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Valbiotis

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  1. [verwijderd] 5 februari 2020 18:42
    En ja hoor eindelijk beet.
    Valbiotis heeft een grote partner! Nestlé

    Andere Franse biotech aandelen deden het in 2019 en de eerste maand van 2020 al: enorm stijgen.

    Morgen is het de beurt aan Valbiotis dat in 2017 voor 10 euro naar de beurs ging. Had oktober 2019 geld nodig, maar staat er door deze deal prima voor.

    www.businesswire.com/news/home/202002...


    VALBIOTIS Announces a Global Strategic Partnership With NESTLÉ HEALTH SCIENCE For the Development and Commercialization of TOTUM-63, a Plant-derived Active Substance With Clinically Demonstrated Metabolic Health Benefits on Prediabetics
    Nestlé Health Science’s global reach and metabolic diseases focus expected to support TOTUM-63 development and global commercialization;
    Strategic partnership secures funding for the latest clinical development phase until the obtention of health claims from American and European Authorities;
    Deal is structured around an upfront payment of CHF 5 million, development & sales milestone payments up to a maximum of CHF 66 million and tiered royalties on net sales;
    Agreement also includes TOTUM-63 supply to Nestlé Health Science representing an additional source of revenue.
    February 05, 2020 12:30 PM Eastern Standard Time
    LA ROCHELLE, France--(BUSINESS WIRE)--Regulatory News:

    “The research and development that VALBIOTIS is doing is very promising. We look forward to working together to realize the commercialization of TOTUM-63, an innovative approach to reducing the risk of Type 2 Diabetes.”


    VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME eligible ), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the signature of a global long-term strategic partnership with Nestlé Health Science for the development and commercialization of TOTUM-63, an innovative and patented combination of 5 plant extracts specifically designed to reduce the risk of developing Type 2 Diabetes on prediabetics.

    Sébastien PELTIER, CEO of VALBIOTIS states: “Nestlé Health Science is an ideal strategic partner for VALBIOTIS. Its global reach, strategic intent to develop science-based nutritional health solutions and focus on fighting metabolic disorders like diabetes will be instrumental to TOTUM-63's worldwide commercialization success. We are excited about the opportunity that this deal brings to VALBIOTIS and to the many millions of people around the world at risk of becoming Type 2 diabetics. This transformational deal arrives just five years after the creation of VALBIOTIS and is a recognition of the hard work, commitment and vision of our team”.

    Hans-Juergen WOERLE, Chief Science & Medical Officer of Nestlé Health Science, said, "The research and development that VALBIOTIS is doing is very promising. We look forward to working together to realize the commercialization of TOTUM-63, an innovative approach to reducing the risk of Type 2 Diabetes."

    Under the terms of the agreement, VALBIOTIS grants Nestlé Health Science exclusive and global commercial rights to use TOTUM-63 in the prediabetes and Type 2 Diabetes market. The agreement defines a number of priority markets for a global commercialization. In exchange for these rights, Nestlé Health Science commits to an upfront payment of CHF 5 million, development & sales milestone payments up to a maximum of CHF 66 million, and tiered royalties on net sales. The partnership will support VALBIOTIS's work in a number of ways, including funding the latest clinical development phase until health claims are obtained by the appropriate authorities in the United States and Europe. The financial terms of this agreement significantly extend VALBIOTIS’s cash runway.

    The commercialization of TOTUM-63 may take place before obtaining health claims.

    Agreement also includes TOTUM-63 supply to Nestlé Health Science, representing an additional source of revenue for VALBIOTIS.

    As part of the agreement, a joint steering committee comprised of representatives of both companies will oversee clinical development, regulatory matters, supply and commercialization.

    Beyond this strategic partnership on TOTUM-63 to reduce the risk of developing Type 2 Diabetes, VALBIOTIS intends to pursue its other R&D programs: TOTUM-070, to reduce blood LDL-cholesterol, an independent risk factor for cardiovascular diseases, TOTUM-8541, to reduce blood pressure, an independent risk factor for cardiovascular diseases and TOTUM-4481, in fatty liver disease, a condition with high risk of developing NASH.

    The Company will provide further details on its pipeline in a subsequent communications.

    Resumption of trading of VALBIOTIS shares on Euronext Growth will take place on February 6, 2020 at 9:00 am.

    ABOUT TOTUM-63

    TOTUM-63 is a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms 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 international randomized, placebo-controlled Phase II study showed that TOTUM-63 reduced fasting and 2-hour blood sugar levels, two risk factors for Type 2 Diabetes, in prediabetics compared to placebo. In these subjects, who also had abdominal obesity, TOTUM-63 significantly reduced body weight and waist circumference.

    TOTUM-63 benefits from intellectual property granted in the main markets worldwide: Europe (covering 39 countries), the United States, Russia and national phases are underway in more than 20 countries including China, Japan, Brazil, Australia. The ability to produce TOTUM-63 industrially, in compliance to North American and European standards, has been validated. TOTUM-63 already has marketing authorizations related to its status in Europe.


  2. [verwijderd] 5 februari 2020 18:42
    ABOUT NESTLE HEALTH SCIENCE

    Nestlé Health Science (NHSc), a wholly-owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and VMS brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. Headquartered in Switzerland, NHSc employs over 5’000 people around the world, who are committed to making a difference in people’s lives, for a healthier today and tomorrow.

    For more information, please visit: www.nestlehealthscience.com.

    ABOUT VALBIOTIS

    VALBIOTIS is a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases in response to unmet medical needs.

    VALBIOTIS has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of nutritional health solutions designed to reduce the risk of major metabolic diseases, based on a multi-target approach and made possible by the use of plant-based ingredients.

