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
Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector18.12.2025 03:41:00 CET | Press release
SteQeyma™45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD)1The new autoinjector option increases convenience, enhances individual patient experience and expands administration options Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a biosimilar to Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD). The positive CHMP opinion is for SteQeyma autoinjector in 45mg/0.5mL and 90mg/1mL, expanding the currently approved SteQeyma™ presentation, which includes 45mg/0.5mL, 90mg/1mL in a pre-filled syringe and 45mg/0.5mL in a vial for subcutaneous injection, as well as 130mg/26mL concentrate for solution f
Megaport Expands into India, Accelerating Global Growth with Extreme IX Acquisition18.12.2025 02:15:00 CET | Press release
Through the Extreme Exchange (IX) acquisition, Megaport gains seven Internet Exchanges and access to 40+ data centres across India’s fastest-growing digital hubs. Megaport Limited (ASX: MP1) (“Megaport”), the world’s leading Network as a Service (NaaS) provider, today announced the acquisition of Extreme IX,India’s leading Internet Exchange operator, from Extreme Labs, a Bulgaria-headquartered software and network engineering company that incubated the Extreme IX platform. The acquisition expands Megaport’s global platform into one of the world’s fastest-growing digital infrastructure markets and supports the Company’s strategy to deliver scalable, high-performance connectivity services across APAC. The acquisition establishes Megaport’s presence across seven Internet Exchanges in major Indian metros: Delhi, Kolkata, Hyderabad, Chennai, Bengaluru, Mumbai, and Pune, connecting 40+ data centres and more than 400 customers. It also accelerates Megaport’s planned market entry by nearly thr
IonQ and QuantumBasel Expand Long-Term Partnership in Next-Generation Quantum Systems17.12.2025 22:10:00 CET | Press release
Extension solidifies QuantumBasel as IonQ’s Innovation Center in Europe; adds IonQ Tempo and next-generation system to advance quantum commercialization IonQ (NYSE: IONQ), the world’s leading quantum company, today announced an expanded agreement with QuantumBasel, the quantum initiative of uptownBasel, Switzerland’s innovation campus. The extended contract grants QuantumBasel ownership of its existing IonQ Forte Enterprise system and secures ownership of a next-generation Tempo system. This new agreement brings the total deal value of the QuantumBasel and IonQ partnership to over $60 million and extends IonQ’s on-site presence in Switzerland four more years, continuing through 2029. QuantumBasel is IonQ’s official Innovation Center in Europe, serving as a hub for European industry, academia, and research institutions to explore practical quantum computing applications and access IonQ’s latest enterprise-grade systems. “Our extended partnership with QuantumBasel represents a cornerston
Suzano Starts Up New Production Line, Boosting Its Fluff Pulp Capacity by 400%17.12.2025 21:50:00 CET | Press release
A R$490 million investment expands the supply of raw material used in the production of absorbent items Suzano, the world’s largest pulp producer, has commenced operations this week at its new fluff pulp production line located in its Limeira unit in Brazil’s São Paulo state. This R$490 million investment increases Suzano’s total fluff pulp production capacity by more than 400%, from 100,000 to 440,000 tonnes per year. The project involved converting the existing pulp line at the Limeira unit into a flexible machine, capable of producing both Eucafluff® and market pulp. Eucafluff® is used in the production of absorbent and personal hygiene products, such as baby and adult diapers, sanitary pads and pet pads. Then market pulp is supplied for making products including toilet paper, printing and writing papers, and paper packaging. Launched in 2015, Eucafluff® is the world’s first fluff pulp made from eucalyptus, delivering unique advantages like enhanced softness and flexibility, which t
SES Acknowledges Moody’s Rating Action and Reiterates Deleveraging Commitments17.12.2025 21:36:00 CET | Press release
SES S.A. (“SES” or the “Company”), a leading space solutions company, acknowledges the credit rating action announced by Moody’s Investor Service today, which follows the release of SES’ Q3 2025 results and Intelsat integration update. SES management reiterates that the Company continues to execute on its strategy with a clear plan to strengthen its key credit metrics over time. Consistent with this plan, it remains management’s intention to de-lever and return to credit metrics that are commensurate with investment grade, with a policy objective of reducing adjusted net leverage1 to at least 3.0x or below. Today’s rating action does not change the Company’s ability to operate its business, serve customers, or execute its strategic plan. SES maintains a balanced weighted average debt maturity profile of approximately five years, and the rating action from Moody’s is not expected to have a material impact on the interest payable under the Company’s existing debt facilities. SES also ben
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