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Avivagen Announces CEO Update Including OxC-beta(tm) Livestock Trial Results Versus Colistin

V.VIV

(via Thenewswire.ca)

Ottawa, ON / TheNewswire / Jan 8 2015 / - Avivagen Inc. (TSXV: VIV, OTC Pink: CHEXF), a life sciences company that develops and delivers products that support and enhance the health of livestock, pets and people, announces the release and website posting of a letter from its CEO providing updates about the company and its business plans. In addition to reading the letter, we encourage you to visit the Avivagen website at www.avivagen.com to learn more.

Dear Shareholders,

Avivagen has achieved a lot since my last letter to you and important changes have also taken place within our field of work. It is my pleasure to update you about those developments.

Avivagen continues the process of commercializing its non-antibiotic and naturally-occurring products based on OxC-beta(TM) Technology that, among their uses, are showing efficacy as a replacement for antibiotics in helping to maintain optimal health and growth in livestock.

We believe more strongly than ever in the value of our products following the discovery of widespread and readily-transmitted resistance to a commonly-used class of livestock antibiotic, known to industry as colistin or polymyxin and better known to consumers for being a part of Polysporin(R) antibacterial products: In November, the journal Lancet Infectious Diseases published work from Chinese researchers who found bacteria have developed resistance to that class of antibiotics and are spreading: They found the bug in livestock, people and as much as 28% of meat samples tested1. Closer to home, it was very recently announced that Canadian meat is also impacted: Samples of ground beef from Ontario were found to contain bacteria with the same antibiotic-resistance reported in China.2

This is not surprising. Like China, Canada is dependent on using antibiotics in its livestock feeds. In fact, in November, The College of Veterinarians of Ontario released a report stating that "The use of antibiotics is a cornerstone of food animal production systems in Ontario. Antibiotics are broadly used in the treatment and prevention of infectious disease, and sub-therapeutically to promote growth and increase feed efficiency.3" That seems in conflict with many human health specialist opinions about the Lancet findings, such as "The only way to stop this problem is to stop the antibiotic use in animals - otherwise we risk a major public health catastrophe.4"

As previously indicated, OxC-beta(TM) Livestock has demonstrated efficacy in helping to maintain optimal food animal health and growth without having any antibiotic effects. We now detail that in the disclosed Vietnamese swine trial, OxC-beta(TM) Livestock was tested head-to-head versus colistin plus tetracycline.5 For in-feed growth promotion and disease prevention for the first month post-weaning, as little as 2 parts-per-million (2 ppm) of OxC-beta(TM) Livestock convincingly outperformed colistin at 100 ppm plus tetracycline at 150 ppm. Further swine trials testing OxC-beta(TM) Livestock versus colistin are now underway to confirm the reproducibility of such results.6

Furthermore, Avivagen believes changes are happening concerning the livestock industry and the routine use of antibiotics in animal feeds. A representative of a global fast food chain summarized it well at a veterinary conference we attended in 20157, noting that "These issues are no longer driven by special interests but are instead beyond the tipping point and are mainstream" and going on to also say, "This tidal wave will change your business." We believe those assertions are evidenced by the following developments:

  1. 1.Retailers Responding to Customer Demands. Further restaurant chains and grocers committing to move away from meat that relies on routine use of antibiotics for its production. New promises in 2015 included Subway U.S., McDonalds Canada, Costco and Walmart. In most cases, their implementation timelines range from one to three years.

  1. 2.Governments Tightening Restrictions. Aligning with regions like the E.U., important new legal restrictions on the use of antibiotics in livestock feed were recently adopted by California - a state long regarded as a leader in progressive public policies.8 Additionally, the European Medicines Agency has released a new strategy for antibiotic usage that proposes further restrictions and notes "Antimicrobials should never be used preventatively to compensate for the impact of husbandry systems or a lack of biosecurity.9"

  1. 3.New Proof of Dangers. It seems difficult to overstate the danger posed by the widespread transmission of resistance to colistin/polymyxins. This class of antibiotics is used as a last-ditch defense against drug-resistant bacterial infections in humans and the resistant bacteria are being found in animals, store-bought meat and, likely in consequence, have spread to and sickened people - even in Ontario. The Lancet article concludes with the warning that "In the absence of new agents effective against resistant Gram-negative pathogens, the effect on human health by mobile colistin resistance cannot be underestimated."

  1. 4.Global Livestock Integrators Responding. One of the largest U.S. poultry producers has stopped giving antibiotics used in human medicine to half its healthy birds.10 Among those potential Asian customers with whom we have met, multiple large feed and livestock producers are quickly and quietly moving away from the use of antibiotics in feeds for their healthy animals. While OxC-beta(TM) Livestock isn't the only available replacement for antibiotics in feeds, our view is that our trial results indicate that it seems the best.

In light of growing awareness of the dangers posed by the use of antibiotics in livestock feeds and ballooning interest in alternatives to antibiotics, we believe we are making strong progress towards global commercialization of OxC-beta(TM) Technology. Notable achievements and ongoing work include the following:

  1. 1.Program of Further Trials. Recalling that OxC-beta(TM) Livestock outperformed colistin in each swine production parameter we measured, it is worth noting the Lancet reported sales of colistin alone to be US$229.5 million in 2015. Each new positive study strengthens the case for national approvals and for producers to switch to our product. We are aggressively pursuing additional trials of OxC-beta(TM) Livestock in Asia in order to provide such support for our commercialization efforts.

