Biofrontera AG

Pre-NDA meeting scheduled with FDA for the approval of Ameluz® and BF-RhodoLED®

Biofrontera AG / Biofrontera AG: Pre-NDA meeting scheduled with FDA for the approval of Ameluz® and BF-RhodoLED® . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• pre-NDA-Meeting scheduled by FDA for 8 October 2014

Briefing Book submitted

Leverkusen, Germany, 21 August 2014 - Biofrontera (AIM/FSE:B8F), the European biopharmaceutical company, announces that the US Food and Drug Administration (FDA) has scheduled the pre-NDA (New Drug Application) meeting for 8 October 2014. The pre-NDA meeting represents an important step in Biofrontera registering its medicinal product Ameluz^® in combination with its medical device BF-RhodoLED^® in the USA since it is the last opportunity to obtain direct feed-back to the dossier by the FDA prior to filing.

Ameluz^® is a prescription drug approved in Europe by the European Medicines Agency (EMA) for the treatment of mild to moderate actinic keratosis on the face or scalp. BF-RhodoLED^® is a CE-marked red light LED lamp used in combination with Ameluz^® in photodynamic therapy (PDT). Both products are by now sold in most major European markets. Biofrontera is in the process of preparing the filing for approval in the US. In a first meeting with the FDA (see press release on 23-07-2012) the FDA requested some additional studies. In the meantime, Biofrontera has performed two phase I trials and one phase III study (the results of which are expected by the end of September or early October) to satisfy all requirements of the FDA. Biofrontera has also submitted an elaborate Briefing Book to the FDA which will serve as a guide to introduce all major elements of the dossier as well as discuss remaining questions.

Hermann Luebbert, CEO of Biofrontera commented: "We are looking forward to the opportunity to discuss our dossier for the combination of Ameluz^® and BF-RhodoLED^® with the FDA. Since we have addressed all requests that the FDA had in the last meeting, we are confident that our data package will now satisfy all the requirements for filing. Whilst we had hoped for an earlier meeting, this delay will not influence the rest of our time table of filing the final dossier by the end of Q1 2015."

Enquiries

Biofrontera AG Prof. Hermann Lübbert, Chief Executive Officer Thomas Schaffer , Chief Financial Officer Anke zur Mühlen, Corporate Communications	[phone] [e-mail] www.biofrontera.com
Brainwell Asset Solutions Jürgen Benker	[phone]
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