Photocure ASA

Regulatory Filings • Jan 7, 2015

PHOTOCURE ANNOUNCES END OF PHASE 2 STATUS ACHIEVED FOR CEVIRA IN U.S.

PHOTOCURE ANNOUNCES END OF PHASE 2 STATUS ACHIEVED FOR CEVIRA IN U.S.

Cevira® advances towards Phase 3 for treatment in patients with cervical high

grade lesions (HSIL)

Oslo, Norway, 7 January 2015: Photocure ASA (OSE:PHO), a specialty

pharmaceutical company focused on photodynamic technologies in dermatology and

cancer, announces the conclusion of the Phase 2 program, and FDA clearance to

prepare Phase 3 protocol for the clinical development of Cevira, the innovative

breakthrough for the treatment of precancerous lesions of the cervix.

The conclusion of a Phase 2 meeting with the FDA confirmed that the Phase 2 data

supports the proposed Phase 3 program, and are sufficiently robust to continue

the development of Cevira. Following a guidance meeting with FDA in December

2013, Photocure completed the re-analysis of the Phase 2b data as requested by

the Agency. The re-analysis included a new panel read pathology assessment and

applying new clinical success criteria in the end-point definition. The re-

analysis demonstrated that Cevira provides improved treatment efficacy compared

to placebo among patients with cervical high grade lesions (HSIL). Photocure

discussed the results, including target population and statistical sample size,

in the FDA meeting in early December.

Kjetil Hestdal, President and CEO of Photocure, said:  "With End of Phase 2

achieved for Cevira in the U.S., together with the support achieved through

Scientific Advice in key European markets to progress to Phase 3 in women with

HSIL (CIN2), Photocure has reached an important milestone in the development of

Cevira.

Cevira has the potential to treat HPV induced cervical high grade disease and

prevent the development of cervical cancer which affects more than 500 000 women

annually. We will continue discussions with leading companies in women's

healthcare to secure a strategic partnership that will assist in the Phase 3

development and commercialization of Cevira."

Following the positive outcome of the meeting with the FDA, Photocure plans to

submit the proposed Phase 3 protocol for a detailed Special Protocol Assessment

(SPA) to the FDA first half 2015.

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.no

Notes to editors

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(TM) 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, colorectal

cancer 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.

About Cevira®

Cevira® is being developed as an intravaginal drug-device combination with an

integrated light source based on Photocure Technology(TM) for the treatment of

HPV and precancerous cervical lesions.

This press release may contain product details and information which are not

valid, or a product is not accessible, in your country. Please be aware that

Photocure does not take any responsibility for accessing such information which

may not comply with any legal process, regulation, registration or usage in the

country of your origin.

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

(Norwegian Securities Trading Act)

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