Photocure ASA

Regulatory Filings • Aug 10, 2015

PHOTOCURE ANNOUNCES AGREEMENT WITH US FDA FOR CEVIRA PHASE 3 REGISTRATION PROGRAM

PHOTOCURE ANNOUNCES AGREEMENT WITH US FDA FOR CEVIRA PHASE 3 REGISTRATION PROGRAM

Oslo, Norway, 10 August, 2015: Photocure ASA (OSE: PHO), a specialty

pharmaceutical company focused on photodynamic technologies in dermatology and

cancer, announces today the approval of the Special Protocol Agreement (SPA)

from the US FDA on the design of the Phase 3 clinical registration program for

Cevira, which is in development for the treatment of high grade pre-cancerous

lesions of the cervix. The SPA defines the size, design and analysis of clinical

trials that will form the primary basis of approval.

In response to Photocure's request for a special protocol assessment (SPA), the

US FDA has agreed that the design and planned analysis of the pivotal Phase 3

protocols address the objectives in support of a regulatory submission. Ensuring

regulatory alignment before initiating the Phase 3 registration trials reduces

the risk of the development program and is an important milestone in the

continued development of Cevira.

Kjetil Hestdal, President & CEO of Photocure, said: "Gaining alignment with the

FDA on the Cevira registration program through the SPA process is a significant

milestone in the continued development of this breakthrough technology. Cevira

will offer a convenient and effective alternative to surgery in the large number

of affected women globally, while preserving fertility and avoiding the

potential for future neonatal morbidity and mortality which results from

surgery."

With alignment with FDA on Phase 3 clinical studies now obtained, Photocure

plans to finalize necessary documentation for the Cevira device to ensure

readiness for the Phase 3 trial.  The Phase 3 registration program will consist

of two identical double blind, randomized trials, each with approximately 200

patients, comparing Cevira to placebo in women with biopsy proven high-grade

cervical lesions. The primary endpoint will be clearance of the high-grade

lesion, as determined by an independent panel of pathologists, at six months.

For further information, please contact:

Photocure

President & CEO Kjetil Hestdal

Tel: + 47 913 19 535, Email: kh@photocure.no

CFO Erik Dahl

Tel: +47 450 55 000, Email: ed@photocure.com

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.

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

(Norwegian Securities Trading Act)

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