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Overview
At MediWound, our mission is to make NexoBrid accessible to burn patients worldwide. Through strategic partnerships and a growing global presence, we are expanding our reach and working to establish NexoBrid as the new standard of care in burn treatment, improving patients’ well-being and quality of life.
With a presence in over 40 countries, our commercialization efforts are powered by strong global collaborations. Success, we believe, begins with people. By combining MediWound’s innovative technology and dedicated team with our partners’ local market expertise and sales capabilities, we are well-positioned to elevate burn care standards on a global scale.
In addition, we are proud to announce a strategic collaboration with Mölnlycke Health Care, a global leader in wound care solutions. This partnership strengthens our plans for EscharEx and paves the way for substantial long-term value creation for our stakeholders while enhancing the quality of care for patients worldwide.
Strategic Partnerships
We are proud of our strategic collaboration in the U.S. with the Biomedical Advanced Research and Development Authority (BARDA), which has been instrumental in supporting the development and authorization of NexoBrid in the United States. This collaboration also includes the procurement of NexoBrid for the U.S. National Emergency Stockpile, ensuring readiness for burn care in emergency situations.
In addition, we are honored to partner with the U.S. Department of Defense (DoD) to advance NexoBrid as a non-surgical solution for treating burns under field conditions. Through the Medical Technology Enterprise Consortium (MTEC), the DoD has provided continued funding to further develop NexoBrid, addressing the unique needs of the U.S. Army for burn treatment in challenging environments.
We are proud to collaborate with Vericel Corporation (Nasdaq: VCEL), a leader in advanced therapies for sports medicine and severe burn care. Through this partnership, Vericel markets and distributes NexoBrid across North America, including to over 140 burn centers in the United States. This collaboration ensures that patients have access to innovative, cutting-edge treatment for severe burns.
In addition, we have entered into a strategic collaboration with Mölnlycke Health Care, a globally recognized MedTech leader specializing in wound care and surgical solutions. This partnership is designed to advance our strategic plans for EscharEx, strengthening our position in the wound care market.
These alliances reflect our ongoing commitment to leveraging strategic partnerships to expand our reach, enhance our product offerings, and deliver transformative solutions to healthcare providers and patients worldwide.
Global Outreach
We employ a robust global strategy to commercialize NexoBrid, utilizing multiple sales channels to ensure broad availability and accessibility for burn patients. Our approach includes a dedicated European sales force, local sales representatives, and strategic partnerships with distributors across Europe and Asia. This integrated strategy enables us to deliver NexoBrid efficiently and effectively to patients worldwide.
The Republic of China (Taiwan)
Biomedical Advanced Research & Development Authority
Awarded up to $100 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, an additional $7.5 million payment was received following the FDA 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.
U.S. Department of Defense
The U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), has awarded MediWound continued funding for the development of NexoBrid® as a non-surgical solution for field-care burn treatment for the U.S. Army (the “MTEC Research Project Award”).
The MTEC Research Project Award was granted by the DoD’s U.S. Army Medical Research and Development Command (USAMRDC) and funded by the Defense Health Agency through MTEC, a biomedical technology consortium working to advance innovative medical solutions to keep military personnel healthy and fully operational. In alignment with this mission, it’s vital to have field solutions for severe burn treatments that are both easy-to-use and effective. Such solutions should be applicable immediately post-injury and demand minimal preparation and training.
This partnership is designed to strengthen our strategic plans for EscharEx. Under the terms of the agreement, Mölnlycke is granted specific rights, including the appointment of a representative to attend meetings of our R&D Committee. Mölnlycke will also have the opportunity to participate in potential strategic partnership discussions and M&A processes under certain circumstances. Additionally, the agreement includes a stand-still clause that limits Mölnlycke’s ownership to no more than 9.99% of the Company’s issued and outstanding Ordinary Shares.
Mölnlycke Health Care is a world-leading MedTech company that specializes in innovative solutions for wound care and surgical procedures. Mölnlycke products and solutions are used daily by hospitals, health care providers and patients in over 100 countries around the world. Founded in 1849, Mölnlycke is owned by Investor AB and headquartered in Sweden.