Public disclosure of inside information according to article 17 MAR
Biofrontera AG: Biofrontera Receives Favorable CHMP Assessment for Ameluz® in Combination with Daylight Photodynamic Therapy
Leverkusen, Germany (pta024/29.01.2018/12:20 UTC+1) 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 opinion regarding Biofrontera's submission for label extension for the use of its topical prescription drug Ameluz® in combination with daylight Photodynamic Therapy (daylight-PDT). This mode of application eliminates the requirement of illuminating with a special red light in the dermatology office. An additional advantage of daylight-PDT is its good tolerability. Conventional PDT can be accompanied by pain during illumination while daylight-PDT is almost completely pain-free. Based on the positive opinion, Biofrontera anticipates formal approval by the European Commission in the coming weeks, significantly expanding the market opportunity for Ameluz® in Europe. Following final approval Ameluz® can be used without doctor's office procedures, allowing easier reimbursement of Ameluz® in the German but also in other European markets.
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Emitter: |
Biofrontera AG Hemmelrather Weg 201 51377 Leverkusen Germany |
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Contact Person: | Investor & public relations | |
Phone: | +49 (0) 214 87 63 20 | |
E-Mail: | press@biofrontera.com | |
Website: | www.biofrontera.com | |
ISIN(s): | DE0006046113 (Share) | |
Stock Exchange(s): | Regulated Market in Dusseldorf, Frankfurt; Free Market in Berlin, Munich, Stuttgart, Tradegate |