Photocure ASA

Earnings Release • Aug 16, 2017

Photocure files supplemental New Drug Application with FDA for Blue Light Cystoscopy (BLC(TM)) with Cysview®

Photocure files supplemental New Drug Application with FDA for Blue Light Cystoscopy (BLC(TM)) with Cysview®

Oslo, Norway, August 16th Photocure ASA (OSE: PHO) announced

today that it has filed a supplemental new drug application

(sNDA) with the U.S. Food and Drug Administration (FDA) for

BLC(TM) with Cysview® for use during surveillance cystoscopy

to detect recurrence of bladder cancer using a flexible

cystoscope. The filing is a combination drug device

application with the KARL STORZ D-LIGHT C PDD Flexible

Videoscope System. The sNDA also supports the approval for

repeated use of BLC with Cysview and to expand the

indication include detection of carcinoma in situ (CIS).

BLC with Cysview is currently indicated for use in the U.S.

as an adjunct to white light for the cystoscopic detection

of non-muscle invasive cancer of the bladder (NMIBC) in

patients suspected or known to have lesion(s) on the basis

of a prior cystoscopy. The sNDA filing contains data from a

Phase 3 clinical study comparing the detection of bladder

cancer recurrence in patients undergoing surveillance

cystoscopy in the outpatient setting. Results from this

prospective, 17 center study with 304 patients showed that

in patients undergoing surveillance cystoscopy, BLC with

Cysview detected bladder cancer recurrence in 20.6% of the

patients that otherwise would have been missed with white

light (WL) alone, which is highly significant (p<0.0001).

The study also showed that 34.6% of the patients with

carcinoma in situ (CIS), a very aggressive form of bladder

cancer, were detected with only BLC with Cysview but missed

with white light cystoscopy (p<0.0001). Data from the Phase

3 trial was presented earlier this year at the AUA annual

meeting as a late breaking plenary presentation.

"Following on from the strong Phase 3 results we presented

at the AUA meeting in May, we have today filed an sNDA with

the FDA to seek approval for use of BLC(TM) with Cysview® in

the US in patients undergoing surveillance cystoscopy using

a flexible scope, to expand the indication to include

detection of CIS and to allow for repeated use" said Kjetil

Hestdal, President & CEO, Photocure ASA. "We are committed

to working with the FDA to bring this important clinical

tool to the US market in 2018, so that patients and

physicians can benefit from potentially better and more cost-

effective management of the disease."

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.

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. 2 NMIBC remains in the inner layer of cells

lining the bladder. These cancers are the most common (70%)

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.2

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 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.

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

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/webcontent/003

085-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.