YAVNE, Israel, June 07, 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 that the Board of the Italian Drug Agency (AIFA) has approved the pricing and reimbursement conditions for NexoBrid® for the removal of eschar in adults with deep partial and full-thickness thermal burns.
Paolo Palombo, M.D., Chief of Plastic Surgery and of Sant’Eugenio Burn Centre, Rome and President of SICPRE (the Italian plastic surgeons society), said, "On behalf of SICPRE, we greatly appreciate AIFA’s decision not only to provide access to NexoBrid in our country, but also to ensure appropriate reimbursement for use of this product. NexoBrid represents a clear step forward in the management of severe burns as it allows burn specialists to rapidly remove the eschar from burn victims immediately upon admission, without surgical trauma. It also preserves precious dermis that can heal spontaneously and significantly reduces the need for skin grafting, with attendant additional trauma to healthy donor sites. In addition, NexoBrid’s rapid eschar removal plays an important role in the direct visual assessment of burn depth, which is a critical factor in determining the subsequent treatment plan.”
"We appreciate AIFA’s decision to reimburse NexoBrid in Italy in line with the price of NexoBrid in Europe. Governmental support such as this is imperative in order to allow the development and access of innovative orphan drugs that aim to significantly improve the condition of patients suffering from life-threatening and debilitating diseases. We are delighted that in Italy, where the vast majority of burn centers are routinely treating patients with NexoBrid, reimbursement will further assist burn specialists in providing improved, minimally invasive care to more patients. With national reimbursement now in place, we can embark on formulary inclusion at the hospital and regional levels in the coming months with the goal of establishing NexoBrid as the standard-of-care. We look forward to the continued adoption of NexoBrid across Europe in order to allow this treatment to improve the lives of more burn victims,” said Gal Cohen, President and Chief Executive Officer of MediWound.
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 tissue. 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 tissue. 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, thereby necessitating further surgical treatments. The ongoing U.S. Phase 3 clinical trial and registration process for NexoBrid 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.
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 tissue.
MediWound's second innovative product, 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 the wealth of existing development data on NexoBrid. In two Phase 2 studies, EscharEx demonstrated safety and efficacy in the debridement of chronic and other hard-to-heal wounds, within a few daily applications. 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|