Photocure ASA

Earnings Release • Aug 2, 2016

Photocure: New meta-analysis shows that BLC with Hexvix®/Cysview® significantly reduces rate of progression in bladder cancer

Photocure: New meta-analysis shows that BLC with Hexvix®/Cysview® significantly reduces rate of progression in bladder cancer

Oslo, Norway, August 2, 2016 -- Photocure ASA announced today a new systematic

review and meta-analysis on the impact of Blue Light Cystoscopy (BLC) with

Hexvix(®) (Hexaminolevulinate) - versus White Light Cystoscopy (WLC) on

progression in Non-Muscle Invasive Bladder Cancer (NMIBC). In this meta-

analysis, the rate of progression was significantly lower in patients treated

with BLC with Hexvix(®) versus WLC alone. The data was published online in the

August issue of the peer-reviewed journal, Bladder Cancer.

This is the first meta-analysis to demonstrate the significant impact of BLC

with Hexvix on the rate of cancer progression in patients with NMIBC. The

results of this meta-analysis support the therapeutic potential of BLC with

Hexvix in patients with NMIBC. The article shows the impact of BLC with Hexvix

on progression of disease and adds to the existing clinical evidence that BLC

with Hexvix-guided transurethral bladder tumor resection (TURBT) improves the

detection of Ta-T1 non-muscle-invasive bladder cancer, carcinoma in situ (CIS)

as well as reduction in rate of recurrence.

The meta-analysis was based on studies of BLC with Hexvix versus white light

cystoscopy in patients with NMIBC conducted between 2000 to 2016 and included a

total of 294 studies of which five (4 randomized and 1 retrospective) were

considered for final analysis. Of the 1,301 patients, 644 underwent BLC with

Hexvix (49.5%) and 657 with WLC (50.5%):

* Progression was found in 6.8% of BLC with Hexvix patients, (44) and 10.7% of

WLC patients (70) which was highly significant ( p=0.01)

* Progression-free survival was reported in a single study and was longer

after BLC with Hexvix (p=0.05)

"This meta-analysis is especially exciting because it continues to show that BLC

with Hexvix is the optimal treatment for bladder cancer patients. These

significant clinical benefits are also the foundation of inclusion of BLC with

Hexvix/Cysview in the majority of guidelines, including the recently released

2016 American Urological Association (AUA) and Society of Urologic Oncology

(SUO) guideline. In addition to the National Comprehensive Cancer Network

(NCCN), the European Association of Urology (EAU) and the National Institute for

Health and Care Excellence (NICE) guideline in the UK," commented Kjetil

Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

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 disease(2). 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 2012(3). 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

Investor relations:

Trout International LLC

Lauren Williams

Tel: +44 20 3780 4972

Email: lwilliams@troutgroup.com

References

1. Gakis G, Fahmy O. 2016. Systematic Review and Meta-Analysis on the Impact of

Hexaminolevulinate- Versus White-Light Guided Transurethral Bladder Tumor

Resection on Progression in Non-Muscle Invasive Bladder Cancer. Bladder Cancer

Journal, p: 293-300. In press.

2. Globocan. Incidence/mortality by population.  Available at:

ttp://globocan.iarc.fr/Pages/bar_pop_sel.aspx (accessed March 2015)

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

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

(Norwegian Securities Trading Act)

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