Valbiotis Announces Its Roadmap for 2023: a Pivotal Year in the Execution of Its Clinical, Industrial and Commercial Strategy
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 20281."
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
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Corporate communication / Valbiotis
Director of Communications and Public Affairs
+33 5 46 28 62 58
Financial communication / Actifin
+33 1 56 88 11 14
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Lattice Collaborates with NVIDIA to Accelerate Edge AI5.12.2023 19:00:00 CET | Press release
Today at the Lattice Developers Conference, Lattice Semiconductor (NASDAQ: LSCC) introduced a new reference sensor-bridging design to accelerate the development of edge AI applications using the NVIDIA Jetson Orin and IGX Orin platforms. Based on power-efficient Lattice FPGAs and NVIDIA Orin, the open-source reference board is designed to address developers’ needs for connectivity to a diverse variety of sensors and interfaces, design scalability, and low latency when designing high-performance edge AI applications for healthcare, robotics, and embedded vision. Lattice’s collaboration with NVIDIA is set to expand the open-source developer community by improving the efficiency of connecting sensors to edge AI compute applications. “With AI technology at the forefront of transforming various markets, including manufacturing, transportation, communications, and medical instruments, this collaboration will accelerate this fundamental shift,” said Esam Elashmawi, Chief Strategy and Marketin
Lattice Continues Rapid Product Portfolio Expansion Enabling the Next Era of Innovation5.12.2023 18:20:00 CET | Press release
Today at the Lattice Developers Conference, Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, continued its rapid product portfolio expansion with the launch of multiple new hardware and software solutions. Lattice introduced two new innovative mid-range FPGA device families built on the award-winning mid-range Lattice Avant™ platform – Lattice Avant™-G and Lattice Avant™-X, designed for general purpose and advanced connectivity, respectively. Lattice announced new versions of its application-specific solution stacks for artificial intelligence (AI), embedded vision, security, and factory automation, each of which are expanded with new features and capabilities to help accelerate customer time-to-market. Lattice released updated versions of its software tools and Glance by Mirametrix® computer vision software. “At Lattice, we’re focused on enabling our customers to accelerate their designs with new levels of power efficiency and performance through our rapidly gr
HVPD Norway endrer navn til Monitra5.12.2023 15:54:00 CET | Pressemelding
Monitra, tidligere kjent som HVPD som er en pioner innen utviklingen av nyskapende produkter for tilstandsovervåking av eiendeler, kunngjør i dag en spennende rebranding. Vårt selskap vil nå operere under det navnet Monitra, som representerer vår dedikasjon til overvåking og håndtering av tilstandskontroll, støttet av patentert fjernovervåkingsteknologi. Vi satser stort på forskning, utvikling og helhetlige løsninger, som er tydelig gjennom vår tilstandsdataplattform, Atlas by Monitra™. De seneste årene har vist at våre kunder også har behov for helhetlige løsninger i tillegg til enkeltstående produkter og tjenester. Monitra vil ikke bare være et nytt navn, men en refleksjon av vår evne til innovasjon, samarbeid og operativ pålitelighet. Monitra vil levere bredere og mer integrerte tjenester til våre kunder. Monitra vil være drivkraften bak vår neste fase av vekst, og vi ser frem til å fortsette å være en pålitelig partner for alle dine tilstandsovervåkings behov. Data blir visuelt pre
Foodmate Acquires Barth Industrial Automation5.12.2023 15:00:00 CET | Press release
Foodmate B.V. (“Foodmate”), a leading global designer and manufacturer of poultry processing equipment and a member of the Duravant family of operating companies, has acquired Barth Industrial Automation (“BIA”) enhancing its technology offerings and expanding its services for integrated production line solutions. The acquisition further strengthens Foodmate’s deep design and development capabilities for their core product portfolio, which spans weighing, grading, cutting and deboning technologies. Headquartered in ‘s-Gravendeel, The Netherlands, BIA has established itself as a leading provider of engineering, vision, robotics and automation solutions to OEM partners in the food industry. Specializing in hardware and software engineering services, their expertise resides in their ability to deploy controls solutions for complete production lines. “Foodmate and BIA have been strategic partners for over 15 years, and we’re excited to bring together BIA’s team of engineers, technicians an
CIOs and CTOs Across Australia and New Zealand Struggle Balancing IT Modernization Efforts with Business Growth and Profitability, According to New Survey5.12.2023 15:00:00 CET | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, products and services, the leading third-party support provider for Oracle and SAP software, and a Salesforce and AWS partner, today announced findings of the Tech Research Asia Survey Report, “Operational Excellence is a Key Part of System Modernisation,” examining the challenges, opportunities, and priorities of CIOs and CTOs in their modernization journey. The Rimini Street-sponsored research was conducted among more than 300 CxOs across Australia and New Zealand from retail, manufacturing, construction, banking, travel and hospitality, telecommunications, and utilities industries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231205618916/en/ CIOs and CTOs Across Australia and New Zealand Struggle Balancing IT Modernization Efforts with Business Growth and Profitability, According to New Survey (Photo: Business Wire) The sur