Biofrontera Inc. Announces Notice of Allowance for Nanoemulsion Composition-of-Matter U.S. Patent
September 06 2022 - 9:31AM
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 granted a notice of
allowance to Biofrontera Bioscience GmbH for patent application No.
12/520,759 (the ’759 patent), titled “Nanoemulsion Formulation with
Improved Stability and Cell Penetration.” Biofrontera Inc. has an
exclusive license to market and sell Ameluz®, an FDA-approved drug
utilizing the technology covered by the patent, in the U.S.
The ’759 patent relates to the compositions of
Biofrontera’s nanoemulsions and an active agent (such as in
Ameluz®) and the preparation of the nanoemulsions or compositions,
and describes its use in the treatment of dermatological,
virus-associated and cell proliferation diseases, as well as in
cosmetics. Biofrontera’s compositions of nanoemulsions overcome the
disadvantages of other nanoemulsion formulations through a reduced
particle size that contributes to improved stability, better
penetration into cells and tissues and lower production costs. The
notice of allowance precedes the granting of the patent by the
USPTO, which typically follows soon after the patent holder pays
the required fee.
“This new patent will further protect
Biofrontera’s growing position in the dermatology market and our
continued investment in the market. Compound-of-matter patents
provide the strongest protection of all patent types. Our license
agreement covers all combinations of the patented nanoemulsion
technology with aminolevulinic acid, the active ingredient in
Ameluz®. Together with Biofrontera Bioscience we are now even more
strongly positioned to broaden the use of photodynamic therapy
(PDT) in dermatology,” stated Hermann Lübbert, Executive Chairman
of Biofrontera Inc.
“Utilizing nanoemulsion technology can help
elevate PDT to the leading choice in treating actinic keratosis
(AK). When formulated together with aminolevulinic acid, our
nanoemulsion has demonstrated increased efficiency in cell uptake.
This improves selectivity and also shortens the penetration period,
or the time between applying the composition and irradiating the
diseased tissue with light, providing a distinct relief for
patients and process efficiency for offices. By enhancing
penetration, we are able to treat diseases that reside more deeply
in the skin,” stated Erica Monaco, Chief Executive Officer of
Biofrontera Inc.
The Company also announces the granting of a
special designation from the USPTO that enables expedited review of
a recently submitted patent application relating to novel
illumination protocols for the treatment of skin diseases with PDT.
The patent, which was recently granted to Biofrontera Bioscience
GmbH in Australia, covers treatment protocols that combine the
lower pain of daylight PDT with the higher cure rates and lower
recurrence rates of conventional therapy. The development of the
illumination combinations protected by this patent will, once
granted in the U.S., further protect Ameluz®-PDT.
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 photodynamic therapy (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 Company’s business and marketing
strategy, future operations and business, potential to expand the
label of Ameluz®, market presence and position of Ameluz® and
ongoing clinical trials conducted by our licensing partners and the
future impact of such trials on the market for Ameluz®. 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 ability of the Company’s licensors to fulfill their
obligations to the Company in a timely manner; 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; the Company’s ability
to complete the transition to a public company; 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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