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

More Than Half of Visitors to teamLab Planets in Toyosu, Tokyo Now Come From Overseas. Starting in March, Artworks Featuring Cherry Blossoms That Bloom Across the Space Will Be on View for the Spring Season Only27.1.2023 20:00:00 EET | Press release

Approximately 100,000 people from overseas visited teamLab Planets in Toyosu, Tokyo, between December 9, 2022 and January 9, 2023. (*1) Of the visitors across one month, around 60% , or 1 in 2 visitors, were non-residents visiting Japan (*1), and the number of visitors from overseas has tripled compared to the same month in 2019 (before COVID-19). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230126005440/en/ teamLab, Floating in the Falling Universe of Flowers © teamLab Furthermore, according to a survey conducted by the museum, about 70% of the visitors from overseas knew about the museum before considering their trip to Japan, and there was a trend of the museum being one of the main purposes to visit Tokyo. (*2) *1 From the official website tickets purchaser data (survey period: December 9, 2022 - January 9, 2023) *2 From the visitor survey data (survey period: December 17, 2022 - January 10, 2023) We will continue to p

Global Processing Services Appoints Former Visa Executive Jim McCarthy to Lead Global Sales and Product27.1.2023 13:01:00 EET | Press release

Global Processing Services (“GPS”), a fast-growing next-gen global payments technology platform, today announced the appointment of Jim McCarthy as Executive Vice President – Global Head of Sales and Product, and Kevin Fox as the company’s new Chief Revenue Officer. In this newly created role, Jim will lead GPS’ global commercial and product teams in close collaboration with Kevin on sales acceleration. Jim is a highly accomplished payments veteran with over 30 years of experience, including 18 years at Visa where he held senior roles in sales, risk and authentication, consumer credit, digital products and product innovation. As Visa’s EVP of Innovation and Strategic Partnerships, Jim was responsible for the development of Visa’s product and technology roadmap, innovation efforts, and led business development for strategic partnerships. While at Visa he was responsible for the introduction of 3D Secure and Visa Token Service, which have become industry standards, and also contributed t

Major Landowner Federations to Support AMR Against Nordic Mining ASA (NOM) in the Norwegian Supreme Court27.1.2023 12:59:00 EET | Press release

Key landowner federations declare 3rd party intervention in support of Arctic Mineral Resources’ appeal to the Supreme Court in the case against Nordic Rutile AS (NRU), a wholly owned subsidiary of Nordic Mining ASA (NOM). Arnold Rørholt, lawyer and AMR’s Chairman, welcomes the 3rd party intervention in favour of AMR: “The intervention will ensure that the Supreme Court, as opposed to the courts of lower instance, appreciates the principal nature of the case and the Constitutional issues underpinning it, and interprets the Mineral Act in light of these – to the favour of AMR.” “The Western part of the Engebø garnet and rutile province contains around half of the proven reserves in the Engebø deposit, as well as a majority of inferred resources and will support a highly profitable 50 years plus fully underground mining project without a need for deposits on land or in the sea” continues Rørholt. Arctic Mineral Resources (AMR) and the federations argue that the two mineral categories – o

Ipsen Receives CHMP Negative Opinion for Palovarotene as a Treatment for Fibrodysplasia Ossificans Progressiva in E.U.27.1.2023 09:00:00 EET | Press release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended not to grant marketing authorization for investigational palovarotene as a treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). In the E.U. there are currently only symptomatic treatments for FOP, which do not reduce the formation of extra-skeletal bone in patients with the condition. Ipsen will be requesting a re-examination of the CHMP opinion, based on scientific data available from the existing palovarotene clinical trial program. FOP causes permanent and continuous new bone formation in soft and connective tissues, like muscles, tendons and ligaments, a process known as heterotopic ossification (HO).1 Once formed, it is irreversible.1 The average age of diagnosis is 5 years old2 and ultimately FOP shortens the median life expectancy to 56 years as untimely death is

Green Steel Technology Company Boston Metal Announces $120M Series C Financing Led by ArcelorMittal27.1.2023 08:01:00 EET | Press release

Boston Metal, a company developing technology to fully decarbonize steel production, today announced the $120 million first close of Series C fundraising led by multinational steel company, ArcelorMittal S.A. (NYSE: MT). Microsoft's Climate Innovation Fund and SiteGround Capital also joined as new investors in this round, alongside current investors. ArcelorMittal’s lead investment was made through its XCarb® Innovation Fund. Commenting, Aditya Mittal, CEO, ArcelorMittal, said, “In Boston Metal, we are investing in a team that has made impressive progress over a relatively short period of time, developing a technology that has exciting potential to revolutionize steelmaking. In our extensive discussions with them, we have been impressed by the passion and vision they have to contribute to the decarbonization of steelmaking. They are an exciting and welcome addition to the XCarb® Innovation Fund’s portfolio.” Boston Metal’s patented Molten Oxide Electrolysis (MOE) process is being comme

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