The company has been allowed by South Korea’s Ministry of Food and Drug Safety (MFDS) to make the claim “to maintain healthy joints” for its signature joint-health compound FlexPro MD.
In fact, South Korea is the first Asia-Pacific market where products containing FlexPro MD are allowed to make a health claim. The proprietary blend consists of krill oil omega-3, as well as Valensa’s astaxanthin marketed as Zanthin and its proprietary lower molecular weight hyaluronic acid marketed as Flexonic.
Speaking to NutraIngredients-Asia, CEO Umasudan Pal said the firm hoped to provide an alternative solution to the South Korean market which has been seeing a slowdown in terms of innovation for joint health supplements, based on market survey by its Korean business partner, contract manufacturing firm Novarex.
“The key takeaway was that the joint supplement market was commoditised. There was a lot of commodity ingredients like glucosamine chondroitin, msm, and there was not a lot of product differentiation.
“Therefore, the brands when looking for something unique where they could have a different proposition to the customers,” Pal said, adding that some of the existing products require consumers to take two to three pills per day, causing a sense of pill fatigue.
On the other hand, FlexPro MD contains krill oil – an ingredient which is well-known in South Korea but not yet considered as a health functional food ingredient when used on its own.
Pal pointed out that the blend, which contains krill oil and is allowed to make joint health claim, would circumvent the limitations surrounding krill oil.
“Krill was getting a lot of attention in the Korean market, but you cannot make a health claim against krill. You will just be selling krill as krill.
“Our partner found the opportunity to use this formulation which also uses krill, but it's got a functional benefit now with a health claim.”
Based on clinical studies, a daily intake of 356mg of FlexPro MD has been shown to support joint health.
So far, the company has conducted two mechanistic studies and one human clinical trial in South Korea, as well as a human clinical study in the US using the blend.
“It's not about the three components but about the synergy that makes the product more effective,” Pal highlighted.
He recounted that the opportunity to introduce the blend to South Korea came in year 2016, when Novarex expressed its interest after seeing the results of FlexPro MD’s clinical study in the US.
“They found the outcome from our US study very intriguing, and we subsequently gave them the license to apply for health approval in South Korea.”
Channel exclusivity
Following its entry into South Korea, Valensa hopes to further expand within the Asia-Pacific region into China, Australia, and New Zealand. To do so, the company is adopting a channel-exclusive strategy for its potential brand partners.
For instance, the company is seeking to work with only one brand exclusively for each retail channel.
In the case of South Korea, the company is on the lookout for the right brand partners that have expertise in home TV shopping channel and pharmacies – two of the largest nutraceutical retail channels in the country.
“We will prefer to give exclusivity based on channel, or territory focus, so that we maximise the footprint of the portfolio.
“At the same time, we don't want our brand partners to be facing channel conflicts and we give them the opportunity to grow their share of joint health portfolio in that specific channel,” Pal explained.
“In a way, South Korea is a good opportunity for us to learn more about consumer preferences in Asia and leverage those insights both from the consumer end, the business model, and the regulatory approval process before expansion,” chief marketing officer Juan Motta added.
So far, the blend has been used in finished products branded MegaRed under Schiff Nutrition by Reckitt Benckiser as well as Life Extension’s Krill Healthy Joint Formula and Purity products’ Flexuron Joint Formula in the US.
The blend could be used in applications across gelatin soft gel, gummy, and liquid capsule. Pal said that it has also been used in pet supplements as a dog chewable in the US which is sold via veterinary pharmacies.
Evidence
The FlexPro blend has been found to work at the gene transcription and tissue levels based on mechanistic studies.
For example, the blend was shown to significantly inhibit NF-κB activation, expression levels of pro-inflammatory markers such as, TNF-α, IL-6 and IL 1β and matrix-degradation enzymes MMP1 and MMP2.
“It targets inflammation and some of the mechanistic studies that we have done shown at the gene transcription level that it's reducing anti-inflammatory factors, like NF-κB, TNF-α, IL-6, also key markers of cartilage degradation MMP.
“So it's targeting at the tissue level the inflammation which is causing these tissue damage and thereby joint pain and stiffness,” Stephen Hill, vice president product technology quality and regulatory explained.
In a clinical trial conducted in the US, it was found to have outperformed a standard full dose of glucosamine and chondroitin for providing joint comfort by three times.
Elsewhere in South Korea, a 12-week, multi-centre human clinical trial with 100 participants was also conducted.
Results showed a significant improvement in self-reported (VAS) and physician-assessed (K-WOMAC) joint pain assessments compared to placebo. The study also found significant differences in total joint health (pain, stiffness, physical function).
The findings are expected to be published later this year.