Review of operations and financial results
The company continued to expend monies in furthering its effort in developing a non-antibiotic therapy and as a result shows a loss after tax of $402,285 for the interim period (2015: $1,179,181).
During the half year to 31 December 2016, the Company made significant progress in continuing to transition Anatara's lead program, Detach(TM) towards commercialisation in livestock, starting with pigs, and importantly this year with advancing human applications for the technology.
Under the guidance of Co-Founder and Chief Scientific Officer, Dr Tracey Mynott, Anatara has now completed several successful trials on Australian commercial pig farms. Through trials, Detach(TM) continues to reduce the incidence and severity of diarrhoea, demonstrating an almost 50% reduction in mortality among young pigs, whilst increasing the average weight of piglets at time of weaning. These improvements have the ability to make a significant impact on animal health and reduce the use of antibiotics.
Our pivotal Target Animal Safety (TAS) study was completed for Detach(TM) and announced to the ASX in September 2016. The study demonstrated that Detach(TM) was safe for pigs, even when administered at much higher doses and more frequently than recommended. Data from this study reinforces Anatara's pre-existing large safety database.
The TAS study was conducted according to the VICH guidelines, the highest international standard of major commercial territories and may reduce the need for separate TAS studies in each global jurisdiction where product registration is needed. Long term, this strategy presents the most efficient and cost effective way to prepare for the global roll out of Detach(TM).
The six months to December were critical for Anatara as the Company submitted its application to the Australian Pesticides and Veterinary Medicines Authority (APVMA) to request marketing approval for its lead product, Detach(TM). The dossier application was a clear, primary point of focus and one which brought to a close over two years of considerable effort from the whole team. The strong application which supports the use of Detach(TM) as an alternative to the mass use of antibiotics to control diarrhoea in livestock production - in this case, in pigs, was submitted on 4th October 2016 and brings the Company closer to market launch in Australia. Approval in Australia will pave the way for approval and launch in a number of key Asian countries.
The appointment in 2016 of Dr Michael West as Chief Operating Officer, has been of great benefit in readying Anatara for commercial supply. With Dr West's input, the Company produced the necessary manufacturing documentation for the APVMA registration and now has the ability to reproducibly manufacture commercial scale batches of Detach(TM). In addition to Dr West's appointment, the Anatara team has been further expanded in preparation for the roll-out of Detach(TM) and pipeline expansion into human indications.
Zoetis licensing option
A very pleasing start to the 2016 calendar year came via the significant announcement that the Company had entered into an exclusive agreement with leading global animal health company, Zoetis Inc.
Under the agreement, Zoetis has the exclusive right to evaluate the potential applications of Detach(TM) for veterinary use in food production animals in all countries aside from Australia and New Zealand. As the world's largest international animal health company, Zoetis has access to substantial research resources and facilities.
Discussions were held during the period with Zoetis researchers at their facilities in the USA, who after receiving material (announced 1st April 2016), began an aggressive Detach(TM) evaluation program. Milestone payments were announced prior to the period under review, on 1st April 2016 and then post the half year, on 30th January 2017. The milestone payments assisted Anatara with retaining a strong balance sheet during the period.
Importantly, under the evaluation agreement with Zoetis, Anatara retains rights to all intellectual property protecting its technology. In this context, it should be noted that the Company has applied for two new patents covering both the formulation and active ingredient.
Anatara's initial focus remains on the pork industry globally, however, with the pending Australian APVMA registration, the team is increasingly focussing on pursuing lucrative human applications for our technology.
Following the submission of the APVMA registration application for Detach(TM), the Anatara team turned its attention to planning for the direct roll-out of Detach(TM) in Australia and New Zealand, and to further progressing the Company's pipeline of novel products, including products focused on the treatment of gastrointestinal diseases in humans.
During the period, Anatara continued a research and development collaboration with The La Trobe Institute for Molecular Science at La Trobe University (Melbourne) to explore the potential of the active components within Detach(TM) for the treatment of gastrointestinal diseases in humans.
R&D tax refund
In October 2016, Anatara received $420,460 from the Australian Tax Office for the Research and Development (R&D) Tax Incentive. The company expects a further cash tax rebate this financial year.
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About Anatara Lifesciences Ltd
Anatara Lifesciences (ASX:ANR) is developing therapeutics for gastrointestinal diseases in production animals and humans. Its lead product Detach(R) is a natural plant based product that will help address global concerns around the overuse of antibiotics in production animals that is contributing to the rise of so-called “super bugs” that make infectious diseases harder to treat. The Anatara team has a strong track record in biological science as well as building and growing international biotech companies. Please see http://www.anataralifesciences.com for further background.
Anatara Lifesciences Ltd