MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the signing of a distribution agreement granting Balance Medical Pty Ltd. 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,” stated Sharon Malka, Chief Executive Officer of MediWound. “This distribution agreement is part of our global 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.
"We are thrilled at this opportunity to introduce NexoBrid to Australia, New Zealand and Singapore as it demonstrates a significant improvement to burn patients outcomes,” said Shawn Garson, Managing Director of Balance Medical. “Broad evidence-based clinical studies and firsthand experience of worldwide leading experts treating burn patients in routine and mass casualty incidents demonstrate that NexoBrid may play a major role in the future of burn care in these countries. It is yet another milestone in our commitment to bring innovative and life changing therapies to patients in Australia, New Zealand and Singapore. We look forward to collaborating with MediWound towards successful register and launch of NexoBrid in Australia, New Zealand and Singapore."
