Highlights
? Second field trial site secured – Detach™ on site
? Third field trial site in advanced planning stage
? Additional GMP manufacturing runs scheduled
? International partnering discussions advanced
? US FDA fee waiver granted
? Dr Kevin Woodward appointed as International Regulatory Affairs Advisor
? Collaborative Agreement with Pork CRC on track for signing
? Registration complete for R&D Tax Rebate – cheque received from the ATO
? Anatara to present at BIO Conference in Philadelphia
BRISBANE, 9 June 2015: Gastrointestinal therapeutic company, Anatara Lifesciences (ASX: ANR) is pleased to announce positive progress across a wide range of areas and remains on track to deliver on its key milestones.
Anatara Chief Scientific Officer (CSO), Dr Tracey Mynott has confirmed that the second field trial site has been selected and that Detach™ is on site in readiness for the start of the trial. Anatara expects dosing of the pigs to commence within weeks. The company will advise the market immediately upon the start of this trial. Dr Mynott also confirmed that the third trial site has been agreed and planning for the commencement of that trial is on track.
With the first manufacturing run of Detach™ complete, planning is well advanced on completing additional batches of GMP product.
Anatara has been receiving significant international interest from leading animal health companies to enter into commercial partnering agreements. The Anatara executive team are attending and presenting at BIO, the leading international biotechnology conference to be held in Philadelphia later this month. Further partnering meetings have been scheduled at this conference.
Anatara is also pleased to announce that it has received written confirmation from the US FDA that the Company has been granted a sponsor fee waiver. The issuing of the fee waiver means that Anatara can initiate its INAD application for field studies in the US without having to pay the US$100,000 annual Sponsor User Fee. Anatara can also commence seeking guidance from the FDA on their likely approach to Detach™ registration. The FDA have granted the waiver based on their assessment that Anatara is pursuing innovative animal drug products and technology for the prevention of diarrhoea.
Anatara CEO, Dr Paul Schober said, “This is a very positive outcome for our plans to conduct trials in the US with the view to registering and launching Detach™ in the US and other international markets”.
In further support of Anatara’s global strategy, the Company is pleased to announce the appointment of Dr Kevin Woodward as International Regulatory Affairs Advisor. Dr Woodward has significant scientific expertise and animal health leadership experience with former roles including Director of Global Pharmacovigilence for Intervet/Schering Plough Animal Health. Dr Woodward was also responsible for all aspects, both scientific and administrative, within the Veterinary Medicines Directorate, and for liaison with the Medicines and Healthcare products Regulatory Agency (MHRA), with other European veterinary regulatory agencies and with the European Medicines Agency. He has been a member of the Committee for Medicinal Products for Veterinary Use (CVMP), chairman of its Safety of Residues Working Party, and a member of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). He has also been a delegate to the Codex Committee on Residues of Veterinary Drugs in Foods. Dr Woodward is a Fellow of the Royal College of Pathologists and a Fellow of several other prestigious Colleges, and is a Member of the European Association for Veterinary Pharmacology and Toxicology (EAVPT).
Dr Schober said “Dr Woodward is considered a leader in his field and Anatara is privileged to have secured his services as a senior advisor to the company, particularly in planning its European regulatory pathway”.
Anatara Chairman, Dr Mel Bridges advised that, “We are now in the final stages of formalising an important collaborative agreement with Cooperative Research Centre for High Integrity Australian Pork (Pork CRC) and expect to announce the signing of this agreement shortly. Once announced we will provide a full market briefing on the positive aspects of this important industry relationship” Dr Bridges added.
The Company also confirms that it is successfully registered with the Commonwealth Government R&D Tax Rebate Scheme, and it has received its first refund of $61,000 from 2013 research activities. Future refunds will increase significantly. Dr Schober said “the R&D tax rebate is an important source of non-dilutive funding for the company and will provide an ongoing source of valuable funds for the company’s R&D initiatives”.
Anatara looks forward to continuing to update its shareholders as progress continues.
ENDS
For more information please contact:
General inquiries Media inquiries
Dr Paul Schober Gavin Lower
CEO Buchan Consulting
+61 (0)412 026 657 +61 (0)3 8866 1215
pschober@anataralifesciences.com glower@buchanwe.com.au
About Anatara Lifesciences
Anatara Lifesciences (ASX: ANR) is developing therapeutics for gastrointestinal diseases in production animals and humans. Its lead product Detach™ is a natural, plant based product that will help address global concern about 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. For more information visit www.anataralifesciences.com.
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