YAVNE, Israel--(BUSINESS WIRE)--
MediWound Ltd. (Nasdaq: MDWD), a fully-integrated
biopharmaceutical company bringing innovative therapies to address unmet
needs in severe burn and wound management, announced today the signing
of an agreement granting COVALEO SA de CV exclusive rights to market and
distribute NexoBrid® in Mexico for the treatment of severe
burns. Severe burns are primarily treated at approximately 20 hospitals
and burn centers in Mexico.
NexoBrid is an easy-to-use, topically-applied pharmaceutical product
that removes dead or damaged tissue, known as eschar, in approximately
four hours without harming the surrounding healthy tissue. This
innovative treatment for severe burns has received marketing
authorization from the European Medicines Agency for the removal of
eschar in adults with deep partial and full-thickness thermal burns, and
was commercially launched in Europe and Israel. Sales of NexoBrid in
Mexico will commence after receipt of local regulatory approval, which
will be filed with the Mexican regulatory authorities by COVALEO and is
expected to be granted within a year or possibly longer.
In addition to this agreement in Mexico, MediWound has executed
exclusive distribution agreements for NexoBrid to treat severe burns in
Argentina, Russia and South Korea.
"We are pleased to announce our second distribution agreement in the
Latin America region and look forward to working with COVALEO to bring
NexoBrid to patients across Mexico. COVALEO is known for its experience
and expertise in the wound care field and already distributes several
products in this market. In Mexico more than 50% of the population has
access to public healthcare. We believe that COVALEO's knowledge of the
Mexican market, sales teams and distribution centers will be very
beneficial for successful market entry, especially to the governmental
hospitals, which are the dominant healthcare provider in Mexico in
general and specifically when it comes to the treatment of severe burns
patients," stated Gal Cohen, President and Chief Executive Officer of
MediWound.
"We are executing our global marketing strategy as planned and continue
to seek opportunities to expand our collaborations with the inclusion of
additional distributers within the Latin America, Commonwealth of
Independent States (CIS) and Asia-Pacific regions with the goal of
growing NexoBrid sales and creating additional value for our
stakeholders," he added.
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
was commercially launched in Europe in December 2013. 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 and
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.
About COVALEO SA de CV
COVALEO SA de CV is a Mexican company and part of SAVI Distribuciones SA
de CV, one of largest supplier to the Mexican public health care system.
The mission of COVALEO is to market innovative wound care and surgical
solutions successfully in Mexico. COVELO has exclusive distribution and
representation of some major global medical device and pharmaceutical
manufacturers.
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,
received marketing authorization from the European Medicines Agency for
removal of dead or damaged tissue, known as eschar, in adults with deep
partial and full-thickness thermal burns and was launched in Europe.
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 and, without
harming viable tissues. 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 assumptions and results
related to financial results forecast, commercial results, clinical
trials and regulatory authorizations. 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 including, but not limited to,
unexpected results of clinical trials, delays or denial in the FDA, EMA
or other regulatory authorities' approval process or additional
competition in the market. 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.
MediWound
Sharon Malka
CFO
ir@mediwound.co.il
or
LHA
Anne
Marie Fields, 212-838-3777
Senior Vice President
afields@lhai.com
Source: MediWound Ltd.
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