Photocure ASA

Regulatory Filings • Nov 28, 2016

Photocure ASA: Blue Light Cystoscopy (BLC) with Cysview®/Hexvix® decreases the risk of progression and recurrence in bladder cancer

Photocure ASA: Blue Light Cystoscopy (BLC) with Cysview®/Hexvix® decreases the risk of progression and recurrence in bladder cancer

Oslo, Norway, November 28th, 2016 Photocure ASA

announced the publication of The Comparative

effectiveness of fluorescence cystoscopy versus white

light cystoscopy (WLC) for initial diagnosis or

surveillance of bladder cancer on clinical outcomes:

Systematic review and meta-analysis in the Journal of

Urology. This review, which was sponsored by the US

Agency for Healthcare Research (AHRQ), concluded that

Blue Light Cystoscopy with Cysview®/Hexvix® was

associated with decreased risk of progression and

recurrence of non-muscle invasive bladder cancer

versus White Light Cystoscopy alone.

"We are pleased that this comprehensive and evidence

based review provides further support for the use of

BLC with Cysview® /Hexvix® in the management of

bladder cancer. The risk of disease progression or

recurrence is a significant concern for patients with

bladder cancer and so the availability of treatment

approaches that have been shown to reduce that risk is

extremely important," said Kjetil Hestdal, MD, PhD,

President and CEO, Photocure ASA.

The AHRQ through its Evidence-based Practice Centers

(EPC's), sponsors the development of systematic

reviews to assist public and private-sector

organizations in their efforts to improve the quality

of health care in the United States. These reviews

provide comprehensive, science based information on

common, costly medical conditions, and new health care

technologies and strategies.

The comparative review can be found at: Comparative

Review - AHRQ-BLCC

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.[i], [ii], [iii] 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.[iv] [v]

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.[vi] 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.[vii]

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 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(TM) 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

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[i] SEER Cancer Statistics Factsheets: Bladder Cancer.

National Cancer Institute. Bethesda, MD.

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

Accessed April 2016.

[ii] Bladder Cancer. American Cancer Society.

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

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

[iii] 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.

[iv] Avritscher EB et al., Clinical model of lifetime

cost of treating bladder cancer and associated

complications. Urology. 2006; 68:549-553.

[v] Botteman et al. Clinical model of lifetime costs

of treating bladder cancer: a comprehensive review of

the published literature. Pharmacoeconomics. 2003;

21:315-1330.

[vi] Bladder Cancer. American Cancer Society.

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

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

[vii] Bladder Cancer. American Cancer Society.

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

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