ChromaDex is gearing up for a commercial launch of Nicotinamide riboside (NR) - a next generation version of vitamin B3 (niacin) claimed to help protect the brain, battle the bulge and improve blood glucose control - at the end of this year or early next.
Chief executive Frank Jaksch was speaking to NutraIngredients-USA.com after securing exclusive rights to multiple NR-related patents from Dartmouth College covering applications and methods to produce NR via fermentation of engineered yeast strains.
A vitamin found naturally in milk, NR is a more potent version of niacin (vitamin B3) and a precursor to nicotinamide adenine dinucleotide (NAD), increased cellular levels of which confer multiple health benefits, said Jaksch.
However, it is not commercially viable to manufacture NR from milk, says ChromaDex, which recently secured exclusive worldwide rights to a novel synthetic manufacturing process for the ingredient from Cornell University.
Cost-effective manufacturing process
The fermentation method licensed from Dartmouth is an alternative production method that ChromaDex “will also explore in an effort to find the most cost effective/efficient route to make NR”, said Jaksch.
He added: “We are currently working on scaling up the synthetic method of manufacturing NR. We are also working on developing the brand for our NR as well as the technical and marketing materials, as we will be following a similar path as we did path for pterostilbene [a compound found in blueberries ChromaDex has synthesized to create a branded ingredient called pTeroPure].
“We do not have an exact launch date for NR, but we are estimating late Q4 2012 or Q1 2013.”
Safety and toxicology studies and regulatory filings
Many of the safety and toxicology studies on NR “have already been completed, based on the research that is underlying the patents we have licensed”, he said.
“[But] we fully intend to continue to invest and complete further safety and toxicological studies on NR. We also look forward to start our first human clinical study.
“We will most likely pursue the GRAS (Generally Recognized as Safe) route with NR, just as we did with pTeroPure, as we will look to participate in the food industry with NR. I expect you will see published human clinical trials in the future, based on ChromaDex studies as well as those of other research groups.”
Our job is to not only prove NR is clinically effective, but also to find a good way to message that to consumers
But what will the focus be - and how will the benefits be communicated to consumers?
Says Jaksch: “We are still making decisions on what the primary focus for NR will be, and I am sure that will become more apparent when we announce our first human clinical study."
Brand name still being decided
As for consumers, he added: “We are still working on the messaging and I think that will also become clear over the next 3-6 months. Some consumers may understand NAD pathways, but it would be safe to assume otherwise.
“Consumers will ultimately understand the specific health benefits they are supposed to take NR for, and it will be our job to not only prove that NR is clinically effective, but also to find a good way to message that to consumers.”
ChromaDex has not come up with a brand name for NR yet, but is likely to announce this before the end of the year, he said.
In 2004, Dr. Charles Brenner, then of Dartmouth College and now Head of Biochemistry at the University of Iowa, discovered NR as an additional vitamin precursor of nicotinamide adenine dinucleotide (NAD) and believes it has “profound potential for improvements to human health, particularly in maintenance of healthy plasma lipids, and protection against over-nutrition and neurodegeneration”.
We will rigorously defend our patents and trademarks
Asked about IP protection around NR, Jaksch said the following patents have been licensed to ChromaDex from Dartmouth: US patent # 8,197,807 and #8,114,626 plus US patent applications #11/542,832 and # 13/260,392.
He added: “ChromaDex has made significant investments in IP/patents as well as trademarks for both pTeroPure and our new NR.
“We have also invested heavily in further developing science and manufacturing processes so these novel ingredients could be made commercially available.”
A side of ChromaDex the market has not seen yet
And ChromaDex did not make significant investments in science and IP so “competitors could simply come in and copy what we did and compete with us in what may look like an open market”, he said.
“We will rigorously defend our patents and trademarks, and we are fully prepared to do what is necessary to protect our position, which is a side of ChromaDex the market has not seen yet.”