Photocure launches Cysview Commercial Operations in Canada

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Jan 03, 2022, 01:53 ET

STOCKHOLM, Jan. 3, 2022 /PRNewswire/ -- Press release - Oslo, Norway, 3 January 2022: Photocure ASA (Photocure, PHO: OSE) today announces the start of its Cysview^® sales, marketing and distribution operations in the Canadian market. In August 2021 Photocure had reached an agreement with BioSyent Pharma Inc. ("BioSyent") to reacquire the marketing and distribution rights to Cysview in Canada, effective on January 1^st, 2022.

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 diagnosed⁵.

*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.

Important information

This announcement is not and does not form a part of any offer to sell, or a solicitation of an offer to purchase, any securities of Photocure ASA (the "Company"). The distribution of this announcement and other information may be restricted by law in certain jurisdictions. Copies of this announcement are not being made and may not be distributed or sent into any jurisdiction in which such distribution would be unlawful or would require registration or other measures. Persons into whose possession this announcement or such other information should come are required to inform themselves about and to observe any such restrictions.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "strategy", "intends", "estimate", "will", "may", "continue", "should" and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control.

Actual events may differ significantly from any anticipated development due to a number of factors, including without limitation, changes in investment levels and need for the Company's services, changes in the general economic, political and market conditions in the markets in which the Company operate, the Company's ability to attract, retain and motivate qualified personnel, changes in the Company's ability to engage in commercially acceptable acquisitions and strategic investments, and changes in laws and regulation and the potential impact of legal proceedings and actions. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not provide any guarantees that the assumptions underlying the forward-looking statements in this announcement are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this announcement or any obligation to update or revise the statements in this announcement to reflect subsequent events. You should not place undue reliance on the forward-looking statements in this announcement or any of its attachments.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm, or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

This announcement is for information purposes only and is not to be relied upon in substitution for the exercise of independent judgment. It is not intended as investment advice and under no circumstances is it to be used or considered as an offer to sell, or a solicitation of an offer to buy any securities or a recommendation to buy or sell any securities of the Company.

This information is subject of the disclosure requirements of section 5-12 of the Norwegian Securities Trading Act.

For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]
David Moskowitz
Head of Investor Relations
Tel: +1 202 280 0888
Email: [email protected]
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]