Biofrontera submits New Drug Application for Ameluz® to FDA
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Biofrontera AG /
Biofrontera submits New Drug Application for Ameluz® to FDA
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* Comprehensive dossier filed with FDA on Friday
* FDA 'Acceptance to file' response within next 60 days
* Submission represents outstanding milestone achieved by very few biotech
companies worldwide
Leverkusen, Germany, 13 July 2015 - Biofrontera AG (AIM/FSE: B8F), a
biopharmaceutical company focusing on sun induced skin cancer, has completed a
major milestone by submitting a New Drug Application ('NDA') to the US Food and
Drug Administration ('FDA') for its combination prescription drug Ameluz(®) and
medical device BF-RhodoLED(®). The combination of both products shall be applied
in photodynamic therapy in the USA.
Unlike the US which requires combination approval, Ameluz(®) and BF-RhodoLED(®)
were listed under separate filings in the EU. Ameluz(®) was granted marketing
authorization by the European Medicines Agency ('EMA') in December 2011 for the
treatment of mild and moderate actinic keratosis on the face and scalp.
Biofrontera's PDT lamp BF-RhodoLED(®) was approved as a medical device in the
EU.
The FDA combination drug and device application is extremely complex and
required additional phase III testing prior to submission. The phase III actinic
keratosis field therapy study with the drug/light combination reported complete
clearance in over 90% of treated patients, along with a strong skin rejuvenation
effect. The filing also includes results from two additional Phase III studies
as well as results from two drug safety studies requested by the FDA. The
comprehensive dossier was submitted to FDA on Friday July 10(th). It comprises
of more than 1,000 text files and documents, covering more than 50,000 pages,
and data sets representing a multiple of these.
Biofrontera has been in close dialogue with FDA since July 2012 in order to
prepare the NDA in coordination with the authority. The positive review during
the pre-NDA meeting in October 2014 gives the company great confidence in the
application.
According to US guidelines FDA has 60 days to respond as to whether the
application will be accepted ('acceptance to file'). During this initial review
period, FDA confirms completeness of the application and upon 'acceptance to
file' FDA conducts a thorough review that is normally completed within 9-12
months after submission. FDA provides a mid-term review about six month after
'acceptance to file', which could provide a strong indication that approval will
be granted.
Prof. Hermann Lübbert, CEO of Biofrontera commented: "A New Drug Application in
the US, in particular a combination drug/medical device submission, is a huge
endeavor and it involves every single employee in our small company. Worldwide,
only very few small biotech companies have accomplished such a milestone with an
in-house developed drug. We believe we delivered excellent clinical data and are
therefore very confident in our application. If approved, this product will
generate outstanding growth potential for Biofrontera as well as a significant
increase in shareholder value."
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 / Justine James +44 (0)7872 061007
Background:
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
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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#1937602]
Unternehmensinformation / Kurzprofil:
Datum: 13.07.2015 - 10:45 Uhr
Sprache: Deutsch
News-ID 406215
Anzahl Zeichen: 7359
contact information:
Town:
Leverkusen
Kategorie:
Business News
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