The new company, which has been giving the holding name of PharmaCo, will be a totally separate entity for the Norwegian company. NattoPharma ASA will continue to serve the global dietary supplement and functional foods businesses, said the company.
The announcement has echoes of Lovaza/Omacor where the strength of the science for omega-3 fatty acids allowed a dietary supplement ingredient to transition to a pharmaceutical.
“This is a huge win for the natural products industry,” Eric Anderson, SVP marketing and new business development at NattoPharma, told NutraIngredients-USA. “K2 is the poster child for what’s right about nutrition: This is something that is found in food and correlated to bone and CV health, the nutrition industry identified and standardized it, NattoPharma validated the efficacy in multiple human studies, including healthy subjects, and this attracted attention from the medical community, who are now investigating it in drug studies.”
From bones to arteries
There are two main forms of vitamin K: phylloquinone (vitamin K1), which is found in green leafy vegetables, and menaquinones (vitamins K2), which can be found in foods like cheese, natto, and animal meat, and can also be synthesized by the gut microflora.
While most of the early work focused on bone health (and the majority of finished dietary supplements on the market are positioned for bones), the Rotterdam Study (published in 2004 in the Journal of Nutrition, Vol. 134, pp. 3100-3105) was one of the first to show that adequate intake of menaquinone was associated with less aortic calcification and a lower risk of all-cause mortality.
“There are currently over 300 products with Vitamin K2 in the US, and more in the EU,” said NattoPharma’s Eric Anderson. “Australia and New Zealand are robust markets, while Brazil is also growing and Asia is opening up.”
“For our first 10 years we’ve been a science-based company, funding and publishing studies to substantiate the efficacy of MenaQ7 vitamin K2,” said Anderson. “We’ve researched the ingredient using private funding and grants, and now there are 19 human studies to date using MenaQ7, with several underway.”
The majority of these studies were in healthy people, and the company has shown that MenaQ7 supplementation improved bone health measures versus placebo, it kept calcium out of the arteries, and could even regress hardening of the arteries (this is covered by a US patent, #9,364,447). The ingredient was also used in three trials in dialysis patients, which is an interesting group because they are very prone to calcification because of compromised kidney function, , said Anderson.
“The medical community has been paying attention,” he added, “and drug studies are already underway using menaquinone-7 as MenaQ7.” The studies look at progression of coronary artery calcification, valve calcification, and the progression of bicuspid aortic valve stenosis.
Accelerated drug development?
The “compelling” clinical data as a dietary supplement has “created a strong basis for a focused pharmaceutical path”, said the company. An external CRO has estimated that the company’s investment in vitamin K2 research to date could accelerate the timelines to market for the drug while also reducing the costs association with drug development. Specifically, the CRO company estimated there is the potential for the product to be on the market in 5 to 6 years and to the estimated costs of US$ 40-60 million, compared to a 8 to 10 years, or more, and costs in excess of $150 - 200 million..
The NattoPharma ingredients used predominantly in supplements are 96% active fermented or nature-identical 98% active all-trans menaquinone-7, explained Anderson. The pharmaceutical ingredient will be a 99.9% API, achieved using an additional purification step, while the dosage for pharmaceutical endpoints will also change: As a dietary supplement, doses of between 45 and 180 micrograms are recommend. In the drug trials, so far dosages have been between 360 and 720 micrograms, yet sufficient dosages have to be considered for each specific disease study group.
“Sales of our supplement business continue to reach new, and record, levels, and the pharma business is progressing into a very exciting stage. The timing of the spin-off has been carefully planned,” said CEO Daniel Rosenbaum.
“I’m confident that the spin-off will enable greater focus across the entire organization, so we can continue to build the global leadership within vitamin K2 and MenaQ7. Further, we believe it’s time to add more critical mass to our dietary supplement business by focusing additional resources on expanding our product portfolio with new, scientifically validated ingredients. An expanded product offering also allows us to take advantage of our existing global sales and customer technical support organizations,” added Rosenbaum.
Indeed, the company recently launched a new ingredient, called MenaQ7 Full Spectrum K2, which includes more of the menaquinone forms found in natural fermented cheese (menaquinones 6, 7, 8 and 9) a range of isomers vital for cardiovascular health.