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Hexvix real world evidence show improved recurrence free survival and health care savings

Oslo, Norway, 14 March 2016: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, is pleased to announce presentations  by urology researchers on Hexvix during the European Association of Urology (EAU) annual meeting held in Munich, Germany 11-15 March 2016.  The EAU is one of the largest International meetings in urology, showcasing the latest and most relevant knowledge with more than 12,000 urologists and exhibitors from over 100 countries.  Hexvix is a photosensitizing agent taken up selectively by the tumor cells in the bladder that when exposed to blue light during a cystoscopic procedure results in a bright pink fluorescence of the suspicious tissue.  Using Hexvix as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Dr. Kjetil Hestdal, President  & CEO of Photocure ASA comments: "We are delighted to see the expanding body of evidence supporting Hexvix and its role in the detection and management of bladder cancer.  Real world data now demonstrates the clinical and health economic benefits of Hexvix in a day-to-day clinic setting supporting its widespread use. As more urologists are exposed to the continued flow of data with Hexvix, more patients will have access to its substantive benefits."

The Hexvix evidence from theory with its unique mode of action, randomized clinical trials, and real world evidence were presented by Professor Dr. Maximillian Burger, Chair of Urology of the University of Regensburg during a symposium "Moving Forward in Urological Cancers" sponsored by Ipsen Uro-oncology, strategic commercialization partner for Hexvix in Europe, excluding the Nordic region.    

Burger highlighted that bladder cancer is often under recognized and undertreated.  Despite the large majority of the audience voting that they follow the guidelines he stated that there is still room for improvement.  He concluded that "Hexvix has been proven to offer significant benefits in the detection and reduction in recurrence rates and emerging real world evidence now confirms these findings, and even indicates better patient outcomes- especially in high risk non-muscle invasive bladder cancer (NMIBC) patients, where it matters most.  The strong real world data can give us even more confidence managing patients in our daily clinical practice.  It improves recurrence free survival and there are significant savings to the health care system as every third follow up TURB can be avoided."

Hexvix is recommended for use in the diagnosis and management of NMIBC patients in the EAU guidelines, NICE guidelines as well as a number of country specific guidelines across Europe. The EAU guidelines for the management of non-muscle invasive bladder cancer (NMIBC) have been developed after thorough assessment of all clinical, safety and outcomes evidence to provide recommendations on the best practice for managing these patients, from diagnosis through treatment.  

However, there is currently considerable variability across Europe with adherence to EAU guidelines, as reported in a poster presentation by Dr. E. N. Xylinas, Cochin Hospital, Paris Descartes University. "Improved adherence to the EAU guidelines on the management of patients with NMIBC would ensure all patients across Europe have access and may benefit from the optimal methods for detecting and managing the disease like Hexvix Blue-Light cystoscopy" concludes Dr. Xylinas.  

For further information, please contact:

Kjetil Hestdal
President and CEO
Photocure ASA
Tel. +47 913 19 535
KH@photocure.com

About Photocure ASA

Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical company and world leader in photodynamic technology.  Based on our unique propriety Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions in disease areas with high unmet medical needs such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions.  Our aim is to provide solutions that can improve health outcomes for patients worldwide.  Photocure is listed on the stock exchange (OSE: PHO).  Information about Photocure is available at www.photocure.com

About Hexvix®/Cysview®(USA name)

Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence. Hexvix®/Cysview® is approved in Europe, USA and Canada.

About bladder cancer

Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple surveillance cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4,9 billion Euro in 2012.There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)

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