BELLEVILLE, ON, Oct. 5 /CNW/ - 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 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:
For further information: Jennifer Shea, Corporate Communications &
Investor Relations Manager, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com