It means that Bioniche can supply its E. coli O157:H7 vaccine to veterinarians for use in Canadian cattle.

Yes. However, the Company is restricted in terms of marketing and promotion of the vaccine until a full license is in place.

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Veterinarians will be required to submit a formal request in writing to Bioniche for the vaccine which indicates that they are aware that the product is not fully licensed in Canada and that the efficacy is still under investigation. Bioniche will then obtain permission from CFIA to release the vaccine to the requesting veterinarian.

The CFIA has asked us for more efficacy data related to the reduction of shedding of E. coli O157:H7 in the manure of vaccinated cattle. Bioniche supplied this information in the spring of 2007.

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The CFIA indicated that they wanted to see more efficacy data. This is the first vaccine of its kind - a vaccine for animals against a bacterium that does not make the animals ill, but can be very dangerous to human health. The regulators wish to ensure that efficacy is well demonstrated before granting full registration.

The timeline for review of data and licensure of products is up to the regulator.

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Limited quantities of the vaccine are available for purchase now. We are seeking financing to apply to production scale-up at our manufacturing facility in Belleville, Ontario which will significantly increase the supply available.

The vaccine sells for less than $10 per animal. To put this in perspective, a cattle carcass will usually weigh around 600 pounds at maturity, so the cost would be less than 2 cents per pound of beef.

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The decision to vaccinate will be made by the individual cattle producer, however, there is expected to be significant pressure to do so from the outbreaks related to contamination of food by this bacterium which is a serious health concern for their customers.

There are approximately 115 million cattle in North America, 25 million of which are conditioned on feedlots. The feedlot cattle population is our first target market.

The CFIA has authorized a three-dose treatment regimen.

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The vaccine will be manufactured in Belleville, Ontario - at a Bioniche-owned facility. We grow the bacteria, then extract certain key proteins. The proteins are necessary for the unique attachment mechanism employed by the bacterium, and the vaccinated cow's immune system will produce antibodies which interfere with the bacteria's attachment proteins. The bacteria are not able to attach and reproduce in a cow that is vaccinated.

Escherichia coli (E. coli) bacteria are normal organisms found in the intestinal tract of all animals. There are hundreds of strains, most of which are non-pathogenic (disease causing) to their host; however, certain types cause digestive disturbances and, occasionally, other significant systemic disease. The O157:H7 variant of E. coli is a mutant that has acquired an extremely potent toxin from another bacterium: Shigella Dysenteriae. There are a number of theories about how this bacterium mutated, but the exact cause is not known. E. coli O157:H7 has been found in the intestines of healthy cattle, deer, goats, and sheep.

The O157:H7 strain attaches differently than other E. coli strains. Rather than attaching to a pre-determined receptor site in the host's intestine, it creates its own attachment site - a pedestal - that is developed through an interchange of proteins. Bacteria colonize on the pedestal, and its toxin can be released directly into the bloodstream. This can result in significant damage to human organs, including the kidneys, pancreas and brain.

The Bioniche E. coli O157:H7 vaccine causes the development of antibodies in the cow, which prevent the attachment of the proteins. If they cannot attach, they do not have an opportunity to colonize the animal's intestine where they would replicate extensively. Instead they pass through the intestine and so are not able to grow.

This vaccine is intended for use in cattle, to reduce the shedding of E. coli O157:H7 by cattle. This bacterium has turned up in fresh produce (alfalfa sprouts, lettuce, spinach, etc.) and the reservoir of contamination is the cow. Effective pathogen management consists of multiple interventions against a pathogen. The vaccine is not intended to replace existing methods for the reduction of E. coli O157:H7, such as hide washing, steam cabinets, etc. in the meat processing facility. Rather it is the only licensed pre-harvest (pre-slaughter) intervention, that can be employed at the farm level.

The vaccine is being sold to veterinarians, who will either administer it themselves or will supervise the vaccination. The veterinarian is expected to pass the cost of the vaccine on to the producer.

The vaccine is regulated by the Canadian Food Inspection Agency (CFIA), in consultation with Health Canada. Health Canada had raised concerns about potential health risks associated with accidental injection of the vaccine into the administrator. In order to provide the requested data to the CFIA, Bioniche agreed to conduct an additional animal safety study. The Company found published information about a piglet model, with which it conducted a study. The data from this study were submitted to the CFIA and Health Canada for review. On December 7th, Health Canada advised CFIA that it was their conclusion that there is no significant risk of toxicity associated with accidental self-injection by the vaccine administrator.

This was a study performed with an early prototype of the vaccine, where the method of making the vaccine and the profile of the proteins were markedly different to the later vaccine tested by the University of Nebraska-Lincoln. The earlier method was abandoned as it appeared to destroy the proteins that were essential to the vaccine's efficacy. We now have a method whereby the proteins are preserved and are effective. It is not uncommon to move through several prototypes during the course of developing a vaccine.

Dr. Brett Finlay at the University of British Columbia (UBC) made the original scientific discoveries that led to the development of the vaccine. He was doing basic research in the laboratory in 1995 when he made two fundamental discoveries: that the E. coli O157:H7 bacteria secrete proteins; and that, when injected directly into an intestinal cell wall, one of these proteins serves as a receptor, to which the bacteria adhere, allowing them to colonize the intestine.

Dr. Finlay realized that it might be possible to immunize against the attachment proteins of the bacteria. It initially occurred to him that this would be very useful in childhood vaccines. He subsequently determined that a cattle vaccine might be the better opportunity to pursue. He approached the Vaccine and Infectious Diseases Organization (VIDO) at the University of Saskatchewan to assist in making secreted proteins to immunize cows.

Bioniche Life Sciences, through the Canadian Bacterial Diseases Network (CBDN), became the commercial partner on the recommendation of Dr. Dragan Rogan, V-P of Animal Health research at Bioniche, who recognized the potential of the vaccine and the need for it. The partnership of UBC, VIDO, the Alberta Research Council and Bioniche, led by Dr. Rogan and his team, developed the vaccine.

In terms of financing, Bioniche Life Sciences was granted a contract (repayable loan) with Technology Partnerships Canada (TPC) in 2001, for the development of this vaccine. TPC agreed to contribute $7.6 million Cdn. to this project.

Yes we are. A quantity of data has been sent to the United States Department of Agriculture (USDA) for review. The USDA is the U.S. regulator of the vaccine. We plan to apply for registrations in Europe and other countries with significant cattle populations.

Providing the strain utilizes the same attachment mechanism as E. coli O157:H7, we expect that our vaccine will be effective. Studies are ongoing to assess this.

Given that some of the outbreaks of foodborne illness in produce from this bacterium are being traced back to contamination from non-beef cattle operations, there is potential for this vaccine to be utilized in dairy and cow/calf settings for reduction of shedding of E. coli O157:H7. Additionally, some human illness has been traced to exposure at show barns and petting zoos, demonstrating another cattle population that should be vaccinated.