Hexvix® / Cysview® with Flexible Cystoscopy improves Bladder Cancer detection. Data presented at the EAU congress in Barcelona.

(The press release is updated with the following sentences: This means that in this survey more than 50% of the patients said they were willing to pay $100 or more out of their own pocket to get the blue light procedure. This is not linked to the price or reimbursement of the Cysview® drug. From January 2019 Cysview® for use in the office with flexible scopes is reimbursed.)

Oslo, Norway March 19, 2019, Photocure ASA (PHO:OSE), is pleased to announce that Blue Light Cystoscopy (BLC™) with Hexvix® was presented at the European Association of Urology (EAU) congress held in Barcelona, Spain, March 15th -18th. The EAU annual meeting is one of the largest international meetings in the urology calendar, showcasing the latest and most relevant knowledge in urology with more than 14,000 urologists and exhibitors from over 110 countries.

Dr. Yair Lotan, M.D., Professor of Urology, University of Texas Southwestern Medical Center presented on “Blue Light Flexible Cystoscopy with Hexaminolevulinate for Surveillance of Bladder Cancer” at the Ipsen hosted symposium Saturday March 16th.

The positive data for the use of Hexvix® / Cysview® (hexaminolevulinate) with flexible cystoscopes in the office / surveillance setting of bladder cancer patients, was obtained from the phase 3 trial that led to the FDA label expansion approval. Patient Reported Outcomes results from the trial demonstrated a positive patient evaluation of Hexvix® / Cysview® as well as more than 50% willing to pay $100 or more for the procedure. This means that in this survey more than 50% of the patients said they were willing to pay $100 or more out of their own pocket to get the blue light procedure. This is not linked to the price or reimbursement of Cysview®. From January 2019, Cysview® for use in the office with flexible scopes is reimbursed.
Link to study: https://onlinelibrary.wiley.com/doi/full/10.1111/bju.14481

“We have known for a long time that BLC with rigid cystoscopes significantly improves the detection of patients with bladder cancer, leading to more complete tumor removal during surgery (TURBT) which is crucial for patient outcomes. The significantly improved tumor detection also with flexible cystoscopes gives us a new valuable tool to improve our management of patients with recurring bladder cancer. BLC with flexible scopes should be used for all high- and intermediate risk patients at the initial 3 months cystoscopy after TURBT and definitely in the continued management of high risk patients,” says Dr. Yair Lotan.

“It was very good to see Dr. Lotan presenting the positive Hexvix® / Cysview® data from the US that is aligned with the experience of our European and Nordic customers. The use of Hexvix® / Cysview® with flexible cystoscopes in the surveillance of patients in the office will give a large number of new patients access to better management of their disease”, says Dan Schneider, President and CEO of Photocure.

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 US1, 2, 3. In 2018, it is estimated that there will be 81,190 new cases of bladder cancer will occur along with 17,240 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 year4,5

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 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.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 (BLCTM). BLCTM 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 Cysview® /Hexvix® 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://bit.ly2lsohgp for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. 

About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in Princeton, New Jersey. For more information, please visit us at www.photocure.com, www.hexvix.com or www.cysview.com 

For further information, please contact:
President and CEO, Daniel Schneider
Tel: +1 5084108044
E-mail: ds@photocure.com

CFO Erik Dahl
Tel: +47 450 55 000
E-mail: ed@photocure.com

1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute. Bethesda, MD. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2018.

2. Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2018.

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.