YAVNE, Israel, Jan. 21, 2016 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD ), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announces the signing of an agreement granting Avalon Pharmaceutical S.A (Avalon) exclusive rights to market and distribute NexoBrid ® in Colombia, Peru, Chile, Ecuador and Panama for the treatment of severe burns.
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 and is planned to be launched in Argentina in the coming months.
Sales of NexoBrid in the new Latin American territories will commence after receipt of local regulatory approvals, which will be filed with the local regulatory authorities in each country by Avalon and is expected to be granted within a year or possibly longer.
This agreement follows similar distribution agreements for NexoBrid in Argentina, Russia, South Korea and Mexico and is in line with MediWound’s strategy to expand the reach of NexoBrid to patients in Latin America, Asia Pacific and CIS regions.
“We are pleased to announce our third distribution agreement in Latin America and look forward to working with Avalon to expand access to NexoBrid for burn victims across many additional countries in the region. With the upcoming launch of NexoBrid in Argentina and the submission of the registration file in Mexico, NexoBrid is expected to have a wide presence in Central and South America,” 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 further expand our collaborations. We have distribution partners in most of South America and will now focus our efforts towards Brazil as well as on the major Asia Pacific countries with the goal of making NexoBrid more broadly accessible to burn victims worldwide, while growing NexoBrid sales and creating 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 and Israel. 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 Avalon Pharmaceutical S.A
Avalon markets and distributes pharmaceutical products throughout Central and South America. Avalon offers an extensive portfolio based on strategic in-licensing, contract manufacturing and distribution agreements focused in rare disease, niche therapeutic hospital products for the treatment of oncology, infectious diseases, orthopaedics, cardiology and specialty pharmaceuticals.
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 as well as the Israeli and Argentinian Ministries of Health, 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 and Israel, with plans for a launch in 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 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 US 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 the regulatory authorizations and launch dates. 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 our annual report on Form 20-F for the year ended December 31, 2014 and information contained in other documents filed with or furnished to the 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: Sharon Malka Chief Financial & Operations Officer MediWound ir@mediwound.co.il Anne Marie Fields Senior Vice President LHA 212-838-3777 afields@lhai.com
