Medlab, which is based in Sydney, will enter the US market in conjunction with American Nutritional Corp Inc., a contract manufacturer located in Las Vegas, NV.
The deal covers Medlab’s proprietary probiotic products, branded as NRGBiotic and MultiBiotic.
NRGBiotic is a formula that pairs three proprietary probiotic strains (one each of Lactobacillus acidophilus, Bifidobacterium bifidum and Streptococcus thermophilus) with magnesium orotate and CoQ10. The product provides about 5 billion CFU of the three organisms taken together. The product has been researched at the Queensland University of Technology as a adjuvant therapy for the treatment of depression. MedLab has an Australian patent on the formula.
The MultiBiotic product includes 7 proprietary strains from Medlab’s library. The total CFU count for one capsule is a bit more than 21 billion CFUs.
Pawns, or queens?
Sean Hall, CEO of MedLab, said the proprietary nature of his company’s probiotic strains should give it a leg up in the market. All too many probiotic products in the market in his view seek to cover the field with a vast army of pawns by way of less well researched or plain commodity strains, when a few rooks or a queen or two gets the job done better.
“In fairness I think the US is behind most of the world in its understanding of probiotics. Most nutraceutical companies still hype on more, more, and more. Its not about more but the combination, and I find, as we lecture extensively, our work impresses US doctors,” Hall told NutraIngredients-USA.
“Probiotics are not the panacea for everything, but in right combinations, they are a very powerful adjuvant medicine that don’t get the attention they deserve,” he said.
The QUT research is progressing through phased clinical trials, Hall said. A second phase trial is in the recruitment phase with a target of 150 participants in a study that will pair the probiotic formula with a selective serotonin reuptake inhibitor (SSRI), the standard of care in cases of diagnosed depression.
With the regulatory differences between Australia and the US, it’s unclear how much of that information (if any) can be used marketing the product in the US. But it helps bolster the company’s position as a serious, capable player, Hall said.
“It is our patents, research and strong clinical capabilities that makes us attractive,” he said.
Another area of the company’s expertise lies in developing delivery modes for pharmaceutical as well as nutraceutical ingredients. The company’s patented oro-buccal delivery system, dubbed NanoCelle, is also part of the agreement with ANC.
The technology, which can be applied to swabs or sprays, has been developed in Australia for use with three cannabis products, more than twenty drugs and five nutraceutical ingredients, Hall said. It will be applied to dietary ingredients within the ANC stable including vitamins D3 and B12.
While buccal or sublingual delivery systems technically fall outside of approved delivery modes for dietary supplements, they are frequently seen on the market. As with some other gray areas at the edges of the envelope (such as nasal sprays or patches), FDA seems more concerned with how the products are marketed and manufactured in terms of disease claims and GMPs than it is with delivery modes per se.
Hall said the precise date for market entry is still up in the air as MedLab and ANC hammer out the final details of their deal, but said the companies are shooting for December, 2019.