Many companies in the nutraceuticals market spend a lot of money and resources on multiple ingredients spanning multiple health platforms. Not so for Eagan, MN-based Biothera. This biotechnology firm spends millions of dollars specifically to support one health indication—immune function—using one ingredient—Wellmune WGP. According to company president and CEO Richard Mueller, this is because “there is still so much work to be done in the immune health category. And we will continue to spend quite a bit of money on this ingredient for a very long time.”
Biothera is split into two divisions: The Pharmaceutical Group and The Healthcare Group. The latter caters to customers involved in dietary supplements, functional foods, nutritional beverages, cosmetics and animal nutrition.
At the center of it all is Wellmune WGP, a natural ingredient derived from a proprietary strain of yeast, which engages and directs neutrophils—immune cells that are the body’s first line of defense—to more quickly find and kill foreign invaders. “Wellmune enhances the innate immune system and primes it for challenges, so this is an ingredient that must be consumed for year-round prevention,” Mr. Mueller explained. Importantly, the patented technology used to create Wellmune results in broad protection without over-stimulation of the immune system. And there is no shortage of scientific substantiation to prove its worth.
Currently the company is involved in several phase 2 clinical trials using its beta-glucan-based ingredient in directing the innate immune system. These studies are being carried out in collaboration with the National Cancer Institute and the Mayo Clinic, as well as several universities. To date, the company has invested $300 million in research and development.
Most recently, Wellmune was studied in a population of stressed women, who, after taking it, experienced fewer cold/flu symptoms and higher energy levels. This research was presented at the 51st Annual Meeting of the American College of Nutrition in early October.
In April this year, data on Wellmune’s ability to reduce upper respiratory tract infections (URTIs) and improve the psychological well-being of individuals with stressful lifestyles were presented at the Experimental Biology 2010 conference. In a study of 122 healthy volunteers, participants taking 250 mg of Wellmune WGP daily for 12 weeks reported a statistically significant (58%) reduction in URTI symptoms compared with individuals taking a placebo. Further, those taking Wellmune rated their overall well-being and vigor 9.5% and 11% higher, respectively, compared with the placebo group.
These and several other published studies have been beneficial to the company in many ways. “In every study we have seen dramatic and statistically significant results, which has helped us gain traction with major food and beverage companies,” said Mr. Mueller.
Biothera was also instrumental in developing a method for beta-glucan analysis. Details of the “Glucan Enzymatic Method” (GEM) were published in the September 1, 2010 edition of the Journal of Agricultural and Food Chemistry, a peer-reviewed publication of the American Chemical Society. Explaining its importance, Mr. Mueller said, “For the first time, food, beverage and supplement manufacturers can confirm scientifically the purity and quality of the ingredients they are adding to their products. Consumers also can have confidence that GEM-tested products contain the beta-glucan dosage as labeled.”
With the science piece firmly in place, the company has also been hard at work with regulatory agencies around the globe. The good news is Biothera has cleared several of the regulatory hurdles necessary to formulate this ingredient into many food, beverage and dietary supplement products. Stateside, Wellmune achieved GRAS (Generally Recognized As Safe) approval in 2007, and is also kosher, halal, non-allergenic and GMO-free. Meeting these requirements has paved the way for its use in more than three dozen foods, beverages and supplements worldwide.
For the future, Mr. Mueller is excited about the company’s prospects. “The company’s sales continue to grow,” he said. “In fact, we are already up 160% compared to this time last year.”—R.W.
3388 Mike Collins Drive
Eagan, Minnesota 55121