Dr. Reddy's Laboratories Signs Commercialization Deal with Hatchtech

Dr. Reddy's Laboratories

today announced the signing of a commercialization 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 $10MM, up to US $50 million based on pre commercialization milestones and an undisclosed amount based on post commercialization 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% 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.