APVMA Submission Major Milestone Achieved
Brisbane, Oct 4, 2016 AEST (ABN Newswire) - Anatara Lifesciences (
ASX:ANR) is pleased to announce that it has lodged its application for approval to register Detach(TM) with the Australian Pesticides and Veterinary Medicines Authority (APVMA). Detach(TM) is a natural, non-antibiotic alternative for the control of diarrhoea in piglets.
Highlights:
- Anatara achieves a significant milestone through submission of its application to register Detach(TM) for commercial marketing in Australia.
- Approval, when granted, paves the way for the launch of Detach(TM) in Australia; assists with entry into key Asian markets
- Extensive safety and efficacy data in Anatara's submitted dossier reinforces the value of Detach(TM) as an effective alternative to the use of antibiotics
- Submission coincides with United Nations' statement that antimicrobial resistance is "the greatest and most urgent global risk"
The submitted dossier is a compilation of technical documents that include data on efficacy and safety, chemistry and manufacturing as well as other statutory criteria that satisfy quality and clinical performance of the product.
Once the dossier has been approved by the APVMA, a marketing authorisation or registration will be issued, and then Detach(TM) will be allowed to be made commercially available to farmers for the control of diarrhoea in their piglets. More detail on the application and registration process can be found on the APVMA website: http://apvma.gov.au.
Anatara Chairman and CEO, Dr Mel Bridges said, "The submission of the APVMA application brings to a close over two years of hard work by our team, and I thank them for their sustained efforts. We believe we have put together a very strong application which supports the use of our lead product, Detach(TM) as an alternative to the mass use of antibiotics in livestock production - in this case, in pigs."
"The importance of the submission is underscored by the United Nations' assertion last month that antimicrobial resistance is 'the greatest and most urgent global risk'. It is clear we need viable alternatives to antibiotics to address the growing issue of drug resistance."
"With the APVMA dossier now submitted, the Anatara team will turn its attention to further progressing our pipeline of novel products, including a product focused on the treatment of gastrointestinal disease in humans," finished Dr Bridges.
About Anatara Lifesciences Limited
Anatara Lifesciences Limited (ASX:ANR) is developing and commercialising innovative, evidence-based products for gastrointestinal health where there is significant unmet need. Anatara is a life sciences company with expertise in developing productsfor human and animal health. Anatara is focused on building a pipeline of human gastrointestinal health products. Underlying this product development program is our commitment to delivering real outcomes for patients and strong value for our shareholders.
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