MediWound Announces Successful GMP Manufacturing Audit By The Israeli Ministry Of Health
YAVNE, Israel, May 03, 2017 (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 successful completion of a Good Manufacturing Practice (GMP) audit of the Company's facility in Yavne, Israel by the Israeli Ministry of Health (IMOH). The audit was performed as part of the IMOH’s routine evaluation of the Company's manufacturing facility for its proteolytic enzyme therapeutics.
The audit concludes that MediWound's manufacturing facility conforms to the requirements of cGMP for the manufacture of sterile and biological medicinal products. This compliance status is valid for an additional three years from the time of the audit.
As the IMOH is also a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, this audit is also issued under the provisions of the Conformity Assessment and Acceptance of Industrial Products Agreement between the European Union and Israel.
“As a fully integrated company, manufacturing is a core competency of MediWound and is critical for our R&D and commercial success. We take great pride in maintaining the highest quality standards and are particularly pleased that the IMOH is granting us a compliance certificate for sterile manufacturing for three years rather than the customary two years for the second consecutive time. This underscores the viability, quality and high standards MediWound upholds in the manufacture of our proteolytic enzyme therapeutics for commercial and clinical use in compliance with rigorous international standards,” said Gal Cohen, President and Chief Executive Officer of MediWound.
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.
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® 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.
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, 2016 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: Sharon Malka Chief Financial and Operations Officer MediWound ir@mediwound.co.il Anne Marie Fields Senior Vice President LHA 212-838-3777 afields@lhai.com