Ad hoc: Biofrontera AG: Phase III data of BF-200 ALA demonstrate superiority against Metvix®|
Biofrontera AG / Misc. matters / Ad hoc: Phase III data of BF-200 ALA
demonstrate superiority against Metvix®
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Leverkusen, Germany, 02 December 2009 - Biofrontera (DSE: B8F)
announces that the company has today been informed about preliminary
results of the final pivotal phase III trial with its leading drug
candidate BF-200 ALA.
The results show with high statistical significance that 78% of the
patients were totally cleared from all actinic keratoses after
treatment with BF-200 ALA, while comparator Metvix® showed total
clearance in only 64% of the patients. A total clearance rate of 17%
was measured in the placebo group. In spite of the higher efficacy of
BF-200 ALA the incidence of side-effects was not increased compared
The first, already completed phase III trial has shown that the light
source has an immense effect on the efficacy of the treatment.
Several different light sources were also tested in the current
study, but the individual results have not been analyzed thus far.
Therefore, the detailed analysis is expected to show substantially
better clearance rates with the best light source.
"Results were obtained earlier than expected due to the outstanding
data management of the responsible clinical research organization
Accovion GmbH. The statistically significant superiority of BF-200
ALA over Metvix® exceeds the original goals of the study," commented
Prof. Hermann Lübbert, Biofrontera's CEO.
In the treatment, superficial tumors were covered with one of the two
drugs, followed by an illumination with red light for a few minutes.
The treatment was repeated in those cases where residual keratoses
were still present three months after the treatment. Treatment
success was monitored another three months later.
570 patients were included in this phase III trial performed with
photodynamic therapy of actinic keratoses. The study, which was
ongoing since 2008, compared the efficacy of BF-200 ALA with that of
Metvix®. Additionally placebo-controlled, this comparator study is
the final pivotal trial required for the Marketing Authorization
Application (MAA) of BF-200 ALA, which will be filed after obtaining
the last stability data in the next summer.
On Thursday, December 3, at 10 a.m. CET Biofrontera will hold a
telephone conference, in which the Biofrontera management will inform
about the results of the phase III trial in more detail and answer
The dial-in numbers for the telephone conference will be: +49 (0)69
9897 2623 (from Europe) or +44(0)20 7138 0844 (from UK).
Please dial in 10 minutes before the conference starts to warrant a
About BF-200 ALA
BF-200 ALA is a gel applied within photodynamic therapy for the
treatment of actinic keratosis, a superficial, malignant skin cancer.
The gel combines Biofrontera's proprietary nanoemulsion BF-200 with
the active ingredient 5-aminolevulinic acid (ALA). The photodynamic
therapy consists of a one-time application of BF-200 ALA, followed
with some time-delay by a brief illumination with red light.
Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen, Germany
ISIN: DE0006046113, WKN: 604611
Anke zur Mühlen
Tel.: +49 (0214) 87 63 222
Fax.: +49 (0214) 87 63 290
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