YAVNE, Israel, Feb. 29, 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 Learning Organized LLC exclusive rights to market and distribute NexoBrid® in India, Bangladesh and Sri Lanka for the treatment of severe burns.
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, is commercially available in Europe and Israel and will be launched in Argentina in the coming months.
“We are particularly pleased to announce this distribution agreement with Learning Organized, as reports indicate that India has more than 400,000 hospitalized burn patients each year and this figure is expected to continue to increase by 7% annually. The number of burn patients is challenging to manage with existing surge capacity and underscores the benefits NexoBrid can provide to patients by rapid, non-surgical removal of eschar, which is critical for avoidance of eschar-related complications,” stated Gal Cohen, President and Chief Executive Officer of MediWound.
Rajeev B. Ahuja, MS, MCh, DNB,FACS, FICS,FAMS, Department of Burns and Plastic Surgery, Maulana Azad Medical College in New Delhi, and President of the International Society of Burn Injuries (ISBI), commented, “We are delighted that NexoBrid will be available to burn patients in India. As an investigator in several NexoBrid clinical studies, including the recent global Phase 3 study, I have first-hand experience with its effectiveness in removing eschar while preserving the surrounding healthy tissue. This innovative product facilitates the timely, direct visualization and assessment of the wound bed and reduces the surgical burden on patients, which is so important given the large number of hospitalized burn cases in India.”
“For my term as President of the ISBI, our mission is 'Guiding burn care in low and middle income countries.’ One key requirement in pursuit of this goal is to develop guidelines for burn care in low resource settings, utilizing evidence-based recommendations on cost-effective interventions. I believe NexoBrid can be an important component in helping us to achieve our goal,” added Dr. Ahuja.
“In earlier global clinical trials of NexoBrid we treated nearly 70 severe burn patients in India. As a consequence, a number of leading burn specialists already have experience with NexoBrid and will be pleased to be able to remove eschar again in a minimally invasive manner,” concluded Mr. Cohen.
Sales of NexoBrid in India, Bangladesh and Sri Lanka will commence after receipt of local regulatory approvals, which will be filed with each local regulatory authority by Learning Organized and are expected to be granted within a year, or possibly longer.
This agreement follows similar distribution agreements for NexoBrid in Latin America, Asia Pacific 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, and was commercially launched in Europe and 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 necessitating further surgical treatments.
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|