Anatara preps manufacturing for Detach trial

Anatara Lifesciences (ASX:ANR) is ready to commence manufacture of its non-antibiotic diarrhoea treatment Detach as part of its product registration in Australia for use in pigs.

The company has completed a pilot manufacturing run of Detach and will now commence the manufacture required for registration with the Australian Pesticides and Veterinary Medicines Authority (APVMA).

The product will then be used in Anatara’s Australian field trials at pig farms, which are expected to commence in November. The goal is to determine the safety and efficacy of the treatment in an Australian setting.

“While we know from recent field trials in other countries that Detach has been proven safe and efficacious, running these Australian trials are an important box for Anatara to tick as we move towards registration of the product with the AVPMA,” Anatara Chairman Dr Mel Bridges said.

Anatara has meanwhile been granted SME status by the European Medicines Agency, allowing for a 90% fee reduction on consultations with the regulators regarding medicinal product development, as well as any inspections on manufacturing, clinical and laboratory practices required.

“It is significant that Anatara has gained SME status as a non-European company. The overwhelming majority of companies to gain this status are based in Europe,” Bridges commented.

He said the company plans to use approvals in Australia and Europe to springboard into launches in other markets.

Anatara Lifesciences (ASX:ANR) shares were trading 3.9% higher at $0.40 as of around 2 pm on Tuesday.