Business Wire

Valbiotis Announces Its Roadmap for 2023: a Pivotal Year in the Execution of Its Clinical, Industrial and Commercial Strategy

Share

Regulatory News:

Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces its roadmap for 2023. This year promises to be rich in strategic advances, with the completion of the clinical development of TOTUM•63 (prediabetes), the objective of signing a license and/or distribution agreement for TOTUM•070 (LDL hypercholesterolemia), and the preparation of commercial launches by 2024 for these two active substances.

On the R&D front, Valbiotis will continue its clinical development efforts for its plant-based active substances, to reinforce their scientific and medical value and obtain health claims. After the major success of the HEART Phase II clinical study in 2022, which demonstrated the efficacy of TOTUM•070 against excess LDL cholesterol in the blood (press releases of June 13, 2022 and October 3, 2022), 2023 will be marked by expected clinical advances, in particular for TOTUM•63, against prediabetes:

  • The first major milestone, before the end of the first half of the year, will be the clinical results of Phase II/III REVERSE-IT, a large pivotal study conducted on 600 people with the primary endpoint of reducing fasting blood glucose levels with TOTUM•63. These results will represent the final step before marketing and the filing of a health claim. In parallel, clinical results on the mode of action of TOTUM•63 will be obtained and communicated this year.
  • For TOTUM•854, a major milestone should be reached at the end of the first half of the year with the completion of enrollment in the first Phase II/III clinical study (INSIGHT studies) for blood pressure reduction. The results of the clinical bioavailability and mode of action study will be known early in the year.
  • The latest clinical advance announced for 2023 is the launch of a clinical study with TOTUM•448 against the early stages of metabolic liver disease, or "fatty liver disease", which is growing rapidly worldwide.

Alongside these R&D advances, Valbiotis will accelerate the commercialization strategy announced last October (press release of October 7, 2022), based on two main priorities:

  • Structuring the Company to support the global strategic agreement signed with Nestlé Health Science for TOTUM•63 and to conclude future licensing and/or distribution partnerships for TOTUM•070, TOTUM•448 and TOTUM•854.
  • Direct marketing in France of TOTUM products (except TOTUM•63) in pharmacies, drugstores and via a dedicated e-commerce site.

On the industrial and manufacturing processes front, which are essential for supporting strategic partnerships and marketing active substances in France, Valbiotis is continuing to develop galenic forms and to set up the supply chain, from the sourcing of plant raw materials to market launch, with the internalization of specific skills.

A dedicated team has been set up to look for new agreements worldwide (except in France), bringing together AEC Partners and Valbiotis' Business Development department. At the heart of the first partnership with Nestlé Health Science concluded in February 2020, AEC Partners has already identified a panel of global or regional players in the world of health and nutrition and initiated the first exchanges. The goal remains the signature of a partnership for TOTUM•070 by the second half of 2023.

With regard to direct marketing in France, the second major focus of the strategy, Valbiotis is gearing up for the launch of TOTUM•070 in the first half of 2024, to be followed by TOTUM•448 and TOTUM•854. Market research with healthcare professionals and consumers has helped establish the commercial strategy, combining medical recommendation and open access for consumers. This strategy is based on in-house medical promotion officers (MPOs), whose main focus is on key prescribers such as general practitioners, certain specialists and pharmacists, and on an e-commerce site that is scheduled to go online in the first half of 2024.

Valbiotis enters this new fiscal year with a strengthened financial position thanks to the success of the recently finalized fundraising (press release of November 9, 2022), for an amount of 9.7 million euros (€M).

Sébastien PELTIER, Chairman of the Valbiotis Board of Directors, states: "After years devoted to R&D and the clinical advancement of our plant-based active substances, we are embarking on a new phase of development designed to make the most of our TOTUM products and rapidly generate sales. This goal is based on a two-pronged strategy: local, with our own revenues from direct marketing in France, and international, with worldwide revenues generated by partnerships. The year 2023 will bring us major clinical results for TOTUM•63, in particular for the Phase II/III REVERSE-IT study, the last step before market launch and health claim application. In 2023, we will also complete the first steps of our strategic acceleration with the signature of a license and/or distribution agreement for TOTUM•070, while we continue to structure the Company and ramp up our industrial operations to prepare for the launch of TOTUM•070 in France and the delivery of the first commercial batches of TOTUM•63 by the first half of 2024. With a consolidated financial situation thanks to the recent fundraising and a product portfolio with a high level of scientific evidence in the prevention of metabolic and cardiovascular diseases, Valbiotis is equipped to achieve its goals in the fast-growing food supplement market in France and abroad, estimated at €272 billion in 2028 1."

About Valbiotis

Valbiotis is a commercially oriented Research & Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases in response to unmet medical needs.
Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic diseases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.
Its products are intended to be licensed to players in the health sector.
Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and a subsidiary in Quebec City (Canada).
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI label. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs via the European Regional Development Fund (ERDF). Valbiotis is a PEA-SME eligible company.
For more information about Valbiotis, please visit: www.valbiotis.com

Name: Valbiotis
ISIN code: FR0013254851
Ticker symbol: ALVAL
EnterNext© PEA-PME 150

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 Valbiotis at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be affected by changes in economic conditions and financial markets, as well as certain risks and uncertainties, including those described in the Valbiotis Universal Registration Document filed to the French Financial Markets Regulator (AMF) on May 19, 2022 and completed by an amendment on November 8, 2022. This document is available on the Company’s website (www.valbiotis.com).
This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe to Valbiotis’ shares or financial securities in any country.

