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 can cause intestinal disease and, occasionally, other significant systemic disease. The E. coli O157:H7 bacterium, which was first identified in South America in the late 1970s and drifted northward, produces a powerful toxin (shiga/vero toxin) that can cause severe illness in humans and often result from consumption of contaminated food or water.
Today, the bacteria can be found in most cattle herds in North America, South America, Europe and Asia. Ruminant livestock (e.g. cattle) are considered the major reservoir of E. coli O157:H7 worldwide. Numerous studies have demonstrated that the incidence of E. coli O157:H7 in beef and dairy cattle is widespread and that the organism is found in, on, and around cattle in all parts of the world. Use of manure as fertilizer for crop production and run-off from beef and dairy cattle operations are a source of contamination for the general environment, as well as surface and ground water. E. coli O157:H7 contamination of food and water as a result of fecal shedding by livestock is a well-recognized and documented threat to human health.
About E. coli O157:H7 Infection
The U.S. Centers for Disease Control estimates that E. coli O157:H7 infection affects some 73,000 people per year in the United States, and that 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. The annual cost in the United States is estimated at more than $650 million due to medical expenses, lost productivity and death.
About the E. coli O157:H7 Cattle Vaccine
This vaccine received international recognition last week by the Animal Pharm Industry Excellence Awards as the best new veterinary product for livestock. 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 195 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. For more information, please visit http://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.
|SOURCE Bioniche Life Sciences Inc.|
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