Kappa's India approval for patented vitamin K2 product to open doors for NPD in APAC
With the help of Kappa's long-time distribution partner, Indian marketing company SA Pharmachem, K2VITAL DELTA has now become the only microencapsulated vitamin K2 product approved for use in medical drugs in India.
Kappa has said that this launch will be accompanied by the firm's complete educational materials, along with almost 150 licence-free product formulations customers can use to speed up the launch of their own vitamin K2 products.
K2VITAL DELTA is essentially almost 100% (over 99.7%) pure vitamin K2 — crystalline, all-trans MK-7 (menaquinone-7) produced in Norway via a patented microencapsulation process that makes the ingredient highly stable.
Kappa felt this was necessary, as vitamin K2 is unstable in certain combinations, one of which is with calcium, which enters the body through diet and supplementation but cannot enter the bones unless certain enzymes ae activated by vitamin K2.
One of these enzymes is osteocalcin, which is needed to direct calcium into the bone matrix. Without it, calcium remains in the blood and is either excreted by the body, or absorbed into soft tissue.
In a worst-case scenario, calcium enters the heart and arteries, causing the arteries to harden and increasing the risk of a heart attack and cardiovascular disease.
The other enzyme is matrix gla protein (MGP), which binds excess the calcium that does not enter the bones, and prevents it from entering soft tissue.
While vitamin K2 has been reported to reduce the risk of hardening and plaque in the arteries, as well as cardiovascular disease, calcium tends to degrade it, causing it to be unable to meet shelf life requirements.
Kappa therefore developed a microencapsulation system to protect vitamin K2, resulting in K2VITAL DELTA.
Kappa's communications lead Jim Beakey told NutraIngredients-Asia: "There have been about 50 clinical trials, which we use quite frequently when we write our scientific papers. They look at things like fracture reduction, and bone mass at different life stages.
"These trials have basically demonstrated that vitamin K2 can improve and maintain bone health over a long period of time.
"In the cardiovascular area, there aren't as many trials at this point, but there are a few really strong ones. One trial, called KNAPEN, demonstrated that after three years of supplementation, women over the age of 45 had less arterial stiffening (than those in the control group).
"But what's really interesting is they had less arterial stiffening than when they'd started the trial, so not only does K2 prevent arterial stiffening, it can even reverse it."
Regarding Kappa's work in India, Beakey said, "We identified India as a market with significant opportunity some years ago, with the size of its population and ageing population, as well as the growing prevalence of osteoporosis.
"It also has a very strong calcium market, which is key to vitamin K2, because it is a helper and mediator for calcium. India has plenty of supplementation and prescriptions for osteoporosis and bone health, but without vitamin K2, the triangle is essentially incomplete.
"And now, for the first time in India, calcium can be formulated with vitamin K2 in a bone health prescription, and maintain shelf life for up to two years."
India's regulations allow for only certain types of vitamins to be sold as food ingredients and dietary supplements, a category in which K2VITAL DELTA was initially registered. However, with drug approval, it can now be used in pharmaceutical formulations, sold in pharmacies, and recommended by physicians and medical practitioners.
Beakey said, "It can now be represented in pharmacies through consultations and prescriptions, which opens up a whole new area for K2VITAL DELTA and Kappa Bioscience.
"As the vitamin K2 market grows over time — and that might be a timescale of a decade — I do think we will see more of such developments around the world."
He added that bone and heart health supplements were the main applications for K2VITAL DELTA (primarily in capsule or tablet form), and that any other category of nutritional supplementation that could benefit from bone or heart health was also a strong market category, including women’s health, child development, and sports nutrition.
Formulating the future
At the moment, Kappa has 35 distributors in over 50 markets, including Australia, Malaysia and Singapore.
Beakey revealed: "Interestingly, SA Pharmachem is one of our original and earliest distributors, so we've had a longstanding partnership with them. The Indian regulatory landscape is somewhat complicated and they proved to be the right partner for this.
"The process took multiple years, from the beginning to getting the final approval just recently, and they were very active and instrumental in pushing it through."
When it comes to further overseas expansion, Beakey believes "the challenge is that each country has a different regulatory environment".
However, he is confident that vitamin K2 will continue to increase its market share, with new innovations and rising demand for different delivery formats across the APAC region.
"As the market has grown, we’ve moved beyond the traditional capsules and tablets. We’re seeing liquids, gummies, and innovative film strips that dissolve on the tongue.
"In Thailand, there's very high interest in vitamin K2 in different beverages, including probiotic drinks and the like. Over time, I think we'll see a whole new category for K2 in the beverages arena."