One year ago, the European Food Safety Authority issued a positive scientific opinion on Wellmune as a novel food.

We have two European distributors. Immetec is our primary distributor with the exception of Italy where our distributor is DKSH. According to Jan Oddvar Johansen, Immitec chairman, “Wellmune WGP is finally ‘ready to go’ in the European Union. The food and beverage industry has an unprecedented chance to capitalize on the commercial potential of introducing Wellmune to a market of savvy, increasingly health conscious consumers.”

He added, “The fact that Wellmune WGP will finally be available in Europe should transform the way in which governments, business and consumers approach preventative health. Make no mistake, this breakthrough could dwarf the impact that Omega 3 had several years ago.”

If you’re attending Vitafoods, be sure to visit Immitec at stand 1239 for more information. Several Wellmune experts from Biothera will be attending as well and we’re eagerly awaiting the NBT 2012 awards ceremony, as Wellmune is a named a finalist in the R&D category!

The folks at LiveWell were sold on the immune health clinical research behind Wellmune WGP and you’ll see that our logo is displayed on the filter’s packaging.

You can learn more about this novel delivery system in the following news release from LiveWell, a company committed to health, wellness and addressing safety issues for drinking water.

LiveWell™ introduces LiveHealthy Immune Support System with Wellmune WGP® for daily immune support

Boise, Idaho, 4/30/12-  LiveWell LLC is expanding the offerings in its LiveWell Healthy Hydration System to include the LiveHealthy with Immune Health Support System with Wellmune WGP®. LiveWell Healthy Hydration Systems enable consumers to enjoy clean, enhanced, filtered water while on the go and without the cost and waste of bottled water.

The all-natural Wellmune WGP immune health ingredient is clinically proven to safely prime the immune system to keep the body healthy. Numerous peer-reviewed, published studies demonstrate that Wellmune WGP mobilizes billions of innate immune cells that are part of the body’s natural defenses without over stimulating the immune system. LiveHealthy with Immune Health Support comes in a choice of Lemon Lime or Orange Creamsicle flavors. The filters can be used on specially designed LiveHealthy water bottles or on almost any bottled water. As with all LiveWell systems, they are BPA free and biodegradable.

The Livewell system was first developed by a youth soccer coach who wanted his kids to hydrate with safe, healthy water instead of popular sports drinks loaded with sugar and artificial ingredients.

“LiveWell understands that consumers are seeking new, effective vitamin delivery forms that are easy to use and provide benefits for immune support,” said Rick Anson, CEO, LiveWell. “We chose WellmuneWGP^® as our core immunity ingredient because of the science backing its health benefits.”

“Busy families now have the convenience of filtration, hydration and clinically proven immune support right at hand with the introduction of the LiveHealthy with Immune Support hydration system,” said Rich Mueller, president and CEO, Biothera. “It’s easy to use and a novel delivery system to reap the everyday benefits of Wellmune WGP.”

Wellmune WGP is patented, Generally Recognized As Safe (GRAS) under U.S. FDA regulations, Kosher, Halal, non-allergenic and GMO-free.

For more information on LiveHealthy with Wellmune WGP, please visit www.livewellwater.com and www.wellmune.com.

About LiveWell™

LiveWell LLC is committed to consumer’s health and wellness, addressing safety issues for drinking water, and becoming the industry leader in eco-efficient products that are as environmentally and economically sustainable as possible.

About Wellmune WGP^®

Wellmune WGP is a natural carbohydrate that is clinically proven to prime key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient is Generally Recognized as Safe (GRAS) under U.S. FDA regulations. It is also patented, Kosher, Halal, non-allergenic and GMO-free. The ingredient is a recipient of an IFT Innovation Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

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Wellmune WGP is scientifically proven to activate innate immune cells that help keep the body healthy.  Specifically, Wellmune primes neutrophils, the largest population of immune cells in the body and an important part of the body’s natural defenses.  This award-winning functional ingredient is contained in numerous foods, beverages and supplements in more than 30 countries.

The article notes that upper respiratory tract infection (URTI) is the most frequent infectious disease in humans, with an average of two to four episodes per year in adulthood and 6 to 10 episodes per year in childhood.  The economic impact of the common cold is significant, costing an estimated $40 billion annually in the U.S. alone, with approximately 500 million non-influenza-related URTI episodes annually.

