YAVNE, Israel, April 26, 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 Kaken Pharmaceuticals Co., Ltd. (KAKEN) (Tokyo Stock Exchange:4521) exclusive rights to develop and distribute NexoBrid® in Japan for the treatment of severe burns.
Sales of NexoBrid in Japan will commence after KAKEN completes the local research and development requirements and obtains local regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW), which are expected to be granted within two years, or possibly longer.
“We are particularly pleased to partner with KAKEN for the development and distribution of NexoBrid in Japan as they share our commitment to improving quality-of-life by bringing superior pharmaceuticals to address patients' needs. KAKEN has nearly 70 years of experience in the Japanese pharmaceuticals market, strong local presence and a history of partnering with leading pharmaceutical companies. The introduction of NexoBrid in Japan will provide burn specialists with a new minimally invasive treatment for severe burns, that significantly decreases surgical excision and grafting, leading to reduction in the long-term incidence of scarring in severe burn patients,” stated Gal Cohen, President and Chief Executive Officer of MediWound. “We look forward to working closely with KAKEN towards a successful market entry in this important market.”
This agreement with KAKEN follows similar distribution agreements for NexoBrid in Latin America, Asia Pacific, India and CIS regions, and is in line with MediWound’s strategy to expand the reach of NexoBrid to severe burn patients 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, is commercially available in Europe and Israel and will be launched in Argentina in the coming months. 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 Kaken Pharmaceuticals
KAKEN is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals and medical devices in the fields of orthopedics, dermatology and surgery. KAKEN has concentrated its R&D resources in inflammation/immunology (dermatitis, rheumatoid arthritis and osteoarthritis), pain relief and fungal infection areas. For more information, please visit www.kaken.co.jp.
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:||Anne Marie Fields|
|Sharon Malka||Senior Vice President|
|Chief Financial and Operations Officer||LHA|