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
Vonage Network APIs Pave the Way for Freenow by Lyft to Advance Urban Mobility Innovation22.1.2026 08:00:00 CET | Press release
Freenow adopts Vonage APIs to access network capabilities, strengthening fraud prevention through faster, verified connections with drivers for millions of riders Vonage, a part of Ericsson, and Freenow by Lyft, a leading taxi and multi-mobility app in Europe, have expanded their partnership with the launch of Vonage Silent Authentication API for customers based in the U.S. Vonage Network APIs enable Freenow by Lyft to tap into real-time network data and insights, helping prevent fraud through seamless user verification, ensuring reliable, efficient, and secure interactions for its customers and drivers. Network intelligence is becoming a critical layer of defense in the transportation space as fraud threats become more sophisticated and targeted. Enterprises worldwide lost 7.7% of their annual revenue on average due to fraud over the past year, representing an estimated $534 billion in losses.¹ With scam/authorization fraud, synthetic identity fraud, and account takeover as the leadin
Daiichi Sankyo Appoints New Leadership at the Daiichi Sankyo Translational Research Center Europe22.1.2026 07:30:00 CET | Press release
Daiichi Sankyo (TSE:4568) has appointed Veronika Rozehnal, Ph.D., to succeed Jürgen Müller, Ph.D., as the Head of the Translational Research Center Europe. Dr. Jürgen Müller will retire after nearly 30 years of research work at Daiichi Sankyo. Under his leadership, the Translational Research Center Europe, previously called the Tissue and Cell Research Center Munich, has grown from three to 40 researchers since it was founded in 1997 and has become an internationally recognized institution that plays a strategic role in the global innovation process of Daiichi Sankyo. Dr. Veronika Rozehnal joined Daiichi Sankyo in 2009 and has held various positions at the Translational Research Center Europe in addition to spending three years at the Daiichi Sankyo R&D Center in Tokyo. Dr. Rozehnal graduated from Ernst-Moritz-Arndt University of Greifswald, Germany with a Ph.D. degree in Clinical Pharmacology. “Jürgen Müller has made significant scientific contributions that have helped Daiichi Sankyo
Azafaros Announces Key Scientific Oral and Poster Presentations on Nizubaglustat Accepted for WORLDSymposium™ 202622.1.2026 07:00:00 CET | Press release
Five presentations will showcase nizubaglustat’s therapeutic potential in Lysosomal Storage Disorders. Nizubaglustat is currently being tested in two global Phase 3 studies for Niemann-Pick type C disease and GM1/GM2 gangliosidoses which are currently recruiting. Azafaros will host a satellite symposium on nizubaglustat on Day 2 of the symposium discussing the Phase 3 studies. WORLDSymposium™ 2026 takes place from February 2 to 6 in San Diego, California. Azafaros, a company building a portfolio to become a leader in lysosomal storage disorders with the goal of addressing neurological symptoms, today announced that its lead asset, nizubaglustat, will feature in five scientific presentations accepted at the WORLDSymposium™ 2026, the leading global conference on lysosomal diseases, taking place in San Diego, California, USA between February 2-6. The company’s conference activities include: Oral Presentations (including Poster numbers 134 and 29-C) Long-term data from a Phase II study wit
I Squared Announces Launch of Radiant Energy Solutions22.1.2026 07:00:00 CET | Press release
I Squared Capital (“I Squared”), a leading global infrastructure investment manager, announced today the launch of Radiant Energy Solutions (“Radiant”), an investment from I Squared’s Middle East infrastructure strategy, which is focused on targeting transformational, mid-market investments in the region. Reflecting I Squared’s platform-building approach of starting with a core initial investment and scaling over time to build market-leading businesses, Radiant marks the firm’s entry into the Middle East distributed renewables market, providing decarbonization solutions to commercial and industrial customers. The investment for Radiant is the acquisition of FAS Renewables and its 100% owned subsidiary Zahra Energy, a Saudi Arabia–based distributed solar company with a secured and advanced portfolio of over 100MWp of distributed solar projects with established customers and long-term contracted solar power purchase agreements. These include Cenomi Centers, an owner, operator, and develo
IMCAS 2026: Galderma Showcases the Latest Scientific Advances Behind the Industry’s Broadest Injectable Aesthetics Portfolio22.1.2026 07:00:00 CET | Press release
At IMCAS 2026, Galderma will present findings supporting Sculptra’s® regenerative properties and benefits on the body, including improving cellulite appearance, firmness, lift, projection, and contouring following its European Union (EU) Medical Device Regulation (MDR) certification, expanding its use to four body areas1-7 Multiple studies will reinforce the safety and efficacy of Galderma’s hyaluronic acid (HA) treatments range, including post-marketing data on Restylane® Shaype™ in shaping the chin, Restylane Lyft™ in improving jawline definition, Restylane Skinboosters™ in smoothing fine lines and wrinkles in the décolletage and Restylane Volyme™ in correcting hollowing of the temples8-11 New data on the innovative neuromodulator Relfydess™ (RelabotulinumtoxinA) will reinforce its rapid onset as early as Day 1 and sustained efficacy through six months for frown lines and crow’s feet12 As a leader in injectable aesthetic innovation, Galderma will showcase its superior science and edu
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