Biofrontera Inc. Announces Notice of Allowance for U.S. Method-of-Use Patent on PDT-lamp
December 08 2021 - 9:32AM
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 Biofrontera Pharma GmbH’s U.S. patent number
17/215,785 (‘785 patent), titled “Illumination device for
photodynamic therapy, method for treating a skin disease and method
for operating an illumination device,” which protects a number of
innovations relating to the RhodoLED XL lamp.
“This is a patent covered by the exclusive
license of Biofrontera Inc. to sell Ameluz and the RhodoLED lamp
series in the USA. It furthers Biofrontera’s commitment to patient
safety, enhances our lead product’s competitive position and
strengthens the intellectual property portfolio around our lead
product Ameluz in combination with the FDA-approved RhodoLED XL
lamp. The technical improvements claimed in the patent allow for
greater standardization and procedural compliance for photodynamic
therapy (PDT) with the combination product. As previously
announced, in 2022, within the framework of our License and Supply
Agreement, Biofrontera Bioscience GmbH plans to start a Phase 3
trial for the treatment of actinic keratoses on the face and scalp
with three tubes of Ameluz and the RhodoLED XL lamp,” stated Erica
Monaco, Chief Executive Officer of Biofrontera Inc.
The ‘785 patent describes specific features of
the LED arrays of the five panels constituting the lamp head of
RhodoLED XL. These features provide optimized homogenous
illumination by an improved spatial arrangement. The patent further
describes the implementation of a distance sensor in each panel
that improves device positioning. The sensors are connected to
visual feedback mechanisms that support the operator in properly
positioning the five panels at the recommended treatment distance.
This increases standardization of the illumination, while
facilitating handling of the lamp for the treating physician.
The ‘785 patent constitutes a
continuation-in-part of U.S. patent number 17/071,496, and thus
claims the same priority date of October 15, 2020. The
continuation-in-part was filed as a fast-track application on March
29, 2021 and the allowance was granted in less than nine months. A
worldwide patent application based on this invention and claiming
the same priority date has also been filed (PCT/EP2021/078045).
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 RhodoLED® lamp
series, Ameluz®-PDT is indicated for the treatment of actinic
keratoses, 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 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 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.
Contacts
Biofrontera 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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