Photocure announces Hexvix regulatory filing accepted for review in Chile with Fast Track designation

Rhea-AI Summary

Photocure ASA announces that the Marketing Authorization Application (MAA) for Hexvix® has been accepted for regulatory review by the Chilean health authority.

Following this acceptance, Genotests SpA, the exclusive distributor for Hexvix in Chile, will prepare for the product's commercial launch, expected in the fourth quarter of 2021.

This partnership marks Photocure's first entry into South America, aiming to increase accessibility of Hexvix for bladder cancer patients in Chile, where there are approximately 1,500 new bladder cancer cases annually.

Positive

• Marketing Authorization Application for Hexvix accepted for review in Chile, indicating regulatory progress.
• Partnership with Genotests SpA to commercialize Hexvix, with significant funding provisions for regulatory approval and marketing.

Negative

• None.

OSLO, Norway, May 18, 2021 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that notification was given to its partner and exclusive distributor, Genotests SpA by the Instituto de Salud Pública de Chile that the Marketing Authorization Application ("MAA") for Hexvix^® has been accepted for regulatory review.

During the regulatory review process, Genotests will begin to prepare for the commercial launch of Hexvix in Chile. In August 2020, Photocure entered into an agreement with Genotests, a privately held company specializing in the marketing of genetic tests for cancer and targeting cancer specialists, to exclusively market and distribute Hexvix in Chile. Under the terms of the agreement, Genotests will fund all costs to secure regulatory approval and commercialize Hexvix in Chile. Photocure will manufacture the product and support Genotests with regulatory activities, training, and promotional materials.

"Acceptance of the Hexvix MAA with Fast Track designation by the Chilean regulatory authority is a milestone for both Photocure and Genotests as we move closer to bringing this important solution to bladder cancer patients in the region," said Dan Schneider, President and CEO of Photocure. "With Genotests' dedication and strong execution on this initiative, we are hopeful that Hexvix will become accessible to patients in Chile in the fourth quarter of this year. This partnership represents Photocure's first step into the South American continent, and supports our strategy of expanding the availability of Hexvix into new territories to ensure that patients and urologists have access to the benefits of using blue light cystoscopy (BLC^®). The procedure with Hexvix, or Cysview, is recommended in consensus treatment guidelines for the management of bladder cancer around the world."

"It is a privilege to bring this fantastic product to Chile" said Oscar Varas, founder and owner of Genotests. "There are approximately 1,500 new bladder cancer cases annually in our country, an estimated 5,000 TURBT* procedures and nearly 11,000 surveillance cystoscopies. We look forward to building on our established network and the successful demonstration of Hexvix Blue Light Cystoscopy, conducted in collaboration with Karl Storz, at the Chilean Urology Conferences in 2018 and 2019, to launch blue light cystoscopy with Hexvix into the Chilean urology community as soon as possible."

*TURBT: trans-urethral resection of bladder tumors

Note to editors:

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

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

About Hexvix^®/Cysview^® (hexaminolevulinate HCl)

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, Canada, 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

For further information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Tel: +47 22062210
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +47 45055000
Email: ed@photocure.com

David Moskowitz
Head of Investor Relations
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no

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SOURCE Photocure

FAQ

What recent announcement did Photocure ASA make regarding Hexvix?

Photocure ASA announced that the Marketing Authorization Application for Hexvix was accepted for regulatory review in Chile.

Who is handling the commercialization of Hexvix in Chile?

Genotests SpA is the exclusive distributor responsible for the commercialization of Hexvix in Chile.

What is the expected timeline for the launch of Hexvix in Chile?

The commercial launch of Hexvix is anticipated in the fourth quarter of 2021.

How many new bladder cancer cases are reported annually in Chile?

Approximately 1,500 new bladder cancer cases are reported annually in Chile.

What is the significance of the Hexvix MAA acceptance for Photocure ASA?

The acceptance of the Hexvix MAA is a significant milestone as it paves the way for Photocure's expansion into the South American market.