Biofrontera received manufacturing and distribution license
(Thomson Reuters ONE) -
Biofrontera AG / Biofrontera received manufacturing and distribution license processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Leverkusen, Germany - Biofrontera AG (DSE: B8F) announces, that its subsidiary
Biofrontera Pharma GmbH received the permission to import pharmaceutical
products, clear them for European sales and distribute them.
The responsible district government has inspected the Company, assessing all
requirements for granting the manufacturing and distribution license in
accordance with the German pharmaceutical law. Biofrontera has sufficient
qualified personnel, appropriate rooms and facilities as well as a complex
quality management system for importing, approving, storing and distributing
pharmaceutical compounds.
The manufacturing license is needed for the European submission of the marketing
authorization of BF-200 ALA, planned for the beginning of September. By
obtaining the license Biofrontera fulfils another important precondition for a
marketing authorization application in the centralized European procedure.
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 tumors result from UV-light induced
lesions accumulating during the life time. 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 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
[HUG#1437776]
--- 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.
All reproduction for further distribution is prohibited.
Source: Biofrontera AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 13.08.2010 - 10:00 Uhr
Sprache: Deutsch
News-ID 39659
Anzahl Zeichen: 0
contact information:
Town:
Leverkusen
Kategorie:
Business News
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"Biofrontera received manufacturing and distribution license"
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