FDA Approves Xeglyze™ for the topical treatment of head lice infestation
· Xeglyze New Drug Application Approved by the US FDA
· Culmination of a 20-year journey for Hatchtech from drug discovery to approval
· Hatchtech joins small but growing list of Australian biotech companies with FDA approved products
Brisbane, 3 August 2020 – Uniseed investee company Hatchtech, developing an innovative prescription head lice product, today announced that its commercialisation partner, Dr Reddy’s Laboratories, has achieved US Food and Drug Administration (FDA) approval of Xeglyze (abametapir) Lotion 0.74% for the topical treatment of head lice infestation in patients 6 months of age and older. Xeglyze was developed by Hatchtech who completed a full development program through to the submission of a new drug application by the company in September 2015. At the same time, Hatchtech sold the rights to Xeglyze to Dr Reddy’s Laboratories for selected territories, including the US.
“The FDA’s approval of Xeglyze is the culmination of a nearly 20-year journey to gain approval of the product originally developed by Hatchtech. This is a fantastic outcome for Dr Reddy’s, Hatchtech and our shareholders. We are excited to finally see this product gain approval and we look forward to product launch in the United States, enabling availability of this novel product for the treatment of head lice infestation.” stated Hatchtech’s CEO, Hugh Alsop.
Whilst Xeglzye was filed by Hatchtech with the US FDA in September 2015 and subsequently transferred to Dr. Reddy’s, a complete response letter for the application was received in August 2016, citing manufacturing deficiencies at the Dr Reddy’s drug substance manufacturing plant in India, which had received a Warning Letter in November 2015. These deficiencies have only now been resolved, paving the way for approval of the product.
Uniseed was the sole participant in Hatchtech’s first investment round in 2001 when the company was founded by Dr Vern Bowles whilst Deputy Director of the Centre for Animal Biotechnology at The University of Melbourne and Uniseed has provided investment support for the company throughout the entire journey. “Hatchtech was one of Uniseed’s first investments and is the first of our human therapeutics companies to get product approval, validating our model of facilitating early stage commercialisation of research partner IP”, said Uniseed CEO, Dr Peter Devine. “ The approval of Xeglyze is the culmination of over a decade of Dr Bowles’ work on human head lice, and the University of Melbourne continues to be a significant shareholder in the company”.
The FDA approval triggers a further US$20 million milestone payment which will result in further returns for Hatchtech’s venture capital investors, including Uniseed, QIC, GBS Ventures, OneVentures and BlueSky Ventures, along with a number of private sophisticated investors. A total $33 million of capital was invested since the formation of the company and the company has also received in excess of $5.9 million in grants from a number of Australian federal government programs including the Biotechnology Innovation Fund (BIF), Commercial Ready, ARC Linkage, Export Market Development Grant (EMDG), and R&D Tax Rebate scheme.
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Hatchtech Pty Ltd is an Australian specialty pharmaceutical product company developing technology for the control of invertebrate pests. The Company’s lead product is Xeglyze™ Lotion, a novel, next generation prescription head lice product in development that aims to overcome the frustrating, costly and inconvenient cycles of retreatment for head lice infestation currently experienced by children and their parents. The Company’s investors include Uniseed, OneVentures Innovation Fund, University of Melbourne Endowment Trust, Queensland Biotechnology Fund, and GBS Venture Partners.
Despite its prevalence and high cost to the community, there have been few major advances in controlling head lice infestation in recent years. Most head lice products have little ovicidal activity and require two treatments (approximately 7 to 10 days apart), with the second application required to treat those lice that have hatched from eggs that survived the first treatment and were not physically removed by nit combing. Non-compliance with this regimen and the difficulty in choosing the optimal time for the second application, are major drawbacks in using these products. Xeglyze, a topical formulation containing abametapir, an inhibitor of metalloproteases, has demonstrated both ovicidaland lousicidal activity and offers the potential for a more effective treatment using only a single, 10-minute application.
Formed in 2000, Uniseed is Australia’s longest running university commercialisation fund – a collaboration between the University of Queensland, the University of Melbourne, the University of NSW, the University of Melbourne and the CSIRO. Uniseed has supported over 50 start-ups including a number of highly successful companies arising from partner research organisations, such as the University of Melbourne’s Fibrotech (sold to Shire in 2014) and Hatchtech (sold to Dr Reddy’s Laboratories in 2015); the University of Queensland’s Spinifex (sold to Novartis in 2015); and the University of NSW’s Smart Sparrow (sold to Pearson in 2019) and Exonate (major research collaboration with J&J announced in 2020). Uniseed is a mutual fund, owned by research organisations, for research organisations. The fund facilitates the commercialisation of its research partners’ most promising intellectual property and secures targeted investment in resulting products and technologies. For more information, visit: www.uniseed.com
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to accelerating access to affordable and innovative medicines, because it believes Good Health Can’t Wait. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – the company offers a portfolio of products and services that include active pharmaceutical ingredients, (APIs), custom pharmaceutical services, generics, biosimilars and differentiated formulations. With operations in 26 countries across the globe, the major therapeutic areas of Dr. Reddy’s are gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infectives. For more information, log on to: www.drreddys.com
 Bowles VM, HanegraafS, Ahveninen T, et al. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Global Pediatric Health. 2019; Volume 6; https://doi.org/10.1177/2333794X19831295
 Bowles VM, VanLuvanee LJ, AlsopH, et al. Clinical studies evaluating abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol.2018; 35:616–621. https://doi.org/10.1111/pde.13612