Antibiotic Alternative for Cattle Approved for Sale in Canada by the Canadian Food Inspection Agency

13 July 2016

Belleville, Ontario – NovaVive Inc., a Canadian immunobiology company, today announced that its cattle immunotherapeutic – Amplimune™ - has received approval for sale in Canada by the Canadian Food Inspection Agency (CFIA). The Company believes this is the first antibiotic alternative therapy for livestock to receive Canadian regulatory approval.

Amplimune reduces the clinical signs and mortality associated with E. coli K99 diarrhea in neonatal calves. The product is an emulsion of mycobacterium cell wall fractions (MCWF) that enhances innate immunity to fight bacterial infections without the use of antibiotics. The product can be administered by intravenous, intramuscular or subcutaneous injection.

Antibiotic resistance is an ever-increasing problem in both humans and animals, in Canada and globally. In animals, this has primarily resulted from indiscriminate use and overuse of antibiotics as preventative therapies or growth promoters. “The development of antimicrobial-resistant pathogens in animals can pose serious risks to human health when they are transmitted as food-borne or water-borne contaminants. Antimicrobial-resistant infections are associated with a greater risk of death, more complex illnesses, longer hospital stays and higher treatment costs.” (Health Canada)

In Canada, more than three quarters of all antimicrobials (antibiotics) are sold for use in animals. In 2013, this amounted to approximately 1.6 million kilograms (1,600 tonnes). Only 10% of animal antibiotics are used to treat disease and infection, while the remaining 90% are used routinely to promote growth or prevent disease. (Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS) 2008 and Canadian Antimicrobial Resistance Surveillance System – Report 2015)

“There is a growing market for effective antibiotic alternatives,” said Graeme McRae, President of NovaVive Inc. “Products like Amplimune that activate the body’s innate immune system to fight infection and disease are one such alternative. Having met the rigorous efficacy and safety standards of the Canadian Centre for Veterinary Biologics (CCVB) division of the CFIA, we are excited to be taking this proactive step to help Canadian cattle producers curb antibiotic use in their herds.”

There are approximately 960,000 dairy cattle and approximately 3.8 million beef cattle in Canada (producing 3.9 million calves per year) (Statistics Canada).

About NovaVive Inc.

NovaVive is a private company founded in July, 2014. The Company acquired an advanced veterinary immunotherapeutic platform based on mycobacterium cell wall fraction (MCWF) with four regulator-approved products. Certain formulations have demonstrated the capability of reducing the reliance on antibiotics in the treatment of diseases of horses and cattle. Other formulations have been developed as anticancer therapies in dogs and horses and as a respiratory disease treatment for horses.

NovaVive has also acquired the global license to mycobacterial cell wall-nucleic acid complex (MCNA) for treating animal cancers. MCNA is an advanced formulation of mycobacterium cell walls and nucleic acids formulated for human applications. MCNA has been advanced through Phase III in the treatment of human bladder cancer by Bioniche Life Sciences (now Telesta Therapeutics).

-----------------------------------------------------------------------------------------------------------------------------------------------------------

For more information about the Company, please visit www.NovaVive.ca, or contact:

Graeme McRae, President
Graeme.McRae@NovaVive.ca
Phone: 613-391-3837

or

Jennifer Shea, V-P, Investor Relations & Business Development
Jennifer.Shea@NovaVive.ca
Phone: 613-391-2097

Sign up to stay up-to-date with NovaVive news.