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
IFF Expands Latin American Footprint With New Enzyme Hub, Brazil Application Lab10.3.2026 21:30:00 CET | Press release
IFF (NYSE: IFF) — a global leader in flavors, fragrances, food ingredients and health & biosciences — is enhancing regional production and innovation capabilities to better support the continued growth of its Health & Biosciences (H&B) business in Latin America, one of the fastest-growing markets for the company. The effort includes the transformation of the Arroyito site in Argentina into IFF’s first full fermentation‑based enzyme production hub in the region and the opening of a household care application laboratory at IFF’s Innovation Center in Brazil. Together, these enhancements expand IFF’s regional footprint and are expected to improve speed, reliability and locally relevant solutions for markets including brewing, animal nutrition, biofuels and home care. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310253993/en/ IFF's home care application lab in Brazil. “This is about turning science into impact where it matte
Andersen offentliggør regnskab for fjerde kvartal og helåret 202510.3.2026 19:52:00 CET | Pressemeddelelse
Andersen Group Inc. (NYSE: ANDG) ("Andersen"), en førende udbyder af uafhængig rådgivning inden for skat, vurdering og finans til private kunder og familiekontorer, virksomheder og fonde i USA, vil offentliggøre sine finansielle resultater for hele året og fjerde kvartal 2025 efter børslukketid tirsdag den 17. marts 2026. Andersens administrerende direktør og bestyrelsesformand, Mark L. Vorsatz, og Andersens økonomidirektør, Neal Livingston, vil afholde en telekonference for at fremlægge Andersens økonomiske resultater tirsdag den 17. marts 2026 kl. 17.00 ET. Deltagere kan følge webcasten på https://event.choruscall.com/mediaframe/webcast.html?webcastid=J3Hvslre. Et link til optagelsen af webcasten vil kunne findes på Andersens Investor Relations-webside på investor.andersen.com inden for et par timer efter begivenheden og vil være tilgængeligt på websiden i seks måneder. Om Andersen Andersen er en førende udbyder af uafhængig rådgivning inden for skat, vurdering og finans til private
Xtep-Sponsored Chinese Teenage Dancer Claims World Championship at Juste Debout Street Dance World Finals10.3.2026 19:46:00 CET | Press release
Xtep, a well-known sportswear brand from China, proudly announced that Xtep-sponsored Chinese teenage dancers delivered an electrifying performance at the Juste Debout Street Dance World Finals in Paris on Sunday, March 8, 2026, claiming top honors and showcasing a unique fusion of traditional Chinese culture with modern street dance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310519224/en/ Chinese Teens Dance to Glory at Juste Debout World Finals Li Yongqiu, a 14-year-old from Southwestern China’s Chongqing Municipality, made history by winning the Global Championship in the Junior Dance Tour, becoming the third Chinese dancer to achieve this feat. His explosive power and technical mastery, honed through years of training that integrates Kungfu elements, captivated judges and audiences alike. The Chinese contingent's success didn't stop there. Zhang Xinlan and Zhang Chuyi secured a Top 8 finish in the Popping Adult D
ATLAS Infrastructure Invests in H2O America, Backs Long-Term Growth Strategy10.3.2026 18:29:00 CET | Press release
ATLAS anchors H2O America’s equity raise and establishes new substantial shareholdingUpsized transaction highlights strong market support for H2O’s long-term strategy and sector leading growth outlookH2O’s organic growth fully equity funded into 20281 ATLAS Infrastructure (“ATLAS”) is a specialist Global Listed Infrastructure investor managing funds on behalf of long-term infrastructure clients. Following the recent equity placement, ATLAS’s actively managed accounts hold ~10.8% voting and economic interest in H2O America (“H2O”). ATLAS was pleased to support H2Os long‑term strategy to invest in local water and wastewater utility operations through our participation in the recent equity raise. ATLAS recognises the disciplined approach from H2O management which focuses on organic investment in existing businesses alongside targeted and accretive transactions such as the acquisition of Quadvest which materially expands H2O’s regulated water footprint in a premium high‑growth jurisdiction
TIXiMED Announces Promising Preclinical Data: Oral TIX100 Prevents Weight Regain After GLP-1 Cessation in Obesity Model10.3.2026 18:22:00 CET | Press release
TIX100 prevented weight regain in mice after semaglutide discontinuation Supports potential role as oral weight maintenance therapy following GLP-1 Receptor Agonist (GLP-1) treatment, addressing a major challenge in long-term obesity management TIXiMED, Inc., a clinical-stage pharmaceutical company developing a novel oral therapy targeting thioredoxin-interacting protein (TXNIP) for diabetes and metabolic disorders, is pleased to highlight new research by investigators at the University of Alabama at Birmingham (UAB) Comprehensive Diabetes Center. The study demonstrates that its oral compound, TIX100, effectively prevents weight rebound following discontinuation of GLP-1 treatment in a mouse model of diet-induced obesity. In the study, mice treated with semaglutide experienced significant weight loss of over 13% body weight during a 2-week treatment period while continuing a high-fat diet. Upon discontinuation of semaglutide, untreated mice rapidly regained 14% of their body weight, mi
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