Photocure ASA

Regulatory Filings • May 15, 2020

AUA abstracts further support role for Cysview[®] in the office setting

AUA abstracts further support role for Cysview[®] in the office setting

OSLO, Norway, 15 May 2020 -- Photocure ASA (OSE: PHO) today announced key data

was published by the 2020 American Urological Association (AUA) Annual Virtual

Meeting. Three abstracts featured Blue Light Cystoscopy (BLCT) with Cysview, and

on June 27, 2020 BLC with Cysview will be included in a virtual session of the

AUA program: "Surgical Techniques: Tips & Tricks Oncology: Bladder Cancer Blue

Light" with Dr. Anne Schuckman.

MP 73-11: Role of blue light cystoscopy in detecting invasive bladder tumor:

Data from a multi-institutional registry

https://www.auajournals.org/doi/10.1097/JU.0000000000000959.011

MP 24-06: Gender based Variations in the Detection of Bladder Cancer with Blue

Light Cystoscopy: Insights from a Multicenter Registry

https://www.auajournals.org/doi/10.1097/JU.0000000000000857.06

MP 73-02: Malignant urinary cytology of unknown origin-blue light flexible

cystoscopy at the outpatient clinic may be a valuable diagnostic tool

https://www.auajournals.org/doi/10.1097/JU.0000000000000959.02

The Role of blue light cystoscopy in detecting invasive bladder tumor: Data from

a multi-institutional registry showed that in the registry enrolled patients, a

considerable proportion of invasive bladder tumors were detected by BLC alone: A

total of 55 invasive lesions, of the 494 invasive lesions detected, were

detected only by blue light cystoscopy. The benefit of using BLC in earlier

detection of invasive bladder tumors could have an effect on the treatment

approach and potentially lead to improved survival in the high-risk population.

The study included 3514 lesions (1257 unique patients), from 9 sites in the U.S.

"Out of the overall 494 invasive lesions detected, 11% of them were only

detected by BLC alone. Also, of 47 patients with BLC-only positive invasive

lesions, 60% had concurrent CIS and 49% had an additional T1 lesion. Knowing

when these high-risk tumors are present, especially concurrently, is critical to

the optimal management of a patient's disease. We need this information in order

to make the best treatment decisions, which can have a significant impact on the

prognosis and quality of life, for our patients." says Siamak Daneshmand, MD,

Director of Urologic Oncology Associate Professor of Urology, USC Institute of

Urology.

Gender based Variations in the Detection of Bladder Cancer with Blue Light

Cystoscopy: Insights from a Multicenter Registry showed that similar to existing

evidence, BLC-alone was significantly more sensitive than WLC-alone in males

(91.1% vs 80.0%, p<0.001) and in females (86.7% vs 79.5%, p = 0.036).

Furthermore, the sensitivity with BLC between the genders was significantly

greater in males than in females (91.1% vs 86.7%, p = 0.035). Additionally, the

false-positive rate in females was significantly higher than in males in BLC

(35.9% vs 28.5%, p=0.008) and WLC (33.8% vs 27.4%, p=0.029).  These findings

highlight the differences in detection rates of NMIBC between genders, an area

that warrants further investigation, and they continue to validate the existing

evidence of increased sensitivity of BLC with Cysview in the detection of NMIBC.

Malignant urinary cytology of unknown origin ? blue light flexible cystoscopy at

the outpatient clinic, a Nordic prospective multicenter registry study, showed

that the majority of patients, 93% (27/29), stated that they preferred to have

BLC with Cysview performed with a flexible cystoscope at the outpatient clinic

versus the operating room under general anesthesia.  It was concluded that using

BLC with Cysview with a flexible cystoscope at the office may be a simple way to

solve unclear cases with malignant or suspicious urinary cytology.

"At a time when patients and physicians are seeking to ensure bladder cancer

detection and surveillance are being maintained in appropriate intervals, it is

encouraging to see more data supporting the use of BLC with Hexvix/Cysview in

the office setting." says Dan Schneider, President and CEO of Photocure.

"Additionally, Cysview for use in high-risk patients helps both physicians and

patients make difficult decisions that can impact patients' outcomes and quality

of life.  As The Bladder Cancer Company we are proud to see that more data is

being collected, and that it continues to add to the already existing evidence

that the use of Hexvix/Cysview can play a critical role in disease management."

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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 is selectively taken up by tumor cells in

the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM).

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 US and Canada, Hexvix[®] is the tradename in

all other markets. Photocure is commercializing Cysview[®] /Hexvix[®] directly

in the US 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.

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.

For more information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Tel: + 1-609 759-6515

Email: ds@photocure.com

Erik Dahl

CFO

Photocure ASA

Tel: +4745055000

Email: ed@photocure.com

About Photocure

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