“Strategies to decrease the frequency and severity of URTI symptoms…would have a highly beneficial impact on health and socioeconomic performance,” said Richard Fuller, M.D. of The Dove Clinic for Integrated Medicine and principal investigator for the study. “Wellmune WGP activates innate immune cells, the body’s first line of defense, which helped students become more resilient to health challenges.”

The citation for the paper is:  Fuller R, et al., Influence of yeast-derived 1,3/1,6 glucopolysaccharide on circulating cytokines and chemokines with respect to upper respiratory tract infections. Nutrition (2012), doi: 10/1016/j.nut.2011.11.012. Click here for the abstract.

Study Design & Results

The study was conducted during the peak of the 2010 cold-flu season.  During the 90-day, double-blind, placebo-controlled study among 100 healthy medical students, participants taking 250 mgs of Wellmune WGP daily reported 43 fewer days of URTI symptoms than their classmates who received a placebo. The results are a strong statistical trend (p=0.06). The findings were originally presented at a British Society for Immunology conference in Liverpool, UK, in 2010.

While the authors note that larger studies are needed, results of this study demonstrated that Wellmune WGP provided real immune health benefits to the students. Specifically:

• There was a reduction (18%) in the total number of days with self-reported URTI symptoms in Wellmune WGP group compared to placebo.

• In total, 24 episodes of URTI were medically confirmed, 12 episodes in each group.

• Wellmune WGP did not induce inflammatory cytokines. No cytokine change was seen during symptomatic URTI between study groups.

“The results are consistent with eight other clinical studies regarding the immune support effects of Wellmune WGP,” said Don Cox, Ph.D., senior vice president of research and development at Biothera.

Biothera and its research collaborators have previously conducted clinical studies involving marathon runners, wildland firefighters, women and other individuals with high lifestyle stress. To learn more, go to www.wellmune.com/research/scientific-literature/clinical-research.

About Wellmune WGP^®

Wellmune WGP is a natural beta 1,3/1,6 gluco polysaccharide that is clinically proven to prime key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient has regulatory approval around the world, including GRAS status in the U.S. and novel foods approval in Europe and China.  It is also patented, Kosher, Halal, non-allergenic and GMO-free. In addition to receiving an IFT Innovation Award, Wellmune has received a SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

Richard Fuller B.Med.Sci.(Hon.), B.M.B.S., M.R.C.G.P. a,*, Hamza Butt M.B. b, Paul S. Noakes Ph.D. b,
Julian Kenyon M.D., M.B., Ch.B. a, Tat Shing Yam M.Sc., M.B., B.Ch., B.A.O., M.R.C.P., F.R.C.Path. c,
Philip C. Calder Ph.D., D.Phil. b

a The Dove Clinic, Winchester, United Kingdom
b School of Medicine, University of Southampton, Southampton General Hospital, Southampton, United Kingdom
c Southampton University Hospitals NHS Trust, Southampton General Hospital, Southampton, United Kingdom

Nutrition (2012), doi:10.1016/j.nut.2011.11.012

Objective: Wellmune WGP is a food supplement containing a refined 1,3/1,6 glucopolysaccharide that improves the antimicrobial activity of the innate immune cells by the priming of lectin sites. This study aimed to investigate whether Wellmune decreases the frequency and severity of upperrespiratory tract infection (URTI) symptoms over 90 d during the peak URTI season in healthy university students. The secondary aims included an assessment of plasma cytokine and chemokine levels.
Methods: This was a randomized, double-blinded, placebo-controlled trial lasting 90 d. One hundred healthy individuals (18–65 y old, mean age w21 y) were randomized to 250 mg of Wellmune once daily or to an identical rice flour-based placebo. Health was recorded daily and two or more reported URTI symptoms for 2 consecutive days triggered a medical assessment and blood collection within 24 h. The URTI symptom severity was monitored. Plasma cytokines and chemokines were measured at day 0, day 90, and during the confirmed URTI.
Results: Ninety-seven participants completed the trial (Wellmune, n ¼ 48; placebo, n ¼ 49). The Wellmune tended to decrease the total number of days with URTI symptoms (198 d, 4.6%, versus 241 d, 5.5% in the control group, P ¼ 0.06). The ability to “breathe easily” was significantly improved in the Wellmune group; the other severity scores showed no significant difference. Cytokines and chemokines were not different between the groups at study entry or day 90, but monocyte chemotactic protein-1 was lower in the Wellmune group during the URTI.
Conclusion: Wellmune may decrease the duration and severity of URTI. Larger studies are needed to demonstrate this.

