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Avivagen Announces CEO Update & Preliminary Study Results

Thursday, 25 September 2014 08:00 AM

Avivagen Inc.

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Ottawa, ON / ACCESSWIRE / September 25, 2014 / Avivagen Inc. (TSXV: VIV, OTC Pink: CHEXF), a wellness company developing and delivering products that support and enhance the health and quality of life of animals and the people who care for them, announces the release and website posting of a CEO update letter that includes a discussion of the preliminary results from two Asian livestock studies. In addition to reading the contents of the CEO update letter below, we encourage you to visit the Avivagen website to learn more about the company, at www.avivagen.com.

Dear Shareholders,

It is my pleasure to provide a further update on the progress of our Company.

Previously, I've made reference to the dedication of our team, the properties of our OxC-beta technology and what we've been doing to position Avivagen for success. Today, I'm pleased to provide you an update concerning the results of our work.

First, our strategy of pursuing markets in Asia for OxC-beta is progressing. We have developed relationships in several important Asian countries and aim to achieve market access and formalize distribution arrangements in those markets over the coming quarters. Once approvals and distributors are in place, it is our goal to be able to immediately "ask for the order" when presenting our livestock study results to prospective customers in these large Asian markets.

Second, we have recently received preliminary results from our previously-disclosed swine study in Vietnam and poultry study in Korea. Although preliminary and still subject to multiple caveats, results appear very positive and numerically emulate prior swine and poultry studies conducted in Canada that showed improvements in feed conversion efficiency, growth and health. Specifically, even the lowest doses of OxC-beta tested are showing what we believe to be commercially-meaningful performance benefits that match or outperform the (positive) control animals treated with antibiotics. If the current trends hold, we believe that OxC-beta should be well received by swine and poultry producers. Final results of the swine study should be received in late 2014 and final poultry results are expected early in the second quarter of 2015. The salient characteristics of the two studies are summarized below:

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 |Study Species and Location:    |Swine– Vietnam                                       |Poultry– Korea                                                       |
 |-----------------------------------------------------------------------------------------------------------------------------------------------------------|
 |Study Title:                   |Evaluation of OxC-beta as a Growth                   |Preventative Effect of OxC-beta on                                   |
 |                               |Promoting Health Supplement for                      |Necrotic Enteritis Model with Broiler                                |
 |                               |Swine                                                |Chickens                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------------------------------------|
 |Levels of OxC-beta tested:     |2, 4&8 parts-per-million in feed                     |2, 4&6 parts-per-million in feed                                     |
 |-----------------------------------------------------------------------------------------------------------------------------------------------------------|
 |Positive Antibiotic Control(s):|Colistin Sulfate                                     |Bacitracin&Virginiamycin                                             |
 |-----------------------------------------------------------------------------------------------------------------------------------------------------------|
 |Study Period (per repeat):     |140 days                                             |28 days                                                              |
 |-----------------------------------------------------------------------------------------------------------------------------------------------------------|
 |Growth Measurements:           |ADFI, ADG, FCR, MBW                                  |ADG, FBW, FCR                                                        |
 |-----------------------------------------------------------------------------------------------------------------------------------------------------------|
 |Disease Challenge:             |Background Environmental                             |Clostridium perfringens                                              |
 |-----------------------------------------------------------------------------------------------------------------------------------------------------------|
 |Disease Measurements:          |Survival, clinical signs of illness, rate of diarrhea|Survival, clinical illness, lesions, CFU in feces, overall protection|
 |-----------------------------------------------------------------------------------------------------------------------------------------------------------|
 |Key: ADFI = Average Daily                                                                                                                                  |
 |Feed Intake, ADG = Average                                                                                                                                 |
 |Daily Weight Gain, FBW =                                                                                                                                   |
 |Final Body Weight, FCR = Feed                                                                                                                              |
 |Conversion Ratio, MBW = Mean                                                                                                                               |
 |Body Weight, CFU = Colony                                                                                                                                  |
 |Forming Units.                                                                                                                                             |
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Third, while we believe the science behind OxC-beta is strong, it becomes more compelling once peer-reviewed and published in recognized scientific journals. A first publication, on OxC-beta's composition, appeared in the Canadian Journal of Chemistry earlier this year (www.nrcresearchpress.com/journal/cjc). Since then, Avivagen and its collaborators have been writing further foundational science manuscripts and we hope to see one or more published before the end of calendar 2014. Such articles are expected to help us with both customers and regulatory authorities.

Fourth, we believe our option on a novel drug-based technology for the permanent sterilization of female mammals provides us the potential for a second exciting product. This fall, we expect the results of a proof-of-concept study showing whether this technology merits commercial development. If so, we believe this technology may replace the surgical spaying of dogs and cats - potentially transforming pet care and veterinary practice to provide us with what we believe to be a large market opportunity.

To summarize, we continue to advance the livestock applications of OxC-beta and are aiming to achieve meaningful product sales in Asia in calendar 2015. Such achievements could be supplemented by positive proof-of-concept data from the non-surgical sterilization technology.

But like all growth companies, we still have our challenges, including the following:

First, we are not satisfied with the progress of our U.S. marketing partner on our Oximunol pet care line or that we are achieving directly with our Vivamune pet care line. We believe this is partly due to the current lack of published science about OxC-beta and to the marketing restrictions placed on nutritional supplements. To be specific, most vets and pet owners have never heard of OxC-beta and we cannot make any therapeutic (disease curing) claims - so it is hard to distinguish our science-based pet-directed supplements from "Mom & Pop" products that seem to make outlandish efficacy claims but appear to be less scrutinized by regulators. We are working to address these challenges.

