Positive review of the European Medicines Agency in the approval process of BF-200 ALA
(Thomson Reuters ONE) -
Biofrontera AG /
Positive review of the European Medicines Agency in the approval process of
BF-200 ALA
Processed and transmitted by Thomson Reuters.
The issuer is solely responsible for the content of this announcement.
Leverkusen, Germany - Biofrontera has received a positive interim report of the
responsible committee of the European Medicines Agency (EMA) in the ongoing
centralized approval process of BF-200 ALA for the treatment of actinic
keratosis.
The "Committee for Medicinal Products for Human Use (CHMP)" provides applicants
on day 120 of the centralized approval process with an intermediate opinion and
the open questions of the agency. The opinion considers the expert reviews of
the rapporteurs (see adhoc 16-12-2010) and additional questions of all other EU
member states. In the approval process of BF-200 ALA for actinic keratosis no
major objections were raised at this point that would seriously endanger the
approval. The agency recommended approval under the provision that satisfactory
responses are given to the list of questions.
Biofrontera plans to respond within the scheduled time frame. In the centralized
approval process, to which BF-200 ALA is eligible due to its high level of
innovation, the marketing authorization will be granted for all EU member states
in a single step.
BF-200 ALA is a drug for the treatment of actinic keratosis, a form of
superficial non-melanoma skin cancer. Large clinical trials demonstrated the
excellent efficacy of the new medicinal product and its clear superiority over
the most relevant marketed competitor product. Actinic keratosis constitutes a
major medical problem with patient numbers constantly growing due to the
demographic development and the increasing exposure to UV light. Every other
consultation of dermatologists in the USA is already related to this disease.
Biofrontera therefore foresees an enormous market potential for its new drug.
'It is outstanding for a small biotech company to be able to start a centralized
approval process for a drug fully developed in-house, and to successfully pass
the initial hurdles of the process without any major objections. Most companies
choosing this stony path failed in the clinical trials or the registration
process. The positive interim statement of the CHMP reflects the concentrated
and high-quality work of Biofrontera's employees. Provided that we give
satisfactory responses to all the questions, the planned market introduction in
the fall seems possible", stated Prof. Dr. Hermann Lübbert, CEO of Biofrontera
AG.
About Actinic keratosis
Actinic keratoses are caused by the life-long accumulation of damage in the
genetic material of skin cells. The damage is induced by UV-light and
accumulates in the elderly. With its large prevalence - already now about 10% of
the fair-skinned population worldwide is affected - actinic keratosis
constitutes a growing health economic challenge. The disease is already the
second-most reason for consulting a dermatologist in the USA.
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 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(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
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biofrontera AG via Thomson Reuters ONE
[HUG#1482887]
Unternehmensinformation / Kurzprofil:
Datum: 27.01.2011 - 11:00 Uhr
Sprache: Deutsch
News-ID 50787
Anzahl Zeichen: 5667
contact information:
Town:
Leverkusen
Kategorie:
Business News
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