Wellmune WGP is clinically proven to safely prime the immune system to keep the body healthy. Numerous peer-reviewed studies demonstrate that Wellmune WGP mobilizes billions of innate immune cells that are part of the body’s natural defenses without over stimulating the immune system.

Praeventia cookies are also loaded with polyphenols (antioxidants), 16 percent of recommended daily dietary fiber and whole grain. Along with Wellmune WGP to support immune health, the cookies also contain prebiotic inulin fiber to support digestive health. A product of Groupe Biscuits Leclerc Ltd., Praeventia cookies contain no trans fats and are low in saturated fats and sugar.

“We believe the addition of Praeventia cookies aligns with Walmart’s overall commitment to offering nutritious food choices to consumers,” said Frédéric Langlois, vice president of R&D at Groupe Biscuits Leclerc. “The carefully chosen ingredients make Praeventia cookies a great option for customers who want their food dollar to support an overall healthier lifestyle.”

“We are thrilled that the world’s largest retailer will now carry Praeventia cookies with Wellmune WGP,” said Rich Mueller, president and chief executive officer, Biothera. “Praeventia cookies are a great example of innovations in functional foods that offer consumers foods that are healthier yet don’t compromise convenience or taste.”

There are two varieties: Ginger and Chocolate Chip with 70% cocoa and cranberry. They are conveniently packaged in seven single-serve pouches per box. Each serving has about 150 calories.

The Praeventia ginger cookies contain: Wellmune WGP, a natural ingredient derived from a yeast β-glucan for a healthier immune system; ginger, also known for its polyphenol (antioxidant) content and the whole oat, a whole grain, contributes daily dietary fiber. The Chocolate Chip with 70% cocoa and cranberry also includes polyphenols.

About Groupe Biscuits Leclerc

Founded in 1905 by François Leclerc, Groupe Biscuits Leclerc has grown tremendously in the last 15 years and boasts five ultramodern plants and more than 570 employees. The family-run company is headquartered in François Leclerc Industrial Park in the Quebec City suburb of Saint-Augustin-de-Desmaures.

Leclerc specializes in manufacturing cookies, snack bars, crackers, and breakfast cereals, and exports to more than 20 countries. With its product lines of healthy, nutritious foods, it is known as an innovative company attuned to the tastes and needs of informed customers who care about the food they eat and like to treat themselves to life’s pleasures.  For more information about Praeventia, visit http://www.praeventia.ca/en/index.php.

About Wellmune WGP

Wellmune WGP is a natural carbohydrate that is clinically proven to prime key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient is Generally Recognized as Safe (GRAS) under U.S. FDA regulations. It is also patented, Kosher, Halal, non-allergenic and GMO-free. The ingredient is a recipient of an IFT Innovation Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)
dwalsh@biothera.com

The company recently introduced Praeventia Nut Burst and Praeventia Nuts & Dark Chocolate Chip 70% Cocoa. Both products contain six bars created with carefully selected ingredients. Each bar contains 100 milligrams of Wellmune WGP and 5 grams of protein.

Wellmune WGP is beta 1,3/1,6 gluco polysaccharide derived from the cell wall of a proprietary strain of baker’s yeast. Wellmune activates neutrophils, which are the largest population of immune cells in the body and part of the body’s first line of defense. Peer-reviewed clinical research consistently demonstrates the ability of Wellmune WGP to reduce upper respiratory tract infection symptoms and improve overall health even during periods of high physical and lifestyle stress.

“Leclerc is proud to offer delicious products that contribute to overall health and well-being of our customers,” said Richard Couture, vice president of Innovation and R&D at Groupe Biscuits Leclerc. “Wellmune’s strong scientific foundation reflects this core company philosophy.”

Leclerc first introduced products with Wellmune WGP in 2010 with the launch of two flavors of Praeventia Cookies, an innovative line of functional cookies that contained healthy ingredients including inulin and polyphenols (antioxidants).