Second, we are building Avivagen on a very frugal basis - trying our best to make every penny count. But we are still incurring net losses that will continue until we succeed in generating material sales of OxC-beta products in the livestock or companion animal markets. To be blunt, we believe our financial limitations reduce our ability to build and maximize shareholder value.

Third, our budget also limits our access to human resources. We believe we are developing two potentially transformative animal health technologies and maintaining the responsibilities of a public company with only a dozen full-time staff, some valued advisors and our corporate directors. This low head-count limits how many tasks we can manage in parallel (i.e., the number of trials, scientific publications and national markets). We are only able to maintain a high level of performance and professionalism due to a great team effort and I am grateful to each and every one on our team.

To summarize, we believe we are making strong progress; addressing our challenges and remaining committed to making Avivagen a pre-eminent creator of products for companion and food animals. We aim to realize that goal by using internal skills for validating product applications, creating marketable product formulations and managing other key commercialization tasks.

Your management believe our business model is capable of building exceptional value for our shareholders and we are deeply appreciative of your engagement and assistance. As evidence of my belief in our company, I have purchased a meaningful number of shares over the past year - in part by way of an irrevocable monthly purchase plan. I am pleased to take this opportunity to announce that I will be renewing that plan and thereby continuing to increase my personal investment into Avivagen.

I look forward to providing further updates and thank you for being a shareholder of Avivagen, for taking the time to read this update and for your continuing support for our efforts.

Sincerely,

Cameron Groome

CEO & President, Avivagen Inc.

About Avivagen Inc.

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

The company has sites located in partnership facilities of the National Research Council of Canada (NRC) - in Ottawa, Ontario and Charlottetown, Prince Edward Island. More information can be found at www.avivagen.com.

About OxC-beta

Avivagen's proprietary and patent-protected technology is based on its discoveries concerning carotenoid antioxidants. The novel natural compounds discovered by Avivagen support the body's own systems to maintain and enhance health, particularly by supporting immune function. Avivagen's commercial-stage application of its technology is Fully-Oxidized beta-Carotene (OxC-beta). OxC-beta compounds occur naturally as carotenoid oxidation products in vegetation, but in minute amounts. They have been developed to support the health of companion animals and for use in the global food animal market.

Research results indicate OxC-beta supports innate immune function, which can help maintain good health. In pets, OxC-beta supports overall vitality and energy, mobility and joint function, skin, coat and gut. Results observed in food animals have included healthier growth, better utilization of feed and decreased morbidity. In food animals, it is intended that use of OxC-beta avoids the feeding of antibiotics.

Avivagen's commercial products are OxC-beta for livestock, Vivamune(TM) Health Chews and Oximunol(TM) Chewables.

About OxC-beta for Livestock

OxC-beta for Livestock is available as a 10% pre-mix sold in 1.0 or 5.0 Kg quantities for parts-per-million addition to animal feeds, in accordance with Avivagen or producer-developed protocols. In past studies, OxC-beta has been shown to support health or growth in species such as fish, chicken, pigs and cattle. OxC-beta for livestock is currently available for commercial sale in the Kingdom of Thailand.

About Vivamune(TM) Health Chews - For dogs and cats

Vivamune(TM) Health Chews, containing Avivagen's proprietary active ingredients, are scientifically-formulated chews for dogs and cats. Vivamune(TM) Health Chews work with a pet's own immune system to maintain overall health and well-being. They are sold in re-sealable packages of 30 chews and are currently available in the United States by ordering on-line at www.vivamunehealth.com.

About Oximunol(TM) Chewables - For dogs

Oximunol(TM) Chewables are scientifically-formulated chewable tablets that contain Avivagen's proprietary, patented active ingredient OxC-beta. OxC-beta has been shown to stimulate innate cellular immunity and may thereby help to maintain overall health and well-being. Oximunol(TM) Chewables are distributed by Bayer Healthcare LLC and are available through veterinarians for dogs of all ages in the United States.

Permanent Non-Surgical Sterilization of Female Mammals

Avivagen has optioned worldwide exclusive rights to a technology for the permanent and non-surgical sterilization of female mammals. A proof-of-concept trial in an indicative species has been started in order to demonstrate whether the technology appears to be safe and effective. It is expected that a patent application covering World Trade Organization countries will be pursued and that technological details will be made available when that patent application is published. Further information will be disclosed as deemed prudent or as required.

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", "anticipated", "appear", "believe", "could", "estimated", "expected", "if", "intended", "goal", "hope", "likely", "may", "plan", "possibly", "potentially", "seem", "should", "whether", "will", "would" and similar expressions. Statements about Avivagen's beliefs about the viability and potential future applications of the technologies described in this news release, including the achievement of market access or distribution relationships, the meaning or relevance of livestock trial results, the interpretations of livestock trial results by potential customers, the timing of any trial results, the commercial prospects for OxC-beta and the publication of any peer-reviewed scientific work, 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 risks and uncertainties include, but are not limited to, the following: the ability of Avivagen to continue as a going concern; the final results of the livestock trials described herein may not be positive or as positive as the preliminary results described herein; even if the final results of such trials are positive, there is no guarantee that such results cause Avivagen's products to be commercially viable and successful; the timing and results of livestock trials may be delayed or may not be completed at all; there is no guarantee that peer-reviewed publications concerning Avivagen's products will have any impact on the viability and success of Avivagen's products; we cannot predict the outcome of the proof of concept study for the mammal sterilization technology; if the results of the proof of concept study for the mammal sterilization technology are not what we expect, we may never exercise the option to acquire such technology; and Avivagen's intellectual property rights may be challenged and it may not be able to acquire new rights in a timely manner or at all. 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

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 |Copyright© 2014| 
 |Avivagen       |
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SOURCE: Avivagen Inc. 
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