VALBIOTIS
28.5.2019 17:42:20 CEST | Business Wire | Press release
Regulatory News:
VALBIOTIS (FR0013254851 – ALVAL / PEA/SME eligible), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the successful industrial production of VALEDIA® (active substance TOTUM-63), the most advanced product in the VALBIOTIS portfolio. This achievement is the result of a collaboration with the Pierre Fabre group, a world-renowned expert in the industrial production of plant-based active substances.
Since securing industrial property rights in Europe and the United States, VALBIOTIS has made another major breakthrough by demonstrating its capacity to produce VALEDIA® industrially, and in accordance with the regulations governing these two markets.
Sébastien Peltier, CEO of VALBIOTIS, comments: "The industrial production of VALEDIA ® has come at the best possible time for VALBIOTIS, after obtaining strong preclinical and clinical results and securing the industrial property rights, in the lead-up to the publication of our Phase IIA clinical results. This is an important milestone, thus completing our health claim application and supporting our negotiations with a partner company to market the product in 2021. This development confirms the sustainability of our project to market plant-based products which target the causal mechanisms of metabolic diseases. To achieve this, we are following the regulatory process for dietary supplements with a health claim, while maintaining almost pharmaceutical-grade development standards."
VALEDIA® will be the first of a new class of products, aiming to prevent and combat metabolic diseases.
Industrial batches for future studies
VALBIOTIS is currently developing VALEDIA® for two labels: prediabetes and hepatic steatosis. The results of the Phase IIA clinical trial for prediabetes are expected by 31 July, 2019. They will be followed in the second half of the year by the launch of the European Phase IIB clinical study (REVERSE-IT) and the Phase IIB study (PREVENT-IT) in North America. The data from these studies will be used to submit the application to European and North American regulatory authorities, for a health claim to reduce the risk of type 2 diabetes, with a view to marketing the product in 2021.
Murielle Cazaubiel, Director of Development and Medical Affairs at VALBIOTIS, comments: "The success of this industrial production means we can progress to the next stages of clinical development with complete confidence. The new production capacities established with the Pierre Fabre group will be used in our two upcoming confirmation studies. This collaboration has enabled VALBIOTIS to benefit from leading expertise in the production of plant-based active substances, from extraction to standardization, ensuring that these results can be reproduced with both large and small quantities. "
“In 2015, we put our expertise in extracting plant-based active substances at the service of VALBIOTIS and accompanied them in their development. We produce 3 plant extracts that make up VALEDIA ® at our Gaillac (Tarn) extraction site. Today, we are happy to accompany them in this industrial transposition by manufacturing the capsules on our Cahors (Gers) production site specialized in phytotherapy and aromatherapy,” adds François MACAREZ, Business Developer at Pierre Fabre Médicament.
About TOTUM-63, the active substance of VALEDIA®
Prediabetes is a growing public health issue worldwide that has been acknowledged by international organizations. Without appropriate management, 70% to 90% of prediabetic subjects will develop type 2 diabetes.
VALEDIA® intend to be be the first natural and clinically proven solution specifically designed for prediabetics. VALEDIA® contains the active substance TOTUM-63, a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of type 2 diabetes.
The launch of VALEDIA® is planned for 2021, with a health claim for reducing the risk 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 first international Phase IIA study are expected before 31 July 2019.
ABOUT VALBIOTIS
VALBIOTIS is a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases. Its products are made for major players in the health care sector. VALBIOTIS particularly focuses on solutions to prevent type 2 diabetes, NASH (nonalcoholic steatohepatitis), obesity and cardiovascular diseases.
VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers in France and abroad, including La Rochelle University, the CNRS and Clermont Auvergne University located in Clermont-Ferrand. These partnerships have enabled Valbiotis to benefit from strong financial leverage, particularly thanks to experts and technical partners who support its projects. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and an American office in Boston (MA).
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: http://valbiotis.com/
Name: VALBIOTIS
ISIN code: FR0013254851
Mnemonic code: ALVAL
Disclaimer
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 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 5 April 2017 (application number I.17-012), as well as in the 2017 annual financial report, filed with AMF on 3 April 2018. These documents are available on the Company's website (www.valbiotis.com ). VALBIOTIS does not accept any liability regarding the update or revision of these forward-looking statements. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190528005507/en/
Contact:
VALBIOTIS CORPORATE COMMUNICATION Carole Rocher / Marc Delaunay +33 5 46 28 62 58 medias@valbiotis.com
FINANCIAL COMMUNICATION ACTIFIN Stéphane Ruiz +33 1 56 88 11 14 sruiz@actifin.fr
MEDIA RELATIONS MADIS PHILEO Guillaume De Chamisso +33 6 85 91 32 56 guillaume.dechamisso@madisphileo.com
UNITED STATES SOLEBURY TROUT Rebecca John / Patrick Till +1 646 378 2935 rjohn@troutgroup.com ptill@troutgroup.com
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Allianz Delivers Record Result and Is Well on Track to Achieve Its Targets7.8.2026 07:10:00 CEST | Press release
2Q 2026 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806509750/en/ Oliver Bäte, Chief Executive Officer of Allianz SETotal business volume at 45.6 billion euros, an internal growth of 5.7 percent1, with contributions from all segments. Asset Management delivers excellent growth. Operating profit rises 10.6 percent to a record level of 4.9 billion euros. Shareholders’ core net income at 2.6 billion euros; 12.7 percent below last year. Adjusted for a divestment gain last year and offsetting measures following the sale of the stake in our Indian JVs, underlying growth is strong at 10 percent. 6M 2026Total business volume at 98.6 billion euros, an internal growth of 4.3 percent1, driven by Property-Casualty and especially Asset Management. Operating profit rises 8.6 percent and reaches a record level of 9.4 billion euros. Shareholders’ core net income advances 15.5 percent to 6.4 billion euros. Adjusted for divestment effec
Pure Lithium Receives Australian Patent for "Lithium Metal Anode and Battery"6.8.2026 22:49:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery technology company, today announced that the Australian patent office has granted the company a patent (AU2025271196) titled “Lithium metal anode and battery.” Australia mines roughly half of the world’s lithium, yet has no domestic battery production at all; every battery the country uses is imported. The granted patent is directed to ways in which Pure Lithium’s technology can change that. Rather than trying to catch up in lithium-ion, Australia can leapfrog the incumbent technology and establish a next-generation industry. As worldwide demand for batteries grows, every country capable of making batteries needs to be making them. That is Pure Lithium’s central goal: opening up markets around the world through battery technology that enables local, independent supply chains, keeping pace with demand and strengthening economies. China controls the lithium-ion battery supply chain and manufactures th
Vercel Appoints Amit Agarwal, Standard Template Labs CEO and former Datadog President, to Board of Directors6.8.2026 17:00:00 CEST | Press release
The product leader who helped scale Datadog from early-stage startup through IPO brings deep product expertise to Vercel's board Vercel, the agentic infrastructure company, today announced the appointment of Amit Agarwal, former president of Datadog and founder and CEO of Standard Template Labs, an AI-first service management platform, to its board of directors. Agarwal brings 25 years of enterprise software experience and a track record of scaling a product-led company from its earliest days into one of the defining public software companies of the cloud era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806738617/en/ Amit Agarwal Agarwal joined Datadog in 2012 as its Chief Product Officer and was named President in 2022, overseeing product, corporate development, and go-to-market functions as the company grew past $2.5 billion in annual revenue. Across 13 years, including Datadog's 2019 IPO and its first years as a pub
Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries6.8.2026 16:00:00 CEST | Press release
New security suite extends Laserfiche’s proven security controls and adds near real-time data replication for governments, law enforcement and security-conscious enterprises. Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses. With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure wit
AM Best Upgrades Fortegra Insurance Subsidiaries to A (Excellent)6.8.2026 15:00:00 CEST | Press release
Rating actions follow completion of the DB Insurance acquisition The Fortegra Group, Inc. (“Fortegra” or the “Company”), a global specialty insurer and part of DB Insurance Co., Ltd., today announced that AM Best has upgraded the Financial Strength Rating (FSR) of its insurance subsidiaries to A (Excellent) from A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICRs) to “a” (Excellent) from “a-” (Excellent). The outlook assigned to the ratings is stable, and AM Best removed the ratings from under review with positive implications. KBRA has also upgraded all of its ratings for the Company. The upgrade applies across Fortegra’s insurance platform. The property and casualty companies include Lyndon Southern Insurance Company, Insurance Company of the South, Response Indemnity Company of California, Blue Ridge Indemnity Company, Fortegra Specialty Insurance Company and Fortegra Europe Insurance Company SE. The life and health companies include Life of the South Insurance Co
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom