World's First Cattle Vaccine to Reduce E. coli O157 Threat Receives Full Licensing Approval in Canada



    Econiche(TM) now available to reduce risk of food and water contamination

    BELLEVILLE, ON, Oct. 27 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC), a
research-based, technology-driven Canadian biopharmaceutical company, today
announced that Econiche(TM), the world's first vaccine designed to reduce the
shedding by cattle of Escherichia coli (E. coli) O157:H7, has received full
licensing approval from the Canadian Food Inspection Agency (CFIA). Econiche
is now available for unrestricted use by Canadian cattle producers and their
veterinarians.
    Econiche is a Canadian discovery developed by Bioniche Life Sciences Inc.
The vaccine has the potential to significantly reduce the amount of E. coli
O157 shed into the environment by beef and dairy cattle and, in turn, reduce
the risk to human health. The Econiche full license arrives on the heels of an
outbreak in North Bay, Ontario, Canada, where more than 200 people are
reporting symptoms and there are almost 40 lab-confirmed cases of human
illness including one case of Haemolytic Uremic Syndrome (HUS). The illnesses
are associated with a Harvey's Restaurant in that community. Another outbreak
involves iceberg lettuce, with 50 people made ill in Michigan, Illinois and
Ontario since early September, 2008.
    Most strains of E. coli are harmless but some, like O157:H7, can cause
severe illness and even be fatal when ingested by humans from contaminated
meat, vegetables or water. Vaccination of cattle with Econiche can help reduce
the risk of food and waterborne contamination with E. coli O157:H7.
    "Cows carry E. coli O157:H7 but they don't get sick. Where the disease
comes from is people encountering contaminated food or water, usually from cow
feces," said Dr. Brett Finlay, University of British Columbia microbiologist
and bacterial diseases expert, whose research led to the development of the
vaccine. "If we block the colonization of cows by O157, we basically decrease
the number that humans are exposed to, and thus, dropping the disease levels
in humans."
    On-farm interventions to reduce the shedding of E. coli O157:H7 by
cattle, such as simple vaccination of cattle with Econiche, have the potential
to reduce food and water contamination and the consequences associated with
human infection with the deadly bacteria. Clinical trials conducted with
Econiche have shown a significant reduction in the amount of E. coli shed in
the manure of vaccinated cows.
    "We've been trying to do our part to be an industry leader in food
safety," said Kym Anthony, owner of specialty beef producer Top Meadow Farms
in Clarksburg, Ontario, who has been using the vaccine for the past year under
Permit to Distribute Veterinary Biologics. "The E. coli vaccine fits into
that. It's been a missing link in the industry thus far."
    Human exposure and infection with E. coli O157:H7 can result in serious
health consequences, including abdominal pain and severe bloody diarrhea. In
severe cases, kidney damage can occur and progress to serious complications
and even death.
    "The announcement of this vaccine's full Canadian licence is great news,"
said Dr. Hazel Lynn, Medical Officer of Health for the Grey Bruce Health Unit,
which includes the town of Walkerton, Ontario, where seven people died and
more than 2,000 became ill in May 2000 as a result of contamination of the
town's water supply with E. coli O157:H7 in cattle manure from a local farm.
"This is an innovative way to reduce this public health risk."
    Another important risk area for the public to be infected by the bacteria
is through contact with farm animals at petting zoos and agricultural
exhibitions. Vaccinating these animals with Econiche can help greatly reduce
this risk of bacteria transmission, something that has been recognized by the
Canadian Association of Fairs and Exhibitions (C.A.F.E.).
    "C.A.F.E. supports any intervention that will reduce the amount of E.
coli O157:H7 that is shed by cattle and may enter the environment, water
and/or food chain," said Rudy Friesen, President of C.A.F.E. "C.A.F.E. also
recommends widespread adoption of a proof of vaccination policy throughout
Canada, which will ensure that the fairs and exhibition sector has taken all
reasonable steps for the public to safely interact with livestock."
    Econiche will be manufactured in the Bioniche production facility in
Belleville, Ontario, where a $25-million expansion is taking place, supported
by the Ontario and Canadian governments. Vaccine supply will be limited during
this manufacturing expansion period.

    About E. coli O157:H7

    An estimated 100,000 cases of human infection with the E. coli O157:H7
organism are reported each year in North America. Two to seven per cent of
those people develop haemolytic 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 Econiche

    Econiche 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 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 six years.
    Two articles were published in a peer-reviewed journal, the Journal of
Food Protection, with regard to the efficacy of Econiche. These articles were
related to field challenge studies conducted at the University of
Nebraska-Lincoln involving close to 900 animals in 2002 and 2003. Among the
findings by researchers Dr. David Smith and Dr. Rod Moxley et al: Vaccinating
a majority of cattle within a pen resulted in a significant protective effect
to unvaccinated cattle in the same pen. This effect is called "herd immunity".
Another article was recently published in Foodborne Pathogens and Disease
outlining the outcome of a clinical vaccine trial of commercially fed cattle
that tested the effect of a two-dose regimen of Econiche against type III
secreted proteins of enterohemorrhagic Escherichia coli (E. coli) O157:H7 on
the probability of detecting the organism on environmental sampling devices.

    U.S. Regulatory Status

    Bioniche Life Sciences Inc. is concurrently working to meet the
requirements for a U.S. conditional license for Econiche. The United States
Department of Agriculture (USDA) informed the Company in February of this year
that the latest data for Econiche "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 the trademark for the
vaccine.

    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.

    Bioniche Life Sciences Inc. is holding a press conference at 10:00 a.m.
EDT, on Monday, October 27, 2008. Real-time video webcast of press conference
is available online. To view it, go to:
http://webcast.marsdd.com/bioniche/2008-10-27/

    
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For further information:

For further information: Jennifer Shea, Vice-President, Communications,
Investor & Government Relations, Bioniche Life Sciences Inc., Telephone: (613)
966-8058, Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com; Ethan Pigott, Hill
and Knowlton Canada, Cell: (416) 558-2783, Ethan.pigott@hillandknowlton.ca

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