BELLEVILLE, ON, Feb. 5 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today received notice from the United States Department of Agriculture (USDA) that the latest data for its E. coli O157:H7 cattle vaccine "meets the 'expectation of efficacy' standard" and is eligible for a conditional license, providing that the Company develops a plan "that would collect sufficient data to move the product to full licensure". The conditional license, when granted, will provide the Company full access to the U.S. market with two restrictions: At least one step in the manufacturing process must be performed in the United States and Bioniche will not be permitted to use a trademark name for the vaccine.
The Bioniche vaccine is the world's first vaccine that may be used as an on-farm intervention to reduce the amount of E. coli O157:H7 shed by cattle. Bioniche and its collaborators have been moving the vaccine towards commercial availability for eight years and it has been extensively tested at the University Nebraska-Lincoln, with efficacy results now being published in peer-reviewed scientific journals, most recently, the Journal of Food Protection, in November, 2007. The E. coli O157:H7 cattle vaccine will be manufactured in the Bioniche production facility in Belleville, Ontario, Canada where a two-year, $25 million expansion is taking place. Vaccine supply will be limited during this manufacturing expansion period.
"This is a large step forward for the E. coli O157:H7 vaccine," said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "The granting of a U.S. conditional license will permit U.S. beef and dairy producers access to a scientifically-validated means to reduce the risk of E. coli O157:H7 contamination."
Rick Culbert, President of Bioniche Food Safety, added, "There are an
estimated 97 million cattle in the United States, many of which carry an
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