MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical
company specializing in innovative therapies to address unmet needs
in severe burn and wound management, announces that it received
from the U.S. Biomedical Advanced Research and Development
Authority (BARDA) a written Notice of Intent to exercise an option
to fund further research and development (R&D) activities for
expanding NexoBrid’s indications.
The BARDA contract advances the development and
manufacturing, as well as the procurement of NexoBrid, MediWound’s
proprietary pharmaceutical product for enzymatic removal of eschar
in deep-partial and full-thickness thermal burns, as a medical
countermeasure for preparedness for mass casualty events.
The five-year base contract signed in September
2015 includes $24 million to support U.S. Food and Drug
Administration (FDA) approval of NexoBrid for use in thermal burn
injuries as well as $16 million for procurement of NexoBrid, which
is contingent upon FDA Emergency Use Authorization (EUA) and/or FDA
marketing authorization for NexoBrid. In addition, the contract
includes options for up to $22 million for expanding NexoBrid’s
indications for which the Company received the Notice of Intent and
an option of up to $50 million for additional procurement. The
total non-dilutive funding to MediWound under the BARDA contract is
up to $112 million.
"BARDA has been a supportive development partner
of NexoBrid in the U.S. for the past 20 months. Their expressed
intent to fund further development efforts to expand NexoBrid's
indications underscores their commitment to NexoBrid, as well as
its potential in the treatment of severe burns and in building
preparedness for mass casualty events,” stated Gal Cohen, President
and Chief Executive Officer of MediWound. “We look forward to
continuing to work in collaboration with BARDA in order to bring
NexoBrid to market to benefit severe burn victims.”
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.
About Emergency Use Authorization
(EUA)
The Emergency Use Authorization (EUA) allows the
FDA to help strengthen public health protections in the United
States against chemical, biological, radiological, and nuclear
(CBRN) threats by facilitating the availability and use of medical
countermeasures needed during public health emergencies. Under the
Federal Food, Drug, and Cosmetic Act, the FDA Commissioner may
allow unapproved medical products or unapproved uses of approved
medical products to be used in an emergency to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused
by CBRN threat agents when there are no adequate, approved, and
available alternatives.
About NexoBrid
NexoBrid is an easy-to-use, topically-applied
product that removes dead or damaged tissue, known as eschar, in
approximately four hours without harming the surrounding healthy
tissues. NexoBrid received marketing authorization from the
European Medicines Agency for the removal of eschar in adults with
deep partial and full-thickness thermal burns, and is commercially
available in Europe, Israel, and Argentina. Representing a new
paradigm in burn care management, NexoBrid demonstrated in clinical
studies, with statistical significance, its ability to
non-surgically and rapidly remove the eschar earlier than other
modalities, without harming viable tissues. The removal of eschar
or “debridement” is a critical first step in the successful healing
of severe burns as well as chronic and other hard-to-heal wounds.
With the current standard of care, burn eschar is removed either
with existing topical agents that have been found to be minimally
effective or that take a significantly longer period of time to
work, or by resorting to non-selective surgery, which is traumatic
and may result in loss of blood and viable tissue necessitating
further surgical treatments. The U.S. phase 3 clinical trial and
registration process for NexoBrid is being funded in whole or in
part with federal funds under a contract with the Office of the
Assistant Secretary for Preparedness and Response, Biomedical
Advanced Research and Development Authority.
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, connective
tissue disorders and other indications. MediWound’s first
innovative biopharmaceutical product, NexoBrid®, received marketing
authorization from the European Medicines Agency as well as the
Israeli and Argentinian Ministries of Health, for the removal of
dead or damaged tissue, known as eschar, in adults with deep
partial- and full-thickness thermal burns and was launched in
Europe, Israel, and Argentina. NexoBrid® represents a new
paradigm in burn care management, and clinical trials have
demonstrated, with statistical significance, its ability to
non-surgically and rapidly remove the eschar earlier, relative to
the existing standard of care, without harming viable tissues.
MediWound's second innovative product candidate,
EscharEx®, is a topical biological drug being developed for
debridement of chronic and other hard-to-heal wounds and is
complementary to the large number of existing wound healing
products, which require a clean wound bed in order to heal the
wound. EscharEx® contains the same proteolytic enzyme technology as
NexoBrid®, and benefits from existing development data on
NexoBrid®. In January 2017, MediWound reported final results from
its second phase 2 study evaluating EscharEx for the debridement of
chronic and other hard-to-heal wounds. In this phase 2
clinical trial, EscharEx met its primary endpoint demonstrating
higher incidence of complete debridement with statistical
significance. For more information, please visit
www.mediwound.com.
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 U.S. Securities Exchange Act
of 1934, as amended, and the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. Forward-looking
statements are statements that are not historical facts, such as
statements regarding MediWound’s expectations regarding BARDA’s
intent to exercise its option and its continued funding for
research and development and procurement; the adequacy of BARDA
funding to support NexoBrid® development efforts; the potential
exercise of BARDA’s option to further increase funding for
development and/or BARDA’s option for additional procurement, the
potential role NexoBrid® may play in mass casualty events; the
potential of NexoBrid® to be a new paradigm in burn care
management, MediWound’s ability to leverage existing data for the
development of EscharEx®, and MediWound’s expectations for the
clinical development of both NexoBrid® and EscharEx®, including its
expectations for regulatory approval. 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 based on 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 factors. In particular, you should consider the risks
discussed under the heading "Risk Factors" in MediWound’s annual
report on Form 20-F for the year ended December 31, 2016 and
information contained in other documents filed with the U.S.
Securities and Exchange Commission. You should not rely upon
forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that
future results, levels of activity, performance and events and
circumstances reflected in the forward-looking statements will be
achieved or will occur. The forward-looking statements made herein
speak only as of the date of this announcement and MediWound
undertakes no obligation to update publicly such forward-looking
statements to reflect subsequent events or circumstances, except as
otherwise required by law.
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Contacts: |
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Anne Marie Fields |
Sharon Malka |
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Senior Vice
President |
Chief Financial and
Operations Officer |
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LHA Investor
Relations |
MediWound |
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212-838-3777 |
ir@mediwound.co.il |
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afields@lhai.com |
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