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
Merrithew® Expands Global Mindful Movement Leadership with Acquisition of the GYROTONIC® Organization11.6.2026 17:30:00 CEST | Press release
Strategic acquisition strengthens Merrithew International Inc.’s position as a leading global authority in mindful movement education, equipment, and wellness Merrithew®, a global leader in mindful movement education and equipment and creator of internationally recognized programs including STOTT PILATES®, ZEN•GA®, Halo® Training and Total Barre®, today announced the acquisition of the GYROTONIC® organization, creator of the globally respected GYROTONIC® and GYROKINESIS® methods. Founded by Juliu Horvath, the GYROTONIC® and GYROKINESIS® methods are internationally recognized for their distinctive approach to movement, combining fluidity, strength, mobility, coordination, and rehabilitation through specialized equipment and movement sequences. Practiced in studios and wellness centers worldwide, the methods have cultivated a deeply loyal global community of instructors, trainers, therapists, and movement professionals. The acquisition marks a significant milestone in Merrithew Internati
GigaDevice Expands Optical Communication Portfolio with New GD32E512 and GD32E252 Series MCUs for Optical Modules11.6.2026 16:00:00 CEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, has introduced the new GD32E512 and GD32E252 series MCUs specifically designed for optical module applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611850679/en/ Empowering Optical Interconnect Innovation, GigaDevice Unveils Dedicated MCUs for Optical Modules. As a leading supplier of MCUs for optical module applications, GigaDevice has maintained a strong focus on the optical communication market, continuously aligning its product development with evolving industry requirements and next-generation optical interconnect technologies. Leveraging years of expertise in optical module control solutions, GigaDevice has established a strong position in the market through continuous innovation and close collaboration with industry partners. To further support the advancement of high-sp
Saudi Arabia at the Center of the Global Water Industry as IDWS 2026 Reshapes the Future of Water11.6.2026 15:47:00 CEST | Press release
In an increasingly resource-constrained world, water has become critical to both economic growth and national security, driving demand for global leadership in sustainability, innovation, and water solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611388456/en/ Saudi Arabia at the Center of the Global Water Industry as IDWS 2026 Reshapes the Future of Water (Graphic: AETOSWire) The Saudi Water Authority has announced the return of the Innovation Driven Water Sustainability Conference (IDWS), taking place from 7 to 9 December 2026 at The Ritz-Carlton, Jeddah, as the Kingdom consolidates its position at the center of the global water conversation. As home to one of the world’s most advanced and rapidly evolving water management ecosystems, Saudi Arabia currently operates more than 500 water production facilities across the Kingdom with total water production capacity exceeding 16.2 million cubic meters per day. The
Onera Will Showcase Its Onera hPSG® Solution at the SLEEP 2026 Conference June 14-17, 2026 in Baltimore, MD, USA.11.6.2026 15:00:00 CEST | Press release
Onera hPSG®, an end-to-end home polysomnography solution from Onera Health, will be prominently featured at SLEEP 2026. The medtech company will showcase its innovative technology at booth #600, present clinical experience with their solution in 3 poster sessions, and host an educational symposium titled “Scaling PSG for the Next Decade: Expanding Utilization of High-Complexity Home Testing.” Onera Health, a leader in transforming sleep medicine, announces that its end-to-end home polysomnography solution, the Onera hPSG® solution, will be prominently featured in multiple scientific presentations at the forthcoming SLEEP 2026 conference. The medtech company will showcase this innovative solution at booth #600 during the largest annual sleep medicine conference, which brings together leading experts and innovators in the field. Furthermore, in anticipation of new CPT codes, Onera Health will host an educational symposium on Scaling PSG for the Next Decade: Expanding Utilization of High-
Xsolla to Meet With Mobile Game Developers and Publishers at Pocket Gamer Connects Barcelona 202611.6.2026 15:00:00 CEST | Press release
Company to Highlight Direct-to-Consumer Web Shop Solutions and Global Payments Infrastructure at Europe's Premier Mobile Gaming Conference Xsolla, a leading global video game commerce company, today announced its participation in Pocket Gamer Connects (PGC) Barcelona 2026, taking place June 15-16 at the Hyatt Regency Barcelona in Barcelona, Spain. Xsolla will be on the ground for meetings with mobile game developers, publishers, and strategic partners, bringing its direct-to-consumer commerce infrastructure to one of the most deal-focused events in the European games calendar. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611487209/en/ Graphic: Xsolla Now in its second year, PGC Barcelona has quickly established itself as a destination conference for mobile game businesses, drawing more than 1,000 attendees from over 47 countries and facilitating thousands of structured business meetings through its dedicated matchmaking
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