Photocure ASA

Regulatory Filings • Feb 16, 2018

Photocure Announces U.S. FDA Approval of New Indications for Blue Light Cystoscopy with Cysview®

Photocure Announces U.S. FDA Approval of New Indications for Blue Light Cystoscopy with Cysview®

Oslo, Norway, February 16, 2018 Photocure ASA (OSE: PHO), announced today that

the U.S. Food and Drug Administration (FDA) approved its supplemental new drug

application (sNDA) to extend the indication for Blue Light Cystoscopy (BLC(TM))

with Cysview(® )to include Flexible Cystoscopes, which are used in the ongoing

surveillance of patients with bladder cancer. This is the only combination of

drug and device approved for the detection of bladder cancer.

The approval of this new indication is based on the results from a large Phase

3 study using KARL STORZ blue light enabled rigid and flexible cystoscopes. This

study showed that BLC(TM) significantly (p<0.0001) improves detection of

patients with recurrent bladder cancer.

"This approval is an important milestone for Photocure. With 1.2 million

surveillance cystoscopies performed annually in the U.S., this represents a

significant opportunity for the company and allows us to bring solutions to

current clinical challenges," said Kjetil Hestdal M.D. Ph.D., President & CEO.

"The expanded label now allows repetitive use in the same patient which enables

physicians to provide an improved continuum of care to their bladder cancer

patients and should lead to reduced cost."

The expanded indication includes the combination of Cysview with the KARL STORZ

PDD Flexible Blue Light Videoscope System. The approval also expands the

indication in the current rigid setting (TURBT) by including the detection of

carcinoma in situ (CIS) in bladder cancer patients as well as the repeated use

of BLC with Cysview.

"This expanded approval in both rigid and flexible blue light cystoscopy (BLC)

means that Cysview can now be used during transurethral resection of bladder

cancer surgery for diagnosis and staging, as well as with follow-up surveillance

of non-muscle invasive bladder cancer (NMIBC). Patients with NMIBC, especially

high grade, require careful and frequent follow-up due to the high rate of

recurrence and progression. Blue light cystoscopy with Cysview, will enable

physicians to provide appropriate and more accurate treatment earlier, which in

my experience results in improved outcomes for my patients. In my high-risk

NMIBC clinical practice, I recognize the benefit of using BLC with Cysview to

more readily detect carcinoma in-situ, i.e. aggressive high-grade flat lesions.

In this study, an additional 35% of CIS patients were found by using BLC with

Cysview alone and missed with white light," says Gary Steinberg, M.D., The Bruce

and Beth White Family Professor, Vice Chairman and Director of Urologic

Oncology, University of Chicago Medicine.

In collaboration with KARL STORZ Endoscopy-America, Inc., Photocure plans to

launch Cysview in combination with blue light enabled flexible video cystoscopy

in mid-2018.

For more information about the study:

https://clinicaltrials.gov/ct2/show/NCT02560584

About Bladder Cancer

Bladder cancer is the fifth most commonly diagnosed cancer in the U.S. and is

the fourth most common cancer found in men in the U.S.(1,2,3) In 2016, it was

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 KARL STORZ Endoscopy-America, Inc.

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

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

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

STORZ SE & 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

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.