Bioniche Receives Comment from USDA on a Field Trial for E. coli O157:H7 Catt...( BELLEVILLE ON Oct. 5 / Bioniche L...),Health

BELLEVILLE, ON, Oct. 5 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that it has received a letter from the U.S. Department of Agriculture (USDA) regarding field use data submitted in support of licensure of the Company's proprietary E. coli O157:H7 cattle vaccine. The USDA indicated that based on their statistical treatment of results from the field use study conducted by the University of Nebraska-Lincoln last year, the data would not support licensure at this time.

The Company will submit additional statistical analyses and supporting rationale to the USDA in the coming weeks. If the regulator retains its current position, the Company will be required to pursue additional vaccine studies in 2008.

Separately, the vaccine remains under review by The Canadian Food Inspection Agency (CFIA). In the course of its review process, the CFIA approved distribution of the vaccine under its Permit to Release Veterinary Biologics regulations. This is equivalent to a conditional license in the U.S. and allows Canadian cattle owners, through their veterinarians, to request vaccine be supplied to them by Bioniche.

As proven by the recent U.S. recall of 21.7 million pounds of ground beef due to potential E. coli O157:H7 contamination (the third multi-million pound recall in the U.S.) and further produce-related outbreaks/recalls, there remains a pressing need for reducing E. coli O157:H7 shed into the environment by cattle. Pre-harvest interventions to reduce the shedding of E. coli O157:H7 by cattle may assist in reducing the potential for food and water contamination and the resulting human illnesses and deaths.

About E. coli O157:H7

Escherichia coli (E. coli) bacteria are normal organisms found in the intestinal tract of all animals and humans. Most E. coli are non-pathogenic (non-disease-causing) to their host. However certain strains
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