The partnership grants Nestlé exclusive and global commercial rights to use TOTUM-63 at an upfront cost of €4.7m with further payments up to a maximum of €62m, along with tiered royalties on net sales.
“The research and development that Valbiotis is doing is very promising,” says Hans-Juergen Woerle, chief science & medical officer of Nestlé Health Science.
“We look forward to working together to realise the commercialisation of TOTUM-63, an innovative approach to reducing the risk of type 2 diabetes."
Further details of the agreement will see Nestlé provide funding for the latest clinical development phase of TOTUM-63 until health claims are obtained by the appropriate authorities in the United States and Europe.
However, both parties agree the commercialisation of TOTUM-63 may take place before obtaining these claims.
The firm has already applied for patent protection for TOTUM-63 in more than 60 countries, including Europe, USA, Canada, China, Russia, Japan, Brazil and Australia.
The patent was granted in France in 2014, in the United States in 2018, in Europe in 2019 (39 countries) and in Russia in 2020.
The agreement will also see the formation of a joint steering committee comprised of representatives of both companies, who will oversee clinical development, regulatory matters, supply and commercialisation.
TOTUM-63 is a patented combination of five plant extracts, which Valbiotis says demonstrates high potential to target type 2 diabetes’.physiopathological mechanisms.
The combination has already been proven safe and effective in healthy human volunteers during a phase I/II clinical study.
The results of the international randomised, placebo-controlled phase II study showed that TOTUM-63 reduced fasting and two-hour blood sugar levels, two risk factors for type 2 diabetes, in prediabetics compared to placebo.
In these subjects, who also had abdominal obesity, TOTUM-63 significantly reduced body weight and waist circumference.
According to preclinical studies its areas of target include the intestinal microbiota, where it may improve its overall composition and imbalances observed in prediabetes.
Other target areas include the skeletal muscle and adipose tissue, where TOTUM-63 appears to reduce insulin resistance, restoration of insulin intracellular signaling pathways (Akt) and reduction of inflammation in adipose tissue;
TOTUM-63 also looks to have an effect on the pancreas, where it may play a role in preservation of insulin secretion capacity.
“Nestlé Health Science is an ideal strategic partner for Valbiotis,” says the firm’s CEO Sébastien Peltier.
“Its global reach, strategic intent to develop science-based nutritional health solutions and focus on fighting metabolic disorders like diabetes will be instrumental to TOTUM-63’s worldwide commercialisation success.
“We are excited about the opportunity that this deal brings to Valbiotis and to the many millions of people around the world at risk of becoming type 2 diabetics,” he adds.
“This transformational deal arrives just five years after the creation of Valbiotis and is a recognition of the hard work, commitment and vision of our team.”