“We are pleased that Wellmune continues to part of the healthy and great-tasting choices of the Praeventia product line,” said Rich Mueller, Biothera president and chief executive officer.

About Groupe Biscuits Leclerc
Founded in 1905 by François Leclerc, Groupe Biscuits Leclerc has grown tremendously in the last 15 years and boasts five ultramodern plants and more than 570 employees. The family-run company is headquartered in François Leclerc Industrial Park in the Quebec City suburb of Saint-Augustin-de-Desmaures.

Leclerc specializes in manufacturing cookies, snack bars, crackers, and breakfast cereals, and exports to more than 20 countries. With its product lines of healthy, nutritious foods, it is known as an innovative company attuned to the tastes and needs of informed customers who care about the food they eat and like to treat themselves to life’s pleasures. For more information about Praeventia, visit http://www.praeventia.ca/en/index.php.

About Biothera
Biothera is a U.S. biotechnology company dedicated to improving immune health. It manufactures and markets patented, natural ingredients for functional foods, beverages and nutritional supplements worldwide. Its flagship ingredient, Wellmune WGP®, is the culmination of more than $300 million in research with leading university and government institutions. Wellmune WGP is formulated in food, beverage and supplement products in more than 35 countries. It has broad regulatory approval worldwide including GRAS status in the U.S. and novel foods approval in Europe and China. Wellmune is a recipient of an IFT Innovation Award, a 2011 SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606
dwalsh@biothera.com

Wellmune WGP is clinically proven to safely prime the immune system to keep the body healthy. Numerous peer-reviewed studies demonstrate that Wellmune WGP mobilizes billions of innate immune cells that are part of the body’s natural defenses without over stimulating the immune system.

“We are gratified that MonaVie has chosen to expand its offering of good-for-you beverages with Wellmune WGP. The line extension underscores both market acceptance of products with Wellmune as an ingredient and its flexibility to meet a range of formulation requirements,” said Rich Mueller, Biothera president and chief executive officer.

Described as offering a powerful punch of antioxidants, including 19 fruits and 11 vegetables, MonaVie MX is formulated with MonaVie BioEssence™ technology, which provides greater bioavailability, and features AçaVie™, the most potent form of açai available.

“MonaVie MX is the ultimate juice blend,” said Shawn Talbott, PhD, and MonaVie’s vice president of product research and development. “It synergistically combines the immunity-strengthening defense of Wellmune with scientifically validated glucosamine to increase joint mobility and a broad array of powerful antioxidants. This triple combination of health benefits helps safeguard the body against potentially harmful microorganisms, promotes joint health and fights oxidative damage and aging.”

Mueller added, “As consumers look for more ways to support their health and vitality, the broader availability of clinically proven Wellmune WGP in brands they trust offers peace of mind and worry-free convenience that contributes to healthy habits for a lifetime.”

About Wellmune WGP

Wellmune WGP is a natural carbohydrate that is clinically proven to prime key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient is Generally Recognized as Safe (GRAS) under U.S. FDA regulations. It is also patented, Kosher, Halal, non-allergenic and GMO-free. The ingredient is a recipient of an IFT Innovation Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

About MonaVie

MonaVie is a leading product innovator in the health and wellness category. Starting with the açai berry, MonaVie has fulfilled its mission to bring the rarest and most efficacious nutritional products to a global market. Its reputation as an innovative leader has been confirmed again with the introduction of its revolutionary new product philosophy, MonaVie Nutritional Chemistry™, that delivers custom nutrition to meet an individual’s unique nutritional needs in an easy-to-use delivery system. Learn more about MonaVie at www.monavie.com.

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Research Terms

Bioavailability – The rate at which our body absorbs a nutrient. If the bioavailability is too low, the nutrient might be expelled from our bodies before we can get its benefit.

Clinically proven – The product/ingredient has tested in a clinical study to see how it works in people, and the results support the health claim(s). To evaluate a “clinically proven” claim, look for multiple double-blind, placebo-controlled studies using that specific brand, that were conducted by university-level experts in that research field. Be sure that the product includes the same efficacious serving sizes used in the clinical studies.

Human clinical research – Research done using people as subjects. Participants are generally within a subject group that researchers believe are likely to benefit from the ingredient or product being tested.

In-vitro research – Research conducted on organs, tissues or cells outside of the living body.

