VALBIOTIS
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
Andersen Consulting styrker sine kompetencer med BMA27.11.2025 22:48:00 CET | Pressemeddelelse
Andersen Consulting udvider sine kompetencer inden for bæredygtighed og virksomhedsforandring gennem en samarbejdsaftale med BMA, der er et sydafrikansk firma, som arbejder for at styrke konkurrenceevnen i fremstillingsindustrien og fremme inkluderende industriel vækst. BMA, der blev etableret for mere end to årtier siden, arbejder på tværs af produktionsværdikæder – fra producenter til deres kunder – sammen med myndigheder og udviklingsagenturer for at fremme bæredygtig industriel konkurrenceevne. Gennem sine sektorfokuserede industrielle klynger leverer firmaet integrerede tjenester inden for industriel politik og strategisk udvikling, værdikædestrategi, produktionskonkurrenceevne og lean-rådgivning, reduktion af CO2-udledning samt udvikling af små og mellemstore virksomheder og samler interessenter omkring fælles prioriteter og skalerbare, langsigtede løsninger. "Bæredygtig produktion handler om mere end effektivitet. Det drejer sig om at skabe økosystemer, der er regenerative, resi
Stronghold’s SHx Token Lists on Uphold27.11.2025 16:00:00 CET | Press release
Multi-Chain Expansion Accelerates With New Listing on a Trusted Platform Supporting Both Stellar and Ethereum Stronghold announced that its SHx token is now available for retail users to trade on Uphold, the global multi-asset digital money platform known for its transparency, regulatory alignment, and seamless support for assets across both the Stellar and Ethereum networks. The listing marks a major milestone for SHx, expanding access for users and businesses who rely on Stronghold’s token for payments, settlements, and governance participation. "Uphold is one of the only platforms that provides seamless support for both Stellar and Ethereum-based tokens, making it a perfect fit for SHx as we grow our multi-chain ecosystem. This listing was championed by our community, and we’re thrilled to deliver on a request that so many SHx holders have been asking for." — Tammy Camp, CEO & Co-Founder, Stronghold SHx is Stronghold’s native utility token, powering interoperable payments, DeFi-base
Wipro to Power Odido’s Digital Future Through AI-enabled End-to-End IT Modernization27.11.2025 14:22:00 CET | Press release
The multi-year engagement marks a significant shift in Odido’s IT strategywith Wipro bringing deep domain expertise, AI-powered delivery, and a design-led approach to drive innovation Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading AI-powered technology services and consulting company, today announced a multi-year engagement with Odido Netherlands B.V.* to transform its IT landscape and enhance customer experience across their enterprise and consumer segments. By combining AI and deep consulting expertise, Wipro will help Odido improve customer engagement and satisfaction, improve productivity, and streamline operations to reduce costs. A key highlight of this multi-year engagement is the use of a self-funded model, where productivity-driven savings are reinvested to continuously fund new digital initiatives, ensuring that innovation remains both sustainable and scalable. As part of the engagement, Wipro will lead a full-scale modernization of Odido’s digital and enterpri
Klarna Set to Take off With Lufthansa Group, Bringing Flexible Payments to Travellers Across Europe and the U.S.27.11.2025 14:00:00 CET | Press release
Klarna, the global digital bank and flexible payments provider, today announces a new multi-market partnership with Lufthansa Group, Europe’s leading airline group. The new agreement is facilitated by Klarna’s integration with Adyen, the financial technology platform of choice for leading businesses. From November, Lufthansa Group customers will be able to choose Klarna’s flexible payment options at checkout when booking travel experiences. This new integration gives travellers greater control and convenience by offering the choice to pay in full, pay later, or spread the cost of their journey over time. The new options will be available first to customers in Austria, Belgium, Denmark, Finland, Germany, the Netherlands, Norway, Sweden, Switzerland, and the United States. “Travel is one of the most meaningful investments people make,” said David Sykes, Chief Commercial Officer at Klarna. “Together, we’re giving travellers the confidence to book their trips their way—with more flexibilit
GE HealthCare announces CE Mark for new digital 4D SPECT/CT system, StarGuide GX27.11.2025 12:06:00 CET | Press release
FOR USE IN CE-MARK EUROPEAN COUNTRIES ONLY StarGuide GXi empowers personalized care and research innovation as nuclear medicine expands into new applications The system doubles volume sensitivity,ii maintains high resolution and enables clinicians to virtually scan all energies fast – including the acquisition of investigational alpha emitters like Actinium-225 – with exceptional clarity and quantitation GE HealthCare today announced CE Mark for its new StarGuide™ GX system,i a new digital 4D SPECT/CT designed with excellent precision, clinical efficiency and impressive versatility. This milestone marks a significant moment in molecular imaging’s evolution, helping empower clinicians to expand research and help personalize care across a growing range of nuclear medicine applications and tracers – including the acquisition of alpha emitters. StarGuide GX comes at a pivotal time for the field of nuclear medicine. As complex diseases such as cancer, Alzheimer’s and cardiovascular disease
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