New Data and Forecasts for the U.S. Skin Cancer Market Strongly Support the Commercial Opportunity for Biofrontera’s Ameluz®
May 24 2022 - 11:29AM
Biofrontera Inc. (Nasdaq:
BFRI), a biopharmaceutical company specializing in the
commercialization of dermatological products, views new data on
skin cancer prevalence provided by the American Cancer Society1,
indicating approximately 3.4 million U.S. residents could be
diagnosed with non-melanoma skin cancer (NMSC) in 2022, as strongly
supportive of the commercial opportunity for the Company’s flagship
product Ameluz®. Additionally, a market survey report published
earlier this month by ReportLinker2, titled “Global Non-melanoma
Skin Cancer Market 2022-2026,” forecasts the global NMSC market
will grow by more than $180 million during that period. The report
identifies the increasing incidence of NMSC as a primary driver of
market growth, forecasting a compound annual growth rate of 5.8%
through 2026.
Ameluz® is utilized along with photodynamic
therapy (PDT) provided by the Company’s proprietary lamp devices to
form Ameluz®-PDT. Ameluz®-PDT is approved by the U.S. Food and Drug
Administration (FDA) for the treatment of pre-cancerous skin
lesions known as actinic keratoses (AK) on the face and scalp. AK
is caused by excessive sun exposure over many years and therefore
found predominantly on sun-exposed parts of the body. When left
untreated, AK can develop into potentially fatal squamous cell
carcinoma (SCC), the second most common form of skin cancer.3-5
“With May being Skin Cancer Awareness Month,
there is heightened awareness of the prevalence and associated
risks of skin cancer, the most common and most preventable cancer
in the United States. These updated data and forecasts cast light
on the growing market opportunity for Ameluz® and its commercial
prospects. Our flagship product, Ameluz®, and the RhodoLED lamp
series are gaining significant recognition from clinicians
nationwide as the prevalence of skin cancers, most of which are
basal and squamous cell carcinomas, increases, and as PDT continues
to gain market share from cryotherapy. Expanding PDT as a
first-option treatment for AK, especially in patients with more
than 15 lesions, is a large and growing opportunity for us,” stated
Erica Monaco, Chief Executive Officer of Biofrontera Inc.
“Our company’s goal is to establish Ameluz® as
the leading PDT drug for the treatment of AK in the United States,
and leveraging the potential for future FDA approvals and label
expansions is a key pillar of our growth strategy. Multiple
clinical studies are ongoing by our licensor that are designed to
broaden the addressable market and further strengthen the current
market positioning of Ameluz®,” added Ms. Monaco.
Ameluz® and the RhodoLED® lamps, through the
license and supply agreement with Biofrontera AG, are developed
further in the U.S. in three ongoing clinical studies:
- Biofrontera AG is currently enrolling patients in a Phase 3
clinical study in the U.S. evaluating Ameluz®-PDT in combination
with the BF-RhodoLED® lamp for the treatment of superficial basal
cell carcinoma. This study is approximately 75% enrolled and will
enroll a total of 186 patients.
- Biofrontera AG is currently
enrolling patients in a multicenter, randomized, double-blind Phase
2 clinical study evaluating the efficacy of Ameluz®-PDT for the
treatment of moderate-to-severe acne. The primary endpoint is the
change in number of inflammatory lesions and improvement in
symptoms as assessed by the physicians conducting the study and, as
an objective comparator, by an automated imaging system. This study
enrolled its first patient in December 2021 and will enroll a total
of 126 patients.
- Biofrontera is currently enrolling
patients in an open-label, multicenter Phase 1 study evaluating the
safety and tolerability of Ameluz® for the treatment of AK located
on the face and scalp together with the RhodoLED®-XL lamp. Each
patient receives a field-directed treatment with the content of
three tubes of Ameluz®, better enabling treatment of larger surface
areas. This study enrolled its first patient in December 2021 and
will enroll a total of 100 patients.
Biofrontera AG expects enrollment in the
superficial basal cell carcinoma study to be completed by the end
of 2022, and enrollment in the other two studies to be
completed in the second half of 2022.
About Actinic
Keratosis
Actinic keratosis (AK) is a superficial,
potentially pre-cancerous skin lesion caused by chronic sun
exposure that may, if left untreated, develop into life-threatening
skin cancer called squamous cell carcinoma. AKs typically appear on
sun-exposed areas such as the face, bald scalp, arms or the back of
the hands. According to the Skin Cancer Foundation, in the U.S. AK
affected approximately 58 million people in 2020 and an estimated
12.7 million AK treatments were performed. The most common
treatment for AK is cryotherapy, with approximately 86% of the
market. Topical drugs for the treatment of AK had a market share of
about 12%, followed by photodynamic therapy (PDT) treatments with
about a 2% share.
About
Ameluz®
Ameluz® (aminolevulinic acid hydrochloride gel,
10%), Biofrontera’s flagship product, is FDA-approved for use in
combination with the BF-RhodoLED® lamp for photodynamic therapy
(PDT) for the lesion-directed and field-directed treatment of
actinic keratosis (AK) of mild-to-moderate severity on the face and
scalp. Biofrontera’s commercial focus is to improve the market
positioning of Ameluz® to become the leading PDT drug for the
treatment of AK, especially in patients with more than 15 lesions,
and positioning Ameluz® as the number one treatment choice for
patients with extended skin areas affected by AK. Ameluz® and
Biofrontera’s RhodoLED® lamp series are being further developed
through ongoing clinical studies by Biofrontera’s license and
supply partner.
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
https://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
# # #
1 Basal & Squamous Cell Skin Cancer Statistics
https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html#references2
ReportLinker.com – Global Non-melanoma Skin Cancer Market 2022-2026
https://www.reportlinker.com/p05691253/Global-Non-melanoma-Skin-Cancer-Market.html?utm_source=GNW3
Berman B, Amini S, Valins W, Block S. Pharmacotherapy of actinic
keratosis. Expert Opin Pharmacother. 2009;10(18):
3015-30314 Reinhold U. A review at BF-200 ALA for the photodynamic
treatment of mild-to-moderate actinic keratosis. Future
Oncol. 2017;13(270:2413-24285 AMELUZ [Prescribing
information].
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208081s011lbl.pdf
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