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
Syngenta to Address Global Agricultural Challenges at WEF, Championing AI to Empower Farmers and Create Open Technology Access19.1.2026 08:00:00 CET | Press release
AI and digital tools are unlocking unprecedented opportunities to strengthen farms and secure food security. New IPSOS study reveals technology adoption gap, underscoring urgent need for equitable technology access. Syngenta champions "Agricultural Intelligence" at World Economic Forum, showcasing Cropwise AI solutions that put cutting-edge tools in the hands of all farmers, especially smallholders. As farmers globally grapple with unprecedented economic, geopolitical, and environmental pressures; the agricultural sector faces a continued contraction. An alarming decrease in active farms worldwide and rising financial distress underscore the urgent need for innovation and technology to ensure a resilient food system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260118646017/en/ Jeff Rowe, Syngenta Group CEO "Farmers today are navigating one of the most complex periods in modern agriculture, facing pressures that demand urg
KPMG Enters Strategic Relationship With Uniphore to Build AI Agents Powered by Industry-Specific Small Language Models19.1.2026 07:00:00 CET | Press release
Collaboration uses KPMG’s knowledge in small language models to accelerate delivery of business outcomes to clients across banking, insurance, energy and healthcare Uniphore, the Business AI company, today announced a strategic relationship with KPMG LLP to operationalize AI agents across internal and client-facing workflows, supporting the firm’s continued effort to move from experimental AI pilots to production-grade deployment. As part of the collaboration, KPMG will work with Uniphore to build AI agents using Uniphore’s Business AI Cloud as a platform for agentic AI and fine-tuned small language models (SLMs), supporting clients across regulated industries including banking, insurance, energy and healthcare. Built on a sovereign, composable, and secure architecture, the platform integrates with KPMG’s existing enterprise systems and data environments, meeting governance and compliance requirements essential to regulated industries. This initiative reflects KPMG’s broader effort to
International Chamber of Commerce, Carbon Measures Announce First Group of Global Experts for Carbon Accounting Panel19.1.2026 06:00:00 CET | Press release
Panelists include senior global leaders from business, academia, and civil society. The International Chamber of Commerce (ICC) and Carbon Measures today announced the first cohort of experts selected to serve on the Technical Expert Panel on Carbon Accounting, which will define the principles, scope and real-world applications of a carbon emissions accounting system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260118104674/en/ The panelists are distinguished leaders and experts across industry, science, civil society, and academia – representing diverse disciplines, geographies, and professional backgrounds. The panel will apply their experience across sustainability, technology, public policy, and industrial and financial systems to establish a timely, accurate and verifiable ledger-based carbon emissions accounting system. This system will track product-level emissions across the value chain and support real-world deci
AI-Powered Creator Monetisation Platform, Fanvue, Hits $100m Run Rate and Raises $22m Series A Investment - as Leading Global Creators Rush to Join the Platform19.1.2026 01:01:00 CET | Press release
Fanvue, the AI-powered creator monetisation platform with a $100m-plus run rate, has announced a $22m Series A investment round. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112458975/en/ Joel Morris, Will Monange and Harry Fitzgerald (left to right) Fanvue has bet big on AI-powered tools changing the face of an industry estimated to be worth over $500B by 2030. The platform, which recently crossed $100m annualised revenue, has over 17 million monthly active users, and is home to 250,000 creators who are using Fanvue’s pioneering AI tools to scale their businesses and earn. Instead of competing with legacy platforms, Fanvue is defining a new category, the Creator AI Economy. Fanvue’s belief is that the next generation of creators will accelerate their earnings through utilising technology. And it’s happening in real time. According to Fanvue, just over 93% of creators on the platform used at least one of the platform’s
Andersen Consulting udvider sit udbud af humankapital med tilføjelsen af Jakarta Consulting Group16.1.2026 21:09:00 CET | Pressemeddelelse
Andersen Consulting styrker sine kompetencer gennem en samarbejdsaftale med Jakarta Consulting Group (JCG), der er et rådgivningsfirma, som er kendt for sin ekspertise inden for organisatorisk transformation, humankapitalstrategi og ledelsesudvikling. Med hovedsæde i Indonesien har JCG rådgivet virksomheder inden for brancher som ejendom, minedrift og produktion gennem strategisk og kulturel transformation. Med kerneydelser, der omfatter virksomheds- og administrationsrådgivning, hr-rådgivning, vurdering samt virksomheds- og ledelsestræning, er virksomheden kendt for sin evne til at transformere virksomheder og ledere med agilitet, kulturel intelligens og handlingsorienterede løsninger. "Vi har altid ment, at bæredygtig transformation begynder med mennesker – når ledere udvikler sig, følger organisationer med," siger Patricia Susanto, CEO for Jakarta Consulting Group. "Ved at kombinere Andersen Consultings globale perspektiv med vores regionale indsigt kan vi tilbyde kunderne mere helh
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