YAVNE, Israel, Oct. 16, 2017 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company specializing in the development of innovative therapies to address unmet needs in severe burn and wound management, today announced an agreement with Holy Stone Healthcare, Co., Ltd. (4194.TW) for the distribution of NexoBrid® in Taiwan for the treatment of severe burns. Commercialization of NexoBrid in Taiwan will commence after receipt of local regulatory approvals, which will be filed with the local regulatory authorities by Holy Stone Healthcare and is expected to be granted within two years or possibly longer.
"We are pleased to partner with Holy Stone for the distribution of NexoBrid in Taiwan. This agreement is part of our strategy to expand the use of NexoBrid to international markets by collaborating with local companies that take the responsibility for and possess the expertise in local regulatory, market access and marketing efforts. We are gratified that patients in Taiwan will have access to this life-changing therapy as Holy Stone with our support turns NexoBrid into standard of care in Taiwan," said Gal Cohen, President and Chief Executive Officer of MediWound.
"NexoBrid has been shown to significantly improve the outcomes for patients with severe burns, and we welcome the opportunity to introduce this important therapy to clinicians and patients in Taiwan," said Albert Wu, Chief Executive Officer of Holy Stone Healthcare. "Evidenced-based clinical studies and growing experience reported by numerous experts treating patients in routine and mass casualty events demonstrates that NexoBrid will play a major role in the future of burn care. We look forward to collaborating with MediWound to successfully register and launch NexoBrid in Taiwan."
The agreement with Holy Stone Healthcare is similar to other global distribution agreements for NexoBrid that the Company currently has in Latin America, Asia Pacific, India and CIS regions, and is in line with MediWound's strategy to expand the availability of NexoBrid worldwide.
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 is commercially available in Europe, Israel, and Argentina. 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 as well as 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. The U.S. Phase 3 clinical trial, pediatric phase 3 study and registration process for NexoBrid in the U.S. is being funded in whole or in part with federal funds under a contract with the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).
About Holy Stone Healthcare Co., Ltd.
Holy Stone Healthcare Co., Ltd. (4194.TW), established in Taipei in January 2001, is a subsidiary of Holy Stone Enterprise (3026.TW). Since 2009, the company has focused on a biopolymer drug delivery platform. Holy Stone R&D team has successfully developed "Hyaluronan Drug Delivery (HDD)" technology, which utilizes hyaluronic acid as a carrier to deliver drugs to targeted cells in order to improve efficacy and safety profile. This technology has been applied in the development of Holy Stone's new drug and medical device portfolio. For more information, please visit http://www.hshc.com.tw/en/about_us.php.
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, connective tissue disorders and other indications. 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 the removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns and was launched in Europe, Israel, and 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, relative to the existing standard of care, without harming viable tissues.
MediWound's second innovative product candidate, EscharEx®, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds and is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx® contains the same proteolytic enzyme technology as NexoBrid®, and benefits from existing development data on NexoBrid®. In January 2017, MediWound reported final results from the first cohort of its second phase 2 study evaluating EscharEx for the debridement of chronic and other hard-to-heal wounds in which EscharEx met its primary endpoint demonstrating higher incidence of complete debridement with statistical significance. 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, 2016 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.
Chief Financial and Operations Officer