- clears path for full license -
Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, has received notice from the Canadian Food Inspection Agency (CFIA) that the data package for its E. coli O157 cattle vaccine provides definitive evidence that the vaccine meets the efficacy and safety requirements for full licensing of the vaccine.
Additional data confirming reduction in E. coli O157 shedding by vaccinated animals was provided by the Company, which led to this recognition from the CFIA. The most recent submission to the regulator involved data from a controlled challenge study conducted at the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan. This study demonstrated a significant reduction in the number of bacteria shed by vaccinated animals and the number of animals shedding.
The National Manager of the Veterinary Biologics Section, Animal Health and Production Division of CFIA, Dr. Glen Gifford, stated, "Based on the satisfactory results of the Bioniche-VIDO study, and supplemental information from Bioniche's other studies, we have concluded that Bioniche has met the efficacy and safety requirements for licensing of this product."
As part of standard licensing requirements, the Company is required to complete quality control tests on three pre-commercial batches to verify consistency of manufacturing processes. The Company expects to meet these requirements within the next few months.
The Company was issued notification that it was allowed to distribute the vaccine under the Permit to Release Veterinary Biologics Regulations by the CFIA in December, 2006.
"This news from CFIA is extremely encouraging," said Graeme McRae, Chairman, President & CEO of Bioniche Life Sciences Inc. "We have demonstrated definitive efficacy of the vaccine and, on completing one last task, we'll have a full license in hand."
The Company is concurrently working to meet the requirements for a U.S. conditional license for the E. coli O157 vaccine. The United States Department of Agriculture (USDA) informed the Company in February of this year that the latest data for its E. coli O157 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 vaccine.
Food recalls due to E. coli O157:H7 contamination continue to be a concern in beef, produce and prepared food. This summer, a single U.S. outbreak involved seven states and resulted in at least 60 serious human infections following consumption of E. coli O157:H7-contaminated beef. 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.
An estimated 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 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.
The E. coli O157 cattle vaccine will be manufactured in the Bioniche production facility in Belleville, Ontario, Canada where a two-year, $25 million expansion is taking place, supported by the Ontario and Canadian governments. Vaccine supply will be limited during this manufacturing expansion period.
About the E. coli O157 Cattle Vaccine
The Bioniche E. coli O157 cattle vaccine received international recognition in September, 2007 at 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 five years. Two articles have been published in a peer-reviewed journal, the Journal of Food Protection, in regards to the efficacy of the Bioniche vaccine. These articles 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". Additional publications are pending.
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.
%SEDAR: 00013159EF
SOURCE: Bioniche Life Sciences Inc.
Jennifer Shea, Vice-President, Communications, Investor & Government Relations, Bioniche Life Sciences Inc., Telephone: (613) 966-8058, Cell: (613) 391-2097, This email address is being protected from spambots. You need JavaScript enabled to view it.