Palo Alto, California – (Business Wire) – November 13, 2019 – LifeMax Laboratories, Inc. (“LifeMax”), a private company focused on treating rare diseases with few or no therapeutic options, today announced that the European Commission granted orphan drug designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into a pivotal clinical trial for the treatment of Netherton Syndrome. LM-030 previously received orphan drug designation in June and rare pediatric disease designation in July 2019 from the FDA. 

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“We are very pleased to have received orphan drug designation for LM-030 from the European Commission, which, together with orphan drug designation and rare pediatric disease designation from FDA, serves to position us well for a global regulatory development pathway. Netherton Syndrome is a severe genetic disorder with neonatal onset that can be life-threatening. Receiving orphan drug designation represents another significant step in the development of LM-030 for this devastating disease,” said Larry Hsu, LifeMax’s Co-founder and CEO, an industry veteran who previously founded and built Impax Laboratories into a publicly traded multi-billion dollar company. 

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Orphan drug designation is granted by the European Commission for a medicine that is intended to treat and offers significant benefit to a life-threatening or chronically debilitating disease affecting less than 5 in 10,000 people in the European Union. Benefits that come with an orphan drug designation include, but are not limited to, reduced or exempted fees and ten-year market exclusivity.