MediWound announced the signing of a distribution agreement granting Balance Medical the exclusive rights to market and distribute NexoBrid® in Australia, New Zealand and Singapore for the treatment of severe burns. 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. Commercialization of NexoBrid in these territories will commence after receipt of the respective local regulatory authorities approval, which is expected within two years. Balance Medical will employ a special access scheme (SAS) in Australia, to allow treatment of patients prior to marketing approval, using unapproved therapeutic medicines under exceptional clinical circumstances.
"We are pleased to partner with Balance Medical as a distributor of NexoBrid to Australia, New Zealand and Singapore. We are confident that Balance Medical’s local regulatory and market access expertise and proven track record of driving market penetration will maximize the medical and commercial potential of NexoBrid in these territories,” said Sharon Malka, Chief Executive Officer of MediWound. “This distribution agreement is part of our said commercialization strategy to expand global use of NexoBrid to international markets via collaborations with local partners and through additional marketing approvals. We are delighted that patients in these countries will have access to NexoBrid as Balance Medical turns NexoBrid into standard of care in Australia, New-Zealand and Singapore.”
NexoBrid is a topically-administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic agent in the United States, European Union and other international markets.
In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial- and full-thickness thermal burns up to 30% of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal, and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. Filling of the Biological License Application to the U.S. food and Drugs Administration is expected in the second quarter of 2020.