Photocure ASA

Regulatory Filings • Nov 21, 2016

Photocure ASA: Strong recommendations for Blue Light Cystoscopy with Hexvix® in new French Guidelines

Photocure ASA: Strong recommendations for Blue Light Cystoscopy with Hexvix® in new French Guidelines

Oslo, Norway, November, 21 2016: Photocure ASA

(OSE:PHO) announced today that new 2016 French

National Guidelines for the management of Bladder

Cancer includes its Blue Light Cystoscopy (BLC) with

Hexvix®. The new guidelines have been presented on

November 17th, during Association of French Urologists

(AFU) National Meeting, Paris, France published on

line in Progres en urologie. Please click here for an

abstract of the guidelines http://bit.ly/2fj2yID.

The French guidelines recommend BLC with Hexvix® for

the first bladder cancer resection (TURBT) in

essentially all patients and for consecutive TURBT's

in the majority of patients. The recommendations are

at an evidence level Grade B, demonstrating the strong

clinical data supporting BLC with Hexvix®.

"The Association of French Urology National Bladder

Cancer Guidelines for the management of patients with

bladder cancer were last released in 2013. One of the

biggest differences since the last guideline is that

it now includes the situations BLC with Hexvix® can be

used to reduce the risk of recurrence of NMIBC. The

strong recommendation for use of blue light cystoscopy

with Hexvix® should result in contributing to

increasing the level of urological care for the

management of patients with bladder cancer in France,"

said M. Roupret, during his presentation on the

guidelines at the AFU meeting, Professor of Urology

Pitié-Salpétrière - Hôpitaux de Paris University and

one of the authors of the guidelines.

"The updated French National Guidelines recommending

BLC with Hexvix® for such a wide range of patient

types will result in BLC with Hexvix® being seen as

standard of care. It is especially encouraging to see

the strong recommendation for using BLC at the very

critical first TURBT, which allows for the most

correct staging and grading, which is crucial for the

optimal follow-up and management of the patient. The

recommendation for use in the first TURBT is also

supported by Hexvix® cost effectiveness data developed

for French conditions published in 20151," commented

Kjetil Hestdal, MD, PhD, President and CEO, Photocure

ASA.

In 2011, Photocure entered into a strategic

collaboration with Ipsen to commercialize Hexvix®, its

flagship product for the diagnosis and management of

bladder cancer, worldwide except in the United States

of America (USA) and the Nordic region. This

technology represents a significant improvement for

urologists and their patients. Ipsen is notably

responsible for the commercialization of Hexvix® in

France.

About Bladder Cancer

Bladder cancer is the fifth most common cancer in men

with more than 330 000 new cases annually and more

than 130 000 die of the disease2. It has a high

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

78% over five years, making the lifetime costs of

managing bladder cancer one of the highest amongst all

cancers. It is a costly, potentially progressive

disease for which patients have to undergo multiple

cystoscopies because of 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 20123. 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 is still in the

inner layer of cells. These cancers are the most

common (75%) of all bladder cancer 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.

About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydro-chloride)

is an innovative breakthrough technology in the

diagnosis and management of non-muscle-invasive

bladder cancer. It is designed to selectively target

malignant cells in the bladder and induce fluorescence

during a cystoscopic procedure using a blue light

enabled cystoscope. Using Hexvix®/Cysview® as an

adjunct to standard white light cystoscopy enables the

urologist to better detect and remove lesions, leading

to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S.

and Canada. Hexvix® is marketed and sold by Photocure

in the Nordic countries and in the US with the trade

name Cysview®. Photocure has a strategic partnership

with Ipsen for the commercialization of Hexvix® in

Europe, excluding the Nordic region. 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 and world leader in

photodynamic technology. Based on our unique

proprietary Photocure Technology® platform, Photocure

develops and commercializes highly selective and

effective solutions within disease areas with high

unmet medical need, such as bladder cancer, HPV and

precancerous cervical lesions, and skin conditions.

Our aim is to provide solutions which can improve

health outcomes for patients worldwide. Photocure is

listed on the Oslo Stock Exchange (OSE: PHO).

Information about Photocure is available at

www.photocure.com.

For more information, please contact:

Company contacts:

Kjetil Hestdal

President and CEO

Tel: +47 913 19 535

Email: kh@photcure.no

Erik Dahl

Chief Financial Officer

Tel: +47 450 55 000

Email: ed@photocure.no

References

1. Roupret et al, Progres en urologie (2015) 25, 256-

264: Cost effectiveness of TURBT of the bladder with

blue light in patients with non-muscle invasive

bladder cancer in France.

2. Globocan. Incidence/mortality by population.

Available at:

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

(accessed March 2015)

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