MediWound Announces Commercial Launch of NexoBrid® in Japan

YAVNE, Israel, Aug. 01, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that its strategic partner, Kaken Pharmaceutical Co. Ltd, launched NexoBrid^® in Japan for the treatment of deep partial thickness and full thickness burns in adults and pediatric patients. Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive marketing and distribution rights for NexoBrid in Japan.

NexoBrid is indicated for the removal of eschar in deep partial and full thickness thermal burns. The current standard of care is primarily based on non-selective, expensive, and potentially disfiguring surgical excisions. NexoBrid offers burn specialists with an alternative of a single 4-hour topical treatment, after which the dissolved eschar is removed, leaving a clean wound bed ready for healing.

“As one of the top healthcare markets worldwide, Japan holds special strategic importance. Over 6,000 patients are treated for severe burns in Japan every year, with a majority of these patients undergoing eschar removal as a critical first step. NexoBrid can now be a non-surgical treatment option for these patients,” stated Ofer Gonen, Chief Executive Officer of MediWound. “We are proud to have Kaken Pharmaceutical, a trusted and valuable partner, leading the commercialization of NexoBrid in this key market. Kaken Pharmaceutical is a major drug manufacturer in Japan with a unique core marketing competency for both drugs and medical devices, which is critical in promoting a product like NexoBrid.”

Hiroyuki Horiuchi, President and Representative Director of Kaken Pharmaceutical stated, “We are excited to introduce this drug to the Japanese market. The prospects are excellent for it becoming the new standard-of-care for serious and life-threatening burns, bringing significant benefits to providers and patients alike. Given our long-term relationship with MediWound, we have been anticipating this moment. Our experience selling products in the burn treatment area along with our existing relationships in the hospital systems prepares us to transform NexoBrid into the standard of care for severe burns.”

About NexoBrid

NexoBrid^® (concentrate of proteolytic enzymes enriched in bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in over 40 countries, including in the United States and in the European Union where it has been designated as an orphan biologic drug. Development of NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA). The pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30% of total body surface area met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and less blood loss during eschar removal.

About Kaken Pharmaceutical Co., Ltd.

Kaken Pharmaceutical Co., Ltd. (TSE: 4521) is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals in the fields of orthopedics and dermatology. Kaken Pharmaceutical concentrates its R&D resources in the areas of immune system, nervous system and infectious diseases. 

About MediWound Ltd.

MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.

MediWound’s first drug, NexoBrid^®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx^®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.

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Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Specifically, this press release contains forward-looking statements concerning commercial potential of our products and product candidates including NexoBrid^®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain,; the approval of regulatory submission to the FDA, the European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in Japan, the U.S. or other markets;; our ability to maintain adequate protection of our intellectual property; competition risks; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

These and other significant factors are discussed in greater detail in MediWound’s prospectus supplement, the annual report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2023, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.