Biofrontera completes final steps ahead of FDA New Drug Application in the USA
(Thomson Reuters ONE) -
Biofrontera AG /
Biofrontera completes final steps ahead of FDA New Drug Application in the USA
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* Drug Master File for the active substance 5-ALA acknowledged by the FDA
* Biofrontera Pharma GmbH registered as medical device manufacturer
* Successful migration to a pharmacovigilance database which complies with FDA
requirements
* Connectivity test and guidance compliant test submission of dossier achieved
Leverkusen, Germany, 22 June 2015 - Biofrontera AG (AIM/FSE: B8F), the
biopharmaceutical company focussing on sun induced skin cancer, has completed
the final steps ahead of its imminent NDA submission of its prescription drug
Ameluz(®) and its PDT-lamp BF-RhodoLED(®) to the Food and Drug Administration
(FDA) in the USA.
Ahead of the FDA submission the final step was to submit the Drug Master File
for the active substance, which was provided to the FDA several weeks ago and
has now been acknowledged by the FDA. Further, Biofrontera Pharma GmbH has been
registered as manufacturer of the BF-RhodoLED(®) lamp. Our pharmacovigilance
database, a database used to maintain and report all information about drug
safety and mandatory for every pharmaceutical company, was migrated to an FDA
compliant database. As part of the final preparations, the team has successfully
performed a guidance compliant test submission of the dossier and also tested
the electronic connection between Biofrontera and the FDA Electronic Submission
Gateway.
"Having come so far in the run up to the FDA submission, it is essential to test
the final processes in order for the submission to be processed seamlessly and
to ensure all the initial requirements are adhered to in order for the file to
be accepted by the FDA. We are now preparing the final documents and expect to
make the submission shortly." said Prof. Hermann Luebbert, CEO of Biofrontera.
Ends
Enquiries, please contact:
Biofrontera AG +49 (0) 214 87 63 2 0
Prof. Hermann Lübbert, Chief Executive Officer press(at)biofrontera.com
Thomas Schaffer, Chief Financial Officer www.biofrontera.com
IR Germany: Brainwell Asset Solutions +49 (0) 152 08931514
Jürgen Benker
Nomad and Broker: Shore Capital +44(0) 20 7408 4090
Bidhi Bhoma / Toby Gibbs
IR UK: Seton Services +44(0) 20 7603 6797
Toni Vallen
Financial PR: Gable Communications +44(0) 20 7193 7463
John Bick +44 (0)7872 061007
Background:
The Biofrontera Group (FSE/AIM: B8F, ISIN DE0006046113) is a biopharmaceutical
company specialising in the development, sale and distribution of drugs and
medical cosmetics for the care and treatment of skin diseases. Biofrontera's
most important product is Ameluz(®), a prescription drug which is approved in
Europe for the treatment of mild and moderate actinic keratosis (superficial
skin cancer) with photodynamic therapy (light therapy). Biofrontera is the first
German pharmaceutical start-up company to obtain centralised approval for a drug
it has developed itself. The company also plans for Ameluz(®) to be approved for
basal cell carcinoma and is currently preparing for approval in other countries,
especially in the largest pharmaceutical market in the world, the United States.
The company also markets the Belixos(®) dermatological range of cosmetics.
Belixos(®) products contain combinations of active substances extracted from
plants, relieve itching and redness and are used for the regenerative care of
chronic skin conditions such as atopic dermatitis or psoriasis. At the moment,
Belixos(®) cream, gel and scalp tonic are available through Amazon.
The Biofrontera Group was established in 1997 by Prof. Dr Hermann Lübbert, the
Chairman of the company's Management Board, and has its headquarters in
Leverkusen, Germany.
www.biofrontera.com
This communication expressly or implicitly contains certain forward-looking
statements concerning the business activities of Biofrontera AG. These forward-
looking statements reflect the opinion of Biofrontera at the time of this
communication and involve certain known and unknown risks. The actual results
achieved by Biofrontera may differ significantly from future results or
performances which are published in its forward-looking statements. Biofrontera
assumes no responsibility to update its forward-looking statements.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(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 GlobeNewswire
[HUG#1930121]
Unternehmensinformation / Kurzprofil:
Datum: 22.06.2015 - 08:00 Uhr
Sprache: Deutsch
News-ID 401955
Anzahl Zeichen: 5753
contact information:
Town:
Leverkusen
Kategorie:
Business News
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