Vericel Corporation ו-MediWound
Ltd. הודיעו היום על התחלת הגישה המורחבת לפרוטוקול
הטיפול (NEXT) ב-NexoBrid® בארה"ב לטיפול בחולי כוויות עם כוויות עמוקות בעובי חלקי
ומלא בארה"ב בזמן ההכנה והבחינה של הבקשה לרישיון ביולוגי (BLA) של NexoBrid.
Vericel and MediWound Announce Initiation of U.S. NexoBrid Expanded Access Treatment Protocol
CAMBRIDGE, Mass.
and YAVNE, Israel, Oct. 02, 2019, (GLOBE NEWSWIRE):
Vericel
Corporation (NASDAQ: VCEL) and MediWound Ltd. (NASDAQ: MDWD) today announced
initiation of the NexoBrid® expanded access treatment protocol
(NEXT) to treat burn patients with deep partial- and full-thickness burns in
the U.S. during the preparation and review of the NexoBrid Biologics License
Application (BLA).
“We are excited to
initiate NEXT in the U.S. in tandem with preparations with Vericel for the BLA
filing,” said Sharon Malka, MediWound’s Chief Executive Officer. “NEXT, which
is supported and funded by the Biomedical Advanced Research and Development
Authority (BARDA), allows for the continued clinical use as well as
non-declared emergency use of NexoBrid for U.S. patients prior to NexoBrid
approval by the FDA. We believe NEXT will enhance national preparedness for
burn mass casualty incidences, where it has the potential to meaningfully
impact patients’ lives.”
Nick Colangelo,
president and CEO of Vericel said, “After a successful pre-BLA meeting with the
FDA, we remain on track for the BLA submission in the second quarter of 2020.
NEXT will further extend the number of NexoBrid-trained physicians and
healthcare providers in the U.S. and generate additional awareness, advocacy
and use at U.S. burn centers prior to commercialization of NexoBrid.”
NEXT 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. NEXT has been designed to be consistent with
current real-life burn treatment practices in the U.S. and up to 30 U.S. burn
centers will participate. The increased number of burn centers trained and
familiar with NexoBrid prior to FDA approval 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.
About
NexoBrid
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, 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% 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, twelve-month long-term safety follow up data have been collected and
are now being analyzed.
At the end of July
2019, MediWound and Vericel participated in a pre-BLA meeting with the FDA and
received concurrence that the existing safety and efficacy data including the
two Phase 3 clinical studies and the twelve-month safety follow up data from
DETECT are adequate to allow for BLA submission and review of NexoBrid.
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 considered an investigational product in the United States. The
companies anticipate filling the BLA in the second quarter of 2020.
About
Vericel Corporation
Vericel 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 MediWound
Ltd.
MediWound is a
fully-integrated biopharmaceutical company focused on developing, manufacturing
and commercializing novel therapeutics based on its patented proteolytic enzyme
technology to address unmet needs in the fields of severe burns, chronic and
other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical
product, NexoBrid, non-surgically and rapidly removes burn eschar without
harming viable tissue. The product has received marketing authorization from
the European Medicines Agency as well as the Israeli, Argentinian, South
Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative
product, EscharEx® is a topical biological drug candidate for the
debridement of chronic and other hard-to-heal wounds using the same proteolytic
enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has
demonstrated safety and efficacy in the debridement of various chronic and
other hard-to-heal wounds, within a few daily applications. For more
information, please visit www.mediwound.com.
About
BARDA
The 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 technical support for
development of NexoBrid including this expanded access treatment protocol
(NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing
approval registration process for NexoBrid in the U.S. is provided by the
Biomedical Advanced Research and Development Authority (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. Additional projects for evaluation of NexoBrid funded under
the BARDA contract include randomized, controlled pivotal clinical trial for
use in pediatric population, establishment of a pre-emergency use data package
and development of the health economic model to evaluate the cost savings impact
to enable market adoption in the US.
About
FDA expanded access program
The U.S. Food and
Drug Administration’s (FDA) expanded access program 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.
Cautionary
Note Regarding Forward-Looking Statements
This release
includes forward-looking statements within the meaning of Section 27A of the
U.S. Securities Act of 1933, as amended, Section 21E of the US Securities
Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. In some cases, you can
identify forward-looking statements by terminology such as “believe,” “may,”
“estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,”
“predict,” “potential,” or the negative of these terms or other similar
expressions. Forward-looking statements are statements that are not historical
facts, and are based on Vericel’s and MediWound’s current knowledge and its
present beliefs and expectations regarding possible future events and are
subject to risks, uncertainties and assumptions. Actual results and the timing of
events could differ materially from those anticipated in these forward-looking
statements as a result of several important factors, including but not limited
to the ability to successfully develop and commercialize NexoBrid; the ability
to submit to FDA a BLA in the timeframe expected; the ability to fund the development
of NexoBrid until BLA submission; FDA may not accept part or all of the BLA;
FDA may not provide marketing approval for NexoBrid in the United States; risks
related to the timing and conduct of our NEXT; risks related to the contract
with the U.S. Biomedical Advanced Research and Development Authority; the
impact of government laws and regulations; and the additional risks discussed
under the heading “Risk Factors” in MediWound’s annual report on Form 20-F for
the year ended December 31, 2018, Quarterly Reports on Form 6-K and other
filings with the Securities and Exchange Commission ("SEC"), as well
as information contained in Vericel’s Annual Report on Form 10-K for the year
ended December 31, 2018, filed with the SEC on February 26, 2019, Quarterly
Reports on Form 10-Q and other filings with the SEC.
These
forward-looking statements reflect Vericel’s and MediWound’s current views and
neither Vericel nor MediWound undertakes 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.
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