- Australian Quarantine and Inspection Service (AQIS) issues permit to import EconicheTM -
BELLEVILLE, ON, Dec. 12, 2011 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that the Australian Quarantine and Inspection Service (AQIS) has granted an import permit for the Company's E. coli O157 cattle vaccine - EconicheTM.
The AQIS permit is a necessary first step in gaining access to the Australian market. The vaccine will require regulatory review by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The Company is preparing a regulatory dossier for submission to the APVMA in coming months.
There are approximately 38 million cattle in Australia and New Zealand (FAOStat). "Australia enjoys an estimated A$4.9 billion beef export market," said Mr. Rick Culbert, President of Bioniche Food Safety. "A vaccine such as EconicheTM would add further protective measures to preserve and enhance the reputation of Australian beef exports to key customers such as Japan, the U.S. and Korea."
EconicheTM has the potential to significantly reduce the amount of E. coli O157 shed into the environment by beef and dairy cattle. E. coli O157 does not cause illness in cattle, but cattle are the primary reservoir for it. Vaccination of cattle with EconicheTM can help reduce the risk of food and waterborne contamination with E. coli O157. The Company has been actively exploring opportunities to introduce EconicheTM to markets beyond North America, where it has a full license in Canada and a pending conditional license in the U.S.
The EconicheTM vaccine is currently produced in a product development laboratory at the Company's Belleville, Ontario headquarters. The new Animal Health and Food Safety Vaccine Manufacturing Centre (VMC) in Belleville continues to undergo validation and commissioning. This process is expected to be completed by early 2012, after which production scale-up will occur whereby EconicheTM will be moved into the VMC fermentors. It is expected that a first commercial batch of the product will be made in the VMC by mid-2012.
About E. coli O157
E. coli O157 can cause severe illness and can even be fatal when ingested by humans from contaminated meat, vegetables, other food products, or water. Human exposure and infection with E. coli O157 can result in serious health consequences, including abdominal pain and severe bloody diarrhea. In severe cases, kidney damage can occur and progress to serious complications and even death. Lingering, long-term medical conditions can persist in individuals exposed to the bacterium. These include post-infectious irritable bowel syndrome (PI-IBS), reduced kidney function, diabetes, hypertension and reactive arthritis.
An estimated 100,000 cases of human infection with the E. coli O157 organism are reported each year in North America. Two to seven per cent of those people develop haemolytic uremic syndrome (HUS), a disease characterized by kidney failure. Five percent of HUS patients die, many of them children and senior citizens, whose kidneys are more sensitive to damage. Among the many outbreaks recorded, a 1996 Japanese outbreak made more than 9,000 people sick while the Walkerton, Ontario outbreak in 2000 sickened 2,500. Recent outbreaks have been tied to romaine lettuce in the U.S., a state fair in the U.S., and a nursery school in North Wales.
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 and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.
Bioniche Life Sciences Inc. has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2010. 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.
SOURCE Bioniche Life Sciences Inc.