ELLEVILLE, Ontario – The Australian Quarantine and Inspection Service (AQIS) has granted an import permit for Bioniche Life Sciences Inc.’s Econiche E. coli O157 cattle vaccine. The AQIS permit is a required first step in gaining access to the Australian market.
Regulatory review of the vaccine by the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required. As a result, Bioniche is preparing a regulatory dossier to submit to the APVMA in the near future.
Approximately 38 million cattle exist in Australia and New Zealand (FAOStat). "Australia enjoys an estimated A$4.9 billion [US$5 billion] beef export market," said Rick Culbert, president of Bioniche Food Safety. "A vaccine such as Econiche would add further protective measures to preserve and enhance the reputation of Australian beef exports to key customers such as Japan, the US and Korea."
Econiche has the potential to significantly reduce the amount of E. coli O157 shed into the environment by beef and dairy cattle, the company relays. Although E. coli O157 does not cause illness in cattle, cattle are the primary reservoir for it. Vaccinating cattle with Econiche can help reduce the risk of food and waterborne contamination with E. coli O157, the company claims. Bioniche has been researching opportunities to introduce Econiche to markets beyond North America, where it has a full license in Canada and a pending conditional license in the US.
The Econiche vaccine is being produced in a product development lab at the company's Belleville, Ontario headquarters. The new Animal Health and Food Safety Vaccine Manufacturing Centre (VMC) in Belleville is still in the process of undergoing validation and commissioning, which is expected to be completed by early 2012. After that, production scale-up will occur and Econiche will be moved into the VMC fermentors. A first commercial batch of the product is expected to be made in the VMC by mid-2012.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing and marketing of proprietary, innovative products for human and animal-health markets worldwide.