Photocure ASA

Earnings Release • Jul 31, 2017

Photocure ASA: First European study to show that Blue Light Flexible Cystoscopy with Hexvix® can replace conventional follow up of CIS patients

Photocure ASA: First European study to show that Blue Light Flexible Cystoscopy with Hexvix® can replace conventional follow up of CIS patients

Oslo, Norway, July 31, 2017: Photocure ASA (OSE: PHO) today

announced that a study investigating the use of Blue Light

Flexible Cystoscopy with Hexvix® (BLFC(TM)) in patients with

Carcinoma in Situ (CIS) has been published in the

Scandinavian Journal of Urology.

Click here

(http://www.tandfonline.com/doi/full/10.1080/21681805.2017.13

53542) for a link to the abstract.

The results demonstrate that bladder examinations and

biopsies of lesions performed with Blue Light Flexible

Cystoscopy in the outpatient setting are equivalent to those

performed in the inpatient setting with rigid scopes in the

operating room and the patient under general anaesthesia.

Furthermore, there were significant Quality of Life (QoL)

benefits to the patients in the outpatient setting versus

the inpatient setting.

The study was a prospective open comparative non-inferiority

study on 31 patients that had received standard therapy with

the recommended immunotherapy BCG six weeks prior to the

examination. Nine patients had primary CIS and 22 patients

had recurrent disease. The median patient age was 72.

"CIS are flat aggressive tumors that are difficult to detect

using standard white light alone, and many randomized

controlled trials have demonstrated that rigid BLC(TM) with

Hexvix® is superior in detecting these flat tumors. This new

study shows that BLFC(TM) with Hexvix® does not compromise

the ability to monitor patients with CIS following

immunotherapy. By moving the monitoring of the patient to

the outpatient setting there is the potential to reduce the

burden on the patient and provide savings to the healthcare

system," says Kjetil Hestdal, M.D., Ph.D., President and

CEO, Photocure ASA.

"These results show that managing CIS with Blue Light

Flexible Cystoscopy in the outpatient setting does not

compromise the diagnosis of this rather aggressive form of

bladder cancer, yet it provides considerable QoL benefits to

the patients. With the flexible procedure patients

experienced less pain, urinary symptoms and only 90 minutes

of outpatient hospital stay as compared to 1-3 days of

hospital inpatient admittance with the current standard of

care in Denmark when using rigid cystoscopy in the operating

theatre," said Dr Gregers G. Hermann, Consultant Urologist,

DM Sc. F.E.B.U. Herlev and Gentofte Hospital, University of

Copenhagen and an investigator in the study."

About Bladder Cancer

There are 167 000 new cases of bladder cancer in Europe and

more than 59 000 deaths from the disease annually. Approx.

75% of all bladder cancer cases occur in men1. It has a high

recurrence rate with an average of 61% in year one and 78%

over five years, making the lifetime costs of managing

bladder cancer one of the highest amongst all3,4. Bladder

cancer is a costly, potentially progressive disease for

which patients have to undergo multiple cystoscopies due to

the high risk of recurrence. A recent paper on the economic

burden of bladder cancer across the European Union estimates

that bladder cancer cost the EU 4.9 Billion Euro in 20122.

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 treat5.

1. Globocan. Incidence/mortality by population. Available

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

2. Leal et al, Eur Urol 2016; 69: 438-447

3. 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.

4. Sievert KD et al. World J Urol 2009;27:295-300

5. Bladder Cancer. American Cancer Society.

http://www.cancer.org/acs/groups/cid/documents/webcontent/003

085-pdf.pdf. Accessed April 2016.

About Hexvix®/Cysview®

Hexvix®/Cysview® is a drug that is selectively taken up by

cancer cells in the bladder making them glow bright pink

during Blue Light Cystoscopy (BLCTM). BLCTM with

Hexvix® /Cysview® improves the detection of tumors and leads

to more complete resection, less 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 Hexvix®/Cysview® 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://www.photocure.com/Partnering-with-Photocure/Our-

partners for further information on our commercial partners.

About Photocure ASA

Photocure, headquartered in Oslo Norway, is a specialty

pharmaceutical company focusing on urology. Based on its

unique proprietary Photocure Technology® platform, Photocure

is committed to developing and commercializing highly

selective and minimally invasive solutions to improve health

outcomes for patients worldwide. The company is listed on

the Oslo Stock Exchange (OSE: PHO). More information about

Photocure is available at www.photocure.com, www.hexvix.com,

www.cysview.com.

For more information, please contact:

Company contacts:

Kjetil Hestdal

President and CEO

Tel: +47 913 19 535

Email: kh@photocure.no

Erik Dahl

Chief Financial Officer

Tel: +47 450 55 000

Email: ed@photocure.no