Biofrontera AG / Detailed phase III results confirm superiority of BF-200 ALA over Metvix® processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. 


Leverkusen, Germany - Biofrontera AG (DSE: B8F) announced that it has received
detailed results of the phase III comparative study with BF-200 ALA and Metvix®
for the treatment of actinic keratosis.

 A  total of 27 study centers in Germany, Austria and Switzerland collected 570
Patient with between 4 and 8 independent actinic keratosis lesions. The patients
were  treated by photodynamic therapy, combining one  of the test compounds or a
placebo  with a brief red light illumination.  With different types of red light
sources BF-200 ALA on average erased all lesions of 78% of the patients, whereas
the  registered comparator Metvix® only reached a complete healing rate of 64%,
and the placebo group of 17%.

The  results obtained  with different  light sources  showed that with LED lamps
emitting  a narrow light spectrum, which were in a first phase III study already
recognized  as  the  most  efficient  red  light  sources, BF-200 ALA completely
eliminated  all lesions in 85 % of the  patients, whereas with Metvix® only 68%
and  in  the  placebo  group  13% of  the  patients  were completely healed. The
superiority  of  BF-200  ALA  was  most  impressively demonstrated with the more
persistent  lesions  on  the  scalp.  Averaging  all  light  sources, BF-200 ALA
displayed  the complete removal of all actinic  keratoses in this area in 70% of
the patients, whereas only 40% of the patients were healed with Metvix®.

The  study impressively confirms  that the combination  of the active ingredient
5-aminolevulinic acid  with  Biofrontera's  proprietary  nanoemulsion BF-200 not
only  facilitates the application and handling of the compound but also displays
significantly higher efficacy than Metvix®. This advantage becomes most relevant
in the treatment of deeper lesions. The low placebo rates illustrate the quality
of  the data, which document the superiority of BF-200 ALA with high statistical
significance.

The  determination  of  the  adverse  effects  showed no substantial differences
between  the treatment with BF-200 ALA or Metvix®. In the pain perception during
the  illumination,  BF-200  ALA  showed  a  slight  advantage,  with 25 % of the
patients  reporting severe pain, while 29 % of the patients treated with Metvix®
complained about severe pain.

The  detailed results impressively confirm the outcome of the previous phase III
trial  with BF-200 ALA, in which the  treatment combining BF-200 ALA with an LED
light  source completely erased all lesions in 96% of the patients. The combined
results  of  both  studies  document  an  efficacy  in  the treatment of actinic
keratosis  that has  never before  been achieved  with any  other treatment. The
current  trial completes  the clinical  development of  BF-200 ALA,  after which
Biofrontera will prepare the application for marketing authorization. The filing
is  anticipated in the late summer this year. Due to BF-200 ALA's high technical
innovation  the European agency EMEA has already acknowledged the eligibility of
the  product  for  the  centralized  registration process, such that Biofrontera
anticipates  the approval for the entire European Union in a single registration
process.

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 <http://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




[HUG#1370803]



 --- End of Message --- 

Biofrontera AG
Hemmelrather Weg 201 Leverkusen Germany

WKN: 604611;ISIN: DE0006046113;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München,
Regulierter Markt in Börse Düsseldorf;