FDA approves MediWound burns treatment

Ofer Gonen  credit: Eran Lavie
Ofer Gonen credit: Eran Lavie

Pineapple plant-based NexoBrid is one of the first botanical drugs to receive approval in the US. It is already approved in 43 other countries.

Yavne-based MediWound (Nasdaq: MDWD) announced on Thursday that it had received approval from the US Food and Drug Administration (FDA) for the use of its burn treatment NexoBrid. For the time being, the product is approved for sale in the US for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

NexoBrid is already approved for use in 43 countries, including the European Union, Japan, and India. Vericel Corporation (Nasdaq: VCEL) holds an exclusive license to commercialize NexoBrid in North America. MediWound will receive a $7.5 million milestone payment from Vericel Corporation, triggered by the FDA approval of NexoBrid. At the end of September 2022, MediWound had $35 million cash, and it raised $30 million in October. The US market for NexoBrid as a burn treatment is estimated at $200 million.

MediWound’s share price closed 4% up on Thursday, on a high volume of trading, at $13.38. On Friday, the share price closed at $13.49, giving the company a market cap of $78.5 million.

MediWound’s treatment removes dead tissue from burns. It could also be used for the treatment of chronic wounds, but the current approval is for burns only. It mainly competes with surgery to remove dead tissue, which requires more expensive manpower and means the removal of more healthy tissue.

The product is based on the pineapple plant, and is one of the first to receive approval from the FDA as a botanical drug.

"We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuries," said MediWound CEO Ofer Gonen. "We appreciate and thank the burn patients who participated in our trials, the clinical investigators, and our researchers for their commitment and efforts to attain this significant achievement. We also thank our partner, BARDA, for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the US.

"This US FDA approval of NexoBrid validates our enzymatic technology platform. MediWound will continue to pursue its strategic plans to advance the development of novel therapies for burn care, wound care, and tissue repair; we look forward to an exciting and productive 2023."

Published by Globes, Israel business news - en.globes.co.il - on January 1, 2023.

© Copyright of Globes Publisher Itonut (1983) Ltd., 2023.

Ofer Gonen  credit: Eran Lavie
Ofer Gonen credit: Eran Lavie
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