Nasdaq-listed biopharmaceutical company MediWound Ltd. announced Wednesday it received the approval of the U.S. Food and Drug Administration (FDA) to expand the use of flagship drug NexoBrid for the treatment of Sulfur Mustard injuries.
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Founded in 2001 in central Israel, MediWound develops, manufactures, and commercializes treatments for severe burns and chronic wounds. The company’s flagship product, NexoBrid, is a pineapple enzyme-based treatment used for the removal of dead tissue from burn wounds. MediWound employs 46 people in Israel and 21 in Europe. The company raised around $170 million in total funding to date, $100 million of that sum in a public offering.
In March, MediWound announced it had been approached for a potential acquisition by an unnamed company, adding it has retained the services of Moelis & Company LLC, a global investment bank specializing in mergers and acquisitions.
NexoBrid is a topical pharmaceutical product that removes dead or damaged tissue within hours without harming surrounding healthy tissues. The treatment was granted marketing authorization from the European Medicines Agency and Israeli Ministry of Health, and was commercially launched in Europe and in Israel.
Based on the FDA outline, MediWound would be able to market its drug for the additional treatment course following successful animal efficacy testing based on a single animal species, and would not be required to perform additional clinical trials in humans. The FDA also agreed to accept MediWound’s previously submitted chemistry, manufacturing and control (CMC) information for NexoBrid for the approve the new treatment course.
Gal Cohen, president and CEO of MediWound, said in a statement that the FDA approval leverages the company’s existing enzymatic technology, taking advantage of the advanced stage of development of NexoBrid. “Ten decades of research has not produced an effective treatment for Sulfur Mustard skin injury, except for radical surgical removal of the contaminated skin,” Mr. Cohen said. “An effective non-surgical debridement agent could play a major role in a mass casualty incident involving victims exposed to Sulfur Mustard.”