Biofrontera Inc. Announces Notice of Allowance for U.S. Patent on Innovative Illumination Protocol
03 December 2021 - 1:15AM
Biofrontera
Inc. (Nasdaq: BFRI),
a biopharmaceutical company specializing in the commercialization
of dermatological products, announced today that the United States
Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for the U.S. patent application number 17/234,490, titled
“Illumination for Photodynamic Therapy,” that covers an innovative,
pain-reducing illumination protocol for photodynamic therapy (PDT).
“This patented illumination protocol
demonstrates Biofrontera’s commitment to the patients’ need for
innovative treatments. The patent also strengthens Biofrontera’s
competitiveness for our FDA-approved combination product, Ameluz®
together with our PDT-lamp BF-RhodoLED® and its successor model
RhodoLED® XL in the U.S. by providing an opportunity to pursue
label expansion to include more patient-friendly protocols,” stated
Erica Monaco, Chief Executive Officer of Biofrontera Inc.
The patent application claims a method for
photodynamic therapy in which a dynamic and innovative illumination
protocol is implemented. This protocol consists of changing
illumination intensities combined in a predefined order with
interruptions of the illumination to specifically modulate and
reduce pain perception to the patient. The new illumination
protocol aims at combining the high efficacy of Ameluz® with the
flexibility of BF-RhodoLED® to modulate light for pain reduction to
ultimately become a new standard-of-care in PDT.
Implementation of the protocol to Biofrontera’s
medical devices requires a software installation and can be
rolled-out to both the BF-RhodoLED® and BF-RhodoLED® XL lamps. To
include this illumination protocol in the U.S. prescribing
information, Biofrontera Group, in accordance with pipeline
development under the license and supply agreement (LSA) between
Biofrontera Inc. and Biofrontera AG, will start a Phase 3 trial for
the treatment of actinic keratoses on the face and scalp with 3
tubes of Ameluz® and the RhodoLED® XL lamp involving the new
protocol in 2022.
Within the scope of the LSA between Biofrontera
Inc. and Biofrontera AG and its Germany-based subsidiaries
(together the “Licensor”), Biofrontera Inc. holds the exclusive
rights to market and sell Ameluz® and the PDT-lamps BF-RhodoLED® as
well as the advanced BF-RhodoLED® XL in the United States. Under
the LSA, the Licensor holds the patents for the licensed
products.
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 the
fields of photodynamic therapy (PDT) and topical antibiotics,
Biofrontera currently commercializes the FDA-approved flagship drug
Ameluz® in the United States. When used in combination with PDT and
Biofrontera’s BF-RhodoLED® lamp, Ameluz®-PDT is indicated for the
treatment of actinic keratoses (AK), one of the most common
precancerous skin conditions. Biofrontera also commercializes
Xepi®, an FDA-approved drug for the treatment of impetigo. In
collaboration with dermatologists, Biofrontera is fully committed
to advancing treatment options and patient care. For more
information, visit www.biofrontera-us.com.
Forward-Looking
StatementsCertain 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 financial impact and benefits of the
Company’s recent initial public offering and private placement, the
clinical developments involving the Company’s licenses products and
any other statements about future Expectations, prospects,
estimates and other matters that are dependent on future events or
developments. Statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “likely,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions
constitute forward-looking statements. 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 its
licensors; the outcome of the Company’s litigation with DUSA
Pharmaceuticals, Inc.; 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.
ContactsBiofrontera
Inc.Pamela Keck+1 781 486 1539us-ir@biofrontera.com
LHA Investor RelationsTirth T.
Patel+1 212 201 6614tpatel@lhai.com
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