NexoBrid® Receives Marketing Authorization from Peru’s Ministry of Health
YAVNE, Israel, June 04, 2019 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced receipt of authorization from the Ministry of Health in Peru to market and distribute NexoBrid for the removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. Avalon Pharmaceutical Peru S.A.C, MediWound’s exclusive distribution partner in Peru, received the marketing authorization and intends to launch NexoBrid in Peru in the first half of 2020.
This regulatory approval builds upon the European Medicines Agency (EMA) marketing authorization for the same indication and again validates MediWound’s strategy of using the EMA approved registration file for seeking approval in different international markets around the globe.
“We are delighted to receive marketing approval in Peru and that NexoBrid now will be available to treat patients who are suffering from severe burns in that region. This approval in Peru, which joins the marketing authorizations from the European Medicines Agency (EMA), the Israeli, Argentinian, South Korean and Russian Ministries of Health, builds on our global commercial strategy of expanding the use of NexoBrid in international markets and obtaining additional marketing approvals, through collaboration with companies that possess the expertise in the local regulatory, marketing, and market access and assume the financial commitment and diligence,” stated Sharon Malka, Chief Executive Officer of MediWound. “We are very pleased to be able to advance burn care in Peru with NexoBrid, an effective and minimally invasive treatment modality. Avalon Pharmaceuticals, our exclusive distributer in Peru, Colombia, Chile, Ecuador and Panama, is an excellent partner in this Latin America, and we look forward to continuing to expand on our global reach in this region.”
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® demonstrated in clinical trials, with statistical significance the ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean and Russian Ministries of Health. MediWound’s second innovative product, EscharEx® is a topical biological drug for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has 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.
About Avalon Pharmaceutical Avalon Pharmaceutical markets and distributes pharmaceutical products throughout Central and South America. Avalon Pharmaceutical offers an extensive portfolio based on strategic in-licensing, contract manufacturing and distribution agreements focused in rare disease, niche therapeutic hospital products for the treatment of oncology, infectious diseases, orthopaedics, cardiology and specialty pharmaceuticals.
Cautionary Note Regarding Forward-Looking StatementsThis 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 timeline of NexoBrid launch in Peru or the ability to obtain additional marketing authorization in additional territories. 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 that our distributor, may not be able to meet the timeline for the launch of NexoBrid in Peru and may not be able to successfully commercialize NexoBrid in the Peru; we may not be able to obtain additional marketing approval in additional territories ; and the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2018 as well as 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: Jeremy Feffer Sharon Malka Managing Director Chief Executive Officer LifeSci Advisors MediWound Ltd. 212-915-2568 firstname.lastname@example.org email@example.com