Dr Reddy’s Laboratories signs commercialisation deal with Australia's Hatchtech
14 Sep 2015
Dr Reddy's Laboratories (DRL) has signed a commercialisation deal with Hatchtech, an Australian pharmaceutical company, developing an innovative prescription head lice product, Xeglyze lotion.
The exclusive rights for the product would apply to the territories of the US, Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela.
Hatchtech further announced it would be filing its New Drug Application for Xeglyze with the US Food and Drug Administration (FDA).
If approved, the product would be marketed in the US by Promius Pharma, a wholly-owned specialty company of Dr Reddy's Laboratories.
As part of the agreement DRL would pay Hatchtech an upfront amount of $10 million, up to $50 million on meeting pre commercialisation milestones as also an undisclosed amount based on post commercialisation milestones, linked annual net sales achievement 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.