Photocure ASA

Earnings Release • Dec 19, 2019

Photocure: Reduced recurrence after flexible Blue Light Cystoscopy with Hexvix® in surveillance ? New Publication of study results

Photocure: Reduced recurrence after flexible Blue Light Cystoscopy with Hexvix® in surveillance ? New Publication of study results

Use of flexible Blue Light Cystoscopy at the first follow-up after TURBT*

reduced the risk of tumor recurrence by 33% compared to white light alone. The

randomized controlled multi-center study that included 699 bladder cancer

patients at 3 hospitals in Denmark is now published in Urology, The Gold

Journal.

Oslo, Norway, December 19, 2020, Photocure ASA (PHO:OSE), is pleased to announce

that the results from a new study with Blue Light Cystoscopy (BLCT) with Hexvix

and flexible cystoscopes are now published in Urology. Initial study findings

had been presented at the annual meeting of the Danish Urology Society on

November 16, 2019.

699 patients at 3 hospitals in Denmark were enrolled and randomized 1:1 to

either BLC with Hexvix with flexible cystoscopes or white light (WL) only

flexible cystoscopy at the time of first follow up after TURBT. Primary endpoint

was tumor recurrence within eight months from the randomization. Secondary

outcomes were numbers of procedures (TURBTs) in general anesthesia, time to the

first recurrence, differences in tumor size, risk of tumor progression, and

identification of carcinoma in situ.

A total of 351 patients were allocated to the flexible BLC, and 348 to the

control group. Throughout the following 8 months after randomization, only 117

patients in the BLC group had at least one tumor recurrence compared to 143

patients in the control group (P= 0.049). Odds ratio of 0.67 (P= 0.02, 95% CI:

0.48-0.95) correlates with a tumor reduction of 33% in favor of the BLC group.

"It is very important to Photocure that the scientific community continues to

investigate the benefits of our solution for patients," says Dan Schneider,

President and CEO of Photocure.  "These first results showing reduced recurrence

after flexible Blue Light Cystoscopy with Hexvix in surveillance clearly

demonstrate the efficiency of the procedure and show how important it is to

include Hexvix in the surveillance and management of NMIBC patients."

The study authors** conclude that use of BLC in the first routine surveillance

cystoscopy after TURBT for NMIBC*** reduces subsequent risk of tumor recurrence

compared to WL cystoscopy alone. They explain the reduced recurrence rates

despite no difference in detection rates at randomization by the possibility of

early recurrences arising from small tumors not yet visible at the time of TURBT

or residual tumor. They assume that it could be a consequence of the fact that

by using BLC-guided flexible cystoscopy, it was possible to detect, and treat,

small additional tumors in patients where recurrence was already found at the

time of randomization.

Link to the study can be found here:

https://www.ncbi.nlm.nih.gov/pubmed/31843623

* TURBT: trans-urethral resection of bladder tumors

** Study Authors: Ditte Drejer, Anne-Louise Moltke, Anna Munk Nielsen, Gitte

Wrist Lam, Jørgen Bjerggaard Jensen

*** NMIBC: non-muscle invasive bladder cancer

About Bladder Cancer

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

prevalent cases, 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 (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 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 ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to

improve the lives of bladder cancer patients. Our unique technology, which makes

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 or www.cysview.com