Ameluz® has passed first stage in approval process in Israel

Biofrontera AG / Ameluz® has passed first stage in approval process in Israel . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Leverkusen, 11 August 2014 - Biofrontera (AIM/FSE:B8F), the European biopharmaceutical company,  announces that its licensee Perrigo Company plc has filed the marketing approval dossier with the Ministry of Health in Israel (IMOH). After a preliminary review, IMOH has accepted Ameluz^® for registration and issued a preliminary registration number, in order for the full review process to now start. The underlying exclusive license with Perrigo Israel Agencies Ltd., a subsidiary of Perrigo Company plc, to market Ameluz^® and BF-RhodoLED^® in Israel was signed earlier this year (see press release of 6 January 2014).

The Perrigo dermatology team is the leading dermatology sales team in Israel. In a very short time, through a close collaboration between Biofrontera and Perrigo, the European approval dossier was adapted to the rules in Israel and all relevant documentation for the filing in Israel was collected. With the acceptance of the dossier by IMOH, we expect to obtain approval in Israel next year. Biofrontera's prescription drug Ameluz^®, for the treatment of actinic keratosis with photodynamic therapy, will be marketed in Israel under the same name.

Prof. Hermann Lübbert, Chief Executive Officer of Biofrontera commented: "Perrigo has enabled Biofrontera to accelerate its international development. The Board is delighted that we will have the opportunity to start marketing Ameluz^® in this new territory next year. Perrigo has the leading dermatology sales team in Israel and we are confident of a strong start to the launch of Ameluz^® in this new market."

In addition to the marketing approval application, the elaborate process for pricing and reimbursement required in Israel was recently initiated with the National Health Basket Committee, which is responsible for ensuring that with completion of the approval process the price and the eligibility for reimbursement are determined.

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
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