Biofrontera Inc. Announces FDA Approval of Biofrontera Pharma GmbH as a Contract Laboratory for Ameluz®
April 13 2022 - 9:10AM
Biofrontera
Inc. (Nasdaq: BFRI),
a biopharmaceutical company specializing in the commercialization
of dermatological products, announced today that the U.S. Food and
Drug Administration (FDA) has approved Biofrontera Pharma’s cGMP
laboratory in Leverkusen, Germany, as a contract laboratory for
batch control and stability testing of Ameluz® (aminolevulinic acid
hydrochloride gel, 10%). This recognition enables significant
improvements in product manufacturing efficiency, quality control
and reliability of supply.
The FDA cleared Biofrontera Pharma GmbH’s
laboratory to operate a method of impurity testing, which is a
critical component of the gel’s stability assurance. The clearance
enables part of the necessary testing of production batches to be
performed in the Leverkusen facility, thereby reducing dependence
on third-party suppliers and the risk of production downtime and
product delays. Previously, quality control was conducted entirely
by contract manufacturers in collaboration with third-party
providers.“Impurity testing is extremely complex and one of the
most important components of batch release and stability testing.
To establish such a method at third-party suppliers could take a
year or two, and several contract laboratories have already failed
at establishing the specific methods we need for Ameluz®. Bringing
this important function under the control of our licensor therefore
strengthens quality control, reduces third-party dependence and
enables transparency to identify opportunities for further
developments,” stated Hermann Lübbert, Executive Chairman of
Biofrontera Inc.
“Under a license and supply agreement with
Biofrontera AG, we have exclusive rights to market and sell Ameluz
and the PDT-lamps BF-RhodoLED® and RhodoLED XL in the U.S. As our
U.S. commercial sales build momentum, we appreciate the importance
of optimizing for scale and ensuring commercial supply without
compromising quality,” stated Erica Monaco, Chief Executive Officer
of Biofrontera Inc.
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based
biopharmaceutical company commercializing a portfolio of
pharmaceutical products for the treatment of dermatological
conditions with a focus on PDT and topical antibiotics. The
Company’s licensed products are used for the treatment of actinic
keratoses, which are pre-cancerous skin lesions, as well as
impetigo, a bacterial skin infection. For more information, please
visit www.biofrontera-us.com.
Forward-Looking Statements
Certain statements in this press release may
constitute "forward-looking statements" within the meaning of the
United States Private Securities Litigation Reform Act of 1995, as
amended to date. These statements include, but are not limited to,
statements relating to the expected trading commencement and
closing dates. We have based these forward-looking statements on
our current expectations and projections about future events,
nevertheless, actual results or events could differ materially from
the plans, intentions and expectations disclosed in, or implied by,
the forward-looking statements we make. These risks and
uncertainties, many of which are beyond our control, including, but
not limited to, the impact of extraordinary external events, such
as the current COVID-19 pandemic; any changes in the Company’s
relationship with the Licensor; the Company’s ability to achieve
and sustain profitability; whether the current global disruptions
in supply chains will impact the Company’s ability to obtain and
distribute its licensed products; changes in the practices of
healthcare providers, including any changes to the coverage,
reimbursement and pricing for procedures using the Company’s
licensed products; the uncertainties inherent in the initiation and
conduct of clinical trials; availability and timing of data from
clinical trials; whether results of earlier clinical trials or
trials of Ameluz® in combination with BF-RhodoLED® in different
disease indications or product applications will be indicative of
the results of ongoing or future trials; uncertainties associated
with regulatory review of clinical trials and applications for
marketing approvals; whether the market opportunity for Ameluz® in
combination with BF-RhodoLED® is consistent with the Company’s
expectations; whether the Company will be able to successfully
complete the transition to a public company operating independently
of Biofrontera AG; the Company’s ability to retain and hire key
personnel; the sufficiency of cash resources and need for
additional financing and other factors that may be disclosed in the
Company’s filings with the SEC, which can be obtained on the SEC
website at www.sec.gov. Readers are cautioned not to place undue
reliance on the forward-looking statements, which speak only as of
the date on which they are made and reflect management's current
estimates, projections, expectations and beliefs. The company does
not plan to update any such forward-looking statements and
expressly disclaims any duty to update the information contained in
this press release except as required by law.
Contacts
Biofrontera Inc.Anke zur
Mühlen+1 781 486 1539us-ir@biofrontera.com
LHA Investor RelationsTirth T.
Patel+1 212 201 6614tpatel@lhai.com
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