Mediwound Due Diligence Report: Game Changing Contract Pushes Price Ahead
NEW YORK, NY / ACCESSWIRE / October 1, 2015 / Mediwound Ltd. (NASDAQ: MDWD) a fully integrated biopharmaceutical company specializing in innovative therapies to address unmet needs in severe burn and wound management, announces that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a contract valued at up to $112 million. The contract is for the advancement of the development and manufacturing, as well as the procurement of NexoBrid(R), the Company’s proprietary pharmaceutical product for enzymatic removal of eschar in adults with deep-partial and full-thickness thermal burns, as a medical countermeasure as part of BARDA preparedness for mass casualty events. The five-year base contract includes $24 million of funding to support development activities to complete the U.S. Food and Drug Administration (FDA) approval process for NexoBrid for use in thermal burn injuries, as well as $16 million for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization (EUA) and/or FDA marketing authorization for NexoBrid. In addition, the contract includes options for further funding of up to $22 million for expanding NexoBrid’s indications and of up to $50 million for additional procurement of NexoBrid.
NexoBrid represents a new paradigm in burn care management having demonstrated in clinical studies, with statistical significance, its ability to non-surgically and rapidly remove in a single, four-hour application the dead or the damaged tissue (eschar) earlier than other modalities, without harming viable tissue. In clinical studies NexoBrid has demonstrated a significant reduction in surgical burden with long-term outcomes that are comparable to the current surgical treatment. NexoBrid was granted marketing authorization from the European Medicines Agency and the Israeli Ministry of Health for the removal of eschar in adults with deep partial and full-thickness thermal burns, and has been launched in Europe and Israel. Mediwound is currently conducting a Phase 3 clinical study with NexoBrid in the U.S. for the removal of eschar in adults with deep-partial and full-thickness thermal burns.
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About MediWound Ltd.
MediWound Ltd., an integrated biopharmaceutical company, focuses on developing, manufacturing, and commercializing products for the treatment of severe burns, chronic and other hard-to-heal wounds, connective tissue disorders, and others. It develops NexoBrid that is in Phase III clinical trials for the removal of eschar, a dead or damaged tissue in adults with deep partial- and full-thickness thermal burns. The companys product also includes EscharEx, which is in Phase II clinical trials for the debridement of chronic and other hard-to-heal wounds. MediWound Ltd. was incorporated in 2000 and is headquartered in Yavne, Israel.
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