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Photocure ASA

Environmental & Social Information Mar 2, 2015

3714_iss_2015-03-02_9016f1af-8091-400a-bfcc-24cb8ac429fd.html

Environmental & Social Information

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PHOTOCURE: NICE, UK, PUBLISHES BLADDER CANCER GUIDELINE, RECOMMENDING PHOTODYNAMIC DIAGNOSIS TO IMPROVE DETECTION

PHOTOCURE: NICE, UK, PUBLISHES BLADDER CANCER GUIDELINE, RECOMMENDING PHOTODYNAMIC DIAGNOSIS TO IMPROVE DETECTION

Oslo, Norway, 2 March 2015: Photocure ASA (OSE: PHO), a specialty pharmaceutical

company focused on photodynamic technologies in dermatology and cancer, is

pleased to announce that the National Institute for Health and Care Excellence

(NICE) in the UK has published its first guidelines on bladder cancer,

recommending photodynamic diagnosis for improved detection of bladder cancer.(1

)NICE makes evidence-based recommendations for healthcare, with the aim of

improving treatment and reducing variations in care.

The NICE guidelines recognize cystoscopy as the standard for diagnosis and

follow up for patients with bladder cancer, and recommend that people with

suspected bladder cancer should be offered surgical removal of the tumor using

white-light guided cystoscopy supported by additional techniques to improve

tumor detection, such as photodynamic diagnosis.(1)

Kjetil Hestdal, President and CEO of Photocure, said: "We are pleased to have

photodynamic diagnosis included in the NICE guideline for diagnosis and

management of bladder cancer. This is another important milestone providing

further evidence of the value of Hexvix/Cysview in the diagnosis and management

of bladder cancer patients. NICE is internationally recognised and well

respected for its evidence-based recommendations."

Photodynamic diagnosis of bladder cancer involves the instillation of a

photosensitive compound, such as Hexvix(®)/Cysview(®) (hexaminolevulinate), into

the bladder. Hexvix/Cysview accumulates in tumor tissue and fluoresces pink

under blue light, allowing cancerous areas on the lining of the bladder to be

distinguished from healthy tissue.(2) Using Hexvix/Cysview as an adjunct to

standard white-light cystoscopy (WLC) enables the urologist to better detect and

remove lesions compared with white-light cystoscopy alone.(3) After applying

stringent cost-effectiveness analyses, NICE concluded "Photodynamic diagnosis

appears to be a cost-effective alternative to WLC as an initial diagnostic

test."(1)

Bladder cancer is the fifth most common cancer in Europe, accounting for an

estimated 124,000 newly diagnosed cases and more than 40,000 deaths in 2012.(4)

Bladder cancer has a high recurrence rate (up to 78% of patients experience

recurrence within 5 years of their initial diagnosis), making the lifetime costs

of managing bladder cancer one of the highest of all cancers. If bladder cancer

is detected at an early stage, the risk of recurrence can be reduced, and

management and long-term outcomes for patients improved.

Per-Uno Malmström, Professor of Urology at Uppsala University, Sweden, said:

"NICE is a leading authority in healthcare management; this recognition by NICE

of the benefits that can be achieved from photodynamic diagnosis will open the

door to improved management of bladder cancer for many patients."

Gregers Hermann, Chief Urologist at Frederiksberg Hospital, Copenhagen

University, Denmark, stated: "Patients with bladder cancer deserve the best

evidence-based diagnosis and management of their disease. NICE guidelines

highlight the proven value of photodynamic diagnosis in terms of achieving cost-

effective diagnosis as well as reducing the risk of recurrence for patients with

bladder cancer."

The full NICE bladder cancer guidelines can be found here:

http://www.nice.org.uk/guidance/ng2

For further information, please contact:

Photocure

President & CEO Kjetil Hestdal

Tel: + 47 913 19 535, Email: [email protected]

CFO Erik Dahl

Tel: +47 450 55 000, Email: [email protected]

References

1. NICE. Bladder cancer: diagnosis and management. NICE guidelines NG2.

Available at: http://www.nice.org.uk/guidance/ng2/ (accessed February 2015).

2. Frampton JE, Plosker GL. Hexyl aminolevulinate in the detection of bladder

cancer: profile report. BioDrugs 2006; 20: 317-320.

3. Burger M, Grossman HB, Droller M et al. Photodynamic diagnosis of non-muscle-

invasive bladder cancer with hexaminolevulinate cystoscopy: a meta-analysis of

detection and recurrence based on raw data. Eur Urol 2013; 64: 846-854.

4. Globocan. Incidence/mortality by population. Avaiable at:

http://globocan.iarc.fr/Pages/bar_pop_sel.aspx (accessed February 2015).

About Photocure ASA

Photocure ASA, 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

commercialises highly selective and effective solutions in disease areas with

high unmet medical need, such as bladder cancer, HPV and precancerous cervical

lesions, colorectal cancer and skin conditions. Our aim is to provide solutions

that 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.

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(®)/Cysview(®) is

approved in Europe and the USA.

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

(Norwegian Securities Trading Act)

[HUG#1898417]

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