Valbiotis Obtains Patent for Its Active Substance TOTUM•63 in China, a Large Potential Market for the Prevention of Type 2 Diabetes and Metabolic Diseases

Regulatory News:

Valbiotis (FR0013254851 - ALVAL, eligible for the PEA / SME), a Research and Development company committed to scientific innovation for preventing and combating metabolic diseases, announces that it has obtained a patent in China for TOTUM•63, issued by the China National Intellectual Property Administration (CNIPA). This patent protects the composition and use of TOTUM•63 for the prevention of type 2 diabetes and metabolic diseases until 2035. China, whose economic development has been accompanied by an explosion of metabolic disorders since the 2000s, is now believed to have the largest prediabetic population in the world, with an estimated 390 million people (35% of the adult population)1.

Sébastien PELTIER, CEO of Valbiotis, comments: "We are honored to obtain this Chinese patent. It is the recognition of our ability to develop plant-based active substances by another major global market, after Europe and the United States. In this new and rapidly developing territory, metabolic diseases and type 2 diabetes are critical public health issues. With this patent, we can now envision making our active substance TOTUM•63 available to a very large population, whose need for the prevention of metabolic diseases is huge. This is an exciting prospect and a challenge that we will undertake with great determination, alongside our partner Nestlé Health Science."

The rise of a significant market for the prevention of metabolic diseases in China

Since the 2000s and the acceleration of its economic development, China has been facing a dramatic increase in excess weight, obesity and the associated metabolic diseases such as type 2 diabetes. The rapid change in eating habits and living conditions in the world's largest population has led to an alarming situation for the Chinese authorities: at the end of 2020, 34% of adults in China were overweight and 16% obese, i.e. one adult in two at metabolic risk, an increase of 20% in 20 years2.
As a result of this weight gain in all age groups, blood glucose disorders are becoming more prevalent in the country: the most recent estimates indicate a 35% prevalence of prediabetes among adults, while type 2 diabetes is almost at 11%1. These rates are now equivalent to those recorded in the United States, but in a population four times larger. 390 million adults in China are supposed to be prediabetic1, compared to 86 million in the United States3.

To meet the new health needs of the population, the Chinese healthcare market has grown rapidly, driven by structural reforms and the development of the middle class4. In 2018, China ranked 2nd in the global pharmaceutical market (8.2% of global sales), behind the United States5.

TOTUM•63 now benefits from global patent protection, including in China and 4 other new countries

The patent obtained in China gives exclusive rights to use TOTUM•63 within Chinese territory until 2035. Like the patents already obtained, this patent grants extensive rights that protect, in particular: the active substance TOTUM•63's plant extract and biomolecule composition, the possible combination with other products or substances and, above all, the specific use of this innovation in the field of metabolic diseases.

In addition to China, similar patents for TOTUM•63 have recently been obtained in Japan, Mexico, Indonesia and New Zealand, bringing the total number of countries in which TOTUM•63 is now protected to 48.

TOTUM•63 patent is the subject of a global patent filing strategy in more than 60 countries, including Europe and North America. It is co-owned along with the CNRS (Centre National de la Recherche Scientifique), Clermont Auvergne University and La Rochelle University, each long-standing academic partners of Valbiotis since the Company's creation in 2014.

About TOTUM•63
TOTUM•63 is a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of Type 2 Diabetes.
TOTUM•63 has already been proven safe and effective in healthy human volunteers during a Phase I/II clinical study. The results of the international randomized, placebo-controlled Phase II study showed that TOTUM•63 reduced fasting and 2-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.
TOTUM•63 benefits from intellectual property granted in the main markets worldwide: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New-Zealand and national phases are underway in more than 10 countries including Brazil and Australia. The ability to produce TOTUM•63 industrially, in compliance to North American and European standards, has been validated. TOTUM•63 already has marketing authorizations related to its status in Europe.
In 2020, Valbiotis has signed a global and long-term partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63. This unique partnership in the field of Nutrition Health plans that TOTUM•63 will be put on the market by Nestlé Health Science at a global level, possibly before obtaining a health claim, depending on the areas. It will also provide funding for the latest development stages of TOTUM•63.

About Valbiotis
Valbiotis is a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases in response to unmet medical needs.
Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic diseases, based on a multi-target approach enabled by the use of plant-based ingredients.
Its products are intended to be licensed to players in the health sector.
Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites in France: Périgny, La Rochelle (17) and Riom (63).
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI label. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs via the European Regional Development Fund (ERDF). Valbiotis is a PEA-SME eligible company.
For more information about Valbiotis, please visit: www.valbiotis.com

Name: Valbiotis
ISIN code: FR0013254851
Mnemonic code: ALVAL
EnterNext© PEA-PME 150

This press release contains forward-looking statements about Valbiotis' objectives. Valbiotis considers that these projections are based on rational hypotheses and the information available to the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and uncertainties, including those described in the Valbiotis registration document, approved by the French Financial Markets Regulator (AMF) on 31 July 2020 (application number R 20-018). This document is available on the Company's website (www.valbiotis.com).
This press release, as well as the information contained herein, does not constitute an offer to sell or subscribe to, or a solicitation to purchase or subscribe to, Valbiotis' shares or securities in any country.

1 Limin Wang et al. JAMA. 2017;317(24):2515-2523.
2 Chinese national nutrition and chronic disease report 2020, National Health Commission, www.sciencesetavenir.fr/sante/plus-d-un-chinois-sur-deux-desormais-en-surpoids_150360 (as viewed on April 27, 2021).
3 AEC Partners data on Valbiotis' key markets, 2019.
4 daxueconseil.fr/marche-des-medicaments-en-vente-libre-en-chine/ (as viewed on April 27, 2021).
5 Bilan Economique, Les Entreprises du Médicament, 2019, p. 40 ; www.leem.org/sites/default/files/2019-09/250719-BilanEco2019_6.pdf (as viewed on April 27, 2021).

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