Vericel Provides Regulatory Update for NexoBrid
June 29 2021 - 8:45AM
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies
for the sports medicine and severe burn care markets, today
announced that its development partner, MediWound Ltd., received a
complete response letter (CRL) from the U.S. Food and Drug
Administration (FDA) regarding the Biologics License Application
(BLA) for NexoBrid, a potential treatment for eschar removal in
adults with deep partial-thickness and/or full-thickness burns.
The FDA communicated to MediWound that it had completed its
review of the BLA, as amended, and has determined that it cannot
approve the BLA in its present form. The FDA identified issues
related to the Chemistry, Manufacturing and Controls (CMC) section
of the BLA and requested that MediWound provide additional CMC
information. The FDA stated that it has not reviewed several
amendments submitted by MediWound in response to the CMC
information requests for this action. The FDA also stated that
inspections of manufacturing facilities in Israel and Taiwan are
required before the BLA can be approved, but that it was unable to
conduct the required inspections during the current review cycle
due to COVID-related travel restrictions. In addition, the CRL
referenced observations that were made during good clinical
practice (GCP) inspections related to the DETECT study and
requested that MediWound address questions regarding the impact of
the observations on the study’s efficacy findings. The FDA also
requested that MediWound provide a safety update as part of its BLA
resubmission.
“We are committed to working with MediWound and the FDA on next
steps to address the issues identified in the complete response
letter in order to obtain the potential approval of NexoBrid and
bring this important product to patients as expeditiously as
possible,” said Nick Colangelo, President and CEO of Vericel.
“Importantly, we will continue to support the NexoBrid expanded
access treatment (NEXT) protocol during the resubmission and FDA
review process.”
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 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. © 2021 Vericel
Corporation. All rights reserved.
Forward Looking StatementsVericel 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 relating to our operations
and business environment, all of which are difficult to predict and
many of which are beyond our control. Our 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.
Among the factors that could cause actual results to differ
materially from those set forth in the forward-looking statements
include, but are not limited to, uncertainties associated with the
timing or likelihood of approval by the U.S. Food & Drug
Administration of the NexoBrid BLA for treatment of severe burns in
the United States or other North American markets, availability of
funding from BARDA under its agreement with MediWound Ltd. for use
in connection with NexoBrid development activities, and the
wide-ranging impacts of the COVID-19 pandemic on our business or
the economy generally.
With respect to FDA’s review of the pending NexoBrid BLA, the
COVID-19 pandemic may impact the FDA’s response times to future
regulatory submissions, its ability to monitor our clinical trials,
and/or conduct necessary reviews or inspections of manufacturing
facilities involved in the production of NexoBrid, any or all of
which may result in timelines being materially delayed, which could
affect the development and ultimate commercialization of NexoBrid.
The total impact of these disruptions could have a material impact
on the Company’s financial condition, cash flows and results of
operations.
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, 2020, filed with the Securities and Exchange
Commission (SEC) on February 24, 2021, Vericel’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2021, filed with the
SEC on May 5, 2021, 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 Contacts:Eric Burnsir@vcel.com+1
734-418-4411
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