Biofrontera AG

Biofrontera Receives Favourable CHMP Assessment for Field-Directed Therapy and Files BCC Application

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Leverkusen (pta009/28.07.2016/09:30) - Biofrontera Receives Favourable CHMP Assessment for Field-Directed Therapy and Files BCC Application

- European Commission will issue formal approval in coming weeks
- Expands market opportunity for Ameluz® beyond actinic keratosis lesions (AK) to field cancerization
- Submitted additional label extension application for treatment of basal cell carcinoma (BCC)

Biofrontera AG (FSE: B8F), the specialist for the treatment of sun-induced skin cancer, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive assessment regarding Biofrontera's submission for label extension for its topical prescription drug Ameluz® for actinic keratosis (AK) to include the treatment of field cancerization. Based on the positive opinion, Biofrontera anticipates that the European Commission will issue formal approval within the coming weeks, significantly expanding the market opportunity for Ameluz®.

The positive assessment was largely based on the Company's pivotal Phase III trial ALA-AK-CT007 conducted in Germany. The 86-patient study assessed field-directed treatment using combination Ameluz® plus medical lamp BF-RhodoLED® for photodynamic therapy (PDT) against placebo. The study demonstrated that 91% of patients treated with Ameluz® were completely cleared after a maximum of two treatments, compared to only 22% complete clearance in patients treated with placebo. Over the course of one year, full clearance was sustained in 63% of patients treated with Ameluz®.

In addition to the positive assessment of Ameluz® for field cancerization from the CHMP, the Company has filed for an additional label extension of Ameluz® for the treatment of non-aggressive basal cell carcinoma (BCC), including superficial and nodular BCC. Classified as abnormal, uncontrolled growths that form in the skin's basal cells, BCC is a common form of non-melanoma skin cancer caused by prolonged and intense exposure to the sun. The EMA will begin a thorough review of the Company's application which is expected to last up to six months.

"We are very pleased with the CHMP's favourable review regarding the label extension for Ameluz®, which continues to validate our clinical trial activity and the advantages of Ameluz® as a patient treatment option," commented Prof. Dr. Hermann Lübbert, CEO of Biofrontera. "We look forward to a positive decision by the EC allowing us to expand our sales and marketing efforts to include field-directed therapy alongside our strategic partners throughout the EU over the coming months. Additionally our recently filed label extension application to the EMA for the treatment of BCC bolsters our strategic plan to expand the market for Ameluz® and we look forward to their full review, which is expected by January 2017."