YAVNE, Israel, Oct. 20, 2015 (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 receipt of authorization from the Ministry of Health in Argentina to market and distribute NexoBrid® for the removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. Tuteur S.A., MediWound's exclusive distribution partner in Argentina, intends to launch NexoBrid in Argentina in the next quarter.
This regulatory approval builds upon NexoBrid marketing authorization from the European Medicines Agency (EMA) for the same indication and validates MediWound strategy to use the EMA approved registration file for seeking approval in emerging markets.
"We are delighted NexoBrid will soon be available to treat patients in Argentina, who are afflicted with severe burns and who are mainly treated at a few specialized burn centers. This approval is in line with our strategy to expand the reach of NexoBrid to emerging markets with a focus in Latin America, Asia Pacific and CIS. We look forward to additional marketing approvals in these regions in the coming quarters while we seek to further expand our distribution channels to other markets through our on-going business development efforts. Tuteur has more than 40 years of experience in marketing pharmaceutical products in Argentina and has intimate knowledge of this market. We will work closely with Tuteur to further advance burn care in Argentina by assimilating NexoBrid as an effective and minimally invasive treatment modality," stated Gal Cohen, President and Chief Executive Officer of MediWound.
"Clinical studies have shown with statistical significance that NexoBrid successfully debrides burn wounds much earlier than the current standard of care, and significantly reduces the number and extent of surgical excision and autografting. Importantly, the real-world clinical experiences of burn specialists across Europe using NexoBrid confirm these positive results, as underscored by the more than two dozen papers presented at the recent European Burns Association annual meeting that corroborate NexoBrid's ability to promptly and effectively remove eschar. In addition, NexoBrid may play a major role in mass casualty events where surgical capacity might be limited and rapid assessment of severity is imperative, as was evidenced by our recent multimillion-dollar contract with the U.S. Biomedical Advanced Research and Development Authority," added Mr. Cohen.
"We are very pleased to be working with MediWound to bring this innovative product to burn centers across Argentina. NexoBrid represents a new paradigm in burn care with a proven ability to debride severe burns and reduce the surgical burden on patients," stated Jonathan Hahn, President of Tuteur S.A.
NexoBrid is an easy-to-use, topical pharmaceutical product that removes dead or damaged tissue, known as eschar, in four hours without harming the surrounding healthy tissues. NexoBrid was granted marketing authorization from the European Medicines Agency and Israeli Ministry of Health for the removal of eschar in adults with deep partial and full-thickness thermal burns, and was commercially launched in Europe and in 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.
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 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 financial results forecast, commercial results, clinical trials and the regulatory authorizations. 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 including, but not limited to, receiving reimbursement for the product or additional competition in the market. 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:||Anne Marie Fields|
|Sharon Malka||Senior Vice President|
|Chief Financial & Operations Officer||LHA|