- E. coli O157:H7 vaccine named "best new veterinary product for livestock"
BELLEVILLE, ON, Sept. 27 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that its vaccine against E. coli O157:H7 in cattle has been recognized internationally as the best new veterinary product for livestock. The Company received the Animal Pharm industry excellence award at the Animal Pharm Awards '07 dinner this week in London, UK. Animal Pharm is a worldwide business-to-business news service for the animal health industries, published by Informa Healthcare, part of the Informa Group. The Animal Pharm newsletter has been published for more than 20 years and has more than 2,000 readers in animal health companies and related businesses around the world (http://www.animalpharmnews.com or http://www.animalpharmawards.com ).
The "best new veterinary product for livestock" award recognizes excellence in pharmaceutical or vaccine development for production animals. In this category, the 12-member panel of independent industry judges looks for the product that represents the greatest therapeutic, prophylactic, or production advance. The shortlist of nominees for this award included Merial SAS, Norbrook Laboratories Ltd. and Schering-Plough Animal Health.
"This international recognition of our E. coli O157:H7 vaccine provides external validation of its importance and sophistication by our peers in the animal health industry," said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "This made-in-Canada technology has taken seven years of development and many millions of dollars in investment. It represents the first vaccine for intervention against this dangerous bacterium and we are proud to provide this vaccine to the marketplace."
The vaccine remains under review by The Canadian Food Inspection Agency (CFIA) and The United States Department of Agriculture (USDA). It is important to recognize that there is no precedent for a vaccine against a zoonotic agent (disease that transmits from animals to humans) where the animal is not made ill. In the course of its review process, the CFIA approved distribution of the vaccine under its Permit to Release Veterinary Biologics regulations. This is equivalent to a conditional license in the U.S. These regulations allow cattle owners, through their veterinarians, to request vaccine be supplied to them by Bioniche.
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.
About E. coli O157:H7
Escherichia coli (E. coli) bacteria are normal organisms found in the intestinal tract of all animals and humans. Most E. coli are non-pathogenic (non-disease-causing) to their host, however certain strains can cause intestinal disease and, occasionally, other significant systemic disease. The E. coli O157:H7 bacterium, which was first identified in South America in the late 1970s and drifted northward, produces a powerful toxin (shiga/vero toxin) that can cause severe illness in humans and often result from consumption of contaminated food or water. Today, the bacteria can be found in most cattle herds in North America, South America, Europe and Asia. Ruminant livestock (e.g. cattle) are considered the major reservoir of E. coli O157:H7 worldwide. Numerous studies have demonstrated that the incidence of E. coli O157:H7 in beef and dairy cattle is widespread and that the organism is found in, on, and around cattle in all parts of the world. Use of manure as fertilizer for crop production and run-off from beef and dairy cattle operations are a source of contamination for the general environment, as well as surface and ground water. E. coli O157:H7 contamination of food and water as a result of fecal shedding by livestock is a well-recognized and documented threat to human health, with approximately 100,000 North Americans made ill by it each year. For more information, please visit http://www.fightecoli.com.
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 195 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 http://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.
|SOURCE Bioniche Life Sciences Inc.|
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