MediWound Said Partner Vericel Has Received The First Lot Of Nexobrid Finished Product From Mediwound For The U.S. Commercial Market In June 2023
Portfolio Pulse from Charles Gross
MediWound has delivered the first lot of NexoBrid to Vericel for the U.S. market in June 2023. However, due to a deviation with a third-party testing lab, Vericel is unable to release the product commercially. Both companies and the FDA are working to resolve the issue. Future manufacturing of NexoBrid will not be impacted as the test will be conducted by MediWound. Vericel expects to begin commercial sales of NexoBrid in Q1 2024. The FDA's evaluation will not affect the $3 million committed by BARDA for NexoBrid replacement.
August 04, 2023 | 11:05 am
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NEUTRAL IMPACT
MediWound's delivery of NexoBrid to Vericel is delayed due to a third-party testing lab issue. However, future manufacturing will not be impacted and revenues for 2023-2024 are not expected to be affected.
The news directly pertains to MediWound as it is the manufacturer of NexoBrid. The issue with the third-party testing lab is a temporary setback, but it is not expected to impact future manufacturing or revenues for 2023-2024.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100
NEUTRAL IMPACT
Vericel's commercial release of NexoBrid, received from MediWound, is delayed due to a third-party testing lab issue. However, Vericel expects to begin commercial sales in Q1 2024.
The news directly pertains to Vericel as it is the recipient of NexoBrid from MediWound. The issue with the third-party testing lab is a temporary setback, but Vericel expects to begin commercial sales in Q1 2024.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100