Biofrontera delivers final documents for processing the last open issues in the drug application of BF-200 ALA
(Thomson Reuters ONE) -
Biofrontera AG /
Biofrontera delivers final documents for processing the last open issues in the
drug application of BF-200 ALA
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
Leverkusen, Germany - In the new drug application for Biofrontera's medicinal
product for the treatment of actinic keratosis, ongoing at the European
Medicines Agency EMA, the documents for processing the last open issues have
been submitted as scheduled. BF-200 ALA is in the centralized procedure for the
approval of new medicinal products, in which new, innovative drugs are approved
for the entire European Union in a single step.
The centralized procedure comprises two rounds in which all European agencies
may request additional documents and raise open issues. In May 2011 Biofrontera
delivered documents and answers to the first round of open issues, and on
schedule the agencies started the second round in July. The new documents were
provided to the agencies in September since the EMA does not offer a date in
August.
This final step towards the expected approval in the fourth quarter of this year
constitutes an important milestone in the history of the company. The
responsible committee within the EMA (Committee for Medicinal Products for Human
Use) should now provide their final opinion on the approval in October.
Prof. Hermann Lübbert, CEO of Biofrontera AG commented: "We have an interesting
and work-intensive time behind us, in which we have progressed the development
of the product towards a European approval with a very small, but highly
motivated team. This is a very special milestone, not only for Biofrontera but
for the entire German Biotech industry."
Background
BF-200 ALA gel is a drug for the treatment of actinic keratosis. It is applied
in the relatively novel photodynamic therapy (PDT). This therapy is a one-time
treatment of actinic keratosis lesions with very high efficacy and excellent
cosmetic results, without the side-effects and discomfort of a long-term
treatment.
Actinic keratosis is a superficial skin cancer that is still restricted to the
upper skin layer (the epidermis). These tumours result from UV-light induced
damage accumulating during the entire life time. Thus, they occur very
frequently in sun-exposed skin regions. In about 10-15% of the affected people
the actinic keratosis lesions develop into malignant, potentially fatal squamous
cell carcinomas.
About Biofrontera AG
Biofrontera aims at attending and treating the skin, recognizing the aesthetic
needs of a person's visual reflection. Biofrontera is listed at 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:
Werner Pehlemann
CFO
+ 49 (0) 214 87632 0
+ 49 (0) 214 87632 90
w.pehlemann(at)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 Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München,
Regulierter Markt in Börse Düsseldorf;
This announcement is distributed by Thomson Reuters on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
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originality of the information contained therein.
Source: Biofrontera AG via Thomson Reuters ONE
[HUG#1548929]
Unternehmensinformation / Kurzprofil:
Datum: 22.09.2011 - 13:02 Uhr
Sprache: Deutsch
News-ID 68722
Anzahl Zeichen: 5071
contact information:
Town:
Leverkusen
Kategorie:
Business News
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