Positive clinical data on Blue Light Cystoscopy with Cysview®/Hexvix® presented at AUA

Oslo, Norway, May 9, 2016 -- Photocure ASA announced today new data from a prospective multicenter ongoing registry study that shows Blue Light Cystoscopy (BLC) with Cysview® increases detection rates of flat, more aggressive non-muscle invasive bladder cancer lesions (carcinoma in situ (CIS)) as well papillary lesions over white light cystoscopy (WLC) alone. The data from the prospective registry, real life, study including 175 patients, was presented at the American Urological Association (AUA) annual meeting in San Diego, CA, May 6-10, 2016.

The Blue Light Cystoscopy with Cysview® Registry was established to study the use of BLC with Cysview® in clinical practice in the US in different patient types.[i] The data presented at AUA included an analysis of 175 patients at three major US urology and cancer centers between April 2014 and October 2015. A total of 548 separate lesions were identified from 220 BLC procedures. The detection rate (sensitivity) of WLC, BLC and the combination of WLC/ BLC for any malignant lesion was 73%, 91% and 98% respectively. The addition of BL to standard WLC increased the detection rate by 12% in any papillary lesions and 46% for CIS.[ii]

“This data further reinforces the critical role BLC with Cysview® plays in advancing the care of bladder cancer patients,” says Siamak Daneshmand, MD, Associate Professor of Urology (Clinical Scholar) Director of Urologic Oncology, University of Southern California Institute of Urology and study investigator. “We know that BLC with Cysview® has clear benefits over white light cystoscopy (WLC) alone in improving the detection and management of patients with non-muscle invasive bladder cancer (NMIBC).  That translates into reduction in disease progression and recurrence. Therefore, I believe that BLC with Cysview® should be considered a valuable tool for urologists.”

“The registry will continue to add to the growing body of evidence of how BLC with Cysview® can improve the detection and management of bladder cancer in various patient populations,” says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

Additional data was also presented at AUA 2016. Please see abstract for more information.

Blue Light Cystoscopy: The USC Experience
A separate series of case studies presented at AUA 2016 from the University of Southern California (USC) demonstrated that the use of BLC with Cysview is a useful tool for better detection of NMIBC including CIS in patients undergoing TURBT for bladder cancer. BLC with Cysview  was also useful in detecting involvement of previous resection margins and finding obscured ureteral orifices.[iii]  Please see abstract for more information.

About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer and is the fourth most common cancer found in men in the US.[iv], [v],[vi] 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[vii], [viii].

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.[ix]  NMIBC is still in contained the inner layer of the bladder. These cancers are the most common (75%) of all BC cases and include the stages Ta, carcinoma in situ (CIS) and T1 lesions. MIBC signifies when cancer involving the deeper layers of the bladder wall. These cancers, including stages T2, T3 and T4, are more likely to spread and are more difficult to cure.[x]

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® 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.

Cysview® is tradename in U.S. and Canada, Hexvix® in Europe

For more information, please contact:

Media Relations:
Amanda Merced
MCS Healthcare Public Relations
Tel: +1 908 234 9900
Email: amandam@mcspr.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

Investor relations:
Trout International LLC
Lauren Williams
Tel: +44 20 3780 4972
Email: lwilliams@troutgroup.com


[i] Bazargani ST et al. Blue Light Cystoscopy for Diagnosis of Urothelial Bladder Cancer: Results from a Prospective Multicenter Registry. Abstract printed from AUA2016.org. April 5, 2016.

[ii] Bazargani ST et al. Blue Light Cystoscopy for Diagnosis of Urothelial Bladder Cancer: Results from a Prospective  Multicenter Registry. Abstract printed from AUA2016.org. April 5, 2016.

[iii] Blue Light Cystoscopy: The USC Experience. Bazarganti ST, Djaladat H, et al. Abstract printed from AUA2016.org. April 5, 2016.

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

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

[vi] 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.

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

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

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

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