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 The leading web portal for pharmacy resources, news, education and careers January 22, 2019
Pharmacy Choice - Pharmaceutical News - DGAP-News: Biofrontera AG: Biofrontera receives FDA approval for upscaling of batch size for Ameluz(R) production (english) - January 22, 2019

Pharmacy News Article

 1/8/19 - DGAP-News: Biofrontera AG: Biofrontera receives FDA approval for upscaling of batch size for Ameluz(R) production (english)
Biofrontera AG: Biofrontera receives FDA approval for upscaling of batch size for Ameluz(R) production

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DGAP-News: Biofrontera AG / Key word(s): Miscellaneous
Biofrontera AG: Biofrontera receives FDA approval for upscaling of batch
size for Ameluz(R) production

08.01.2019 / 08:00
The issuer is solely responsible for the content of this announcement.

-

Biofrontera receives FDA approval for upscaling of batch size for Ameluz(R)
production

Leverkusen, Germany, January 8, 2019 - Biofrontera AG (NASDAQ: BFRA;
Frankfurt Stock Exchange: B8F) (the "Company"), an international
biopharmaceutical company, today announced that the U.S. Food and Drug
Administration (FDA), and earlier the European Medicines Agency (EMA), have
approved the upscaling of the batch size for the production of Ameluz(R) to
35 kg from previously 7 kg.

"The approval for a 5-fold increase in batch size ensures a secure supply of
Ameluz(R) to meet the growing demand for Ameluz(R) in all regions. Scaling
the manufacturing process by significantly increasing the batch size also
allows for a substantial improvement of our gross margin," explains Prof.
Dr. Hermann Lbbert, CEO of Biofrontera. "We have reached another milestone
of operational success, which answers to the overall success story of
Ameluz(R)."

The FDA-approval is effective January 3, 2019. The FDA defines a batch as a
specific quantity of a drug that is intended to have uniform character and
quality, within specified limits, and is produced according to a single
manufacturing process in the same cycle of manufacture.

-End-

     For enquiries, please contact:              +49 (0) 214 87 63 2 0
                                                 ir@biofrontera.com
     Biofrontera AG
     Thomas Schaffer, Chief Financial Officer
     IR UK: Seton Services                       +44 (0) 207 224 8468
     Toni Vallen
     IR and PR US: The Ruth Group                +1 646-536-7035
     IR: Tram Bui                                +1 508-280-6592
     PR: Kirsten Thomas
About Biofrontera:

Biofrontera AG is an international biopharmaceutical company specializing in
the development and commercialization of a platform of pharmaceutical
products for the treatment of dermatological conditions and diseases caused
primarily by exposure to sunlight that results in sun damage to the skin.
Biofrontera's approved products focus on the treatment in the U.S. and
Europe of actinic keratoses, which are skin lesions that can sometimes lead
to skin cancer, as well as the treatment of certain forms of basal cell
carcinoma in the European Union. American Depositary Shares representing
Biofrontera's ordinary shares are listed on the NASDAQ Capital Market under
the symbol "BFRA", and Biofrontera's ordinary shares are listed in the
Frankfurt Stock Exchange (B8F, ISIN: DE0006046113). Information is also
available at www.biofrontera.com.

Forward Looking Statements:

Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995 regarding
the public offering and the intended use of proceeds from the offering.
These statements may be identified by the use of forward-looking words such
as "anticipate," "believe," "forecast," "estimate" and "intend," among
others. Such forward-looking statements are 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 actual results, financial condition, performance, or
achievements of the Company, or industry results, to differ materially from
the results, financial condition, performance or achievements expressed or
implied by such forward-looking statements. These risks, uncertainties and
other factors are set forth in the Registration Statement on Form F-1 filed
with the SEC, including in the section "Risk Factors," and in future reports
filed with the SEC. Given these risks, uncertainties and other factors,
prospective investors are cautioned not to place undue reliance on these
forward-looking statements. The Company does not undertake an obligation to
update or revise any forward-looking statement.


-

08.01.2019 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de

-

   Language:    English
   Company:     Biofrontera AG
                Hemmelrather Weg 201
                51377 Leverkusen
                Germany
   Phone:       +49 (0)214 87632 0
   Fax:         +49 (0)214 87632 90
   E-mail:      ir@biofrontera.com
   Internet:    www.biofrontera.com
   ISIN:        DE0006046113, NASDAQ: BFRA
   WKN:         604611
   Listed:      Regulated Market in Dusseldorf, Frankfurt (Prime
                Standard); Regulated Unofficial Market in Berlin, Hamburg,
                Munich, Stuttgart, Tradegate Exchange; Nasdaq



   End of News    DGAP News Service
-

764001 08.01.2019








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