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
Union of Kansai Governments: Kansai Deep Tech Ecosystem Gains Global Visibility31.3.2026 02:00:00 CEST | Press release
Platform Update Reflects 20-Place Rise in GSER Ranking The Union of Kansai Governments has refreshed the Kansai Startup Ecosystem portal, strengthening the region’s global communication platform for startups and deep tech. At the same time, the “DeepTech Frontier Kansai” website has also been updated, further enhancing international visibility for Kansai’s rapidly growing deep tech ecosystem. Kansai’s startup ecosystem has demonstrated steady growth in recent years. The ecosystem’s total value expanded from USD 2.68 billion in 2023 to USD 3.23 billion in 2025. In addition, Kansai rose 20 places in the Global Startup Ecosystem Ranking (GSER) published by Startup Genome, climbing from 99th in 2023 to 79th in 2025, and early-stage funding reached USD 124 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330459051/en/ Kansai’s Strength in Deep Tech Kansai represents a rare ecosystem where fundamental research and indust
Merz Aesthetics® Announces EU Approval of Two New Indications for Their Hyaluronic Acid Filler BELOTERO® Balance30.3.2026 22:49:00 CEST | Press release
Merz Aesthetics®, the world’s largest dedicated medical aesthetics business, is pleased to announce that BELOTERO® Balance has received EU approval for two additional indications: the treatment of infraorbital hollow (including the tear trough) and horizontal forehead lines1*. “With these new approvals, BELOTERO® Balance further strengthens its position as a versatile hyaluronic acid dermal filler, with a wide range of approved facial indications1 designed to integrate seamlessly within the skin and deliver predictable, harmonious aesthetic outcomes,” said Dr. Kerstin Olsson, Head of Medical Affairs EMEA. The approval of these two new indications is supported by compelling clinical evidence: In a clinical investigation on infraorbital hollow, 98.9% of subjects demonstrated visible improvement at Week 8, with long-lasting results sustained up to 72 weeks, and no treatment related serious adverse events reported.2 Similarly, in a postmarket investigation on horizontal forehead lines, 82.
Klarna Payments Now Available at B-Parts, Europe's Largest Automotive Parts Website30.3.2026 21:51:00 CEST | Press release
B-Parts is now offering its customers a more personalised and flexible shopping experience, with interest-free payments via "Pay in 3", amongst other Klarna features. Klarna, the global digital bank and flexible payments provider, is joining forces with B-Parts, a leading online retailer of used and original car parts, to offer consumers greater flexibility, convenience, choice and control at the point of payments, with no interest or hidden fees. Through Klarna’s interest-free installment payments, B-Parts customers will benefit from greater flexibility and control over their finances. Klarna also ensures a secure shopping experience thanks to its buyer protection scheme, as well as a range of features such as cashback and deals. "We continue to grow locally, with an increasing number of brands across different sectors recognising the enormous advantage of offering their customers more payment options, those that make for a more convenient and seamless checkout experience," explains I
Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings & Gatbits IT Infrastructure Announce Launch of GTBS Digital Ecosystem; Mainnet Set for April 202630.3.2026 20:30:00 CEST | Press release
The Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings, in collaboration with Gatbits IT Infrastructure, has officially announced the launch of the GTBS Digital Ecosystem, marking a significant step forward in the global Web3 space. The announcement follows the successful launch of the native GTBS Coin on December 25, with the ecosystem’s mainnet scheduled to go live in April 2026. GTBS represents a full-stack Web3 ecosystem integrating blockchain, artificial intelligence, decentralized finance (DeFi), entertainment, gaming, media, and cloud infrastructure into a unified platform. Built on the philosophy of “All Commitment On Time,” the ecosystem focuses on delivering reliability, scalability, and real-world utility. Designed as a comprehensive digital infrastructure, GTBS goes beyond standalone crypto platforms by offering an integrated environment for users, developers, creators, and enterprises. Its proprietary Layer-1 blockchain powers seamless interaction across se
Yubico Appoints Poupak Modirassari Enbom as Chief Marketing Officer to Accelerate Global Momentum and Drive Market Leadership30.3.2026 15:00:00 CEST | Press release
Yubico (NASDAQ STOCKHOLM: YUBICO), the creator of the most secure passkeys and a leading provider of hardware authentication security keys, today announced the appointment of Poupak Enbom as Chief Marketing Officer (CMO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330278027/en/ Enbom joins Yubico at a pivotal moment as organizations worldwide accelerate the shift to phishing-resistant authentication and modern identity security in the age of AI. “We’re excited to welcome Poupak to Yubico,” said Jerrod Chong, acting chief executive officer, Yubico. “As the threat landscape evolves with AI-driven attacks and increasing automation, organizations are rethinking how they secure digital identities of both humans and AI agents at scale. She brings a unique combination of technical depth, global leadership, and customer-first mindset that will help us continue to expand our impact and support our customers and partners around
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