USDA Agrees to Grant Conditional License to Bioniche for its E. coli O157:H7 Cattle Vaccine
BELLEVILLE, ON, February 5, 2008 – 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 and shed E. coli O157:H7. We look forward to working with producers to implement vaccination as the first licensed on-farm intervention for E. coli risk reduction."
In order to begin providing vaccine to U.S cattle producers, the Company is required to produce three validated production lots, which will be filled in the United States, in accordance with the Virus-Serum-Toxin Act of 1913, as amended 1985.
It has taken some months for USDA reviewers to complete their assessment of vaccine efficacy data against a pathogen with a complex life cycle in variable real-world environments. Both the USDA and Bioniche have been diligently working through these challenging issues with a view to benefiting public health and the cattle industry. "We are very pleased that the USDA reviewers recognize the scientific merit and importance to the market of this vaccine," added Mr. McRae. "The vaccine is especially novel in that it reduces shedding of an organism that, while potentially lethal to humans, causes no disease in cattle. As a result, it was particularly challenging for regulators – understanding the many implications of this vaccine as a tool in reducing the shedding and colonization of E. coli O157:H7 in cattle."
Food recalls due to E. coli O157:H7 contamination continue to be a concern in beef, produce and prepared food. On-farm interventions to reduce the shedding of E. coli O157:H7 by cattle, such as vaccination, may assist in reducing the potential for food and water contamination and the resulting human illnesses and deaths.
Approximately 100,000 cases of human infection with the E. coli O157:H7 organism are reported each year in North America. 2% to 7% of those people develop hemolytic uremic syndrome (HUS), a disease characterized by kidney failure (in recent outbreaks, this percentage has risen to as high as 16%). Five percent of HUS patients die, many of them children and senior citizens, whose kidneys are more sensitive to damage.
In addition to being infected by contaminated food or water, individuals can become infected from E. coli O157:H7 by visiting animal exhibits. Petting zoos, fairs, and agricultural exhibits provide many possible routes of transmission for E. coli. Direct animal contact is the obvious route, but contact with contaminated products (e.g., sawdust, shavings, soiled clothing or shoes) can also lead to human infection.
About the E. coli O157:H7 Cattle Vaccine
This vaccine received international recognition in September, 2007 by the Animal Pharm Industry Excellence Awards as the best new veterinary product for livestock globally. The vaccine has been developed by a strategic alliance formed in 2000 between the University of British Columbia (UBC), the Alberta Research Council (ARC), the University of Saskatchewan’s Vaccine & Infectious Disease Organization (VIDO), and Bioniche, which holds the rights for worldwide commercialization of the vaccine. The vaccine prevents the E. coli O157:H7 bacteria from attaching to the intestines of vaccinated cattle, thereby reducing their reproduction within the animal, and reducing the amount of bacteria that can be released through cattle manure in the environment. More than 30,000 cattle have been involved in clinical testing of the vaccine over the past five years.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs approximately 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company’s primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of Canada’s Top Ten Life Sciences Companies for 2008. For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain forward-looking statements that reflect the Company’s current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting.
For further information, please contact:
Jennifer Shea, Corporate Communications, Investor & Government Relations Director
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058
Cell: (613) 391-2097