Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, announced today that it has received notice from the U.S. Department of Agriculture that the latest data for its Escherichia 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 Bioniche full access to the U.S. market with two restrictions: At least one step in the manufacturing process must be performed in the U.S. 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, Ont., where a two-year, $25 million expansion is taking place. Vaccine supply will be limited during this manufacturing expansion period.
In order to begin providing vaccine to U.S. cattle producers, Bioniche is required to produce three validated production lots that will be filled in the U.S., in accordance with the Virus-Serum-Toxin Act of 1913 as amended in 1985.