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 the U.S.
Biomedical Advanced Research and Development Authority (BARDA) has
upsized its awarded contract with MediWound and exercised an option
to fund further research and development (R&D) activities
relating to NexoBrid®.
Under the modified signed contract, BARDA
increased its committed funds to support NexoBrid R&D
activities by $32 million to approximately $56 million, up from the
original $24 million. BARDA maintains an additional option to
further fund $10 million in development activities for other
potential NexoBrid indications. The contract also maintains BARDA's
$16 million commitment for procurement of NexoBrid, which is
contingent upon the U.S. Food and Drug Administration (FDA)
Emergency Use Authorization (EUA) and/or FDA marketing
authorization for NexoBrid, as well as BARDA's $50 million option
for additional procurement of NexoBrid. As a result of the
exercise of BARDA’s option, total non-dilutive funding to MediWound
under the BARDA contract is now valued at up to $132 million.
The BARDA contract serves to advance 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 upsized BARDA contract will fund the
previously committed development activities to support the
submission of a Biologic License Application to the FDA for
NexoBrid for the use in thermal burn injuries. In addition, BARDA
will now fund the Company’s ongoing pediatric phase 3 study and its
planned expansion to include U.S. pediatric burn care sites, as
well as additional NexoBrid development efforts.
“The current management of pediatric burns
requires intensive medical therapy and typically several traumatic
surgical procedures to remove eschar and prevent secondary
complications. In addition, burn surgery in pediatric patients is
more demanding than in adults for a variety of reasons and can
become a major bottleneck in the management of a mass casualty
event,” stated Prof. Lior Rosenberg, M.D., Chief Medical Technology
Officer of MediWound, former Chief of Plastic Surgery at Soroka
University Medical Center (Beer Sheva, Israel) and former Chairman
of the Disaster Committee of the International Society for Burn
Injuries. “BARDA’s exercise of its option demonstrates its
recognition of NexoBrid’s potential to alleviate the unique
challenges in treating children with severe burns, and we are
pleased to have its continued support of our efforts to expand the
use of NexoBrid to the pediatric population.”
“In our recent meeting with the FDA, the FDA
recognized the unmet need for safe and effective treatments for
pediatric patients and agreed on the importance of including U.S.
pediatric patients in our NexoBrid pediatric phase 3 program. This
non-dilutive funding by BARDA, totaling up to $132 million,
provides significant support for our clinical development and
manufacturing programs. We submitted the pediatric phase 3 protocol
to the FDA with the goal of enrolling U.S. pediatric burn patients
into our ongoing pediatric phase 3 study, which is underway in
Europe,” stated Gal Cohen, President and Chief Executive Officer of
MediWound.
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 study, 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 the
continued BARDA funding for research and development and
procurement; the adequacy of the BARDA funding to support NexoBrid®
development efforts; the potential exercise of BARDA’s additional
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.
Contacts: |
|
|
Anne Marie
Fields |
Sharon Malka |
|
|
Senior Vice
President |
Chief Financial and
Operations Officer |
|
|
LHA
Investor Relations |
MediWound |
|
|
212-838-3777 |
ir@mediwound.co.il |
|
|
afields@lhai.com |
MediWound (NASDAQ:MDWD)
Historical Stock Chart
From Mar 2024 to Apr 2024
MediWound (NASDAQ:MDWD)
Historical Stock Chart
From Apr 2023 to Apr 2024