Given that 80% of all antibiotics sold in the U.S. are for use in poultry and livestock for purposes that are not always related to treatment of disease, there is an unmet need to develop and commercialize products that can replace antibiotics in livestock feeds, as doing so could provide health and economic benefits to food producers and have a dramatic effect at curbing the rise of deadly, antibiotic-resistant bacteria strains.
Avivagen believes its proprietary, non-antibiotic, hormone-free OxC-beta™ technology holds the key to balancing the food production industry’s need for the benefits of antibiotics with society’s need to preserve antibiotics for only medically necessary uses.
Avivagen, the National Research Council of Canada, and other funding and research partners have invested over two decades and roughly $30 million into extensive studies of OxC-beta™, ultimately finding that the improvement in animal health using OxC-beta™ is comparable to what occurs using antibiotics. The Company’s scientific studies have been published in four peer-reviewed journals: the Canadian Journal of Chemistry, PLOS ONE, the American Journal of Veterinary Research, and the Journal of Agricultural and Food Chemistry.
The biological effects of OxC-beta™ at stimulating the immune system are host-mediated, meaning there are no direct antibacterial effects and thus zero likelihood of creating antibiotic-resistant pathogens.
OxC-beta™ Livestock is cleared for sale in the Philippines, where commercial sales started during 2016, Thailand, and Taiwan. Avivagen is also pursuing product registration and distribution agreements in other countries, including a joint venture recently established in China—the world’s top market for livestock feed.
In April 2016, Avivagen authored a peer-reviewed article published in the Journal of Agricultural and Food Chemistry detailing a discovery that the bioactive component of OxC-beta™ occurs naturally in human foodstuffs. These findings are helping drive the Company’s human health platform, and are expected to favorably impact the ability of Avivagen to gain regulatory acceptance for its OxC-beta™ technology in humans given the inherent safety of its primary ingredient. New patent applications also stem from this discovery.
The global animal feed additives market is projected to cross $37 billion by early 2022 from $28.6 billion in 2016, growing at a CAGR of over 5.3% over the forecast period.
The rise of drug-resistant bacterial superbugs has been a concern of public health officials for years. In a worst case scenario case, the U.S. CDC reported in January 2017 that a woman with a bacterial infection that was resistant to all FDA-approved treatments had died after being infected with a drug-resistant bacterium, Klebsiella pneumonaiae, that was resistant to all antibiotics available in the U.S.
On January 3, 2017, the FDA announced that it had completed the implementation of Guidance for Industry #213 to transition antimicrobial drugs with importance in human medicine (medically important antimicrobials) that are used in the feed or drinking water of food-producing animals to veterinary oversight and eliminate the use of these products in animals for production (e.g., growth promotion) purposes. With these FDA Guidelines, some farmers, ranchers, veterinarians, and others may face challenges as they adjust to these changes, which is what Avivagen’s product has been developed to address.
The Company is led by a skilled executive management team that combines scientific expertise (chemists, veterinary scientists, and biomedical researchers) with business acumen from the life sciences, pharmaceutical distribution, and corporate finance worlds.
Avivagen’s intellectual property encompasses six patent families, with protections globally as far out as 2036.
At January 31, 2017 (Avivagen’s Q1), Avivagen held cash and cash equivalents of over C$5.4 million, up from C$5.1 million on October 31, 2016. At October 31, 2016 (Avivagen’s fiscal year end), the Company held cash and cash equivalents of over C$5.1 million, up from C$632,247 on October 31, 2015. The increase in cash is primarily due to raising C$6,694,703 in financing activities during the year, which were offset by C$2,752,498 in operating losses.