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Photocure ASA

Earnings Release Oct 23, 2017

3714_rns_2017-10-23_74f638b5-a8e9-4a54-9113-cbeb7f39f648.html

Earnings Release

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Photocure ASA: BLC(TM) with Cysview®/Hexvix® real World Data presented at the Société Internationale d'Urologie 2017 Annual meeting

Photocure ASA: BLC(TM) with Cysview®/Hexvix® real World Data presented at the Société Internationale d'Urologie 2017 Annual meeting

Oslo, Norway, October 23, 2017 Photocure ASA announced that new data

from the Blue Light Cystoscopy (BLC(TM)) with Cysview®/Hexvix®

registry study were presented at the 37th Société Internationale

d'Urologie (SIU) Annual meeting, October 19-22, Lisbon, Portugal.

Data from the registry study, which is the largest US Bladder Cancer

Registry Study, showed that BLC with Cysview resulted in an

upstaging or upgrading of tumor with change in patient management in

13% of patients. The addition of BLC with Cysview to standard WLC

increased the detection rate by 12% for any papillary and 44% for

the more aggressive CIS (Carcinoma in Situ) bladder cancer lesions.

The BLC with Cysview Bladder Cancer Registry Study is a prospective

multicenter registry that included patients undergoing Transurethral

Resection of Bladder Tumors (TURBT) from nine sites. The results

presented included 533 patients who underwent 641 BLC with Cysview

procedures, resulting in the identification of 1632 lesions.

"In this study, BLC(TM) with Cysview significantly increases

detection rates of CIS and high-grade lesions compared to WLC alone.

This in turn, resulted in a change in management for 13% of the

patients, which can lead to an improvement in outcomes for these

patients" says Dr. Siamak Daneshmand, Associate Professor of Urology

(Clinical Scholar), Director of Urologic Oncology, at the University

of Southern California Institute of Urology and study investigator.

Dr. Daneshmand also presented a Video Abstract which highlighted

different scenarios producing false-positive data. The video

referenced simple techniques to avoid false-positives (FP) and noted

that reported FP rates of BLC decrease with experience and

recognition of these scenarios.

"This registry study demonstrates how BLC with Cysview/Hexvix is

changing clinical outcomes, and provides more real world Data to

further support its clinical use," said Kjetil Hestdal, M.D., Ph.D.,

President and CEO, Photocure ASA.

Link to congress scientific program: http://bit.ly/2yIbv7N

About Bladder Cancer

Bladder cancer ranks as the ninth most common cancer worldwide with

430 000 new cases and more than 165 000 deaths annually. Approx. 75%

of all bladder cancer cases occur in men1. It has a high recurrence

rate with an average of 61% in year one and 78% over five years2.

Bladder cancer has the highest lifetime treatment costs per patient

of all cancers3.

Bladder cancer is a costly, potentially progressive disease for

which patients have to undergo multiple cystoscopies due to the high

risk of recurrence. 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 treat.4

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

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

Company contacts:

Kjetil Hestdal, President and CEO

Tel: +47 913 19 535

Email: [email protected]

Erik Dahl, Chief Financial Officer

Tel: +47 450 55 000

Email: [email protected]

References:

1. Globocan. Incidence/mortality by population. Available at:

http://globocan.iarc.fr/Pages/bar_pop_sel.aspx

2. 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. 3.

Sievert KD et al. World J Urol 2009;27:295-300 4. Bladder Cancer.

American Cancer Society.

http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-

pdf.pdf. Accessed April 2016

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