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US FDA approval of Xeglyze™ triggers a milestone payment of $US20 million to Hatchtech from its commercialisation partner, Dr Reddy’s Laboratories.
Xeglyze™ has been approved by the US Food and Drug Administration (FDA) for the treatment of head lice infestation in patients 6 months and older. Xeglyze was developed by pharmaceutical company Hatchtech Pty Ltd based on University of Melbourne research.
FDA approval means that Xeglyze can be sold as a prescription drug in the USA. Total sales of head lice treatments in the USA are approximately $US350 million each year.
The approval triggers a pre-commercialisation milestone payment of $US20 million to Hatchtech from its commercialisation partner, Dr Reddy’s Laboratories.
Hatchtech was launched in 2001 by Associate Professor Vern Bowles. In his research, he had discovered metalloproteases in the shell casings of louse eggs. Inhibiting these enzymes prevented egg hatching. This disrupted the parasite’s life cycle. Hatchtech developed a metalloprotease inhibitor, abametapir, into the topical lotion, Xeglyze. The company completed a full pharmaceutical development program, including Phase III clinical studies.
Hatchtech filed a New Drug Application with the US FDA for Xeglyze in late 2015. At the same time, the company sold the product to Dr Reddy’s Laboratories for commercialisation in the USA and other selected countries. The application was approved on 24 July 2020.
Banner image: Head lice treatment Xeglyze gets US FDA approval
First published on 11 August 2020.
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