BELLEVILLE, ON, Aug. 23 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, today 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 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.
CONTACT: Jennifer Shea, Corporate Communications & Investor RelationsManager, Bioniche Life Sciences Inc., Telephone: (613) 966-8058, Cell:(613) 391-2097, Jennifer.Shea@Bioniche.com