Nestle and Valbiotis in prediabetes partnership

Last week, French-based R&D company Valbiotis signed a global long-term strategic partnership with Nestle Health Science for the development and commercialisation of Totum-63, a patented combination of five plant extracts specifically designed to reduce the risk of developing T2 diabetes in prediabetics. According to reports, Nestle Health Science will pay CHF5mn (US$5.1mn) upfront, development & sales milestone payments up to CHF66mn (US$68mn) and tiered royalties on net sales. The partnership will support Valbiotis’ work in a number of ways, including funding the latest clinical development phase until health claims are obtained in USA and Europe. 

Back in September 2019, Valbiotis released positive results from the Phase IIa study of Totum-63, revealing that it met its primary endpoint of reducing fasting blood glucose levels among 51 participants who received 5g / day or placebo for six months. The full results show that Totum-63 also met secondary endpoints, significantly reducing blood triglyceride levels by 32.2%, fatty liver index by 18.7%, arterial hypertension in hypertensive people and blood LDL cholesterol levels by 11.7% vs placebo. A preclinical study (in mice) also found that Totum-63 corrected blood levels of insulin, glucagon and glucagon-like peptide-1, hormones central to the regulation of blood glucose. At the time, Valbiotis CEO Sebastien Peltier said these results pave the way for new opportunities in “promising markets”, such as non-alcoholic fatty liver or arterial hypertension.

Diabesity was one of the chapters in our recent signature New Paradigms report, with one section looking at the huge potential of supplements for diabetes management. However, many of these are local brands that have only managed to carve out a small niche in their respective markets. The potential for a CHC brand for prediabetes / diabetes with a truly global scale is vast. According to Valbiotis, there are an estimated 900mn people worldwide that are prediabetic, and around 700mn people globally are forecast to contract T2 diabetes by 2045.

Nicholas Hall Writes: When Nestle walked away from the Merck Consumer Health bidding in February 2018, citing high price expectations, I wondered what that meant for the Health Science strategy. To judge by Valbiotis and other recent deals, Nestle seems more interested in buying new technologies than brands. Work we’ve done recently in this category has shown that there is a large population at risk of contracting diabetes, particularly in the Emerging Markets; but this prediabetes initiative will require vast amounts of consumer and HCP education. The question is whether the Valbiotis product, in the safe commercial hands of Nestle Health Science, can persuade consumers to take a pill for a condition they don’t yet have. But it’s worth the effort and could be a significant opportunity for both parties.

Join Nicholas Hall and Everything Health in New Jersey on 8 October 2020 to explore The Future is Now! Consumer Healthcare Reimagined with an optional workshop on 9 October hosted by The CHC Training Institute. To book your place and save with the early-bird booking discount, or to find out about sponsorship opportunities, please contact elizabeth.bernos@NicholasHall.com.

OTCs in Action Episode 47: Natural Sucanon approved to treat Type II diabetes

Last week, OTCs were in Action in Canada, where Sucanon has been evaluated by regulatory authorities, and is now a licensed natural health product for treating Type 2 diabetes.

Marketed by PharmaRoth Laboratories, Sucanon is an insulin sensitiser, lowering a patient’s blood sugar by increasing the muscle, fat and liver’s sensitivity to the body’s own naturally produced insulin. The product is also available as an OTC in Mexico, but has Rx status in China and Peru.

Last year, the US FDA denied PharmaRoth’s New Dietary Ingredient application for Sucanon to be sold as a nutraceutical. According to the US agency, the active ingredients, derived from a dried root and a form of molybdenum, should be classified as a drug.

OTCs in Action will be watching with interest this product’s expansion to various countries as PharmaRoth seeks to give diabetics access to safe and effective treatment. The brand’s tagline is:

Sucanon … Diabetes is not curable but is treatable … enjoy life.

Nicholas Hall’s OTC.NewDirections: FDA rulings in Medical Devices and Dietary Supplements

Two areas we focus on in our latest OTC.NewDirections bulletin are new regulations for dietary supplements and medical devices. In Canada, quality assurance measures are being introduced for Natural Health Products, while across the border in the US, the FDA has issued guidance to help marketers distinguish between liquid dietary supplements and beverages.