Biofrontera Announces NDA Progress Update for BF-200 ALA
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Biofrontera AG /
Biofrontera Announces NDA Progress Update for BF-200 ALA
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* FDA issued suggested labeling for BF-200 ALA for treatment of actinic
keratosis (AK)
* FDA has not requested any further data
* NDA on track
Leverkusen, Germany, April 4, 2016 - Biofrontera AG (FSE: B8F), the specialist
for sun-induced skin cancer, today announced an update on the latest progress of
its New Drug Application (NDA) for lead product BF-200 ALA, which is currently
being reviewed by the U.S. Food and Drug Administration (FDA). The FDA has
issued the proposed labeling for BF-200 ALA, the Company's prescription drug for
the treatment of mild to moderate actinic keratosis (AK) on the face and scalp.
Biofrontera anticipates finalizing the labeling of BF-200 ALA with the FDA over
the next few weeks to adequately reflect the drug's efficacy and safety
indications.
As a part of FDA's review, Biofrontera is addressing the additional questions
posed by the regulatory agency regarding the quality management system and
Biofrontera's photodynamic therapy lamp, which is used in conjunction with and
activates the topically-applied BF-200 ALA. The Company anticipates these
questions to be resolved in the coming days. In addition, the FDA has not made
Biofrontera aware of any major issues or deficiencies with the submitted NDA,
nor have they raised any major issues during their inspections of Biofrontera's
clinical sites or partnered manufacturing facilities. The only inspection still
pending is that of Biofrontera's medical device manufacturing facility, which
FDA has announced for early May.
"We are extremely encouraged by the FDA's initially suggested labeling and look
forward to working with them closely to finalize this important step as we
prepare for the U.S. launch of BF-200 ALA," said Prof. Hermann Lübbert, CEO of
Biofrontera AG. "We have been pleased with the efficiency and seamlessness of
the NDA process and strongly believe we will be able to adequately address any
additional inquiries that the FDA may raise as the May PDUFA date nears. BF-200
ALA represents a unique product that will assist those suffering from actinic
keratosis that can eventually progress to skin cancer."
Ends
Enquiries, please contact:
Biofrontera AG
Thomas Schaffer, Chief Financial Officer
+49 (0) 214 87 63 2 0
press(at)biofrontera.com
www.biofrontera.com
IR and PR US: The Ruth Group
IR: Lee Roth / Tram Bui
+1 646-536-7012 / 7035
PR: Kirsten Thomas
+1 508-280-6592
About Biofrontera
Biofrontera Group (FSE/AIM: B8F, ISIN DE0006046113) is a biopharmaceutical
company specializing 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 BF-200 ALA, a prescription drug approved in Europe
under the name of Ameluz(® )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
centralized 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 of BF-200 ALA 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, a cream, a gel and a scalp tonic, 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. The Belixos(®) Protect, a daily skincare for sun-
damaged skin, complements this dermo-cosmetic line. All products 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.
For more information, visit 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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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biofrontera AG via GlobeNewswire
[HUG#2000062]
Unternehmensinformation / Kurzprofil:
Datum: 04.04.2016 - 11:57 Uhr
Sprache: Deutsch
News-ID 461633
Anzahl Zeichen: 6007
contact information:
Town:
Leverkusen
Kategorie:
Business News
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