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Biofrontera AG: Biofrontera Announces NDA Progress Update for BF-200 ALA

Biofrontera AG / Biofrontera Announces NDA Progress Update for BF-200 ALA.
Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is
solely responsible for the content of this announcement.
* 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


Enquiries, please contact:
Biofrontera AG
Thomas Schaffer, Chief Financial Officer
+49 (0) 214 87 63 2 0

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,

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


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biofrontera AG via Globenewswire


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