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Photocure Completes Enrollment in US Market expansion study of Blue Light Flexible Cystoscopy (BLFC) with Cysview®

Oslo, Norway, February 3, 2017 Photocure ASA (OSE: PHO), announced today that it has completed enrollment in its Phase 3 study with BLFC with Cysview in patients with Non Muscle Invasive Bladder cancer (NMIBC) undergoing follow up (surveillance) cystoscopy in the outpatient setting. The enrollment of 300 bladder cancer patients has secured that a minimum of 100 patients have been referred to and received repeat administrations of Blue Light Cystoscopy with Cysview in the operating room setting. In the study, Cysview was used in conjunction with the flexible KARL STORZ system. Results from the study are expected to be available mid-2017.

"This is an important milestone for Photocure as we plan to use the data from this study to seek FDA approval for the expanded use of BLFC with Cysview into the surveillance market in the United States, where it is estimated that 1.4 million surveillance cystoscopies are performed annually. We believe that availability of BLFC in this setting will allow patients access to optimal surveillance of their disease resulting in earlier treatment, which should result in improved long-term benefits and outcomes for these patients", said Kjetil Hestdal, President & CEO. 

The prospective, multicenter Phase 3 study will define the possible improved detection rates and impact on patient management of bladder cancer in the surveillance setting with BLFC with Cysview as an adjunct to white light cystoscopy. Seventeen leading institutions participated in the study. 

For more information about the study: https://clinicaltrials.gov/ct2/show/NCT02560584 

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.

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 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 remains in the inner layer of cells lining the bladder. 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 

Disclaimer
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References
[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/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

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