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PhotoCure Release: Regulatory Update On Cevira



12/27/2013 8:47:25 AM

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Oslo, Norway, December 27, 2013: Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces an update on Cevira, which is in development for the treatment of oncogenic human papilloma virus (HPV) infection and pre-cancerous cervical abnormalities.

Photocure submitted its application for Fast Track Designation for Cevira to the US FDA in October 2013. Fast Track designation allows for improved access to FDA for feedback and alignment as the clinical development program is conducted. Photocure’s application was based on the significant medical benefit demonstrated by Cevira on treatment of patients with CIN2 in the recently completed phase 2b study. It followed positive previous discussions with the FDA’s Office of Oncology and Hematology Products on the need for new treatments for CIN2.

FDA has informed Photocure that the application for Fast Track Designation for Cevira cannot be granted at this time. The FDA’s decision is based on the recently published consensus recommendation for diagnosis of pre-cancerous lesions of the cervix. In this new diagnostic classification system, severity of disease is divided as either low grade or high grade, in place of previous categorization by grade of lesion severity (CIN 1, CIN 2 and CIN 3).

Photocure will evaluate the existing clinical data in accordance with the new consensus classification system for continued discussion and alignment with the FDA. In addition, Photocure will continue the discussion with FDA on classification of severity as recent clinical management guidelines recommend distinct treatment options for women with CIN2 and CIN3, particularly for the large group of women of child bearing potential. This is to avoid overtreatment of women with CIN 2 due to potential morbidities caused by invasive treatments offered to treat higher grade lesions.

Kjetil Hestdal, President and CEO of Photocure, said: “This decision is surprising and disappointing, particularly following the ongoing discussions with the FDA. The recent results for Cevira in the treatment of HPV associated diseases of the cervix showed a statistically significant and sustained lesion response and high HPV clearance in CIN2 patients. This was further supported by high clearance of HPV subtypes 16 and 18, which carry high oncogenic risk in the overall population. We believe that Cevira has great potential in treating these patients and we will continue our discussions with the FDA on the optimum development route for this product.”

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

Hume Brophy

Mary Clark, Hollie Vile, Supriya Mathur

Tel: +44 20 3440 5653 Email: photocure@humebrophy.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(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.

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