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Blue Light Cystoscopy with Hexvix® reduces recurrence rate at 3 years in real-life experience study

Oslo, Norway, August 18, 2017: Photocure ASA (OSE: PHO) today announced that a prospective controlled study investigating the introduction of Blue Light Cystoscopy (BLC™) with Hexvix® at first presentation in patients with non-muscle invasive bladder cancer (NMIBC) in routine clinical practice has been published in the World Journal of Urology.

http://bit.ly/RealLifeBLCC

The overall recurrence rates at 3 years were significantly less in patients who received BLC with Hexvix® (39.0%) compared to an optimized White Light Cystoscopy (WLC) resection (53.3%; p=0.02). The benefit on the recurrence rate was most pronounced in patients with high-risk disease of (52.1% recurrence at year 3 with BLC with Hexvix® versus 80% with WLC; p=0.01).

In this investigator initiated and independent real-life experience study, conducted at a single center in the UK data were prospectively collected on all new patients over 4 years on all new tumour resections. Of 345 patients with resection meeting strict "good quality criteria", 135/153 who underwent resection with white light (WLC) and 146/192 patients who underwent resection guided by BLC™ with Hexvix® were assessed and compared for recurrence at 3 years.

“These long-term recurrence rate results from this high quality prospective real-life experience study are extremely reassuring.  They reinforce the results from randomized clinical trials and show that BLC with Hexvix®/Cysview® provides long-term benefits in real-life clinical settings for NMIBC patients. The results also strengthen the recommendation to use BLC™ with Hexvix®/Cysview® for all first bladder cancer resections,” says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

About Bladder Cancer
There are 167 000 new cases of bladder cancer in Europe and more than 59 000 deaths from the disease annually. Approx. 75% of all bladder cancer cases occur in men1,2. It has a high recurrence rate with an average of 61% in year one and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all 3,4. Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to 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 2.

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.  Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall.  NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat5.

About Hexvix®/Cysview® 
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM).  BLCTM with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US and the Nordic region, and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO). More information about Photocure is available at www.hexvix.com, www.cysview.com

For more information, please contact:

Company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no

Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no

1. Globocan. Incidence/mortality by population.  Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2. Leal et al, Eur Urol 2016; 69: 438-447
3. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al. EAU Guidelines on non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40.
4. Sievert KD et al. World J Urol 2009;27:295–300 
5. Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.

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