Photocure ASA

Earnings Release • Feb 3, 2017

Photocure Completes Enrollment in US Market expansion study of Blue Light Flexible Cystoscopy (BLFC) with Cysview ®

Photocure Completes Enrollment in US Market expansion study of Blue Light Flexible Cystoscopy (BLFC) with Cysview ®

Oslo, Norway, February 3, 2017 Photocure ASA (OSE:

PHO), announced today that it has completed enrollment

in its Phase 3 study with BLFC with Cysview in

patients with Non Muscle Invasive Bladder cancer

(NMIBC) undergoing follow up (surveillance) cystoscopy

in the outpatient setting. The enrollment of 300

bladder cancer patients has secured that a minimum of

100 patients have been referred to and received repeat

administrations of Blue Light Cystoscopy with Cysview

in the operating room setting. In the study, Cysview

was used in conjunction with the flexible KARL STORZ

system. Results from the study are expected to be

available mid-2017.

"This is an important milestone for Photocure as we

plan to use the data from this study to seek FDA

approval for the expanded use of BLFC with Cysview

into the surveillance market in the United States,

where it is estimated that 1.4 million surveillance

cystoscopies are performed annually. We believe that

availability of BLFC in this setting will allow

patients access to optimal surveillance of their

disease resulting in earlier treatment, which should

result in improved long-term benefits and outcomes for

these patients", said Kjetil Hestdal, President & CEO.

The prospective, multicenter Phase 3 study will define

the possible improved detection rates and impact on

patient management of bladder cancer in the

surveillance setting with BLFC with Cysview as an

adjunct to white light cystoscopy. Seventeen leading

institutions participated in the study.

For more information about the study:

https://clinicaltrials.gov/ct2/show/NCT02560584

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.

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 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 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.[7]

About Photocure ASA

Photocure, headquartered in Oslo Norway, is a

specialty pharmaceutical company and world leader in

photodynamic technology. The company is listed on the

Oslo Stock Exchange.

Information about Photocure is available at

www.photocure.com.

Disclaimer

All trademarks mentioned in this release are protected

by law and are registered trademarks of Photocure ASA

This press release may contain product details and

information which are not valid, or a product is not

accessible, in your country. Please be aware that

Photocure does not take any responsibility for

accessing such information which may not comply with

any legal process, regulation, registration or usage

in the country of your origin.

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] SEER Cancer Statistics Factsheets: Bladder Cancer.

National Cancer Institute. Bethesda, MD.

http://seer.cancer.gov/statfacts/html/urinb.html.

Accessed April 2016.

[2] Bladder Cancer. American Cancer Society.

http://www.cancer.org/acs/groups/cid/documents/webconte

nt/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/webconte

nt/003085-pdf.pdf. Accessed April 2016.

[7] Bladder Cancer. American Cancer Society.

http://www.cancer.org/acs/groups/cid/documents/webconte

nt/003085-pdf.pdf. Accessed April 2016