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:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: email@example.com
CFO Erik Dahl
Tel: +47 450 55 000, Email: firstname.lastname@example.org
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.
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.
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