Gas masks are seen on a table at a distribution point at a shopping mall in Pisgat Zeev, an urban settlement in an area Israel annexed to Jerusalem after capturing it in the 1967 Middle East war, January 30, 2013. A spokesperson for the Israeli postal service, responsible for the distribution of the.
(photo credit: RONEN ZVULUN/REUTERS)
Yavne-based biotechnology company MediWound has been awarded a contract by US health authorities valued up to $43m. for the development of an innovative treatment to treat victims of sulfur mustard attacks, the company announced Monday.
The US Biomedical Advanced Research and Development Authority (BARDA), an office within the Department of Health and Human Services, will provide Mediwound with funding to support research and development activities as part of the office's preparedness for mass casualty chemical warfare attacks.
Sulfur mustard, commonly known as mustard gas, is a chemical warfare agent originally used in the First World War that causes blistering of the skin and mucous membranes. The chemical damages DNA but is usually not fatal.
MediWound will receive approximately $12 million of funding over eight years to support activities to develop its NexoBrid product, with options for additional funding of up to $31 million for additional development activities, animal pivotal studies, and submission for approval of the drug for the treatment of sulfur mustard injuries by the US Food and Drug Administration (FDA).
Nexobrid is a topically-administered burn treatment which removes dead or damaged tissue, known as eschar, without harming surrounding healthy tissues in approximately four hours. Unlike other topical treatments, NexoBrid has demonstrated efficacy levels comparable to surgical procedures.
The treatment has received marketing approval from health authorities including the European Medicines Agency, as well as health ministries in Israel, Argentina, South Korea and Russia.
The contract builds on existing funding agreements between Nasdaq-listed MediWound and BARDA, which has already funded or maintains options for funding the development of MediWound's burn products to the tune of some $132 million.
Established in 2006, BARDA develops and procures medical countermeasures against a range of public health threats. To date, BARDA has stockpiled 21 treatments for use in possible emergencies, both natural and intentional in origin. BARDA played an active role in the international response to the 2014-16 Ebola outbreak in West Africa.
"We are pleased to have the endorsement of our technology by an additional department in BARDA and look forward to collaborating with BARDA on the development of NexoBrid for this new indication as part of the US efforts to prepare for mass casualty events," said Gal Cohen, President and Chief Executive Officer of MediWound.
"Based on promising data from animal studies presented at the 2017 European Burn Association conference, NexoBrid has the unique potential to help victims of mass casualty events involving this chemical warfare agent, who otherwise would have to undergo radical surgical removal of contaminated skin," he added.
The FDA held earlier this year that the development of NexoBrid fell under its Animal Efficacy Rule, according to which animal drug trials are permitted as it is neither ethical nor feasible to conduct human trials with chemical warfare agents.
Such trials are only permitted where studies demonstrate that the drug is reasonably likely to produce clinical benefit in humans.
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