Photocure ASA

Regulatory Filings • Apr 26, 2017

Photocure ASA: Late-Breaking Plenary Presentation at the AUA 2017 Annual Meeting on Blue Light Flexible Cystoscopy with Hexaminolevinulate Phase 3 Study

Photocure ASA: Late-Breaking Plenary Presentation at the AUA 2017 Annual Meeting on Blue Light Flexible Cystoscopy with Hexaminolevinulate Phase 3 Study

Data on US Registry Study for BLC(TM) with Cysview/Hexvix will also be Presented

at AUA

Oslo, Norway, April 26, 2017: Photocure ASA (Photocure, PHO:OSE), today

announced that results from the BLFC with Cysview®/Hexvix®  Phase 3 study will

be presented during a late-breaking plenary session at the American Urological

Association (AUA) Annual Meeting in Boston, Mass., May 12-16, 2017.

The late-breaking presentation will report results from a prospective multi-

center study, carried out at 17 centers in the United States (US), on detection

and impact on patient management of Cysview in patients with non-muscle invasive

bladder cancer undergoing surveillance with a flexible cystoscopy to detect the

recurrence of bladder cancer.

New data will also be presented at AUA on a prospective multicenter registry

that has been established to study the use of BLC(TM) (Blue Light Cystoscopy)

with Cysview in the operating room setting. This registry, which is the largest

non-muscle invasive bladder cancer registry in the US, continues to add to the

growing body of evidence of how BLC with Cysview can improve the detection and

management of bladder cancer in various patient populations.

Key activities during the AUA 2017 meeting include:

* Friday May 12:

* 1 to 3PM ET- BCEC room 252 Poster session MP15-02: Blue Light Cystoscopy

for the diagnosis of Urothelial Bladder Cancer: results from a

prospective multicenter registry.

* Sunday May 14:

* 2 PM ET- BCEC Ballroom: Surgical Techniques: Endoscopic Diagnosis and

Transurethral Resection of Superficial Bladder Cancer

* 3 PM ET- BCEC Ballroom: PPTLBA-02: Late-Breaking Abstract - Blue Light

Flexible Cystoscopy (BLFC(TM)) with Hexaminolevulinate (HAL) and White

Light Flexible Cystoscopy: A Prospective, Comparative, Within-Patient

Controlled Multi-Center Phase 3 Study in the Detection of Bladder Cancer

during Surveillance.  http://www.jurology.com/article/S0022-

5347(17)39292-3/abstract

* 1 PM to 5 PM ET - Westin Waterfront, Douglass Room - Urological Society

of American Veterans (USAV) meeting and program. During the meeting,

there will be a panel discussion that will include BLC with Cysview®

cases from the Veterans Administration Medical Centers.

* Photocure will be exhibiting BLC(TM) with Cysview in Booth 1109 during the

AUA 2017 meeting.

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®/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

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.

About KARL STORZ Endoscopy-America, Inc.

KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ GmbH & Co. KG,

an international leader for more than 70 years in reusable endoscope technology,

encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL

STORZ GmbH & Co. KG is a family-owned company that designs, engineers,

manufactures, and markets all its products with an emphasis on visionary design,

precision craftsmanship and clinical effectiveness. For more information, call

(800) 421-0837 or visit the company's website at www.karlstorz.com.

For more information, please contact:

Kjetil Hestdal

President and CEO, Photocure ASA

Tel: + 47 91319535

Email: mailto:kh@photocure.no

Erik Dahl

Chief Financial Officer

Tel: +47 450 55 000

Email: ed@photocure.no

Media Relations:

Emily Dell

MCS Healthcare Public Relations

Tel: +1 908 234 9900

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.