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Photocure ASA

Regulatory Filings Sep 15, 2022

3714_rns_2022-09-15_20257dfa-44cf-4238-83fb-8f2d8bd801bb.html

Regulatory Filings

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Photocure Partner Asieris announces coverage of Hexvix by the Lecheng Global Specialty Drug Insurance

Photocure Partner Asieris announces coverage of Hexvix by the Lecheng Global Specialty Drug Insurance

Press release - Oslo, Norway, September 15, 2022: Photocure ASA (PHO: OSE), The

Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:

688176) has communicated today on the inclusion of Hexvix[®] in the 2022 edition

of the Lecheng Global Specialty Drug Insurance Specialty Drug List.

As a new specialty drug benefit plan developed under the guidance of the

government covering 40 domestic specialty drugs and 60 overseas specialty drugs,

the Lecheng Global Specialty Drug Insurance allows Hainan citizens access to

more advanced medical resources and comprehensive coverage of their medical

needs.

In December 2021, Hexvix received initial clinical use in the Boao Lecheng

International Medical Tourism Pilot Zone in Hainan Province when the first

prescription in China was issued at Hainan General Hospital, and the first

patient procedure was completed. Asieris received approval from the National

Medical Products Administration (NMPA) for Hexvix to be included in phase III

clinical trials in the first quarter of 2022 as well as a real-world clinical

data pilot study.

Asieris expects the incorporation of Hexvix into the Lecheng Global Specialty

Drug Insurance to help them explore innovative access models, so that innovative

drugs can be introduced into China and covered by commercial insurance earlier

and faster.

Read Asieris' full media release here: Hexvix®, A Diagnostic Drug of Asieris, is

Now Covered by the 2022 Lecheng Global Specialty Drug Insurance - Asieris

Pharmaceuticals (https://asieris.com/hexvix-a-diagnostic-drug-of-asieris-is-now

-covered-by-the-2022-lecheng-global-specialty-drug-insurance/)

Note to editors

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.

About Bladder Cancer

Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most

common in men - 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 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 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 [January 2022].

[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)

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, New Zealand and Isreal. 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

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]

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