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