 "Dr Reddy's inks commercialisation deal with Aussie firm Hatchtech for Xeglyze lotion")
The Hyderabad-based Dr Reddy’s Laboratories yesterday signed a commercialisation deal with Hatchtech Pty Ltd, an Australian pharmaceutical company developing an innovative prescription head lice product, Xeglyze lotion. The exclusive rights for Xeglyze lotion are applicable for the territories of the US, Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela.
Additionally, Hatchtech also filed its new drug application (NDA) for Xeglyze with the US Food and Drug Administration (FDA) on September 14, 2015. If approved, the product will be marketed in the US 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 $10 million, up to $ 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 percent 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.
Additionally, Hatchtech also filed its new drug application (NDA) for Xeglyze with the US Food and Drug Administration (FDA) on September 14, 2015. If approved, the product will be marketed in the US 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 $10 million, up to $ 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 percent 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.