Vericel Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns
September 16 2020 - 7:30AM
Vericel Corporation (NASDAQ: VCEL) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for filing the
recently submitted Biologics License Application (BLA) for
NexoBrid® (concentrate of proteolytic enzymes enriched in
bromelain) for eschar removal (debridement) in adults with deep
partial-thickness and/or full-thickness thermal burns. The FDA
assigned a Prescription Drug User Fee Act (PDUFA) target date of
June 29, 2021. In addition, the FDA communicated that it is not
currently planning to hold an advisory committee meeting to discuss
the application.
“The FDA’s acceptance of the NexoBrid BLA for review represents
another important milestone toward our goal of providing a new
standard of care for eschar removal in patients with severe burns,”
said Nick Colangelo, President and CEO of Vericel. “We look
forward, together with MediWound, to working with the FDA during
the BLA review process as we seek marketing approval for NexoBrid
in the United States.”
Sharon Malka, CEO of MediWound added, “The acceptance of the
NexoBrid BLA 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 United States. We thank all of the
investigators, their teams, our employees and all our partners,
especially BARDA and Vericel, for their commitment to the
program.”
Vericel will host a virtual Analyst and Investor Day on Friday,
October 16, 2020, from 9:00 a.m. - 11:00 a.m. EST which will focus
on NexoBrid. In addition to a general corporate update, Vericel
executives will facilitate discussions with burn surgeon thought
leaders on current burn debridement practices and how NexoBrid,
upon approval, could change the current treatment paradigm for
debridement of severe thermal burns.
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 from MediWound Ltd. for North American rights to NexoBrid®,
a registration-stage biological orphan product for debridement of
severe thermal burns. Funding and technical support to MediWound
Ltd. for development of NexoBrid is provided by the U.S. Biomedical
Advanced Research and Development Authority (BARDA). 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. © 2020 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 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 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, Vericel’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020,
filed with the SEC on August 5, 2020, and in other filings with the
SEC. These forward-looking statements reflect our views as of the
date hereof and Vericel does not assume and specifically disclaims
any obligation to update any of these forward-looking statements to
reflect a change in its 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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