Photocure ASA

Earnings Release • Dec 7, 2020

New abstracts on the use of Blue Light Cystoscopy with Cysview presented at SUO

New abstracts on the use of Blue Light Cystoscopy with Cysview presented at SUO

PRESS RELEASE - Oslo, Norway, 7 December, 2020: Photocure ASA (OSE:PHO) today

announced new data and analyses presented at the 21[st] Annual Meeting of the

Society of Urologic Oncology (SUO). Presentations discussed the use of Blue

Light Cystoscopy (BLCT) with Cysview[®], in particular the positive impact on

patient outcomes in the surveillance setting without a significant impact on the

cost of care, as well as the benefits of identifying early recurrences in high

-risk NMIBC patients undergoing BCG treatment.

The SUO meeting, held virtually this year, is led by internationally renowned

urologic oncologists, medical oncologists, and scientists and attracts the

interest of experts from all over the world.

"The use of BLC with Cysview continues to inspire the scientific community as

much as ever for improving the care of patients diagnosed with bladder cancer.

These new abstracts highlight the role of the procedure throughout patient care,

especially focusing on the impact on patient management when used in

surveillance. The Budget Impact Model supports the favorable cost-benefit of

blue light procedures including in the office setting, while reaffirming its

superiority in detection of non-muscle-invasive bladder cancer compared to white

light alone. Both healthcare systems and patients clearly benefit from this

standard of care procedure", said Dan Schneider, President and CEO of Photocure.

BLC with Cysview abstracts and posters have been prominently featured at the SUO

meeting, including:

· Budget Impact of Blue Light Cystoscopy in The Surveillance Setting

Stephen B. Williams, et al. The University of Texas Medical Branch

The Budget Impact Model was developed based on standard protocols for the

treatment and surveillance of NMIBC. Inputs were based on a simulated facility

with 50 newly diagnosed bladder cancer patients. Blue Light Cystoscopy (BLC)

with Cysview was utilized for all surveillance cystoscopies. In the office

setting, the additional use of flexible BLC for surveillance did not

substantially impact cost and resulted in the identification of 9 recurrences

over the course of two years that would otherwise be missed.

Link to the abstract (https://suo-abstracts.secure

-platform.com/a/gallery/rounds/9/details/943)

· Using BLC at the 3-Month Post-BCG Cystoscopy, Impact on Cancer Diagnosis,

and Implications for Clinical Trial Design and Definition of BCG Response

Meera R. Chappidi, et al. University of California San Francisco

"We initiated this study because the utility of blue light cystoscopy (BLC) for

surveillance in patients receiving BCG treatments is really not well understood.

Thus, no recommendations exist in current guidelines. Beyond the obvious benefit

of detecting recurrences that would otherwise be missed, we think that

identifying early recurrences in patients receiving BCG can result in them being

enrolled into clinical trials for BCG unresponsive disease in a timely manner",

said Dr. Max Kates, Assistant Professor of Urology and Oncology, Co-Director,

Bladder Cancer Multidisplinary Clinic, The James Buchanan Brady Urologic

Institute of Johns Hopkins School of Medicine.

Based on findings from the Blue Light Cystoscopy (BLC) with Cysview Multi

-institutional Registry, BLC-alone identified patients with recurrences after

recent BCG treatment that would have been missed with White-light Cystoscopy

(WLC) alone. This could be interpreted as WLC-alone incorrectly assessing

inflated complete response rates in comparison to the more accurately measured

results when BLC is added for surveillance (60% vs 55.3%). The implications of

misidentified complete responses lead to inflated efficacy results, incorrect

statistical findings and misguided conclusions. Future research is needed to

clarify how BLC should be used for both entry into clinical trials and for

surveillance while on trials.

Link to the abstract (https://suo-abstracts.secure

-platform.com/a/gallery/rounds/9/details/912)

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About Bladder Cancer

Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000

prevalent cases (5-year prevalence rate), 550 000 new cases and almost 200 000

deaths annually in 2018.[1]

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. Incidence/mortality by

population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx

[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[TM]). BLCT 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 the Nordic region and has strategic partnerships for

the commercialization of Hexvix[®]/Cysview[®] in Europe, Canada, Australia and

New Zealand. Please refer to https://bit.ly/2wzqSQQ 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:

Photocure

Dan Schneider

President and CEO

Tel: +1-609 759-6515

Email: ds@photocure.com

Erik Dahl

CFO

Tel: +47 45055000

Email: ed@photocure.com

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: geir.bjorlo@corpcom.no