The reacquisition of marketing and distribution rights enables Photocure's direct management of the Cysview brand in Canada and consolidates the territory into Photocure's existing U.S. business to form its North America sales segment. Following the Marketing Authorization transfer expected this month, Photocure assumes all rights and obligations related to Cysview in Canada.

"We are very pleased to integrate the Canadian territory into our U.S. business to form Photocure's North America commercial segment, expanding the direct market opportunity for Cysview in number of procedures by approximately 10%", said Daniel Schneider, President and CEO. "Photocure and BioSyent have ensured active customer support and uninterrupted product distribution during the transition period. We can now fully leverage our commercial infrastructure and our expertise in market access, sales and marketing. In addition, we look forward to broadening patient access to blue light cystoscopy (BLC[®]) with Cysview in conjunction with the recently strengthened Canadian treatment guidelines."

"Since the agreement to reacquire the commercial rights to Cysview in Canada, Photocure has worked actively to build an infrastructure to support product sales in the region," said Geoffrey Coy, Vice President and General Manager North America. "The Company has set up product distribution and fulfilled the regulatory obligations needed to initiate its Canadian operations. Photocure has also begun establishing relationships with key opinion leaders, societies and hospital personnel focused on bladder cancer management and education." 

In 2015, Photocure entered into an exclusive distribution agreement with BioSyent for the commercialization of Cysview in Canada. Photocure has since grown its U.S. operations and executed on its global expansion strategy by reacquiring the commercial rights to its Hexvix[®] brand and business in continental Europe in October 2020. BioSyent has served as a strategic partner in the Canadian market, building awareness and creating interest in the treatment of bladder cancer using BLC with Cysview. BLC is included in the Canadian guidelines, and reimbursement processes are at advanced stages in the main provinces of British Columbia and Ontario. Each year, there are approximately 35,000 TURBT* procedures performed in Canada and 12,000 new bladder cancer patients diagnosed[5]. 

*TURBT: trans-urethral resection of bladder tumors

Note to editors:

About Bladder Cancer
Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000 prevalent cases (5-year prevalence rate)[1a], 573 000 new cases and more than 200 000 deaths annually in 2020.[1b]

Approx. 75% of all bladder cancer cases occur in men.[1] It has a high recurrence rate with an average of 61% in year one and 78% over five years.[2] Bladder cancer has the highest lifetime treatment costs per patient of all cancers.[3]

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike. 

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. 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. In MIBC 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.[4]
[1] Globocan. a) 5-year prevalence / b) incidence/mortality by population.  Available at: https://gco.iarc.fr/today, accessed [April 2021].
[2] Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
[3] Sievert KD et al. World J Urol 2009;27:295-300
[4] Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
[5] Photocure internal patient-based model built on Globocan 2019, Canadian Urological Association guideline on the management of non-muscle invasive bladder cancer: https://cuaj.ca/index.php/journal/article/view/7367/4867

About Hexvix[®]/Cysview[®] (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC[®]). BLC with Hexvix/Cysview[ ]improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe, and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia and New Zealand. Please refer to https://photocure.com/partnering-with-photocure/our-partners/ for further information on our commercial partners.

About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making 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). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

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