Pre-harvest vaccines for management of E. coli in Canadian beef receive favourable conclusion

May 29 2012

-Public Health Agency of Canada study evaluated the effects of various interventions-

Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that a Public Health Agency of Canada study assessing the effects of various interventions on the management of E. coli O157:H7 in Canadian beef came to a favourable conclusion with regard to pre-harvest vaccines such as the Company's Econiche^TM cattle vaccine. The study, "A risk assessment model for Escherichia coli O157:H7 in ground beef and beef cuts in Canada: Evaluating the effects of interventions", has been accepted for publication in an upcoming issue of Food Control (2012) and is now available on-line. Its authors are Ben A. Smith, Aamir Fazil and Anna M. Lammerding, all of whom work in the Science to Policy Division, Laboratory for Foodborne Zoonoses, Public Health Agency of Canada.

In their study, the three researchers developed a stochastic, quantitative risk assessment model to evaluate the public health risks associated with consumption of ground beef and beef cuts contaminated with Escherichia coli (E. coli) O157:H7 in Canada. The researchers evaluated the relative effects of pre-harvest and processing interventions on public health risks, comparing the baseline risks from consumption of beef products.

The research included findings from critical systematic review and meta-analysis of published literature, and 20 different intervention scenarios were assessed. The pre-harvest interventions that were assessed included probiotics, an SRP vaccine, and a Type III protein vaccine. Production/processing interventions that were analyzed included hot water wash, steam pasteurization, acid spray chill, dry-aged chill, and water spray chill. The researchers concluded that the most effective strategy for E. coli O157:H7 management includes a pre-harvest intervention and several processing interventions: "Specifically, application of Type III secreted protein vaccination along with a suite of processing interventions … provided the greatest relative reduction in risks." The Company's Econiche^TM vaccine is a Type III protein vaccine.

The findings from this study support the Company's ongoing efforts to gain widespread uptake of cattle vaccination with Econiche^TM.

Econiche^TM Regulatory/Market Update

Since October, 2008, the Company has had a full license for its cattle vaccine against E. coli O157 - Econiche^TM - in Canada. In the intervening period, there has been limited uptake by Canadian cattle producers. Those who have adopted the technology have been small producers who have a branded beef product and are concerned about the negative impact of an E. coli outbreak on their brand, and those producers/farmers whose cattle have infected humans with E. coli O157. Outbreaks and recalls associated with E. coli O157 infection and contamination continue to occur on a regular basis, so this public health threat remains a grave concern.

In February, 2008, the Company was advised by the United States Department of Agriculture (USDA) that Econiche^TM was eligible for a conditional license once certain conditions were met. Since that time, the Company has been in regular dialogue with USDA officials about this license.

Most recently, the USDA's Center for Veterinary Biologics issued updated guidance regarding the licensing of vaccines as pre-harvest food safety interventions. Company representatives look forward to discussing this new guidance with the USDA, to collaboratively reach consensus on the path to vaccine licensing in the U.S.