MediWound Announces Additional Funding of $9 Million from BARDA to Support NexoBrid BLA… | Your money
YAVNE, Israel, 10 Feb. 2022 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, expanded its awarded contract with MediWound by providing an additional $9 million in funding to support the new NexoBrid® BLA submission with the Food and Drug Administration (FDA) and the ongoing Expanded Access Treatment (NEXT) protocol.
“We greatly appreciate that BARDA is providing additional funds to develop NexoBrid and support the potential approval of NexoBrid to improve US readiness,” said Sharon Malka, CEO of MediWound. “We look forward to continuing our long-standing collaboration with BARDA and our US commercial partner Vericel to make NexoBrid available to burn patients in the US, as we continue to advance preparation of the new BLA submission. expected in mid-2022.”
MediWound won its first BARDA contract for the treatment of thermal burns in 2015. This first BARDA contract, valued at $168 million, supported advanced development and manufacturing, as well as the purchase of NexoBrid as a medical countermeasure in part of the preparation of the United States. for mass casualty events. Under this first BARDA contract, BARDA provided technical assistance and a total of up to $91 million for NexoBrid development activities required to seek US FDA marketing approval. These activities include the NexoBrid (DETECT) Phase 3 study and subsequent requirements for the new BLA submission, the ongoing Phase 3 Pediatric Study (CIDS) and the NexoBrid Expanded Access Treatment (NEXT) protocol. In January 2020, BARDA committed an additional $16.5 million to procure NexoBrid as part of HHS’s mission to strengthen national preparedness for public health medical emergencies. The contract further includes a $10 million option to fund the development of other potential NexoBrid indications, and an option to procure an additional NexoBrid worth up to $50 million.
In addition to this first BARDA contract, BARDA also has a separate contract with MediWound to support the development of NexoBrid as a debridement product to treat sulfur mustard wounds (chemical burns).
The cumulative, non-dilutive financing under the two contracts with BARDA is now valued at $211 million. As of December 31, 2021, the company has received approximately $70 million in funding, in total, from BARDA under the two contracts to support development activities and an additional $14.6 million for the purchase of NexoBrid for emergency preparedness in the United States.
The development of NexoBrid was supported in part by federal funding from BARDA, Assistant Secretary for Preparedness and Response (ASPR), within the United States Department of Health and Human Services (HHS), under contract numbers Current USG HHSO100201500035C and HHSO100201800023C.
Contract number HHSO100201500035C provides funding and technical support, including the Expanded Access Treatment Protocol (NEXT), the Pivotal Phase 3 U.S. Clinical Study (DETECT), and the Approval Registration Process commercialization of NexoBrid in the United States. Additional NexoBrid evaluation projects funded under the BARDA contract include a pivotal randomized, controlled clinical trial for use in the pediatric population, establishment of a pre-emergency use data set, and model development health economics to assess the impact of cost savings to enable market adoption in the United States.
About MediWound Ltd. MediWound is a biopharmaceutical company that develops, manufactures and markets innovative and cost-effective biotherapeutic solutions for tissue repair and regeneration. Our strategy is underpinned by our enzyme technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.
NexoBrid®, our commercial orphan biologic for the non-surgical removal of pressure ulcers from partial and deep thermal burns, is a bromelain-based biologic containing a sterile blend of proteolytic enzymes that selectively removes burn ulcers in four hours without harm the viable tissue environment. NexoBrid is currently marketed in the European Union and other international markets and is in the registration phase in the United States NexoBrid is supported by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and the response, US Department of Health and Human Services.
EscharEx®, our next generation bioactive topical therapeutic under development in the United States for the debridement of chronic and difficult to heal wounds. In two Phase 2 studies, EscharEx was well tolerated and demonstrated safety and efficacy in debridement of a variety of chronic, hard-to-heal wounds with just a few daily applications.
MW005, our topical biologic drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate in development.
Committed to innovation, we are committed to improving the quality of care and the lives of patients. For more information, please visit www.mediwound.com.
Caution Regarding Forward-Looking Statements MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events or developments that we expect, believe or anticipate will will or may occur in the future are forward-looking. research statements. Although we believe we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations regarding future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but not always, made using words or phrases such as “anticipates”, “intends”, “estimates”, “plans”, “expects”, ” continues”, “believes”, “outlook”, “target”, “future”, “potential”, “goals” and similar words or phrases, or future or conditional verbs such as “will fly”, “would”, ” should”, “could”, “can” or similar expressions.
Specifically, this press release contains forward-looking statements regarding anticipated progress, development, study design, expected principal data timing, objectives, expected timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that could cause results to differ materially from those indicated herein are the inherent uncertainties associated with the uncertain, time-consuming and costly nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing authorization for our products and product candidates in the United States or other markets; risks related to our contracts with BARDA; the clinical utility, potential benefits and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional funding; the impact of governmental laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct studies at medical sites, and the rate at which government agencies , such as the FDA, will review and approve regulatory submissions. Quarantines and additional government-imposed requirements to “shelter at home” or other additional mitigation efforts may also impact our ability to source for our operations or our ability to manufacture, sell and support the use of our products and product candidates in the future.
These and other important factors are discussed in greater detail in MediWound’s Annual Report on Form 20-F for the fiscal year ended December 31, 2020, filed with the Securities and Exchange Commission (“SEC”) on February 25. 2021, quarterly reports on Form 6-K and other filings with the SEC from time to time. These forward-looking statements reflect MediWound’s current views as of the date hereof, and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release, except as required by law.