Photocure ASA

Earnings Release • May 15, 2017

Positive data from Phase 3 US Blue Light Cystoscopy with Cysview® study presented at AUA 2017 meeting in Boston

Positive data from Phase 3 US Blue Light Cystoscopy with Cysview® study presented at AUA 2017 meeting in Boston

- 21.5% of patients with recurrence of bladder cancer would

have been missed if BLFC with Cysview had not been used in the

surveillance setting, which is highly significant (p<0.0001)

- Photocure plans to file a supplemental NDA with FDA later

this year

Oslo, Norway, May 15th, 2017: Photocure ASA (Photocure, PHO:OSE),

today announced that new Phase 3 study results with Blue Light

Flexible Cystoscopy (BLFC(TM)) with Hexvix®/Cysview®* were presented

during a late-breaking plenary session at the American Urological

Association (AUA) Annual Meeting in Boston, Massachusetts on Sunday

May 14th. The study showed that BLFC with Cysview detected bladder

cancer recurrence in 21.5% of the patients undergoing surveillance

cystoscopy that otherwise would have been missed with white light

(WL) alone, which is highly significant (p<0.0001). Of note, the

study showed that nine out of twenty-six patients (34.6%) with flat,

more aggressive high grade lesions (carcinoma in situ; CIS) were

diagnosed using confirmatory Blue Light Cystoscopy with Cysview

alone and not WL (p<0.0001). The study also showed that there was no

increase in the rate of related adverse events after repeated

administration of Cysview in bladder cancer patients undergoing

cystoscopy examination.

The study was a prospective, open, comparative, within-patient

controlled study, included 304 patients with non-muscle invasive

bladder cancer (NMIBC) enrolled at 17 academic institutions in the

US. In the study BLFC with Cysview was used with the KARL STORZ D-

LIGHT C PDD Flexible Videoscope System.

"This study shows that BLFC can provide a significant advantage for

patients in terms of early detection of tumor recurrence which may

improve treatment and therefore lead to better outcomes," says one

of the lead investigators J. Stephen Jones, MD, president of

Cleveland Clinic Regional Hospitals and Family Health Centers.

"92.7% of the patients said it was worthwhile to undergo BLFC and

93.8% said that they would do it again. The results of the study

show that BLFC will play a significant role in outpatient management

of bladder cancer."

White light cystoscopy is the current standard of care for bladder

cancer surveillance. Multiple studies have demonstrated that Blue

Light Cystoscopy (BLC) with Cysview using a rigid endoscope in the

operating room improves detection of bladder cancer, with a

reduction in recurrence rates observed when compared to procedures

using white light. The objective of the Phase 3 study in the

surveillance setting was to determine if BLFC using a flexible

cystoscope in the office setting can improve detection of tumors

when compared to WL cystoscopy alone.

"As a result of the extensive follow up that NMIBC patients require

there are approximately 1.4 million surveillance cystoscopies with

flexible cystoscopes performed in the US annually. This market

represents a large potential opportunity for Photocure. We are very

pleased with these significant results for the detection of

recurrent bladder cancer. The patient related outcomes also

indicate that BLFC with Cysview adds considerable value to the

patient. With these positive efficacy and safety results we believe

we have fulfilled our post marketing commitments for the current

approved use and we are committed to working with the Food and Drug

Administration (FDA) to bring BLFC with Cysview to the physicians

and patients in the US." said Kjetil Hestdal, M.D., Ph.D., President

and CEO, Photocure ASA."

Click here for a link to the abstract: http://bit.ly/BLFCC-

LateBreaking.

In addition, on May12th at the AUA annual meeting, data from the

largest Bladder Cancer Registry Study in the US was presented at a

Poster session "Blue Light Cystoscopy for the diagnosis of

Urothelial Bladder Cancer: results from a prospective multicenter

registry". The results from 9 centers included 1325 lesions, from

517 procedures in 426 patients. The conclusion of the study was

that BLC significantly increased the detection of CIS and papillary

lesions over WLC alone and can result in upstaging and upgrading in

about 13% of patients, which can affect patient outcomes.

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® 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: +47 913 19 535

Email: kh@photocure.no

Erik Dahl

Chief Financial Officer

Tel: +47 450 55 000

Email: ed@photocure.no

Emily Dell

Media contact

MCS Healthcare public relations

Tel: +1 732 589-0757

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-

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.