  1. 2.Enhancing Intellectual Property. While Avivagen already has five families of issued or pending patents, we continue to build our intellectual property portfolio, aided by the results of each new livestock trial run using our product. We started our fifth patent family in 2015 and over the past 24 months one of our existing patents issued in the countries of Argentina, Chile and New Zealand.

  1. 3.Additional Publications. We believe that peer-reviewed scientific publications and abstract presentations generate value by building our credibility with all stakeholders. Our initial chemistry article, two biology articles and two livestock abstracts will soon be followed by other published science. Those new works are intended to expand the awareness and credibility of oxidized carotenoid polymers' natural presence in foods and the health and nutrition benefits observed in species such as pigs, chickens and dogs.

  1. 4.Marketing Approvals. We hope to obtain marketing approvals in further Asian nations in 2016. We also believe that the combination of further Asian marketing approvals, results of additional livestock trials and new scientific publications will assist us in obtaining marketing approvals both in Europe and North America.

  1. 5.New Commercial Relationships. Our network of livestock industry relationships continues to expand and we hope to announce further relationships with potential feed and livestock customers in 2016.

  1. 6.Human Health Applications. While our initial commercial focus has been companion animals and livestock, we believe that our, OxC-beta(TM) Technology may be as relevant to helping maintain optimal human health as it seems to be for to the health of other animals. We have therefore recently initiated human proof-of-concept discussions with multiple qualified parties.

While no CEO update can address all shareholder questions and concerns, I hope that this letter provides you greater clarity about where management has been focusing Avivagen's resources. We remain energized and optimistic about our company's prospects. On behalf of the entire Avivagen team, I thank you for your support.

Sincerely,

Cameron Groome - CEO & President, Avivagen Inc.

References

1. Lancet Infectious Diseases: Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study, Liu et al., Published online 2015-11-18.

2. The Toronto Star: 'Disturbing' drug-resistant superbug gene has been detected in Canada, also The Globe and Mail: Everything you need to know about the ominous new 'superbug' 2015-1-06.

3. The College of Veterinarians of Ontario, Antibiotic Use in Food-Producing Animals in Ontario: A Study of the Current Practices and Perceptions of Ontario Veterinarians - Final Report 2015-11-17.

4. Drug Discovery & Development News: Antibiotics On Our Plate Could Lead to Human Health Crisis, 2015-11-23.

5. Avivagen News Release entitled "Avivagen Summarizes Final Swine Trial Results", 2015-2-11.

6. Avivagen News Releases entitled "Further Swine Trial Agreement with National Institute of Animal Sciences for Vietnam" and "Swine Trial Agreement with COFCO NHRI of the People's Republic of China" 2015-10-26 & 2015-10-30.

7. The VetHealth Global 2015 conference, held in Charlottetown, P.E.I., Canada on June 8-10, 2015.

8. Associated Press: California Adopts Strict Limits on Livestock Antibiotics - State bans giving antimicrobial drugs to livestock unless ordered by veterinarian, 2015-10-30

9. European Medicines Agency, Committee for Medicinal Products for Veterinary Use (CVMP), CVMP Strategy on antimicrobials 2016-2020 - 2015-11-17

10. The New York Times: Perdue Sharply Cuts Antibiotic Use in Chickens and Jabs at Its Rivals, 2015-7-31

About Avivagen Inc.

Avivagen Inc. is a publicly-listed life sciences company trading on the TSX Venture Exchange under the ticker symbol "VIV" and on OTC Pink as "CHEXF." The Company's goal is to develop and deliver scientifically-proven solutions that benefit companion and production animals by employing natural mechanisms for maintaining good health. Target markets include Livestock Productivity and Pet Wellness.

Avivagen is based in partnership facilities of the National Research Council of Canada (NRC) - in Ottawa, Ontario and Charlottetown, Prince Edward Island. For more information, visit www.avivagen.com.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "aim", "anticipate", "appear", "believe", "consider", "could", "estimate", "expect", "if", "intend", "goal", "hope", "likely", "may", "plan", "possibly", "potentially", "seem", "should", "whether", "will", "would" and similar expressions. Statements about uses of the technologies described in this news release, including their importance to animal or human health, their novelty, safety, efficacy or affordability, whether trial conditions represent typical commercial conditions or are repeatable, intentions to conduct additional trials and to publish additional papers regarding technologies, intentions to seek additional marketing approvals and whether that will be successful, the continued ability to protect and expand the intellectual property portfolio, corporate activities or their relevance, when and whether meaningful sales will be achieved, changes within the livestock feed industry and food industries, characterizations of the views of prospective customers and activities in livestock, pet or human health , are all forward looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. Such Avivagen risks and uncertainties include, but are not limited to, the following: its ability to continue as a going concern; the results of ongoing or future trials may not be positive or sufficiently positive; even if the results of trials are positive, there is no guarantee that its products will be commercially successful or that requisite regulatory approvals will be obtained; the timing and results of trials may be delayed or may not be completed at all; and intellectual property rights may prove inadequate to protect its inventions. Accordingly, readers should not place undue reliance on forward-looking statements. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.

Cameron Groome, CEO & President
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Head Office Phone: 613-949-8164
Website: www.avivagen.com

Copyright (C) 2015 Avivagen Inc.

OxC-betaTM, Vivamune(TM) and Oximunol(TM) are trademarks of Avivagen Inc.

Copyright (c) 2016 TheNewswire - All rights reserved.



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