2009-11-25 11:10:06 -
London, November , 25, 2009
Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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Leverkusen, Germany - Biofrontera AG (DSE: B8F) announced, that the
data collection for its last pivotal phase III trial with BF-200 ALA
has been completed and the statistical analysis can now commence. The
aim of the study is to confirm the excellent efficacy of
Biofrontera's leading development candidate in the treatment of
actinic keratosis, a malignant tumor of the upper skin layer.
BF-200 ALA gel is applied in combination with a red light
illumination, to remove keratotic lesions in a one-time treatment
without scar formation.
In the now complete placebo controlled study comparing BF-200 ALA
with a competing product, a total of 571 patients were treated by
such a photodynamic therapy. About 43% of the patients were treated
with BF-200 ALA, and the same number with the comparator Metvix®. In
addition, about 14% of the patients were treated with a placebo gel.
The trial was performed with patients from 27 study centers in
Germany, Austria and Switzerland under the clinical supervision of
Dr. med. Thomas Dirschka.
Following the closure of the database the results can be
statistically evaluated. The goal of the study is to demonstrate that
BF-200 ALA has the same or a better efficacy than the approved drug
Metvix®.
This phase III study completes the clinical development of BF-200
ALA, such that Biofrontera expects to apply for drug registration in
the middle of 2010. The European agency EMEA has already approved the
eligibility of BF-200 ALA for the centralized registration process
due to its high technical innovation.
In the previous, already completed phase III trial comparing the
efficacy of BF-200 ALA with a placebo treatment the excellent
efficacy of the drug was impressively demonstrated. Up to 96% of the
patients could be completely cleared from all their actinic
keratoses. The treatment led to a remarkable cosmetic result without
leaving visible scars or pigmentation changes.
"The database closure has occurred within the time frame that
Biofrontera has anticipated. We now expect to obtain the results of
the trial before the end of the year," commented Dr. Reinhold
Gahlmann, head of Biofrontera's development team.
About Biofrontera AG
Biofrontera AG is specialized in the development of pharmaceutical
products in the area of dermatology. The company is characterized by
a broad, relatively close to the market product portfolio.
Biofrontera is listed in the regulated market of the Düsseldorf stock
exchange under the symbol B8F and the ISIN number DE0006046113.
www.biofrontera.com
This press release contains forward-looking statements based on the
currently held beliefs and assumptions of the management of
Biofrontera AG, which are expressed in good faith and, in their
opinion, reasonable. Forward-looking statements involve known and
unknown risks, uncertainties and other factors, which may cause the
assumptions expressed or implied in this press release to be faulty.
Given these risks, uncertainties and other factors, recipients of
this document are cautioned not to place undue reliance on the
forward-looking statements. Biofrontera AG disclaims any obligation
to update these forward-looking statements to reflect future events
or developments.
For further information please contact:
Anke zur Mühlen
Corporate Communication
+ 49 (0) 214 87632 22
+ 49 (0) 214 87632 90
a.zurmuehlen@biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
--- End of Message ---
Biofrontera AG
Hemmelrather Weg 201 Leverkusen Germany
WKN: 604611;
ISIN: DE0006046113;
Listed: Freiverkehr in Börse Berlin, Freiverkehr in Bayerische Börse
München,
Freiverkehr in Börse Stuttgart, Open Market (Freiverkehr) in
Frankfurter Wertpapierbörse,
Regulierter Markt in Börse Düsseldorf;
