MediWound Enters into Exclusive License Agreement with Vericel for Commercial Rights to NexoBrid in North America.
ENPNewswire-May 8, 2019--MediWound Enters into Exclusive License Agreement with Vericel for Commercial Rights to NexoBrid in North America
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Release date- 07052019 - YAVNE - MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that it has entered into exclusive license and supply agreements with Vericel Corporation (Nasdaq: VCEL) to commercialize NexoBrid in North America (NA).
NexoBrid is a topically-administered biologic product that removes eschar in patients with deep partial and full-thickness thermal burns, which is approved in the European Union and other international markets. The pivotal U.S. phase 3 DETECT clinical study met its primary and all secondary endpoints, and the submission of the Biological License Application (BLA) to the U.S. Food and Drug Administration (FDA) is planned for the fourth quarter of 2019.
Pursuant to the agreements, MediWound will be responsible for the development activities of NexoBrid to obtain U.S. marketing approval from the FDA, supported and funded by BARDA, as well as the manufacture and supply of NexoBrid. MediWoundretains the commercial rights to NexoBrid in all non-North American territories. Under the terms of the license agreement, Vericel will make an upfront payment to MediWound of $17.5 million, with an additional $7.5 million payment contingent upon U.S. BLA approval and up to $125 million in payments contingent upon meeting certain annual sales milestones. Vericel will also pay MediWound tiered royalties on net sales ranging from high single-digit to low double-digit percentages, a split of gross profits on committed BARDA procurement orders and a double-digit royalty on any additional future BARDA purchases of NexoBrid. Under the terms of the supply agreement, Vericel will procure NexoBrid from MediWound at a transfer price of cost plus a fixed margin percentage.
'We are very pleased with this collaboration with Vericel, a company with significant expertise and commercial infrastructure in place in the burn care community. This deal is strategic for both parties and we believe Vericel is the ideal commercial partner to drive market penetration to maximize the medical and commercial potential of NexoBrid in North America,' stated Stephen T. Wills, MediWound's Chairman.
Mr. Wills continued, 'As our...
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