Cevira update on FDA discussions for Cervical Precancerous Lesions- PhotoCure

Photocure ASA, a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announced an update on Cevira (hexaminolevulinate ointment), which is in development for the treatment of Oncogenic Human Papilloma Virus (HPV) infection and Pre-Cancerous Cervical Abnormalities (CIN2).

Photocure submitted its application for Fast Track Designation for Cevira to the 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 IIb study. It followed positive previous discussions with the FDA�s Office of Oncology and Hematology Products on the need for new treatments for CIN2. The 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.