Significant progress was made during the year transitioning Anatara's lead product, Detach(TM), towards commercialisation in livestock, initially with pigs and importantly this year with human applications for the technology.
On 16 September 2015, the Company reported it had completed a second field trial with Detach(TM) in nearly 500 piglets. The study saw Detach(TM) reduce the incidence and frequency of diarrhoea in weaner piglets - resulting in significant health benefits to the piglets.
Specifically, under the trial, Detach(TM) reduced the number of pigs with scour by 41% and reduced the severity of scour by 45%. The data was consistent with earlier registration trials on commercial pig farms, and further supported Anatara's plans to re-register and launch Detach(TM) in Australia.
Results from the second field trial led to formalising a collaboration with the Pork Collaborative Research Council (CRC). Pork CRC Chief Executive, Dr Roger Campbell remarked at the time:
"the latest results confirm our decision to work with Anatara to pursue Detach as an alternative to antibiotics for control of diarrhoea in young pigs."
"The results are typical of what we see with post-weaning scour. It can be severe or mild but it always has been and always will be present in the industry. Given the increasing global pressure to reduce antibiotic use and resistance in animal agriculture Anatara's technology would seem to have a role in helping achieve these objectives. We are encouraged by the latest results."
At the time of writing, results of a Target Animal Safety Study (TAS) study had just been reported. The purpose of the study was to provide detailed safety data on Detach(TM) when administered orally to piglets at dose rates higher than the recommended single dose. It demonstrated that Detach(TM) was safe for pigs, even when administered at much higher doses than recommended.
The study was conducted in accordance with VICH, a trilateral (EU-Japan-USA) program aimed at harmonising the technical requirements for veterinary product registration. It will support the global roll out of Detach(TM) and forms an important component of the Company's submission to re-register Detach(TM) for sale in Australia with the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Partnering and Commercialisation
The collaboration with the Pork CRC will provide Anatara with services to locate key clinical trial sites and ongoing test sites and promote the results of these trials; with the relationship opening the door for Anatara to work closely with key players in the Australian pork industry. Active partners and participants in the CRC include the largest Australian pork producers, feed manufacturers, key government and farmer industry bodies, ncluding the CSIRO.
On 18 January 2016, Anatara announced an Exclusive Research Evaluation and License Option Agreement with the leading animal health company, Zoetis Inc. Anatara granted Zoetis an option to license Detach(TM) for worldwide development and commercialisation, with the exception of Australia and New Zealand.
Under the terms of the agreement, Zoetis will have exclusive rights to evaluate the potential applications of Detach(TM) for veterinary use in food production animals. Anatara retains all intellectual property rights.
The financial terms of the Zoetis agreement are confidential, however they did include an upfront and subsequent cash payments during the Option period.
On 1 April 2016, Anatara announced it had shipped an evaluation batch of Detach(TM) to Zoetis, triggering the start of the evaluation period.
Key Elements of the Australian Regulatory APVMA Submission
While there have been many highlights in the 2016 financial year, Anatara's submission to register the new formulation of Detach(TM) with the APVMA has been of core significance.
All members of Anatara's small team contributed to the compilation of the APVMA dossier. The registration is pivotal to seeing Detach(TM) return to the Australian market, which we expect will occur in 2017.
Livestock producers have traditionally relied upon antibiotics to treat scour (diarrhoea), a leading cause of death in piglets. Scour costs the Australian pig industry more than $7 million each year, but it has a greater implication for the cost to human health. The high use of antibiotics in meat production has led to the rise of multi-drug resistant bacteria, known as superbugs, and these superbugs affect humans.
Data from the US Centers for Disease Control and Prevention and the World Health Organisation indicate that tens of thousands of people die every year due to the antibiotic resistant superbugs, with many millions falling ill with resistant infections introduced through the food chain.
Furthermore, with 4 billion episodes of human diarrhoea in the world annually and no one product available that prevents all causes of gastro-intestinal disease, the need for better human therapeutics is clear.
On 16 June 2016, it was announced that Anatara had entered into a research and development collaboration with The La Trobe Institute for Molecular Science at La Trobe University (Melbourne) to explore the potential for active components within Detach(TM) for the treatment of inflammatory diseases in humans and companion animals. The agreement is for the production, validation and pre-clinical evaluation of a specific active components isolated from the active ingredient in Detach(TM).
Speaking about the collaboration, Professor Rob Pike of La Trobe University said,
"There are three important molecules in the extract, and two are critical to the treatment of scour.
"Using recombinant DNA technology, we are working to develop methods for testing the components, to isolate and produce the two beneficial proteins, and to learn more about how these molecules interact with gut cells to prevent inflammation and diarrhoea.
"This research is a wonderful opportunity to treat scour in a way that doesn't cause antibiotic resistance," said Professor Pike. "We hope it will open up new avenues for the treatment of diarrhoea in humans."
Experts agree that addressing antimicrobial resistance requires measures that will ensure the judicious use of existing pharmaceutical treatments in combination with a robust pipeline of new drugs. Anatara's naturally derived active components will provide a safe, novel approach to the treatment of diarrhoea and other gastrointestinal diseases in humans, without contributing to antimicrobial resistance.
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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