Australian company Hatchtech has announced commercialisation partner, Dr Reddy’s Laboratories, has secured US FDA approval of XEGLYZE (abametapir) Lotion 0.74% for the topical treatment of head lice in patients six months of age and older.
XEGLYZE was developed by Hatchtech. The company completed a full development program through to the submission of a new drug application in September 2015. At the same time, the company sold the rights to XEGLYZE to Dr Reddy’s Laboratories for selected territories, including the US.
“The FDA approval of XEGLYZE is the culmination of the 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,” said Hatchtech CEO Hugh Alsop.
Hatchtech filed XEGLYZE with the FDA in September 2015 and it 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," said Hatchtech in a statement.
According to Hatchtech chairman and OneVentures managing partner, Dr Paul Kelly, “We are excited that Dr Reddy’s have secured approval for Xeglyze. Whilst this program has experienced a significant delay, we have never wavered in our support for the product or the team that has achieved this outcome. This is a real credit to those that have been involved in this journey over the many years, and is a testament to resilience, teamwork, and an unwavering focus on the issues that really matter.”
University-backed venture capital firm Uniseed provided the initial seed funding for Hatchtech. The company was founded in 2001 by Dr Vern Bowles.
“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."