Biofrontera AG

Files Label Extension for Ameluz® in EU to include Treatment with Daylight-PDT for Actinic Keratosis

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Leverkusen (pta024/12.06.2017/16:10) - Biofrontera AG (FSE: B8F), the specialist for the treatment of sun-induced skin cancer, today announced that it has filed a label extension for Ameluz® with the European Medicines Agency (EMA) on 31 May 2017, to include treatment with daylight photodynamic therapy (PDT) for actinic keratosis (AK), a precursor of squamous cell carcinoma, following positive results from its latest Phase III trial.

Ameluz® in combination with BF-RhodoLED® lamp is approved for the treatment of AK in both the European Union (EU) and United States. While this option requires a doctor to perform each treatment, Ameluz® with Daylight-PDT does not require illumination in the doctor's office, as patients can instead exposure the treatment areas to sunlight. Treatment with Daylight-PDT will allow hospitals throughout the EU health care system to treat more patients. In addition, the procedure will be reimbursed by the public health care system in Germany, as it will not require the PDT procedure at a doctor's office.

Prof. Dr. Hermann Lübbert, CEO of Biofrontera, commented, "As we continue to deliver a highly effective and convenient treatment option for skin cancers using Ameluz®, daylight PDT represents a natural progression from conventional PDT therapy for actinic keratosis. This almost painless alternative is particularly advantageous for the treatment of large fields with broadly distributed cancer precursor cells, for which Ameluz® is the only approved PDT drug. It will also greatly reduce the time required by dermatologists for treating the patient. We believe that approval for Ameluz® with Daylight-PDT will ultimately allow us to serve even more patients without an increased burden on dermatologists in the EU."
The filing with the EMA follows positive data from the Phase III trial of Ameluz® with Daylight-PDT for the treatment of AK. The study met its primary endpoints, demonstrating that it was non-inferior to Metvix®, the current standard of care. It also compared favorably to Metvix® in all secondary endpoints. Complete clearance of the lesions was achieved by a single daylight PDT with Ameluz® in 80% of all lesions, compared to 77% for Metvix®. Lesions on the scalp were fully cleared 72% and 65% of cases using Ameluz® or Metvix®, respectively.