Photocure ASA

Earnings Release • Sep 28, 2016

Photocure: Repeat use of Blue Light Cystoscopy with Hexvix®/Cysview® shows excellent tolerability

Photocure: Repeat use of Blue Light Cystoscopy with Hexvix®/Cysview® shows excellent tolerability

Oslo, Norway, September 28th, 2016: Photocure ASA announced today that a study

published on-line in the peer reviewed Journal of Urology, shows that there is no

significant statistical difference in the frequency or grade of adverse events in

patients having one Blue Light Cystoscopy with Cysview® (BLCC) versus repeat BLCC

procedures. Here is a link to the abstract http://bit.ly/BLCCSafety

This retrospective review of 180 patients who underwent 269 BLCC procedures at two

institutions in the United States compared the incidence and grade of Adverse Events

(AE), after initial and subsequent BLCC procedures. 35% of the patients underwent

BLCC more than once, including 2 patients who underwent BLCC five times.

"We found no statistically significant difference in AEs between those patients

undergoing 1st versus two or more repeat procedures. None of the AEs were classified

as probably or definitely related to BLC with Cysview. These results, along with the

excellent clinical efficacy seen with BLC with Cysview, give those who manage Bladder

Cancer patient's further reassurance in using BLCC repeatedly", said Dr. Badrinath

Konety, Professor and Chair Dept of Urology, University of Minnesota, Associate

Director for Clinical Affairs Masonic Cancer Center.

"It is very encouraging to see more data being generated from the use of BLC with

Cysview in the U.S. These data are supportive of the current clinical practice in

Europe, and demonstrate that using BLC with Cysview repeatedly in the same patient

has no safety concerns", commented Kjetil Hestdal, M.D., Ph.D., President and CEO,

Photocure ASA.

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[1]. 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 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 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 optical imaging agent 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

References

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

ttp://globocan.iarc.fr/Pages/bar_pop_sel.aspx (accessed March 2015)

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