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Photocure ASA: Blue Light Cystoscopy (BLC) with Cysview®/Hexvix® decreases the risk of progression and recurrence in bladder cancer

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Oslo, Norway, November 28th, 2016 Photocure ASA announced the publication of The Comparative effectiveness of fluorescence cystoscopy versus white light cystoscopy (WLC) for initial diagnosis or surveillance of bladder cancer on clinical outcomes: Systematic review and meta-analysis in the Journal of Urology.  This review, which was sponsored by the US Agency for Healthcare Research (AHRQ), concluded that Blue Light Cystoscopy with Cysview®/Hexvix® was associated with decreased risk of progression and recurrence of non-muscle invasive bladder cancer versus White Light Cystoscopy alone.

"We are pleased that this comprehensive and evidence based review provides further support for the use of BLC with Cysview® /Hexvix® in the management of bladder cancer. The risk of disease progression or recurrence is a significant concern for patients with bladder cancer and so the availability of treatment approaches that have been shown to reduce that risk is extremely important," said Kjetil Hestdal, MD, PhD, President and CEO, Photocure ASA.

The AHRQ through its Evidence-based Practice Centers (EPC's), sponsors the development of systematic reviews to assist public and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science based information on common, costly medical conditions, and new health care technologies and strategies.

The comparative review can be found at:  Comparative Review - AHRQ-BLCC

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.[i], [ii],[iii] 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.[iv], [v] 

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.[vi]  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.[vii]

About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an optical imaging agent used in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S. 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 Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology(TM) platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions and skin conditions. Our aim is to provide solutions which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.

For more information, please contact:

Photocure 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


[i] SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2016.

[ii] Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.

[iii] 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.

[iv] Avritscher EB et al., Clinical model of lifetime cost of treating bladder cancer and associated complications. Urology. 2006; 68:549-553.

[v] Botteman et al. Clinical model of lifetime costs of treating bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003; 21:315-1330.

[vi] Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.

[vii] Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.

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