Bioniche Life Sciences
Inc. (TSX: BNC), a research-based, technology driven Canadian
biopharmaceutical company, announced that the first permit has been
issued for its E. coli O157:H7 cattle vaccine ("the vaccine"), and that the
first order of vaccine has been shipped to that customer.
The vaccine will be used for the reduction of shedding of E. coli
O157:H7 bacteria in cattle. Shed bacteria can contaminate food, water and
the environment. Human exposures to this pathogen result in an estimated
100,000 cases of illness per year in North America. Bioniche believes that
use of the vaccine will reduce the amounts of bacteria in cattle and the
related incidence of human disease.
The vaccine remains under review by The Canadian Food Inspection Agency
(CFIA) and The United States Department of Agriculture (USDA). In the
course of its review process, the CFIA notified Bioniche last December that
it was agreeable to issuing permits under the Permit to Release Veterinary
Biologics regulations. These regulations allow cattle owners, through their
veterinarians, to request vaccine be supplied to them by Bioniche. At the
time this arrangement was accorded to the Company, meaningful quantities of
vaccine were not yet available.
Since that time, Bioniche has commenced production of the E. coli
O157:H7 cattle vaccine at its Belleville, Ontario facility. This supply is
now being provided to veterinarians requesting vaccine under the Canadian
Permit to Release regulations. Bioniche will continue to scale up as full
domestic and international approvals are received. Until such approvals are
received, all vaccine will be shipped to Canadian veterinarians as permit
requests are received and approved by the CFIA.
In order to progress from shipping under permits to a full license, the
CFIA indicated that Bioniche was required to provide additional data
confirming reduction in E. coli O157:H7 shedding by vaccinated animals.
This information was provided to the CFIA in the spring and is currently
under review.
Further information about initial vaccine orders will follow as such
customers consent to its disclosure and as Bioniche reports its financial
results.
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 185 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
Bioniche.
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.
Bioniche