DGAP-Adhoc: Biofrontera AG: Biofrontera Reports Positive Phase III Results with Ameluz(R) for photodynamic therapy of actinic keratoses on the extremities and trunk/neck
DGAP-Ad-hoc: Biofrontera AG / Key word(s): Study results
Biofrontera AG: Biofrontera Reports Positive Phase III Results with Ameluz(R) for photodynamic therapy of actinic keratoses on the extremities and trunk/neck
20-March-2019 / 15:50 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
Ad-hoc Release pursuant to Art. 17 MAR
Biofrontera Reports Positive Phase III Results with Ameluz(R) for photodynamic therapy of actinic keratoses on the extremities and trunk/neck
Leverkusen, Germany, 20.03.2019 - Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F), an international biopharmaceutical company, today received positive preliminary results for the primary endpoint of its Phase III clinical trial evaluating the safety and efficacy of conventional photodynamic therapy (PDT) with Ameluz(R) and the BF-RhodoLED(R) lamp for the treatment of actinic keratoses (AK) on the extremities as well as the trunk and neck. The study met its primary regulatory endpoint, demonstrating that Ameluz(R) was superior (p<0.0001) to placebo based on its mean total lesion clearance rate of 86% compared to 33% for placebo. These results will be utilized for the filing of the label extension with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which Biofrontera plans to submit in the third quarter of 2019.
The multi-center, randomized, double-blind, intra-individual study included 50 patients at six study sites in Germany, each with four to ten clinically confirmed AK lesions in comparable areas on the right and left side of the extremities and/or trunk/neck. Mild, moderate and severe actinic keratoses were treated with one or two PDT treatments. The final examination of the patients took place three months after the last PDT treatment. The clinical study phase is now followed by a follow-up phase of twelve months after the last PDT, in which recurrence rates and/or numbers of new AKs and skin tumors are determined.
Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen
ISIN: DE0006046113
WKN: 604611
Contact: Biofrontera AG
Tel.: +49 (0214) 87 63 2 0, Fax.: +49 (0214) 87 63 290
E-mail: [email protected]
20-March-2019 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de
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Language: |
English |
Company: |
Biofrontera AG |
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Hemmelrather Weg 201 |
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51377 Leverkusen |
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Germany |
Phone: |
+49 (0)214 87632 0 |
Fax: |
+49 (0)214 87632 90 |
E-mail: |
[email protected] |
Internet: |
www.biofrontera.com |
ISIN: |
DE0006046113, NASDAQ: BFRA |
WKN: |
604611 |
Listed: |
Regulated Market in Dusseldorf, Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Hamburg, Munich, Stuttgart, Tradegate Exchange; Nasdaq |
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End of Announcement |
DGAP News Service |
789871 20-March-2019 CET/CEST
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2017 |
2018 |
2019 |
2020 |
2021 |
2022 |
2023e |
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12,03 |
21,11 |
31,26 |
30,35 |
28,79 |
25,74 |
31,70 |
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-13,05 |
-17,72 |
-20,22 |
-4,70 |
27,95 |
1,87 |
4,20 |
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-108,48 |
-83,94 |
-64,68 |
-15,49 |
97,08 |
7,26 |
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EBIT1,4 |
-13,93 |
-18,48 |
-23,38 |
-10,03 |
24,66 |
1,12 |
3,30 |
EBIT-Marge5 |
-115,79 |
-87,54 |
-74,79 |
-33,05 |
85,66 |
4,35 |
10,41 |
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-16,10 |
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-7,36 |
-13,02 |
33,86 |
-44,17 |
0,00 |
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-42,90 |
117,61 |
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30,44 |
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0,68 |
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Wirtschaftsprüfer: Baker Tilly
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INVESTOR-INFORMATIONEN |
©boersengefluester.de |
Biofrontera |
WKN |
Kurs in € |
Einschätzung |
Börsenwert in Mio. € |
604611 |
0,328 |
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20,93 |
KGV 2025e |
KGV 10Y-Ø |
BGFL-Ratio |
Shiller-KGV |
0,00 |
2,18 |
0,00 |
-1,34 |
KBV |
KCV |
KUV |
EV/EBITDA |
1,03 |
- |
0,81 |
11,18 |
Dividende '22 in € |
Dividende '23e in € |
Div.-Rendite '23e in % |
Hauptversammlung |
0,00 |
0,00 |
0,00 |
20.06.2023 |
Q1-Zahlen |
Q2-Zahlen |
Q3-Zahlen |
Bilanz-PK |
31.05.2023 |
31.08.2023 |
- |
27.04.2023 |
Abstand 60Tage-Linie |
Abstand 200Tage-Linie |
Performance YtD |
Performance 52 Wochen |
-9,64% |
-34,27% |
-18,20% |
-72,09% |
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