YAVNE, Israel, May 30, 2014 (GLOBE NEWSWIRE) -- 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 BexPharm Korea Co. Ltd. exclusive rights to market and distribute NexoBrid® in South Korea for the treatment of severe burns upon receipt of regulatory approval. An estimated 10,000 patients with severe burns are hospitalized every year in South Korea and primarily are treated at approximately 10 burn centers.
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 in December 2013. Sales of NexoBrid in South Korea will commence after receipt of local regulatory approval, which will be filed with the South Korean authorities by BexPharm and is expected to be granted within a year or possibly longer. According to the distribution agreement, in addition to revenues from the sales of NexoBrid, MediWound is entitled to receive a consideration for the exclusive distribution right in the amounts set forth in the agreement, upon the consummation of certain milestones.
In addition to this agreement in South Korea, MediWound has recently executed exclusive distribution agreements for NexoBrid to treat severe burns in Russia with Genfa Medica S.A. and in Argentina with Tuteur S.A.C.I.F.I.A.
"We are pleased to announce our first distribution agreement in the Asia-Pacific region and look forward to working with BexPharm Korea to bring NexoBrid to patients across South Korea. BexPharm Korea is known within the Korean burn community for excellent marketing and customer responsiveness. We believe this association will benefit MediWound as BexPharm Korea's sales teams will focus on NexoBrid and provide close support to the specialists entrusted with the care of South Korea's burn patients," stated Gal Cohen, President and Chief Executive Officer of MediWound.
"We have now established a marketing and distribution presence for NexoBrid in accordance with our global commercial strategy in four main geographic regions, including the European Union, Latin America, Russia and Asia-Pacific. Each distributor we have engaged to date has been carefully selected for its local-market expertise in promoting innovative products to medical specialists. We intend to build upon this foundation with the addition of distributors within other countries in Latin America, CIS and Asia-Pacific regions with the goal of driving NexoBrid sales growth 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 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 BexPharm Korea Co. Ltd.
BexPharm Korea Co. Ltd. engages in the import, distribution and wholesale sales of pharmaceutical and healthcare products in South Korea. It also engages in the manufacture, import and distribution of medical devices. The company was founded in 2001 and is based in Seoul.
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 or the EMA regulatory 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.
Contacts:
Sharon Malka
CFO
MediWound
ir@mediwound.co.il
Anne Marie Fields
Senior Vice President
LHA
212-838-3777
afields@lhai.com