Embria hails new era of immune health with EpiCor
time about its new immunity supplement, EpiCor - a high-metabolite
immunogen born out of decades of experience and observation in the
animal nutrition field, that could usher in a new era of immune
health.
For more than 60 years Embria Health Sciences' parent company, Diamond V Mills, has been making a propriety yeast culture to increase milk production in cattle. But it began to be suspicious that the culture could have other uses as farmers reported that their animals were not getting sick.
Moreover, in 2004 insurance adjusters noticed that Diamond V employees had far lower sick rates than other workplaces, and the company thought the culture could be boosting the immune systems of workers who handled it.
"We knew it could help animals and humans, but we didn't know how," Stuart Reeves, R&D and technical services told NutraIngredients-USA.com.
A program of research has provided some explanations: EpiCor has been seen to have the antioxidant (ORAC) potency three times that of any known fruit; to cause a four-fold increase in the activity of 'natural killer' cells, which guard the immune system; to activate human B cells that help transfer lymphocytes from the blood to the tissues; and to strengthen the human mucosal immune barrier, which protects against invasion.
Immune health is big business in the United States, worth around $1 bn sales each year. But the company points out that most products either contain indication specific ingredients for the cold and 'flu season, or specialty ingredients for more serious immune conditions.
EpiCor, however, is to marketed for health maintenance. "It is a prophylactic, not a treatment - if you already have a cold it's too late," said Reeves.
"Preliminary research on the product using rates has showed strong immunological effects," said president Paul Faganel. Much of the initial research was carried out using shrimps. In aquaculture, health is a big issue as an entire pond can be lost overnight if it becomes infected.
The shrimps were fed a lethal dose of bacteria, and more were found to have survived in populations that had received EpiCor in advance.
Alongside efficacy, there has been a clear and necessary emphasis on safety, with a number of rat studies, in vitro studies, and an open-label pharmacokinetic study which found a single oral dose of 500mg of EpiCor per day for 28 days to be well tolerated and not to cause any adverse effects.
The R&D spend to date has amounted to a seven-figure sum. Although some of this has been in order to meet legal and regulatory requirements, Faganel said: "We wanted to know where the product works and where it doesn't." He added that the company is prepared to publicise any bad research, as well as the good.
And despite the impending launch, the research phase is far form concluded. Pre-clinical trials have been envisaged to establish the areas in which EpiCor might have an effect, and for there the company is going on to more expensive clinical trials in the areas that it is seen to work.
For example, it is already clear that it will have a positive effect for people who are under stress.
Moreover, Faganel said that EpiCor has the potential to benefit children in developing countries who might contract diarrhoea as a result of drinking bad drinking water.
For now, though, the company is concentrating on one aspect at a time - and there is scope to carry out considerably more research in this, and other areas in the future.
"We refuse to do anything unless it works scientifically", he said. "We have to pursue the direction that will make the sales first, then we can take the revenues and plough them back into new areas."
The product will receive its official launch at SupplySide East in May, but Embria is already identifying potential partners and forging relationships.
It is currently awaiting the FDA to sign it off as a New Dietary Ingredient (NDI). "We are not anticipating any problems," said Faganel.
The company has also just finished its self-affirmed GRAS procedure in the US, which opens up uses beyond dietary supplements and into functional foods.
In Europe, the regulatory process in only just getting underway, and the company is working with local expertise on this.
The manufacturing process, known as MetGen4, involves growing a strain of yeast through aerobic growth bioreactors and concentrating it into a cream yeast. So far so standard and non-proprietary.
But the next stage, anaebolic fermentation to give off metabolites and enzymes, is "where the magic happens," said Reeves. The final stage is drying.
In mid April the location of the production facility, somewhere in the Mid West, will be determined. It is expected that ground will be broken in the summer or early autumn, and the facility will be operational in 2007.
Investment in the new facility is in excess of $10 m, representing the largest single spend in Diamond V Mills' history.
This, said Reeves, is an indication of the confidence it has in the product. "You don't make that kind of investment if your science is iffy," he said.
In the meantime, though, Embria is not without the capacity to meet demand from the supplements industry. Diamond V Mills has the necessary set-up and capacity to carry out most of the process, as it has done so for the animal product. At the final, drying step, however, the product will be shipped out.
Embria anticipates that EpiCor will be used in stand-alone supplements. The GRAS status also opens the way for its use in functional foods.
