Photocure ASA

Earnings Release • Dec 8, 2017

Photocure ASA: Landmark Blue Light Cystoscopy with Cysview® study is published in the Journal of Urology

Photocure ASA: Landmark Blue Light Cystoscopy with Cysview® study is published in the Journal of Urology

Oslo, Norway, December 8, 2017: Photocure ASA (Photocure, PHO: OSE), today

announced that the official Journal of the American Urologic Association (AUA),

the Journal of Urology, published the  BLFCC Efficacy results from a Phase 3

trial investigating the efficacy of Blue Light Cystoscopy (BLC((TM))) with

Cysview(® )for surveillance with a flexible cystoscope.  In 20.6 percent of

patient's recurrence was seen only with BLC with Cysview and missed with WLC

(p<0.0001).

Out of the 304 patients in the study, 103 were referred to the Operating Room

for suspicion of recurrent bladder cancer. Of these, 63 patients were confirmed

as having malignant tumors.  Forty one percent of the patients with malignant

tumors were confirmed as having CIS (Carcinoma in Situ), the most aggressive and

difficult to detect and treat type of non-muscle invasive bladder cancer

(NMIBC).  Importantly, 34% of these patients were detected only with BLC with

Cysview (p<0.0001) but were missed with WLC.

"This study, which despite being carried out in centers with bladder cancer and

BLC expertise, showed that blue light flexible cystoscopy significantly

(p<0.0001) improves detection of patients with recurrent bladder cancer.  BLC

detects lesions, including CIS that were missed with WLC alone.  The detection

of additional tumors in the surveillance setting may have profound effects on

progression rates through earlier diagnosis of high risk lesions which would

have been otherwise missed with WLC.  The results of this study confirm the role

for BLC in the management of intermediate and high risk bladder cancer

patients," says J. Stephen Jones, MD, president of Cleveland Clinic Regional

Hospitals and Family Health Centers.

"This publication reports the data included in the supplemental NDA submitted

to the FDA to get approval for the use of BLC with Cysview in the surveillance

setting with flexible cystoscopy. We look forward to bringing this technology to

bladder cancer patients and their health care providers for the follow-up of

NMIBC in the office setting," said Kjetil Hestdal, M.D., Ph.D., President and

CEO, Photocure ASA."

The study is a prospective, open, comparative within-patient controlled study of

304 patients with high risk of recurrence enrolled at 17 academic centers in the

US.

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(®)/Cysview(®) is a drug that is selectively taken up by cancer cells in

the bladder making them glow bright pink during Blue Light Cystoscopy

(BLC(TM)).  BLC(TM) with Hexvix(®) /Cysview(®) improves the detection of tumors

and leads to more complete resection, less residual tumors and better management

decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all

other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US

and the Nordic region, and has strategic partnerships for the commercialization

of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer

to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further

information on our commercial partners.

About Photocure

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).

More information about Photocure is available at www.photocure.com,

www.hexvix.com, www.cysview.com

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

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.

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trademarks of Photocure ASA

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This information is subject to the disclosure requirements pursuant to section

5-12 of the Norwegian Securities Trading Act.