Photocure ASA

Earnings Release • Sep 12, 2016

Data published in World Journal of Urology show that Blue Light Cystoscopy with Hexvix® significantly improves detection of NMIBC

Data published in World Journal of Urology show that Blue Light Cystoscopy with Hexvix® significantly improves detection of NMIBC

Oslo, Norway, September 12th, 2016: Photocure ASA

announced today that data from the OPTIC III study:

Optimized photodynamic diagnosis for transurethral

resection of the bladder tumor (TURBT) in German

clinical practice, is now available on line in the

World Journal of Urology:

http://link.springer.com/article/10.1007/s00345-016-

1925-0.

The results of this large 30 center study demonstrate

that Blue Light Cystoscopy (BLC) with Hexvix

significantly improves the detection of NMIBC versus

the standard procedure of white light (WLC) alone in

routine clinical practice in Germany.

"This multicenter, prospective, non-interventional

403 patient study from 30 German inpatient surgical

centers is an unprecedented assessment of the

additional detection of cancer lesions with BLC with

Hexvix versus WLC alone. Data from randomized

clinical studies clearly demonstrates the benefit of

BLC with Hexvix, especially in high risk cases. It now

is encouraging to see the growing body of evidence

supporting such benefit in routine clinical practice

in line with current guideline recommendations," said

Professor Dr. Maximillian Burger, Chair of Urology of

the University of Regensburg, Germany.

"We are excited to see the addition of more real world

data which continues to support the advantages of BLC

with Hexvix. These real life data demonstrating the

benefit of Hexvix/Cysview in a routine clinical

setting highlight the significant value of

Hexvix/Cysview, support the strong data delivered in

randomized clinical trials and the inclusion in

significant guidelines. As more urologists are exposed

to the continued flow of data with Hexvix, we will

continue to see even more patients having access to

its substantive benefits," commented Kjetil Hestdal,

MD, PhD, President and CEO, Photocure ASA.

Ipsen Pharma is strategic partner for Hexvix® in

Europe excluding the Nordic region, and accountable

for marketing in Germany. The OPTIC study was

sponsored by Ipsen Pharma.

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 disease1. 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

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 20122. 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 is still in the

inner layer of cells. These cancers are the most

common (75%) of all bladder cancer 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.

About Hexvix®/Cysview®

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® is the tradename in Europe, Cysview® in U.S.

and Canada. Hexvix® is marketed and sold by Photocure

in the Nordic countries and in the US with the trade

name Cysview®. Photocure has a strategic partnership

with Ipsen for the commercialization of Hexvix in

Europe, excluding the Nordic region. 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 and world leader in

photodynamic technology. Based on our unique

proprietary Photocure Technology® platform, Photocure

develops and commercializes highly selective and

effective solutions within disease areas with high

unmet medical need, such as bladder cancer, HPV and

precancerous cervical lesions, and skin conditions.

Our aim is to provide solutions which can improve

health outcomes for patients worldwide. Photocure is

listed on the Oslo Stock Exchange (OSE: PHO).

Information about Photocure is available at

www.photocure.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

Investor relations:

Trout International LLC

Lauren Williams

Tel: +44 20 3780 4972

Email: lwilliams@troutgroup.com

References

1. Globocan. Incidence/mortality by population.

Available at:

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

(accessed March 2015

2. Leal et al, Eur Urol 2016; 69: 438-447