Pivotal U.S. Phase 3 Clinical Study Met
Primary and All Secondary Endpoints
Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell
therapies for the sports medicine and severe burn care markets,
today announced that it has 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. NexoBrid is approved in the European Union and other
international markets and has been designated as an orphan biologic
in the United States.
In January 2019, MediWound announced positive top-line results
from 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% 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
compared to standard of care (SOC). A key safety endpoint,
non-inferiority in time to complete wound closure compared with
patients treated with SOC, was also achieved. Planned twelve-month
and twenty-four month safety follow-ups are ongoing for cosmesis,
function, quality of life and other safety measurements.
“We are delighted to expand our burn care franchise with the
addition of NexoBrid, a highly innovative product with compelling
clinical and pharmacoeconomic data that represents a paradigm shift
in burn care for hospitalized patients,” said Nick Colangelo,
president and CEO of Vericel. “NexoBrid is an excellent strategic
fit with our advanced therapy portfolio and is highly synergistic
with our existing commercial franchise. The addition of NexoBrid
significantly expands our target addressable market and supports a
broader commercial footprint to both drive NexoBrid uptake and
increase Epicel penetration as we broaden our focus to a
significantly larger segment of hospitalized burn patients. We look
forward to working closely with the MediWound team to bring
NexoBrid to the U.S. market.”
The U.S. Biomedical Advanced Research and Development
Authority (BARDA) has awarded MediWound a contract valued at
up to $132 million for the advancement of the development and
manufacturing, as well as the procurement, of NexoBrid in the
United States. Under the contract, BARDA provides technical
assistance and $56 million in funding support towards NexoBrid
development costs including the ongoing DETECT study and a Phase 3
pediatric (CIDS) study to obtain U.S. marketing approval from the
Food and Drug Administration (FDA). The contract also includes a
$16.5 million commitment for procurement of NexoBrid contingent
upon FDA eligibility for use in an emergency or FDA marketing
approval. The contract provides an option to fund up to $50 million
for additional NexoBrid procurement. Independently, BARDA also
awarded a different contract to MediWound for up to $43 million to
support the development of NexoBrid as a debridement product to
treat sulfur mustard injuries.
Under the terms of the license agreement, Vericel will make an
upfront payment to MediWound of $17.5 million, with an additional
$7.5 million payment contingent upon U.S. approval and up to $125
million contingent upon meeting certain annual sales milestones.
The first sales milestone of $7.5 million would be triggered when
NexoBrid annual net sales in North America exceed $75 million.
Vericel also will pay MediWound tiered royalties on net sales
ranging from single-digit to low double-digit percentages, and a
percentage of gross profits on initial committed BARDA procurement
orders and a royalty on any additional BARDA purchases of NexoBrid.
Vericel also entered into a supply agreement with MediWound under
which MediWound will manufacture NexoBrid for Vericel for a supply
price of cost plus a fixed margin percentage.
“In addition to the clear strategic fit with our burn care
franchise, this transaction is attractive from a financial
perspective as well,” said Nick Colangelo. “The performance-based
deal structure, together with BARDA funding support for development
expenses to obtain U.S. marketing approval and medical
countermeasure procurement, makes the transaction essentially
neutral to adjusted EBITDA in the near-term and generates
longer-term margins consistent with expected margins for our
current portfolio.”
Approximately 40,000 burn patients are hospitalized in the U.S.
each year1, most of whom require the debridement of burn eschar to
facilitate healing and reduce the risk of infection.2 Surgical
excision of eschar, or escharectomy, is currently standard of care
and is performed through repeated use of a large surgical blade to
remove necrotic tissue until bleeding, healthy tissue is
reached.2 While effective, surgical debridement is not
selective, results in the loss of both viable tissue and blood, and
requires general anesthesia for the patient and operating
facilities for the burn center or hospital.3 Currently
available enzymatic debridement agents require a minimum of once
daily application4 with dressing changes over a number of days.
NexoBrid enables the rapid and early removal of eschar while
reducing patients' surgical burden and the related loss of blood
and healthy tissue associated with escharectomy.5
“MediWound is excited to partner with Vericel, a company that
shares our commitment to bringing innovative therapies to the
market to meet the needs of burn patients,” said Stephen T. Wills,
Chairman of MediWound. “Vericel’s proven track record of
commercializing novel products and changing standard of care, as
well as their strong history with the burn community, gives us
confidence that they are the ideal partner to realize the full
potential of NexoBrid in North America.”
The U.S. Biologics License Application (BLA) currently is
targeted for submission to the FDA in the fourth quarter of 2019
based on the acute primary, secondary and safety data, with the
analysis of the twelve-month safety follow-up data submitted during
the BLA review and the twenty-four month safety follow-up data
submitted as a BLA supplement, subject to FDA concurrence at a
pre-BLA meeting planned for the first half of 2019.
For more information on this transaction please refer to the
Form 8-K filed today with the U.S Securities and Exchange
Commission (SEC).
About Vericel CorporationVericel is a leader in
advanced cell 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. 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. 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. All rights reserved.
NexoBrid® is a registered trademark of MediWound Ltd. and is
used under license to Vericel Corporation.
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 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, increasing market
penetration for Epicel, 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.
References
- American Burn Association -
https://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/.
- Plast Aesthet Res 2018;5:33.
- Total Burn Care (Fifth Edition), 2018, Pages 131-157.
- Santyl Prescribing Information.
- Burns 43 (2017) 1640 – 1653; Annals of Burns and Fire Disasters
- vol. XXVIII - n. 4 - December 2015; Burns 2014; 40: 466-474.
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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