Photocure ASA

Earnings Release • Apr 26, 2016

Photocure ASA: New analysis shows Hexvix®/Cysview® significantly prolongs time to progression of bladder cancer

Photocure ASA: New analysis shows Hexvix®/Cysview® significantly prolongs time to progression of bladder cancer

Photocure ASA Oslo, Norway, 26(th) April 2016: Photocure ASA (OSE: PHO), is

pleased to announce publication of a new analysis demonstrating that Blue Light

Cystoscopy (BLC) with Hexvix/Cysview significantly prolonged time to disease

progression and showed a trend in the reduction of the rate of progression in

patients with non-muscle invasive bladder cancer (NMIBC).  The data was

published online in the April issue of the peer reviewed journal, Bladder Cancer

http://content.iospress.com/articles/bladder-cancer/blc160048.

The new analysis of a long term follow-up study classified patients according to

the new International Bladder Cancer Group (IBCG) definition of disease

progression,  which was created to more accurately identify patients with high

risk of developing invasive disease at an earlier stage, in order to optimize

treatment decisions(1).

Using the new IBCG definition, overall time to disease progression was

significantly longer in the BLC with Hexvix/Cysview group (p=0.05).

Additionally, there was a clear trend towards a reduction in the rate of

progression, with 31 (12.2%) BLC with Hexvix/Cysview and 46 (17.6%) white light

only patients progressing after 4.5 years (p=0.085). This trend was particularly

pronounced in patients from having smaller, papillary lesions (stage Ta) to high

risk flat lesions (CIS): 4 (1.6%) in the Hexvix/Cysview group compared to 11

(4.2%) in the white light group.

Dr. Ashish M. Kamat MD, MBBS, FACS Professor Department of Urology, Division of

Surgery, The University of Texas, M.D. Anderson Cancer Center, Houston, Texas

and lead author on the publication commented "The updated findings support the

importance of improved tumor detection and resection of bladder tumors at an

early stage and its impact on the long term prognosis for patients.  These

results confirm and extend the prior reported benefits of using BLC with

Hexvix/Cysview over white light alone in the management of NMIBC."

Dr. Kjetil Hestdal, President & CEO of Photocure ASA added: "We are delighted to

see the ever growing body of clinical evidence that supports the beneficial

impact of BLC with Hexvix/Cysview for bladder cancer patients.  Better detection

and reduction in recurrence for patients undergoing BLC with Hexvix/Cysview has

been extensively documented.  This long term follow-up study analyzed with the

new definition of progression further demonstrates that BLC with Hexvix/Cysview

plays an important role in the management of bladder cancer and provides

patients with sustained and long term benefits."

In the original analysis, published in the Journal of Urology in 2012, the

definition of progression was from non-muscle invasive to muscle invasive

bladder cancer.  That analysis demonstrated a prolonged time to recurrence with

a trend towards less progression; after 4.5 years (median), 8 (3.1%)

Hexvix/Cysview and 16 (6.1%) white light patients had progressed.

The new IBCG definition includes the following as indicators of disease

progression: an increase in stage from Ta to CIS or T1, CIS to T1 (indicating

invasion of the bladder lining or lamina propria), development of T2 or greater,

lymph node disease (N+), distant metastasis (M1) or an increase in grade from

low to high.

Hexvix/Cysview is a photosensitizing agent taken up selectively by the tumor

cells in the bladder that when exposed to blue light during a cystoscopic

procedure results in a bright pink fluorescence of the suspicious tissue. Using

Hexvix as an adjunct to standard white light cystoscopy enables the urologist to

better detect and remove lesions, leading to a reduced risk of recurrence and

prolongation in time to disease progression.

For further information, please contact:

Kjetil Hestdal

President and CEO

Photocure ASA

Tel. +47 913 19 535

KH@photocure.no

About Photocure ASA

Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical

company and world leader in photodynamic technology.  Based on our unique

propriety Photocure Technology® platform, Photocure develops and commercializes

highly selective and effective solutions in disease areas with high unmet

medical needs such as bladder cancer, HPV and precancerous cervical lesions and

skin conditions.  Our aim is to provide solutions that can improve health

outcomes for patients worldwide.  Photocure is listed on the stock exchange

(OSE: PHO).  Information about Photocure is available at www.photocure.com.

About Hexvix®

Hexvix®/Cysview® (hexaminolevulinate hydrochloride) is an innovative

breakthrough technology in the diagnosis and management of non-muscle-invasive

bladder cancer. Hexvix®/Cysview® is approved in Europe, USA and Canada.

Cysview® is the trademark in the USA and Canada

About bladder cancer

Bladder cancer is the fifth most common cancer in men with more than 380 000 new

cases annually and more than 150 000(2) die of the disease. 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 surveillance cystoscopies because of 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.

1. Lamm et al: Defining Progression in Nonmuscle Invasive Bladder Cancer:  It

is time for a New, Standard Definition. Journal of Urology, Vol

191, 20-27, January 2014

2. www.globocan.iarc.fr (05-11-2013)

This information is subject of the disclosure requirements acc. to §5-12 vphl

(Norwegian Securities Trading Act)

[HUG#2006551]