Photocure ASA

Earnings Release • Oct 25, 2016

Photocure ASA: New data presented on Blue Light Cystoscopy with Cysview®/Hexvix® at the Société Internationale d'Urologie (SIU) 2016 Annual meeting

Photocure ASA: New data presented on Blue Light Cystoscopy with Cysview®/Hexvix® at the Société Internationale d'Urologie (SIU) 2016 Annual meeting

Oslo, Norway, October 25, 2016 Photocure ASA announced

that new data on Blue Light Cystoscopy with

Cysview®/Hexvix® were presented at the Société

Internationale d'Urologie (SIU) Annual meeting,

October 20th to 23rd, Buenos Aires, Argentina: an

ePoster from a US registry study and an ePoster video

on Blue Light Flexible Cystoscopy.

Data from a prospective multicenter registry from

three different centers in the United States (included

220 Blue Light Cystoscopy with Cysview® (BLCC)

procedures on 175 patients with 548 lesions), showed

that BLCC with Cysview® resulted in an upstaging or

upgrading of tumor in 18% of the patients. The

addition of BLCC to standard WLC (White Light

Cystoscopy) increased the detection rate by 12% in any

papillary lesions and 46% for CIS (Carcinoma in

Situ). Furthermore, 60 patients, (34%) received BCG

therapy at least six weeks prior to BLCC with a

positive predictive value (PPV) of 67% for malignancy

(FP=25%). Please see the ePoster here

(http://hugin.info/131151/R/2051283/767445.pdf).

"Prior treatment with BCG therapy appears to have no

effect on BLCC accuracy. Many patients receive BCG

treatment and it is important to note that the

benefits of BLCC can be seen in this patient

population as well", says Siamak Daneshmand, MD,

Associate Professor of Urology (Clinical Scholar)

Director of Urologic Oncology, at the University of

Southern California Institute of Urology and study

investigator.

Additionally a video abstract demonstrated the

excellent image quality of Blue Light Flexible

Cystoscopy with Hexvix®, using the KARL STORZ Video

cystoscopes was presented by Dr. Reza Zare, MD Head of

Urology department, Baerum Hospital, Vestre Viken,

Norway. Please see the ePoster video here

(https://vimeo.com/188651223).

"It is very satisfying to see the data from the

prospective multicenter registry study and a video

abstract on BLC with Cysview®/Hexvix® being presented

at the prestigious SIU annual meeting. The registry

study demonstrates how BLCC is changing clinical

outcomes and its utility for different patient types

including those that have received BCG treatment. In

addition, the video abstract presented very clearly

shows how well the new technology of BLCC with

flexible cystoscopy performs." says 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 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 hydrochloride) is

an optical imaging agent used 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:

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

(accessed March 2015)

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