Photocure ASA

Regulatory Filings • Dec 5, 2016

US registry shows that Blue Light Cystoscopy (BLC) with Cysview®/Hexvix® leads to improved detection and classification of bladder cancer

US registry shows that Blue Light Cystoscopy (BLC) with Cysview®/Hexvix® leads to improved detection and classification of bladder cancer

Oslo, Norway, December 5, 2016 Photocure ASA (PHO-NO)

announced today new data from a prospective

multicenter real world study that included 338

patients, 415 BLC procedures and 1060 lesions from

nine study sites in the United States. BLCC as an

adjunct to white light cystoscopy (WLC) resulted in

the detection of an additional 151 lesions and 45

patients uniquely with the addition of blue light.

This resulted in upgrading or upstaging of 52 (15%) of

the patients. Correct staging and grading impacts the

management of bladder cancer patients and may have an

impact on patient outcomes. Please see attached

abstract for more information.

The registry data were presented at the SUO 17th

Annual Meeting, November 30th to December 2nd, 2016,

San Antonio, Texas, USA.

"The BLCC registry continues to provide additional

data from real world clinical practice. BLC with

Cysview® has identified additional high grade cancers

and thus change the management of bladder cancer

patients from a diverse group of urologic oncologists

from around the country. With additional follow-up

these data may undoubtedly affect cancer specific

outcomes. In my clinical practice, the inclusion of

BLCC in the AUA/SUO guidelines and the data coming out

from this registry study provide additional strong

evidence that BLCC should be considered as standard of

care by most urologists", says study participant

Trinity J. Bivalacqua, M.D., Johns Hopkins, R.

Christian B. Evensen Professor of Urology and Oncology

and Director of Urologic Oncology at the James

Buchanan Brady Urologic Institute.

In addition, a second poster was presented at the SUO

meeting on the safety of repeat use of BLC with

Cysview®. This retrospective review from two

institutions in the United States compared the

incidence and grade of Adverse Events (AE's) after

initial and subsequent BLCC procedures. 35% of the

patients underwent BLCC more than once; 2 patients

five times. No statistically significant difference in

AE's between those patients undergoing first versus

two or more repeat procedures were found. Please see

attached abstract for more information.

"Many studies have shown that BLCC has clear benefits

over WLC alone in improving the detection and

management of patients with non-muscle invasive

bladder cancer (NMIBC). The registry study is

demonstrating how BLCC is changing patient management

and clinical outcomes in different patient types in

daily clinical practice. Additionally, the safety

data on the repeat use of BLC and Cysview® in the US

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," says Kjetil Hestdal, M.D., Ph.D., President

and CEO, Photocure ASA.

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 US1,2,3. 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 year4,5

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®/Cysview® (hexaminolevulinate hydro-chloride)

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 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 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:

Photocure 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

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-

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.