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Overview
Our goal is to make NexoBrid available to every burn patient worldwide. We are gaining significant traction by engaging and working together with leaders in each geographic region thereby extending our global reach. Working together, we are introducing NexoBrid as the new standard of care to improve burn patients’ care and quality of life.
We continue to expand the commercialization of NexoBrid through global partnerships. We are currently active in over 40 countries and seek to step-up this momentum. We believe it is all about people. Great people make great partners. With our partners’ professionalism, local marketing experience and sales knowledge combined with our technology and team, we will significantly improve the standard of care for patients.
Strategic Partnerships
We are proud of our strategic collaboration in the U.S with the Advanced Biomedical, Research and Development Authority (BARDA), supporting the development and authorization of NexoBrid in the U.S, as well as procurement of NexoBrid for the U.S national emergency stockpile.
In addition, in the private sector, we signed a collaboration agreement with Vericel (Nasdaq: VCEL) for North America. Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets to market and sell NexoBrid to the 140 burn centers across the U.S.
Global Outreach
We globally commercialize NexoBrid via multiple sales channels:
Including our European direct sales force, sales representatives and local distributors throughout the E.U. and Asia
The Republic of China (Taiwan)
Distributors
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Biomedical Advanced Research & Development Authority
Awarded up to $211 Million in thermal burns and chemical burns contracts (under ongoing USG Contract Nos. HHSO100201500035C and HHSO100201800023C) for funding and technical support for development of NexoBrid in the U.S., including the expanded access treatment protocol (NEXT), the pivotal Phase 3 pediatric clinical study (CIDS) and the marketing approval registration process for NexoBrid in the U.S.Initial procurement valued $16.5 Million has begun and BARDA has $50 million option for additional procurement.
Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States and readiness for emergencies.
The Biomedical Advanced Research and Development Authority (BARDA) under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks; pandemic influenza (PI), and emerging infectious diseases (EID).
An exclusive license and supply agreements with Vericel Corporation, in which MediWound will manufacture and supply NexoBrid to Vericel, and the latter will commercialize NexoBrid in North America. Vericel made an upfront payment to us of $17.5 million, additional $7.5 million payment contingent FDA’s approval of our BLA for NexoBrid and up to $125 million in sales milestones. Vericel will also pay MediWound tiered royalties on net sales of NexoBrid and transfer price at cost plus fixed margin.
Vericel (Nasdaq: VCEL) is a leader in advanced therapies for the sports medicine and severe burn care markets. Vericel markets two cell therapy products in the United States: MACI® (autologous cultured chondrocytes on porcine collagen membrane) – an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults and Epicel® (cultured epidermal autografts) – a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel also holds an exclusive license for North American rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns.