VALBIOTIS Receives US and European TOTUM-070 Patent for Reducing Hypercholesterolemia

• TOTUM-070 exclusivity guaranteed in the United States and in Europe for reducing blood LDL-cholesterol levels, a cardiovascular disease risk factor;
• Intellectual property rights protecting the composition of the TOTUM-070 active substance for food and pharmaceutical applications;
• A milestone in the further development of TOTUM-070, in the search for commercial partnerships and in receiving approval for health claims in Europe and North America.

LA ROCHELLE, France--(BUSINESS WIRE)--Regulatory News:

VALBIOTIS (Paris:ALVAL) (FR0013254851 - ALVAL, eligible for the PEA/SME), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, has announced that it has obtained an American and European patent for TOTUM-070, its active substance dedicated to reducing LDL-cholesterol in the blood (“bad cholesterol”).

TOTUM-070 is a combination of plant extracts that contains neither phytosterols nor red yeast rice, designed by VALBIOTIS’ proprietary R&D platform based in Riom (63). The patent has been granted for the United States, Europe and South Africa.

TOTUM-070 targets excess LDL-cholesterol, which is a well-known risk factor for cardiovascular disease and the main cause of atherosclerosis¹. It is believed that over 174 million adults in the US and Europe will suffer from hypercholesterolemia in 2020. The market for non-prescription products is estimated at €1.2 billion in these regions².

Sébastien Peltier, CEO of VALBIOTIS, said: “With TOTUM-070, we are targeting a major market, one in which we stand out for our specific plant know-how, a high level of clinical evidence and robust intellectual property worldwide. This strategy has already borne fruit, with a major partnership aiming at developping and marketing our first active substance, TOTUM-63. Obtaining this patent for TOTUM-070 in regions where populations are particularly affected by hypercholesterolemia marks a milestone in our development model aimed at building new partnerships of this scale.”

The TOTUM-070 patent covers a wide range of food and pharmaceutical applications relating to lipid metabolism disorders, for example dyslipidemia, cholesterol and triglycerides. It is the focus of an international filing strategy reaching beyond the United States and Europe.

A Phase II clinical study evaluating the efficacy of TOTUM-070 in people with untreated moderate hypercholesterolemia will be launched before the end of the year. The initiation of this study will be communicated subsequently.
The objective for VALBIOTIS is to obtain the first proprietary health claim for reducing LDL-cholesterol, notably in Europe and North America, for a product containing neither phytosterols nor red yeast rice.

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 nutritional health solutions designed to reduce the risk of major metabolic diseases, based on a multi-target approach and made possible by the use of plant-based ingredients.
Its products are intended to be licensed to players in the health world.
VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top 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 received the "Innovative Company" status accorded by BPI France. VALBIOTIS has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs by obtaining support from the European Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible company.
Find out more about VALBIOTIS: www.valbiotis.com

Name: Valbiotis
ISIN code: FR0013254851
Mnemonic code: ALVAL

DISCLAIMER
This press release contains forward-looking statements about VALBIOTIS' objectives, 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 can be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and doubts, including those described in the VALBIOTIS core document, filed with the French Financial Markets Regulator (AMF) on 31 July 2020 (application number R20-018), these documents being available on the Company’s website (www.valbiotis.com).

¹ 2018 Guideline on the Management of Blood Cholesterol, a report from the American College of Cardiology / American Heart Association, Journal Of The American College Of Cardiology, 2019.
² AEC Partners data for the United States and VALBIOTIS’ 5 priority European countries (Germany, Spain, France, Italy and the United Kingdom), 2020.