The product, Detach, is a protease, said to be similar to trypsin. It works by preventing diarrhea-causing microbes from attaching themselves to pigs' small intestines, said the Australian biotech company.
The submission to APVMA is a re-registration. The company has reformulated an earlier product with the same name that was developed out of combined Australian public and private research efforts.
Detach was first brought to market by drug developer, Ciba Geigy, in Australia in the early 1990s and was said to have achieved 40% market penetration within six months.
However, it was subsequently pulled from the market as a consequence of corporate reshuffles, with Ciba Geigy going on to form part of Novartis. Anatara is now reintroducing the product.
Feed additive route
Dr Tracey Mynott, chief scientific officer (CSO) at Anatara, told this publication:
“In Australia, we are registering Detach as a medicinal product. This is also the most likely route overseas. We are also exploring the feed additive option for older piglets that eat solid food, as well as in-water delivery.
“Detach is currently formulated as an oral drench for very young piglets, in particular sucker or nursing piglets from two days of age. For older piglets, we are evaluating in feed or in water delivery options.”
Australian approval for the product, said the company, would assist it with entry into key Asian markets.
Detach is being positioned to benefit from a major global shift away from the use of antibiotics in production animals to approaches which don’t have resistance problems, or food chain or excretion issues into agricultural land and water associated with antibiotics, claimed a November 2015 note by market analyst, David Blake, in a biotech stock report.
“This is a key thematic which is likely to sustain interest in the stock both in the short term and the long term,” added the analyst.
Detach is intended to replace the use of prophylactic antibiotics to prevent diarrhea in piglets 0-6 weeks of age, said Mynott.
“We also have evidence it can be used as metaphylaxis in piglets 0-3 weeks of age. We believe it could replace zinc oxide (ZnO), and have evidence that it is as effective as ZnO,” continued the CSO.
By November last year, Anatara had completed two randomized trials of Detach in Australia, in both sucker and weaner piglets, as well as a 2012 trial conducted in Spain in weaner piglets.
In its first Australian trial, in sucker piglets, Detach was shown to deliver an almost 50% reduction in deaths and removals, for ill health, compared to the control arm, said the company. In its second Australian trial, in weaner piglets, Detach was shown to effectively reduce scour by 41%, said Anatara. However, somewhat surprisingly there were far fewer instances of deaths in the control arm and none in the Detach arm, it added.
“Our recent registration trials also show similar improvements,” said Mynott.