MediWound, a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced the expansion of its agreement with GENFA MEDICA SA, granting it the exclusive right to market and distribute NexoBrid^® in Ukraine, Lithuania, Latvia and Estonia.
NexoBrid, currently approved in the European Union and other international markets, is a topically-administered biologic product that removes eschar in patients with deep partial and full-thickness thermal burns and is already approved for marketing in Lithuania, Latvia and Estonia. Commercialization of NexoBrid in Ukraine will commence after receipt of local marketing authorization, which is expected within 2 years.
About NexoBrid
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 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 (BLA) to the U.S. food and Drugs Administration is expected in the second quarter of 2020.
About MediWound Ltd.
MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercialising novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health.
For more information, please visit www.mediwound.com.
About GENFA MEDICA SA
Genfa Medica SA is a Swiss company representing a number of manufacturers of generic pharmaceutical products from Israel, Canada and other countries. Its broad portfolio of high-quality prescription products is used mostly in reimbursed and hospital segments. It was established in Geneva in 2005 by Sergei Zhukovsky.
For more information, please visit www.genfamedica.com
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Company Name: Genfa Medica SA
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Country: Switzerland
Website: https://genfamed.com