BARDA to Fund NexoBrid Expanded Access Treatment Protocol for Thermal Burns
29 Maio 2019 - 8:30AM
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies
for the sports medicine and severe burn care markets, today
announced that the U.S. Biomedical Advanced Research and
Development Authority (BARDA) has agreed to fund the NexoBrid®
expanded access treatment (NEXT) protocol. The NEXT protocol
is being conducted under the U.S. Food and Drug Administration’s
(FDA) expanded access program, which allows access to
investigational products to treat patients with serious or
immediately life-threatening diseases or conditions outside of
clinical trials when no comparable or satisfactory alternative
treatment options are available. U.S. burn surgeons
participating in the NEXT protocol will be able to treat up to
150 patients during the preparation and review of the
NexoBrid Biologics License Application (BLA).
On May 7, 2019, Vericel announced that it had entered into
exclusive license and supply agreements with MediWound Ltd. to
commercialize NexoBrid in North America. NexoBrid 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. MediWound will
receive the additional funding from BARDA under an amendment to an
existing BARDA contract. Under the terms of the License
Agreement, MediWound will continue to conduct all development
activities under the supervision of a Central Steering Committee
comprised of members of each party until the BLA is approved and
subsequently transferred to Vericel.
The NEXT protocol is an open-label, single-arm treatment
protocol which allows for the treatment of up to 150 burn patients
with deep partial- and full-thickness thermal burns up to 30% of
total body surface area. Up to 30 sites will participate in
the NEXT protocol. The protocol has been designed to be
consistent with current real-life burn treatment practices in the
U.S. The increased number of burn centers trained and
familiar with NexoBrid prior to FDA approval and commercial
availability will improve national readiness for potential burn
mass casualty events. To further promote national readiness,
the FDA has agreed that in the event of a burn mass casualty event
that is not a nationally declared emergency, additional patients
could be treated under the NEXT treatment protocol.“We are very
pleased with BARDA’s commitment to make NexoBrid available to
patients under an expanded access protocol,” said Nick Colangelo,
president and CEO of Vericel. “It is a reflection of the
significant need for improved burn treatments and the compelling
body of clinical data supporting the use of NexoBrid. The
NEXT protocol will further extend the number of NexoBrid-trained
physicians and healthcare providers in the United States and
generate additional awareness, advocacy, and use at U.S. centers of
excellence prior to commercialization of NexoBrid.”
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.
About BARDAThe Biomedical Advanced Research and
Development Authority (BARDA), within the Office of the Assistant
Secretary for Preparedness and Response in the U.S. Department of
Health and Human Services, provides an integrated, systematic
approach to the development and purchase of the necessary vaccines,
drugs, therapies and diagnostic tools for public health medical
emergencies. For more information, refer to
www.phe.gov/about/BARDA. Funding and support for development
of NexoBrid has been provided by BARDA, under the Assistant
Secretary for Preparedness and Response (ASPR), within the U.S.
Department of Health and Human Services (HHS), under ongoing USG
Contract No. HHSO100201500035C and HHSO100201800023C.
Epicel® and MACI® are registered trademarks of Vericel
Corporation. © 2019 Vericel Corporation. NexoBrid® is a
registered trademark of MediWound Ltd. and is used under license to
Vericel Corporation. All rights reserved.
This document contains forward-looking statements, including,
without limitation, statements concerning anticipated progress,
objectives and expectations regarding the commercial potential of
Vericel products, intended product development, clinical activity
timing, regulatory process, and objectives and expectations
regarding our company described herein, all of which involve
certain risks and uncertainties. These statements are often, but
are not always, made through the use of words or phrases such as
"anticipates," "intends," "estimates," "plans," "expects," "we
believe," “targeted” and similar words or phrases, or future or
conditional verbs such as "will," "would," "should," "potential,"
"can continue," "could," "may," or similar expressions. Actual
results may differ significantly from the expectations contained in
the forward-looking statements. Among the factors that may result
in differences are the inherent uncertainties associated with
timing and conduct of clinical trial and product development
activities, timing of the commencement of the NEXT protocol,
extension of NexoBrid use, timing or likelihood of regulatory
submissions or approvals, availability of funding from BARDA,
potential payments under the license and supply agreements, growth
in revenue, profit and margins, impact to adjusted EBITDA,
estimating the commercial potential of our products and product
candidates, competitive developments, market demand for our
products and product candidates, product performance, and our
ability to supply or meet customer demand for our products. 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, 2018, filed with the Securities and Exchange Commission ("SEC")
on February 26, 2019, Quarterly Reports on Form 10-Q and other
filings with the SEC. These forward-looking statements reflect
management's current views and Vericel does not undertake 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.
Global Media Contacts:David SchullRusso
Partners LLCDavid.schull@russopartnersllc.com+1 212-845-4271
(office)+1 858-717-2310 (mobile)
Karen ChaseRusso Partners LLCKaren.chase@russopartnersllc.com+1
646-942-5627 (office)+1 917-547-0434 (mobile)
Investor Contacts: Chad RubinSolebury
Troutcrubin@troutgroup.com+1 (646) 378-2947
Lee SternSolebury Troutlstern@troutgroup.com+1 (646)
378-2922
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