Palo Alto, California – (Business Wire) – July 18, 2019 – LifeMax Laboratories, Inc. (“LifeMax”), a private company focused on treating rare diseases with few or no therapeutic options, today announced that the Food & Drug Administration (FDA) granted rare pediatric disease designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into pivotal clinical trials for the treatment of Netherton Syndrome.   

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“We are very pleased to have received the rare pediatric disease designation for LM-030 which has demonstrated safety and clinical efficacy in a Phase I/II study. Netherton Syndrome is a severe genetic disorder with neonate onset that can be life-threatening. Receiving the rare pediatric disease designation on the heel of receiving the 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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Rare pediatric disease is defined by the FDA as a disease affecting less than 200,000 people in the US and the most severe and life-threatening manifestation of which is primarily in pediatric patients. If a new drug application (NDA) for LM-030 is approved, LifeMax may be eligible to receive a rare pediatric disease priority review voucher, which can be redeemed to obtain priority review for any subsequent NDA or biological license application (BLA) and can be sold or transferred.