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
ECU Worldwide Unveils XLERATE 2.0 Expansion to Bypass Asia–Europe Supply Chain Disruptions25.3.2026 14:30:00 CET | Press release
Strategic LAX gateway enables faster, predictable cargo movement through a reimagined sea–air logistics model ECU Worldwide, Allcargo Globals’ wholly-owned global subsidiary, has announced a strategic expansion of its transformative logistics solution, XLERATE 2.0, to provide a high-speed and resilient alternative to Asia-to-Europe trade lanes facing transit disruptions. Under this alternative routing, cargo is transported across the Pacific to the US West Coast, using Los Angeles (LAX) as a temporary hub. The solution leverages XLERATE 2.0’s premium, time-definite ocean services, ensuring greater transit agility and continuity. XLERATE 2.0 offers two distinct shipping solutions from China and Vietnam, providing shippers with flexibility as traditional trade arteries remain impacted by shifts in global logistics. These changes have led to reduced overall capacity and the disruption of standard sea–air services via conventional transit points. Commenting on the rollout, Simon Bajada, Re
Incyte Announces Executive Leadership Appointments25.3.2026 14:00:00 CET | Press release
Incyte (NASDAQ:INCY) today announced appointments among its executive leadership team to support the Company’s strategic focus and long-term growth plans. Pablo J. Cagnoni, M.D., has been appointed President, Incyte and Global Head of Research and Development. In this role, Dr. Cagnoni will retain responsibility for Research and Development, while also supporting enterprise-wide strategic planning and operational execution. Under Dr. Cagnoni’s scientific leadership, Incyte’s R&D progress has been notable, including advancing our mutCALR antibody, povorcitinib, CDK2, KRASG12D and TGFßR2xPD1 programs. Dr. Cagnoni has also continued to strengthen the way Incyte conducts R&D, introducing a new structure, processes and new technologies to improve productivity and keep Incyte competitive. Steven Stein, M.D., has been appointed Executive Vice President, Chief Medical Officer and Head of Late-stage Development. In this role, Dr. Stein will continue to oversee Incyte’s extensive and growing lat
Andersen Consulting indgår en samarbejdsaftale med Ventum Consulting25.3.2026 13:58:00 CET | Pressemeddelelse
Andersen Consulting udvider sin globale platform med tilføjelsen af samarbejdspartneren Ventum Consulting, der er et forretnings- og teknologikonsulenthus med base i Tyskland, der specialiserer sig i digital transformation, enterprise agility, produktudvikling, datadrevet innovation samt nye teknologier såsom AI. Ventum Consulting hjælper organisationer med at bygge bro mellem forretning og teknologi ved at levere skræddersyede løsninger inden for strategi, procesoptimering og implementering af it-løsninger. Virksomhedens ekspertise omfatter data og AI, cybersikkerhed, enterprise architecture, bæredygtighed, cloud-transformation samt agile enablement, hvilket kun er et udsnit af deres omfattende serviceportefølje. Ventum Consulting arbejder med kunder på tværs af brancher, herunder bilindustri og produktion, finansielle tjenester og forsikring, sundhedssektoren og life science-industrien samt den offentlige sektor, for at accelerere digital transformation, styrke driftsmæssig robusthed
OCP Announces Date of Fourth Quarter and Full Year 2025 Earnings25.3.2026 13:30:00 CET | Press release
OCP S.A. (“OCP” or the “Company”), a global leader in the fertilizer industry, will release its fourth quarter and full year 2025 results on Wednesday, April 1, 2026. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts, and market makers on the OCP Intralinks portal from 9:00 a.m. EST, 2:00 p.m. Morocco and London time (GMT+1). OCP senior management will host a conference call to discuss fourth quarter and full year 2025 results at 10:00 a.m. EST, 3:00 p.m. Morocco andLondon time (GMT+1),on Wednesday, April 1, 2026, for holders of the Company’s bonds, qualified institutional buyers, securities analysts, and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma. About OCP OCP is a global leader in the fertilizer industry, backed by almost a century’s production history. OCP has exclusive
SLB Industrializes AI for the Energy Industry with NVIDIA25.3.2026 13:00:00 CET | Press release
Companies will develop modular data center infrastructure and generative AI models for large-scale deployments Global energy technology company SLB (NYSE: SLB) today announced an expansion of its technology collaboration with NVIDIA to design and deploy critical AI infrastructure and models for the energy industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324731936/en/ SLB’s technology center in Louisiana: a 3.1 million square-foot facility dedicated to manufacturing for its modular data center business. The work focuses on three strategic elements: Modular design for data centers: SLB will serve as the modular design partner for NVIDIA DSX AI factories. This modular approach, where components are manufactured offsite, will drive increased quality and reliability while also reducing costs, labor constraints and lead times. It also enables rapid and flexible scaling, which allows customers to expand data center capac
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