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Photocure ASA

Regulatory Filings Mar 23, 2015

3714_iss_2015-03-23_c2fe6aab-558c-45fb-9bf3-1428fde092d5.html

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PHOTOCURE: HEXVIX® BLUE-LIGHT FLEXIBLE CYSTOSCOPY IN THE OUTPATIENT SETTING: PRESENTATION AT EAU ANNUAL MEETING

PHOTOCURE: HEXVIX® BLUE-LIGHT FLEXIBLE CYSTOSCOPY IN THE OUTPATIENT SETTING: PRESENTATION AT EAU ANNUAL MEETING

Hexvix blue-light flexible cystoscopy allows for better identification and

management of recurrent low-grade tumors in the outpatient setting, providing

clinical, patient, and economic benefits.

Oslo, Norway, March 23, 2015: Photocure ASA (OSE: PHO), a specialty

pharmaceutical company focused on photodynamic technologies in dermatology and

cancer, reports that Norwegian investigators have presented positive case

studies with Hexvix blue-light flexible cystoscopy in the outpatient setting at

the European Association of Urology (EAU) annual meeting in Madrid, Spain, on

March 22nd, 2015. The EAU meeting is Europe's largest annual event showcasing

the latest and most relevant knowledge in urology, with more than 14,000

delegates and exhibitors from over 100 countries.

The research, presented as five video case presentations by Dr. Reza Zare, Head

of Urology at Bærum Hospital, Norway, shows how Hexvix blue-light flexible

cystoscopy achieved high-quality images, with improved visibility of tumors

compared with standard white-light flexible cystoscopy alone. Hexvix blue-light

flexible cystoscopy was convenient and well tolerated, with a high level of

patient acceptance. The technology allowed for biopsies of suspicious areas of

the bladder, and small tumors removed in outpatient procedures.

Dr. Zare explained the economical and practical importance of these findings:

"By securing improved detection and limiting the number of patients who have to

be referred to the operating room to have their tumors removed, we can avoid the

need for general anesthesia and overnight hospital stays, thus taking the

pressure off hospital services and reducing the burden of disease on patients."

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

estimated 124,000 new cases and more than 40,000 deaths in 2012.(1) Bladder

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

within 5 years of their initial diagnosis(2 )- causing patients to require

lifelong surveillance. While Hexvix blue-light cystoscopy using rigid

cystoscopes, as an adjunct to white-light cystoscopy, is already a standard of

care in the operating room, with proven ability to improve detection and

management of non-muscle-invasive bladder cancer compared with white-light

cystoscopy alone(3) , Hexvix blue-light flexible cystoscopy is becoming

increasingly feasible. Improvements in equipment allow for early detection of

recurrent tumors and low-grade tumors to be removed in the outpatient setting

without the need for referral to the operating room. In addition, early follow-

up of patients with blue-light flexible cystoscopy following surgical removal of

the tumor is likely to offer advantages in terms of improved detection of

residual tumor and reduced recurrence.

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

"Early and accurate bladder cancer detection and removal can reduce the risk of

recurrence and avoid the need for frequent follow-up visits. With outpatient

follow up of patients using blue-light cystoscopy with Hexvix, tumors can be

detected at an early stage, and small or flat lesions can be removed without

delay, which can be expected to improve the long-term prospects for patients."

Fred Witjes, Chair of Oncological Urology at Radboud University, Netherlands,

said: "In 2014, the European expert consensus panel updated our recommendations,

emphasizing the potential benefits of blue-light flexible cystoscopy with

advances in equipment, which will help to improve patients' experience of

bladder cancer care. I am delighted to see that these advances are being

achieved, as witnessed by the experiences of Dr. Zare and his colleagues using

Hexvix in the outpatient setting."

More information on the EAU 2015 meeting can be found here:

http://eaumadrid2015.uroweb.org/the-congress.

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

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

2. Sylvester RJ, van der Meijden AP, Oosterlinck W et al. Predicting recurrence

and progression in individual patients with stage Ta T1 bladder cancer using

EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials.

Eur Urol 2006; 49: 466-475.

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.

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

commercializes 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#1905063]

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