Photocure and Richard Wolf Enter into Agreement to Develop a High-Definition Flexible Blue Light Cystoscope for Global Commercialization

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Jul 15, 2024, 12:29 ET

OSLO, Norway, July 15, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, today announces that it has entered into a strategic agreement with Richard Wolf GmbH to develop and commercialize a next-generation 4K LED high-definition (HD) reusable flexible blue light cystoscope based on Richard Wolf's System blue technology. The partnership between Photocure and Richard Wolf is focused on developing technologically advanced flexible blue light cystoscopy (BLC^®) equipment for the global market so that physicians who treat patients with bladder cancer can offer the benefits of BLC with Hexvix^® / Cysview^® in an outpatient, or surveillance setting.

Under the Agreement, Richard Wolf will develop the new flexible BLC system with input and guidance from Photocure, tapping into Photocure's extensive knowledge of the surveillance procedure and the Company's experience with urology customers. The new flexible blue light system and underlying intellectual property will be owned by Richard Wolf, who will also serve as the sponsor of market authorizations around the world. Photocure and Richard Wolf will share expenses for the development and regulatory activities necessary for approvals of the HD flexible blue light system in markets where it will be commercialized.

The strategic partnership between Photocure and Richard Wolf builds off a longstanding relationship between the two companies associated with co-promotion, disease awareness, education, market development, and clinical research. Photocure and Richard Wolf will co-promote the new blue light flexible system in the U.S., Europe and other countries globally.

Photocure will leverage its existing sales organization to promote the new reusable flex system in North America and Europe, and will rely on Richard Wolf distributors or commercial partners to co-promote the device in other markets. Additionally, Photocure will utilize data from existing patient registries to leverage real-world evidence to further support the benefits of flexible blue light cystoscopy for patients with non-muscle invasive bladder cancer. Per the agreement, Photocure and Richard Wolf will establish two governance committees to oversee progress of the collaboration including a Joint Development Committee to ensure R&D milestones are successfully achieved and a Joint Commercialization Committee to execute pre- and post-approval go-to-market strategies globally.

New flexible BLC equipment has not been available for purchase since early 2023 in the U.S., as prior systems were outdated and discontinued by the manufacturer. As a leading company focused on the management of bladder cancer, Photocure is dedicated to ensuring that BLC with Hexvix/Cysview is available to physicians worldwide in both the surgical and surveillance settings so that patients with bladder cancer can have access to the best care.

"Entering into this partnership with Richard Wolf is a milestone for Photocure, and more importantly is the first step toward making high-definition BLC equipment in the surveillance setting consistently available for patients globally," said Dan Schneider, President and CEO of Photocure. "Before the phase-down of standard-definition flexible blue light equipment in the U.S., adoption of these systems was on a strong growth path with physicians recognizing the significant benefits of precision monitoring of bladder tumors with BLC and Cysview. We look forward to working with Richard Wolf on the development and anticipated commercialization of a 4K high-definition blue light cystoscope, and bringing a cutting edge and cost-effective solution to physicians and patients in our commercial territories as soon as possible."

"As a full-service provider in endoscopy and a leading manufacturer of blue light cystoscopy equipment, we are very pleased to enter into this Agreement with Photocure, to develop and commercialize a first-in-class/best-in-class high-definition flexible blue light system," said Florian Happe, Vice President R&D at Richard Wolf. "The workmanship that goes into every Richard Wolf device provides the foundation for exceptional precision and longevity in the clinical setting, enabling our institutional and physician customers to deliver excellence in care to their patients. Surveillance of patients with bladder cancer is of critical importance in disease management, and we believe that a high-definition blue light cystoscope designed for out-patient use has potential to set a new standard in this care setting."

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About Bladder Cancer

Bladder cancer ranks as the 8^th most common cancer worldwide – the 5^th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)^1a, 614 000 new cases and more than 220 000 deaths in 2022.^1b

Approx. 75% of all bladder cancer cases occur in men.¹ It has a high recurrence rate with up to 61% in year one and up to 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

¹Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [February 2024].

²Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

³Sievert KD et al. World J Urol 2009;27:295–300

⁴Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html

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, compared to standard white light cystoscopy alone, 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, New Zealand and Israel. Please refer to https://photocure.com/partners/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

About Richard Wolf

Richard Wolf GmbH is a medium-sized medical technology company with over 1,800 employees, along with eighteen subsidiaries and 130 foreign agencies worldwide. The company develops, produces, and distributes numerous products for endoscopy and extracorporeal shock wave treatment in human medicine. Integrated operating room systems round out the product range.

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
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: [email protected]

Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]