In This Article:
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The FDA has approved MediWound Ltd's (NASDAQ: MDWD) NexoBrid (anacaulase-bcdb) to remove eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
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NexoBrid, a botanical drug product containing proteolytic enzymes, is already approved in 43 countries.
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Recently, MediWound signed an agreement with Triskel Integrated Services to market and distribute NexoBrid in Switzerland, with a launch planned for Q1 of 2023. Triskel also holds the distribution rights of NexoBrid in France, where NexoBrid is expected to launch in Q3 2023.
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Vericel Corporation (NASDAQ: VCEL) holds an exclusive license to commercialize NexoBrid in North America.
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MediWound will receive a $7.5 million milestone payment from Vericel, triggered by the FDA approval of NexoBrid.
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NexoBrid can be applied in up to two applications of four hours each. The first application of NexoBrid may be applied to an area of up to 15% body surface area. The second application of NexoBrid may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.
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In addition, BARDA has supported the evaluation of NexoBrid in the pediatric population, and the marketing application is expected to be submitted for FDA approval in 2023.
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Price Action: MDWD shares closed higher by 3.96% at $13.38 on Thursday.
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