Photocure ASA

Earnings Release • May 12, 2017

Photocure ASA: Phase 3 study investigating Blue Light Flexible Cystoscopy with Cysview® in surveillance setting meets primary endpoint

Photocure ASA: Phase 3 study investigating Blue Light Flexible Cystoscopy with Cysview® in surveillance setting meets primary endpoint

Oslo, Norway, May 12th, 2017: Photocure ASA (Photocure, PHO:OSE), today

announced that a Phase 3 trial investigating Blue Light Flexible Cystoscopy

(BLFC(TM)) with Cysview®/Hexvix® in the surveillance setting met the study

primary end point. Results from the study showed a highly statistically

significant improvement (p <0.0001) in the detection of patients with recurrence

of bladder cancer using BLFC with Cysview compared to white light (WL) alone in

patients with non-muscle invasive bladder cancer (NMIBC) undergoing surveillance

cystoscopy. Detailed data from the study will be presented during a late-

breaking plenary abstract session on May 14th at the American Urological

Association, 2017 meeting.

"We are very pleased with the strong results of this Phase 3 study and we

appreciate the work from investigators and patients who participated in the

study. There are approximately 1.4 million surveillance cystoscopies performed

in the US annually. These results represent an important milestone for the

potential improvement in the management of patients. Later this year we intend

to submit the data to the US Food and Drug Administration (FDA) to seek a label

expansion for the indication of BLFC with Cysview in the surveillance setting."

said Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA."

The Phase 3 study was a prospective, open, comparative, within-patient

controlled study, including 304 patients enrolled at 17 academic institutions in

the US.

About Bladder Cancer

Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the

fourth most common cancer found in men in the US(1, 2, 3). In 2016, it is

estimated that 76,960 new cases of bladder cancer will occur along with 16,390

deaths due to bladder cancer. Risk factors for bladder cancer include advancing

age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent,

chronic bladder irritation and infections, and prior diagnosis of bladder

cancer. Bladder cancer is one of the most expensive cancers to manage,

accounting for approximately $3.7 billion in direct costs each year(4, 5).

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(6). NMIBC is still in the inner layer of cells.

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(7).

About Hexvix(®)/Cysview(®)

Hexvix(®) is a drug that is taken up selectively by cancer cells in the bladder

making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with

Hexvix(®) improves the detection of tumors and leads to more complete resection,

less residual tumors and better management decisions (US)/ reduced risk of

recurrence and progression (Nordic).

Hexvix(®) is the tradename in Europe, Cysview(®) in the US 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

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).

Information about Photocure is available at www.photocure.com.

For more information, please contact:

Kjetil Hestdal

President and CEO, Photocure ASA

Tel: + 47 91319535

Email: kh@photocure.no

Erik Dahl

Chief Financial Officer

Tel: +47 450 55 000

Email: ed@photocure.no

Emily Dell

Media contact

MCS Healthcare public relations

Tel: +1 732 589-0757

Email: emilyd@mcspr.com

1 SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute.

Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April

2 Bladder Cancer. American Cancer Society.

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

Accessed April 2016.

3 Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle

Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178

(6):2314-2330.

4 Avritscher EB et al., Clinical model of lifetime cost of treating bladder

cancer and associated complications. Urology. 2006; 68:549-553.

5 Botteman et al. Clinical model of lifetime costs of treating bladder cancer: a

comprehensive review of the published literature. Pharmacoeconomics.

2003; 21:315-1330.

6 Bladder Cancer. American Cancer Society.

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

Accessed April 2016.

7 Bladder Cancer. American Cancer Society.

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

Accessed April 2016.

This information is subject to the disclosure requirements pursuant to section

5-12 of the Norwegian Securities Trading Act.