Vericel Announces Submission of Biologics License Application to the FDA for NexoBrid for the Treatment of Severe Thermal Bur...
June 30 2020 - 7:00AM
Vericel Corporation (NASDAQ: VCEL) today announced the submission
of a Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) seeking the approval of NexoBrid® (concentrate
of proteolytic enzymes enriched in Bromelain) for eschar removal
(debridement) in adults with deep partial-thickness and/or
full-thickness thermal burns. NexoBrid is approved in the
European Union and other international markets and has been
designated as an orphan biologic in the United States, European
Union and other international markets. Vericel holds an
exclusive license for North American commercial rights to
NexoBrid. Funding and technical support to MediWound Ltd. for
development of NexoBrid is provided by the U.S. Biomedical Advanced
Research and Development Authority (BARDA).
The BLA submission for NexoBrid is based on
multiple preclinical and clinical studies including the pivotal
Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients
with deep partial-thickness and full-thickness thermal burns up to
30% of total body surface area. The study met its primary
endpoint of complete eschar removal as well as all secondary
endpoints, including shorter time to eschar removal, a lower
incidence of surgical eschar removal, and lower blood loss during
eschar removal compared to standard of care (SOC), including both
surgical and non-surgical debridement methods. A key safety
endpoint, non-inferiority in time to complete wound closure
compared with patients treated with SOC, was also achieved.
Long-term follow-up data to assess cosmesis, function, and quality
of life, including 12-month results from the DETECT study, were
also included in the submission.
“The BLA submission for NexoBrid marks an important
milestone in our partnership with MediWound, bringing us one step
closer to providing NexoBrid as an innovative treatment for the
thousands of patients admitted to burn units each year with deep
partial-thickness and full-thickness burns who would benefit from
rapid and selective eschar removal,” said Nick Colangelo, President
and CEO of Vericel. “We look forward, together with
MediWound, to working with the FDA during the BLA filing and review
process as we seek marketing approval for NexoBrid in the United
States.”
Sharon Malka, CEO of MediWound added, “Submitting
the NexoBrid BLA has been a team effort and we thank all of the
investigators, their teams, our employees and all our partners,
especially BARDA and Vericel, for their commitment to the
program. This is a major milestone for MediWound and it is
gratifying to know NexoBrid is one step closer to being available
to help burn victims in the U.S.”
About NexoBridNexoBrid is a
topically administered biological product that enzymatically
removes nonviable burn tissue, or eschar, in patients with deep
partial and full-thickness thermal burns within four hours of
application without harming viable tissue. NexoBrid is
approved in the European Union and other international markets and
has been designated as an orphan biologic drug in the United
States, European Union and other international markets.
Vericel holds an exclusive license for North American
commercial rights to NexoBrid. In January 2019, MediWound announced
positive top-line results from the acute phase of the pivotal Phase
3 U.S. clinical study (DETECT) of NexoBrid in adult patients with
deep partial-and full-thickness thermal burns up to 30 percent of
total body surface area. The study met its primary endpoint of
complete eschar removal compared to gel vehicle as well as all
secondary endpoints compared to standard of care (SOC), including
shorter time to eschar removal, a lower incidence of surgical
eschar removal and lower blood loss during eschar removal.
Safety endpoints, including the key safety endpoint of
non-inferiority in time to complete wound closure compared with
patients treated with SOC, were also achieved. In addition,
the twelve-month follow-up safety data of cosmesis and function
were found to be comparable between the treatment and SOC arms, and
no new safety signals were observed. Additional
twenty-four-month long term safety follow up data will be submitted
as a safety labeling update as part of a post-approval commitment.
NexoBrid is currently an investigational product in the United
States.
About Vericel CorporationVericel
is a leader in advanced therapies for the sports medicine and
severe burn care markets. The company markets two cell
therapy products in the United States. MACI® (autologous
cultured chondrocytes on porcine collagen membrane) is an
autologous cellularized scaffold product indicated for the repair
of symptomatic, single or multiple full-thickness cartilage defects
of the knee with or without bone involvement in adults.
Epicel® (cultured epidermal autografts) is a permanent skin
replacement for the treatment of patients with deep dermal or
full-thickness burns greater than or equal to 30% of total body
surface area. The company also holds an exclusive license for
North American commercial rights to NexoBrid®, a registration-stage
biological orphan product for debridement of severe thermal
burns. For more information, please visit the company’s
website at www.vcel.com.
Epicel® and MACI® are registered trademarks of
Vericel Corporation. NexoBrid® is a registered trademark of
MediWound Ltd. and is used under license to Vericel Corporation. ©
2019 Vericel Corporation. All rights reserved.
Cautionary Note Regarding Forward-Looking
Statements Vericel cautions you that all statements other
than statements of historical fact included in this press release
that address activities, events or developments that we expect,
believe or anticipate will or may occur in the future are
forward-looking statements. Although we believe that we have
a reasonable basis for the forward-looking statements contained
herein, they are based on current expectations about future events
affecting us and are subject to risks, assumptions, uncertainties
and factors, all of which are difficult to predict and many of
which are beyond our control. Actual results may differ
materially from those expressed or implied by the forward-looking
statements in this press release. These statements are often,
but are not always, made through the use of words or phrases such
as “anticipates,” “intends,” “estimates,” “plans,” “expects,”
“continues,” “believe,” “guidance,” “outlook,” “target,” “future,”
“potential,” “goals” and similar words or phrases, or future or
conditional verbs such as “will,” “would,” “should,” “could,”
“may,” or similar expressions.
Specifically, this press release contains
forward-looking statements concerning the anticipated progress,
development, objectives, expectations and commercial potential of
NexoBrid. Among the factors that may cause results to be materially
different from those stated herein are the inherent uncertainties
associated with the timing and conduct of clinical trial and
product development activities; the timing or likelihood of
regulatory approvals; the ability to successfully develop and
commercialize NexoBrid, including its commercial growth potential
and the market demand for the product; the availability of funding
from BARDA under its agreement with MediWound for use in connection
with NexoBrid development activities; competitive developments;
whether FDA will accept all or part of the BLA and provide
marketing approval for NexoBrid in the United States; the risks
related to the timing and conduct of our NEXT Study; the impact of
applicable laws and regulations; and the uncertainties associated
with the scope, scale and duration of the impact of the COVID-19
pandemic. For example, we are unable to predict how the
pandemic will affect the overall healthcare infrastructure,
including the pace with which governmental agencies, such as the
FDA, will review and approve regulatory submissions.
Additional government-imposed quarantines and requirements to
“shelter at home” or other incremental mitigation efforts also may
impact our ability to source supplies for our operations or our
ability to sell and support the use of NexoBrid in the future.
These and other significant factors are discussed
in greater detail in Vericel’s Annual Report on Form 10-K for the
year ended December 31, 2019, filed with the Securities and
Exchange Commission (“SEC”) on February 25, 2020, Quarterly Reports
on Form 10-Q and other documents filed by the Company with the SEC
from time-to-time. These forward-looking statements reflect
management’s current views as of the date hereof and Vericel does
not undertake, and specifically disclaims, any obligation to update
any of these forward-looking statements to reflect a change in our
views or events or circumstances that occur after the date of this
release except as required by law.
Investor Contact:Lee SternSolebury
Troutlstern@troutgroup.com+1 (646) 378-2922
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