Indian Drug maker, Dr Reddy's Laboratories has signed a commercialization deal with Australia's Hatchtech for its head lice product called the Xeglyze Lotion.
As part of the agreement, Dr Reddy's will pay Hatchtech an upfront USD 10 million, followed by up to USD 50 million based on pre-commercialization milestones and an undisclosed amount based on post-commercialization milestones, linked to achievement of annual net sales targets.
"The exclusive rights for this product are applicable to the territories of the United States, Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela," said Dr Reddy's Laboratories.
"Additionally, Hatchtech announced it will be filing its New Drug Application for Xeglyze with the US Food and Drug Administration (FDA) today. If approved, the product will be marketed in the United States by Promius Pharma, a wholly-owned specialty company of Dr Reddy's Laboratories."
Dr Reddy's said Hatchtech in September 2014 had announced positive results from its two pivotal phase three clinical studies, evaluating Xeglyze Lotion as a potential treatment for head lice infestation. The active drug substance was developed in collaboration with Dr Reddy's Custom Pharmaceutical Services (CPS) business unit.
"The studies involved 704 people across 14 clinical trial sites in the US and resulted in an 81.5 percent success rate, following the observation period of 14 days after a single 10 minute application," it added.
Xeglyze Lotion, a topical formulation containing abametapir, an inhibitor of metalloproteases, has demonstrated both ovicidal and lousicidal activity and offers potential for a more effective treatment using only a single application, said the company.