MediWound Expands Distribution Of Nexobrid To Mexico Through Agreement With COVALEO SA

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.

“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”

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.