2013-03-12 09:32:54 -
Biofrontera AG /
Biofrontera explains corporate strategy and clinical development program in
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Leverkusen, 12 March 2013 - Biofrontera AG announces that in a telephone
conference on Friday, 15 March 2013, it will illustrate its strategy for the
national and international development of the company. The conference for
shareholders and interested investors will start in German language at 9:30
a.m., in English at 11:00 a.m..
March 15, 2013, 9:30 a.m. (German), 11:00 a.m. (English)
Dial-in number: +49 (0)69 271 340 800
Room number: 17675723#
Please dial into the conference 10 minutes earlier to allow a start in time.
Compared to similar companies, Biofrontera has been choosing a rather low-risk
this corporate strategy it has, as first German Biotech ever,
managed to obtain a centralized European approval for a prescription drug that
was entirely developed in-house. The product, called Ameluz®, has now been
marketed since one year by Biofrontera in Germany. Distribution deals for other
European countries were formed with regional representatives, some of whom
already launched Ameluz(®) in the second half of 2012. In parallel, in the past
12 months Biofrontera's market cap increased by about EUR 34.05 mln. If this
number is reduced by the March 2012 capital increase (press release of 23 March
2012) minus the final redemption of the convertible bond 2005/2012 (press
release of 3 May 2012) and the payment to ASAT AG (press release of 16 June
2011), the adjusted increase in value amounted to EUR 27.87 mln.. This
substantial accretion reflects the increasing trust of investors into the future
revenues with the subscription drug Ameluz(®).
The company anticipates further value enhancements through the approval of
further indications for Ameluz(®) as well as the marketing authorization for
other regions, particularly the USA as largest Pharma market of the world. The
indication expansion and the approval in the USA are believed by Biofrontera to
be associated with manageable cost and low risk. The resulting value
appreciation should exceed the cost many fold.
To implement these goals, four clinical trials with Ameluz(®) are currently
being prepared, partly to fulfill the requests expressed in a hearing by the US
Food and Drug Association, FDA (compare press release of 23 July 2012):
1. Ameluz(®) will be tested in the treatment of basal cell carcinoma (BCC)
against the comparator Metvix(®). BCCs are the most abundant infiltrating
tumours in humans and account for 80% of non-melanoma skin cancers. About
30% of all Caucasians worldwide develop at least one BCC during their life-
time, and the global incidence grows rapidly due to increasing UV-
exposure,. Surgical removal may lead to disfiguring scars, while
photodynamic therapy (PDT) represents an alternative particularly for thin
BCCs, resulting in excellent cosmetic outcomes. Biofrontera intends to
compare Ameluz(®) with comparator Metvix(®) which is approved for BCC.
Ameluz has already proven superiority to Metvix(®) with respect to the total
clearance of all lesions of actinic keratosis patients,.
2. A study for actinic keratosis, in which patients are treated on entire
fields, such as forehead, bald scalp etc., and illuminated with
Biofrontera's CE-marked PDT lamp BF-RhodoLED(®). This study is intended to
add data about Biofrontera's own lamp to the existing phase III studies, in
which a variety of different PDT-lamps had been compared. The application of
Ameluz(®) to entire fields may provide additional safety information and
allow a more thorough analysis of the long-term efficacy and cosmetic
3. A trial to test the sensitizing potential of Ameluz(®), i.e. to measure
potential allergic reactions to the product. This study has been requested
by the FDA even though the phase III trials did not reveal any indication
for sensitization and aminolevulinic acid (ALA), the active ingredient of
Ameluz(®), naturally occurs in every cell of the body.
4. A maximal-use pharmacokinetics study. The FDA has requested a trial in which
an entire tube of Ameluz(®) is applied to a maximally damaged skin area, to
observe the potential uptake of ALA into and the elimination from the blood.
Since ALA naturally occurs in the blood, and small temporary increases in
its concentrations do not impose a safety risk, the outcome of this trial
does not appear to be critical.
"This development program is currently initiated with all four trials in
parallel. Through this we anticipate an escalation of the value of Ameluz(®),
reflected presumably by the price of Biofrontera shares. The cost/risk
relationship in studies with approved drugs is greatly advantageous compared to
that of development products. Together we expect costs for the studies in the
range of EUR 5 to 6 mln. which should greatly be outbalanced by the anticipated
value escalation. The sensitization and pharmacokinetics trials should be
completed by the end of this year, the clinical part of the other two studies by
the middle of next year", commented Prof. Hermann Lübbert, chief executive
officer of Biofrontera AG.
 Xetra final price EUR 3.15 on March 8, 2012, and EUR 4.40 on March 8, 2013
 Leiter & Garbe, Adv Exp Med Biol. 2008;624:89-103
 Walling et al., Cancer Metastasis Rev. 2004;23(3-4):389-402
 Wolberink et al., J Eur Acad Dermatol Venereol. 2012 [Epub ahead of print]
 Ameluz(®) SmPC
 Dirschka et al., Br J Dermatol. 2012;166(1):137-46
About Biofrontera AG
Biofrontera aims at attending and treating the skin, recognizing the aesthetic
needs of a person's visual reflection.
Biofrontera is listed in the regulated market of the Frankfurt stock exchange
under the symbol B8F and the ISIN DE0006046113.
For further information:
Anke zur Muehlen
+ 49 (0)214 876 32 22
+ 49 (0)214 876 32 90
Hemmelrather Weg 201
D- 51377 Leverkusen
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