Photocure ASA

Legal Proceedings Report • Aug 18, 2017

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

Photocure ASA: 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(TM)) 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(TM)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(TM)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(TM) 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(TM) with Hexvix®/Cysview® provides long-term benefits in

real-life clinical settings for NMIBC patients. The results also

strengthen the recommendation to use BLC(TM) 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.photocure.com, 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.