In-vivo research – Research conducted on organs, tissues or cells within the living body.

Pre-clinical research – A stage of research that begins before clinical trials (testing in humans) can begin, and during which important data is collected.

Regulatory Terms

Efficacy – A measure of how effective an ingredient or supplement is at delivering its benefit.

Food grade – Meets standards set by the U.S. Department of Agriculture for human consumption.

GRAS-approved – “Generally recognized as safe” means the U.S. Food and Drug Administration agrees with the opinion from an independent panel of experts, which has reviewed science and safety data and determined that an ingredient or product is safe. The FDA issues “no objection” letters when it reviews a voluntarily submitted self-affirmed GRAS dossier and has no objections to the finding of the GRAS panel of experts.

Kosher – Foods or food products that have been processed in accordance with Jewish Dietary laws. In addition to religious and ethnic considerations, a Kosher certification may also be perceived to indicate higher quality.

GMO – Genetically modified organisms. Some nutritional supplements are GMO-free or will specify they are non-GMO. This means that no alteration was made to DNA of the food product used in an ingredient or supplement. Some groups are concerned that there is too little known about the long-term health impact of eating genetically modified foods.

Immune boosters – Also known as immunostimulators, these are substances such as herbs, vitamins and minerals that can stimulate the immune system to grow and multiply the number of infection-fighting cells in the body.

Naturally derived – A product that contains ingredients derived from nature with minimal processing.

Naturally occurring – An ingredient that is delivered in its natural form.

Other Important Terms

Nutraceutical – A combination of the words “nutrition” and “pharmaceutical,” it refers to any substance that is a food or part of a food and provides medical or health benefits.

Non-allergenic – Will not cause an allergic reaction.

Pharmaceutical grade – A term commonly used to indicate that the ingredients used in a supplement meet the highest standards for purity and concentration. The product must be at least 99 percent pure, without additives or unnecessary substances.

Monograph – Official standards that specify the kinds and amounts of ingredients that a drug or substance may contain, the directions for its use, the conditions in which it may be used, and any reasons to withhold its use. Monographs are published by the United States Pharmacopeia (see below).

United States Pharmacopeia (USP) – The USP is a nonprofit, scientific organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide. More than 130 countries rely on USP standards.

The FibeBiotics project is a consortium of four European universities, five research institutions and several private companies that will study the effect of food fibers on the human immune system. Wageningen UR Food & Biobased Research, The Netherlands, is coordinating the 4.5-year project.

Wellmune WGP is gluco polysaccharide that is clinically proven to safely prime key immune cells that help keep the body healthy. Derived from a proprietary strain of yeast, Wellmune WGP mobilizes neutrophils, which are the largest population of immune cells in the body and part of the body’s first line of defense.

“We are pleased that Wellmune WGP is part of this important scientific research project,” said Rich Mueller, Biothera president and chief executive officer. “It will be complementary to our internal research program that is designed to expand understanding of our unique technology and its global immune health benefits.”

According to a FibeBiotics statement: “It is known for a long time that polysaccharides (other than easy digestible starch) and the immune system are connected. The immune response towards invading pathogens like bacteria, fungi and yeast is often initiated by the recognition of the intruder via the sugar chains that are located on the outside of the pathogen. After this recognition the immune system is activated and attempts to remove the pathogen as fast as possible.

“Research indicated that some specific polysaccharides, for example those from the cell wall of yeast or those that are present in various plant products, can activate the immune system starting from the intestine, even when no intruders are present. Various polysaccharides have been shown to activate macrophages, which can ‘digest’ pathogens and unwanted cells. An activated, warned or primed first layer of defence can help to improve the overall resistance of humans.”

About Biothera
Biothera is a U.S. biotechnology company dedicated to improving immune health. It manufactures and markets patented, natural ingredients for functional foods, beverages and nutritional supplements worldwide. Its flagship ingredient, Wellmune WGP, is the culmination of more than $300 million in research with leading university and government institutions. Wellmune WGP is formulated in food, beverage and supplement products in more than 35 countries. It has broad regulatory approval worldwide including GRAS status in the U.S. and novel foods approval in Europe and China. Wellmune is a recipient of an IFT Innovation Award, a 2011 SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606
dwalsh@biothera.com