Investor Update and R&D Tax Rebate
- Company receives $840,000 Research & Development (R&D) tax refund
- Evaluation work with Zoetis on Detach(R) advancing
- Preparation for Australian launch of Detach(R) in train
- Planning for Asia & China well advanced
- Positive outlook for European Detach(R) registration as European Medicines Agency (EMA) rules no Maximum Residue Limit (MRL) for core component in Anatara's lead product, Detach(R)
- Human applications progressing - research collaboration awarded Science and Industry Endowment Fund (SIEF) STEM+Business fellowship grant
R&D Tax Incentive Receipt
Anatara has received a refund of $839,686 from the Australian Tax Office under the Federal Government's Research and Development (R&D) Tax Incentive. This refund is from Anatara's 2015-16 research activities and reflects a year of increased spending while the Company was preparing its application to the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the marketing approval of Detach(R) in Australia. The receipt of these funds has further strengthened Anatara's balance sheet.
The R&D tax rebate remains an important source of non-dilutive funding for Anatara.
Plans well progressed for launch of Detach(R) into global pig market
Anatara has made substantial progress in preparation for Detach(R) market entry across the world's various pig markets. The Company continues to support the Zoetis evaluation, whilst preparing for direct market launch in Australia. Anatara has strengthened its understanding of the potential for Detach(R) in Asia, and has been buoyed by the EMA's "no MRL required" recommendation, reconfirming the product's strong safety profile.
Zoetis Evaluation Trials
Following the exclusive Option Agreement signed with Zoetis in January 2016, the evaluation of Detach(R) continues under close collaboration; with Anatara remaining actively engaged in the investigation of the utility of the product in multiple livestock species.
Australian Plans to Launch Detach(R)
Anatara is well advanced with its plans to launch Detach(R) in Australia, in readiness for APVMA marketing approval. The Company continues to conduct market research prior to product approval, and has sufficient Detach(R) available for launch. Key stakeholder feedback has been positive.
Key Asian Markets
Significant progress has been made on mapping the regulatory route to launch Detach(R) into key Asian pork producing countries, including China. These key markets represent a significant proportion of the world's pork industry, and Anatara or a commercial partner, will be ideally positioned to access these markets.
EMA Rules No Maximum Residue Limit (MRL) for key component in Detach(R)
Following an extensive review process, Anatara is pleased to announce it has received confirmation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use, that the active ingredient in Detach(R) is a non-toxic substance that can safely be used as a therapeutic in pigs. This part of the registration process is known as establishing a "Maximum Residue Limit (MRL)" for food-producing animals.
Obtaining a no MRL status is a significant outcome for Anatara as it confirms the safety of the product when compared to antibiotics and ensures there will be no withholding period for Detach(R).
Anatara CEO & Chairman, Dr Mel Bridges said "We are delighted with the EMA's no MRL finding. Along with the formal target animal safety study we completed last year, this is further affirmation of the strong safety profile we've observed with Detach(R) to date. Providing the market with a non-antibiotic alternative to control diarrhoea will offer farmers a way of delivering both healthy pigs and healthier pork products to consumers."
Human Applications - STEM+Business Fellowship Program Grant
Anatara has opened a fully equipped laboratory in Melbourne, focussed on advancing the development of human therapeutics for key gastrointestinal disorders ("gut health").
In support of this development program, Anatara in conjunction with La Trobe's Institute for Molecular Science (LIMS), has been awarded grant funding of $315,000 under the Science and Industry Endowment Fund's (SIEF) STEM+ Business Fellowship Program. This program supports collaborations between Australian research organisations and SME's to work together on technical projects that improve the SME's competitive advantage.
A Research Fellow has been appointed to work with Anatara and LIMS scientists to develop novel, advanced manufacturing processes for the biologically active components within Detach(R). The project will further support the development of the current veterinary and human product pipeline which is focused on developing specific bromelain proteases for the treatment of gastrointestinal diseases in humans and animals.
Key Investor Message
Dr Bridges added, "The Anatara team is laser focussed on delivering commercial outcomes through application of the Company's technology in both the pork industry, and in human health. More than ever, the world is looking for safe and effective solutions to gut health".
About Anatara Lifesciences Ltd
Anatara Lifesciences (ASX:ANR) develops and aims to partner non-antibiotic, oral products for gastrointestinal diseases in animals and humans where there is significant unmet need and large market opportunity. In May 2018, Anatara granted an exclusive licence to the leading global animal health company, Zoetis Inc., for the worldwide development, manufacturing, distribution and marketing of its lead product Detach as a non-antibiotic approach to aid in the control of diarrhoeal disease (known as scour) in livestock and in horses. Anatara is now focused on developing its human product pipeline for gastrointestinal health applications. For more information, please visit www.anataralifesciences.com.
Anatara Lifesciences Ltd