Biofrontera Inc. Announces FDA Orange Book Listing of U.S. Patent for BF-RhodoLED® XL, Extends Protection of Ameluz®-PDT Through October 2040
15 March 2022 - 12:25AM
Biofrontera
Inc. (Nasdaq:
BFRI), a
biopharmaceutical company specializing in the commercialization of
dermatological products, announced today that the previously
granted U.S. patent No. 11,235,169 (the ’169 patent) for the
BF-RhodoLED® XL illumination device is now listed in the U.S. Food
and Drug Administration (FDA) publication “Approved Drug Products
with Therapeutic Equivalence Evaluations,” commonly known as the
Orange Book.
BF-RhodoLED® XL is a red-light lamp approved by
the FDA for use in photodynamic therapy (PDT) in combination with
Ameluz® (Ameluz®-PDT) for the treatment of mild-to-moderate actinic
keratosis. Inclusion of the ’169 patent in the Orange Book provides
Ameluz®-PDT with protection through October 2040.
The listing of a patent in the Orange Book is
confirmation by the FDA that such patent protects an approved drug
or drug-device combination and constitutes a hurdle for generic
manufacturers who wish to launch a generic product. Should
Biofrontera become aware of a generic product imitating the
Ameluz®-PDT drug-device combination prior to the expiration of the
’169 patent, the filing of a lawsuit would automatically trigger a
30-month stay on the sale of the generic product.
"The Orange Book listing is an endorsement by
the FDA that the '169 patent covers our exclusively licensed
approved drug-device combination and forestalls any potential
generic competition until mid-2040. As previously announced two new
patents related to the advanced BF-RhodoLED® XL lamp have recently
been granted by the U.S. Patent and Trademark Office. Through our
exclusive agreement with Biofrontera Pharma GmbH, our patent
strategy is designed to strengthen our competitive advantage by
enabling long-lasting protection for Ameluz®-PDT," commented 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, 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 outcome of the Company’s
litigation with DUSA Pharmaceuticals, Inc., including the trial
scheduled to begin at the end of November; the Company’s ability to
achieve and sustain profitability; whether the current disruptions
in the supply chain 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 early clinical trials or trials
in different disease indications will be indicative of the results
of ongoing or future trials; whether results of the studies
described above will be indicative of results for any future
clinical trials and studies of Ameluz® in combination with
BF-RhodoLED®; 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 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
# # #
Biofrontera (NASDAQ:BFRIW)
Historical Stock Chart
From Sep 2024 to Oct 2024
Biofrontera (NASDAQ:BFRIW)
Historical Stock Chart
From Oct 2023 to Oct 2024