Dr. Reddy’s Laboratories today announced the signing of a commercialisation deal with Hatchtech, an Australian pharmaceutical company developing an innovative prescription head lice product, Xeglyze Lotion. The exclusive rights for this product are applicable for the territories of the United States, Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela.
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.
As part of the agreement Dr. Reddy’s will pay Hatchtech an upfront amount of US $10 million, up to US$ 50 million based on pre commercialisation milestones and an undisclosed amount based on post commercialisation milestones, linked to achievement of annual net sales targets.
In September 2014, Hatchtech announced positive results from its two pivotal phase 3 clinical studies evaluating Xeglyze Lotion as a potential treatment for head lice infestation. The studies involved 704 people, across 14 clinical trial sites in the US and resulted in an 81.5 per cent success rate, following the observation period of 14 days after a single 10-minute application. Xeglyze lotion, a topical formulation containing abametapir, an inhibitor of metalloproteases, has demonstrated both ovicidal and lousicidal activity and offers the potential for a more effective treatment using only a single application. The active drug substance was developed in collaboration with Dr. Reddy’s Custom Pharmaceutical Services (CPS) business unit.
Despite its prevalence and high cost to the community, there have been few major advances in controlling head lice infestation in recent years. Most pediculicide 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. Hatchtech’s Xeglyze Lotion has demonstrated both ovicidal and lousicidal activity and offers the potential for a more effective treatment using only a single application.