in selected markets and has developed strong partnerships with leading pharmaceutical companies on a regional and global basis. Photocure’s bladder cancer diagnostic product, Hexvix® is approved in the European Union and the US. Setting new standards for diagnosis and treatment of several different conditions, Photocure Technology™ is very selective, targeting only diseased cells and preserving healthy tissue. Photocure Technology™ is being tested for new products and indications including acne, improving the appearance of skin (Allumera™), diagnosing colon cancer (Lumacan® which is outlicensed to Salix Pharmaceuticals) and the treatment of pre-malignant cervical lesions (Cevira®).

Photocure, Inc. is the marketing and sales subsidiary of Photocure ASA in the US. It is located in Princeton, NJ.


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