Biofrontera delivers excellent results from the Phase III study for field therapy of actinic keratosis for publication - Seite 2

The study is an important component of the application that is currently prepared by Biofrontera to obtain approval for Ameluz^® and BF-RhodoLED^® in the USA. No other phase III trial applying PDT in the field-directed approach has ever been conducted, rendering Biofrontera's study an important contribution to the field. The application for approval in the USA is expected to be made by the end of Q2, and approval is anticipated 12 months after application.

For Biofrontera's strategically evenly important study in Basal Cell Carcinoma the number of enrolled patients is now sufficient for a statistical power of greater than 90%, and Biofrontera's request for completion of patient recruitment is currently evaluated by the responsible federal agency.

Commenting on findings of the study, CEO Prof. Hermann Lübbert said: "Field therapy with PDT should be the standard of care for patients with multiple actinic keratoses because of the extremely high efficacy rates, the potent skin rejuvenation effect documented in this study, and the potential to prevent new neoplastic lesions. The latter effect will be documented further during the ongoing follow-up phase of the study, but the fact that no patient presented with new tumours in the treatment field after Ameluz^® treatment, while one patient with new lesions was in fact present in the twice smaller placebo group, may, even though not statistically relevant, indicate the prophylactic effect of field therapy using Ameluz^® PDT."

References:

1. Olsen EA, Abernethy ML, Kulp-Shorten C et al. A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck. J Am Acad Dermatol 1991; 24:738-43.

2. Fernandez-Figueras MT, Carrato C, Saenz X, Puig L, Musulen E, Ferrandiz C, et al. Actinic keratosis with atypical basal cells (AK I) is the most common lesion associated with invasive squamous cell carcinoma of the skin. J Eur Acad Dermatol Venereol. 2014.

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Enquiries, please contact:

Biofrontera AG Prof. Hermann Lübbert, Chief Executive Officer Thomas Schaffer, Chief Financial Officer	[phone] [e-mail] www.biofrontera.com
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