1 www.grandviewresearch.com/industry-analysis/dietary-supplements-market

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Corporate communication / Valbiotis
Carole ROCHER
Director of Communications and Public Affairs

Marc DELAUNAY
Communication Manager
+33 5 46 28 62 58
media@valbiotis.com

Financial communication / Actifin
Stéphane RUIZ
Associate Director
+33 1 56 88 11 14
sruiz@actifin.fr

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

NetApp Empowers Customers to Securely “Talk to Their Data” in Collaboration with NVIDIA19.3.2024 01:00:00 EET | Press release

NetApp® (NASDAQ: NTAP) today announced it is collaborating with NVIDIA to advance retrieval-augmented generation (RAG) for generative AI applications. The new collaboration directly connects the just-announced NVIDIA NeMo Retriever microservices—coming to the NVIDIA AI Enterprise software platform for development and deployment of production-grade AI applications, including generative AI—to exabytes of data on NetApp’s intelligent data infrastructure. Every NetApp ONTAP® customer will now be able to seamlessly “talk to their data” to access proprietary business insights without having to compromise the security or privacy of their data. Enterprises want to leverage publicly available large language models to talk directly and securely to their corporate data with assurance that their private data will never be accessible outside the enterprise. Until now, enterprises that wanted to build internal chatbots, co-pilots, and applications that leverage corporate knowledge were faced with co

KPMG’s "Digital Gateway for Tax" Platform Raises Global Standards in Tax Functionality with Generative AI18.3.2024 20:38:00 EET | Press release

In a landmark move, KPMG has enhanced the capabilities of its Digital Gateway for Tax incorporating generative AI (genAI) as an independent component to communicate directly with data, enabling powerful insights and enhanced levels of efficiency. This pioneering Software as a Service (SaaS) is designed to provide an end-to-end solution for all members of the tax department and marks a significant milestone in tax technology, integrating generative AI for organizations embarking on their tax digital transformation journey. The KPMG Digital Gateway for Tax platform’s real strength lies in its content and transparent data enrichment capabilities. The solution empowers clients to use the Digital Gateway as their Centralized Knowledge Hub, where users can access company-specific documents through the unified genAI platform. The RAG approach (Retrieval Augmented Generation) is relied upon to effortlessly enrich models with additional content which helps ensure the information used to generat

Media invitation: World leaders must make headway for adaptation - there are no alternatives18.3.2024 20:06:00 EET | Press release

A coalition of international climate organizations will come together for an event in Copenhagen on the 20 March 2024 to deliver recommendations on integrating climate and development for climate finance to world leaders, ahead of a year of intense negotiations, starting at the Copenhagen Climate Ministerial. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240318208761/en/ Photo: Mathilde Utzon The year 2024 is of paramount importance for our future. We face an urgent need to handle the climate crisis, within the broader range of Sustainable Development Goals. This year’s high-level meetings leading up to COP29 will focus on climate finance, aiming to address the substantial funding gaps. To kick-start these discussions DanChurchAid, E3G, the International Institute for Environment and Development, CONCITO, NDC Partnerships, and the UN Foundation are coming together to co-host the virtual and in-person event ‘Integrating Clim

Verimatrix Releases Counterspy as a New Anti-Piracy Solution with First-Ever Defensive Capabilities18.3.2024 19:45:00 EET | Press release

Regulatory News: Verimatrix, (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced general availability of its new Verimatrix Counterspy anti-piracy solution -- the most advanced anti-piracy technology seen in the past decade. Counterspy leverages technology first developed by the company's cybersecurity team back in 2021 to offer an innovative new way to counter the rise in video piracy in an era where streaming apps are prevalent. Counterspy is a standalone product within Verimatrix's anti-piracy team, engineered to prevent video content theft, shield apps from attack, and provide ongoing piracy threat prediction, detection and response services. Counterspy goes beyond traditional methods to ensure top-tier security for media app subscribers, safeguarding content across various devices. It fills the gap in authentication created by the shift from operator-controlled set top box hardware to retail or app-based OTT clien

Centrico Spa (Gruppo Banca Sella) and Veracode Enter Deal to Help Secure the Application Development Life Cycle18.3.2024 17:42:00 EET | Press release

Centrico Spa, part of Gruppo Sella and a specialist in providing open banking systems for innovation-oriented financial institutions, has entered a collaboration with Veracode, a global leader in application security risk management. The deal will enhance the analysis, detection, and prioritization of flaws to expedite software fixes at every stage of Centrico’s application development life cycle. Modern banking and finance are exposed to a stringent and evolving landscape, not least as a result of the Digital Operational Resilience Act (DORA) and an increase in frequent and sophisticated cyberattacks. According to data collected in Veracode’s State of Software Security Report, 72 percent of financial organizations contain vulnerabilities—the lowest percentage of all sectors analyzed and an improvement from the previous year. Even so, financial organizations would benefit from increased automation and secure coding techniques to help them prevent, detect, and respond to vulnerabilities

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
HiddenA line styled icon from Orion Icon Library.Eye