| Mar 26, 2015
Date:18 March, 2015
Source: Press release
New Drug Application for Xeglyze™ Lotion on Track for 3Q 2015
MELBOURNE, Australia, March 18, 2015 – Hatchtech Pty Ltd, a specialty pharmaceutical company, today announced that it is exploring strategic alternatives for the possible commercialization in the U.S of its innovative head lice product candidate, Xeglyze™ Lotion. The product is currently on track for a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the third quarter of 2015. Hatchtech has retained NY-based investment bank Molecular Securities to act as an advisor in the strategic review.
“Xeglyze Lotion is emerging as a differentiated development candidate to treat head lice infestations, and we are excited to have progressed the product through to the NDA submission stage,” said Hugh Alsop, chief executive officer of Hatchtech. “As a small, private, single-asset Australian company, we believe that Xeglyze’s true market potential, if approved, may best be promptly realized by a company with an established U.S. marketing presence and a focus on the pediatric market. We have already received interest from several pharmaceutical companies looking to expand their pediatric drug franchises. With the assistance of Molecular Securities, we aim to secure a commercial partner for a U.S. market launch in the event of FDA approval.”
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. Both studies achieved the pre-defined primary and secondary endpoints and were conducted according to a Special Protocol Assessment (SPA) agreement with the FDA. The studies were designed to assess the efficacy, safety and tolerability of a single ten minute application of Xeglyze Lotion compared to a vehicle lotion, when applied to the scalp and hair. The results were assessed in follow up visits on days 1, 7 and 14 following application. In both Phase 3 studies, the proportion of patients who were lice free at all follow-up visits through Day 14 were significantly greater compared to the vehicle control. No Xeglyze-related serious adverse events were recorded and no subjects discontinued the study due to an adverse event.
Abametapir, the active ingredient of Xeglyze Lotion, inhibits metalloproteinases; enzymes that are essential to physiological processes critical for egg development and the survival of nymph and adult lice. In vitro and ex vivo research has demonstrated that Abametapir not only kills the lice, but also prevents hatching of their eggs.
According to the Centers for Disease Control & Prevention, in the U.S. there are between six and twelve million cases of head lice infestations among children 3 to 11 years of age annually. The economic cost of head lice infestation in the U.S. has been estimated at $1 billion annually, and includes the adverse impact of classroom absences, school disruption, and parental workday absences. In many cases, existing treatments require more than two topical administrations 7 to 10 days apart. In addition, increased resistance of lice to some of the currently marketed insecticide treatments, such as permethrin, has been reported to reduce their effectiveness. Market research conducted by Hatchtech with parents and physicians has revealed that, in addition to overall efficacy, a single application without the need for nit combing is a very important product attribute. Further, the American Academy of Pediatrics Clinical Report on Head Lice states that “Because current products are not completely ovicidal, applying the product at least twice, at proper intervals, is recommended … and manual removal of nits after treatment with any product is recommended by some.”
Download the press release here