Indian pharma major in pact with Oz firm for lice lotion
Hyderabad-based pharmaceutical major Dr. Reddy's Laboratories Ltd. on Monday announced that it has signed a commercial deal with an Australian pharmaceutical company Hatchtech to jointly develop an innovative prescription head lice product Xeglyze Lotion. “As part of the agreement, Dr. Reddy's will pay Hatchtech an upfront amount of US$10 million, up to $50 million based on pre commercialization milestones and an undisclosed amount based on post-commercialization milestones, linked to achievements of annual net sales targets,” Dr. Reddy’s said in a statement. In September 2014, the Australian drug manufacturer announced positive results from its two pivotal Phase 3 clinical studies and evaluated Xeglyze Lotion as a potential candidate to treat head lice infestations. The studies were undertaken across 14 clinical trial test sites in the US, involving 704 people, and had 81.5% success rate. The observation period was of 14 days. “Hatchtech's 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,” said the statement. Hatchtech had developed this active drug substance in collaboration with Dr Reddy’s custom pharmaceutical services (CPS) business unit. The exclusive rights for Xeglyze Lotion are applicable for the territories of the United States, Canada, Australia, New Zealand, Venezuela, India and Russia and the CIS (Commonwealth of Independent States). Hatchtech also announced that it will file its new drug application for Xeglyze Lotion with the US Food and Drug Administration (USFDA) to be marketed by Promius Pharma, a wholly owned specialty company of Dr. Reddy's Laboratories.
September 14, 2015 | 1:27pm IST.
to success.