Photocure ASA

Earnings Release • Nov 18, 2019

Photocure: First trial demonstrating reduced recurrence after flexible Blue Light Cystoscopy with Hexvix[®] in surveillance

Photocure: First trial demonstrating reduced recurrence after flexible Blue Light Cystoscopy with Hexvix[®] in surveillance

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.

Randomized controlled multi-center study with 699 bladder cancer patients

presented at Danish Urological Society meeting.

Oslo, Norway November 18, 2019, Photocure ASA (PHO:OSE), is pleased to announce

that results from new studies with flexible Blue Light Cystoscopy (BLCT) with

Hexvix were presented at the annual meeting of the Danish Urology Society on

Saturday, November 16.

Results from a randomized controlled study in 699 patients from three urological

departments in Denmark was presented. Patients were enrolled and randomized 1:1

to either flexible BLC with Hexvix or white light (WL) only cystoscopy at the

time of first follow up after TURBT. Primary endpoint was tumor recurrence

within eight months from the randomization. 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.

The study authors (Ditte Drejer, Anne-Louise Moltke, Anna Munk Nielsen, Gitte

Wrist Lam, Jørgen Bjerggaard Jensen) 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.

The study abstract can be found here (p. 48):

http://urologi.dk/sites/default/files/begivenheder/dus_bog_final_version_0.pdf

Experiences with flexible BLC with Hexvix in 119 patients at Lillebælt hospital

in Denmark were also presented. Flexible BLC with Hexvix was introduced to

replace procedures traditionally performed with rigid cystoscopes under general

anesthesia; in control after intravesical treatment in high-risk patients, in

patients with positive cytology and negative WL cystoscopy, in suspicious

mucosal abnormalities under WL and in treatment of small recurrences.

The authors (Karen Spanggaard, Karsten Zieger, Gitte Kissow, Louise Fauerholt

Øbro) conclude that flexible BLC and the possibility to biopsy in gel anesthesia

was well tolerated and patient satisfaction was high. For most patients, BLC

enabled treatment to be completed in the office. BLC was found to increase

detection of urothelial disease and to add valuable information to WL cystoscopy

and cytology.

The study abstract can be found here (p. 47):

http://urologi.dk/sites/default/files/begivenheder/dus_bog_final_version_0.pdf

* TURBT: trans-urethral resection of bladder tumors

** NMIBC: non-muscle invasive bladder cancer

About Bladder Cancer

Bladder cancer ranks as the ninth most common cancer worldwide with 430 000 new

cases and more than 165 000 deaths annually. 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. MIBC is when 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].

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.

References

1. Globocan. Incidence/mortality by population.  Available

at: http://globocan.iarc.fr/Default.aspx

2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al.

EAU Guidelines on

non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016

Guidelines Edition:1-40.

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

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