    Its products are intended to be licensed to players in the health world.

    VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63).

    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.

    For more information about VALBIOTIS, please visit: www.valbiotis.com

    ============================
    Een dag van ruim 100% zou mij niets verbazen.

    Succes, poil
  3. [verwijderd] 2 april 2020 09:51
    As part of a global partnership with Nestlé Health Science,
    VALBIOTIS initiates the pivotal late stage development
    phase of TOTUM-63, a plant-derived active substance with
    clinically demonstrated metabolic health benefits in people
    with prediabetes
    1
    This last pivotal trial (REVERSE-IT), has been designed jointly with Nestlé Health Science’s
    teams and will be entirely funded by the partnership agreement;
    This international trial will include 600 participants and should be launched before
    mid-2020;
    Its first objective is to confirm the positive results of the Phase II clinical trial on fasting
    blood sugar levels, a well-established risk factor for developing Type 2 Diabetes, to obtain
    strong health claims;
    The trial aims to include a broad population with altered glucose metabolism, spanning
    from elevated fasting glucose to early (yet untreated) Type 2 Diabetes.
    La Rochelle, 2 April 2020 (7:35 AM CEST) VALBIOTIS (FR0013254851 – ALVAL / PEA/
    SME eligible), a Research & Development company committed to scientific innovation
    for preventing and combating metabolic diseases, announces today, that as part of its
    global partnership with Nestlé Health Science, it is launching the pivotal late stage
    development phase of TOTUM-63, a plant-derived active substance with clinically
    demonstrated metabolic health benefits on people with prediabetes.
    This last phase of the clinical development was co-designed with Nestlé Health Science’s
    medical and regulatory teams and consists of one pivotal Phase II/III clinical study, called
    REVERSE-IT. This clinical trial will include people with prediabetes and with early stage
    untreated Type 2 Diabetes. It will pursue two main strategic objectives:
    - Replicate the previous Phase II positive result on fasting blood sugar levels, a well-
    established risk factor for developing Type 2 Diabetes;
    - Extend the evaluation of TOTUM-63 to patients with early stage untreated Type 2
    Diabetes, to enlarge the final target population.
    The launch of the REVERSE-IT trial is planned for the first half of 2020. In order to rapidly
    complete the recruitment, the trial will be led in more than 30 international clinical
    centers. It will be entirely funded by the partnership signed in February 2020 with Nestlé
    Health Science.
  4. [verwijderd] 2 april 2020 09:52
    “The REVERSE-IT study results from the combined expertise of
    VALBIOTIS and Nestlé Health Science. We have strong ambitions for
    this last regulatory clinical phase, that are based on the very good
    results we obtained in the previous Phase II clinical trial. Considering
    the resources we mobilize, we can reasonably expect the topline data
    to be released before mid-2022. We feel enthusiastic for this final
    step of our innovative R&D process and we are confident in the fact
    that it will get TOTUM-63 to wide and successful commercialization,
    which may take place before obtaining health claims.”
    “The scope and conditions of this clinical trial are significant: it is
    being led in 30 international clinical settings with 600 participants.
    The thoroughness of this trial will provide results that are extremely
    useful in demonstrating a safe and effective opportunity to help
    patients who have prediabetes and Type 2 Diabetes.”
    The REVERSE-IT trial will be randomized and placebo-controlled, with the same primary objective
    (reduction in fasting glycemia), the same duration of supplementation (6 months) and the same tested
    dose (5g/day) and regimen (three times per day) than the previous Phase II study, which positive
    results were published in 2019 (Press releases, 3rd July 2019 and 2nd September 2019).
    The study population will include 600 subjects with abnormally elevated fasting blood glucose
    (dysglycemia) and abdominal obesity, two frequently associated conditions. The number of subjects
    included will guarantee the robustness of this pivotal trial.
    Led in a wider population, this trial will also pursue larger clinical objectives, with a three-arm design.
    The regimen of three doses per day, for a total daily dose of 5g, will be tested against placebo
    (200 subjects receiving TOTUM-63 in one arm and 200 subjects receiving a placebo in the second
    arm). The primary criterion is the reduction in fasting blood glucose against placebo, with this three
    doses per day regimen. A third open label arm will test a regimen of two doses per day, for the same
    total daily dose of 5g, on 200 subjects.
    The trial will evaluate several other metabolic criteria of high interest for people with prediabetes or
    early stage untreated Type 2 Diabetes.
    The partnership with Nestlé Health Science also plans an adjunct clinical study to obtain exploratory
    data on TOTUM-63 mode of action in humans.
    VALBIOTIS will provide details on its other products in a subsequent communication.
    Murielle CAZAUBIEL,
    Head of Development & Medical Affairs of VALBIOTIS
    Hans-Juergen WOERLE,
    Chief Scientific & Medical Officer of Nestlé Health Science

    Groet,,poil
  5. [verwijderd] 10 juni 2020 09:41
    Valbiotis: Invest Securities verhoogt haar richtprijs
    CERCLE FINANCE • 06/09/2020 om 09:37
    (CercleFinance.com) - Invest Securities verhoogt zijn richtprijs naar 13E (tegen 11E) en herhaalt zijn advies over het kopen van waarde. Het analysebureau is van mening dat de huidige waardering (29 ME), in perspectief te plaatsen met de met Nestlé ondertekende overeenkomst (67 ME), het potentieel van de pijplijn niet nauwkeurig weergeeft.

    'We werken ons model op verschillende punten bij: (i) we passen onze schattingen voor Totum-63 aan na de ondertekening van de commerciële overeenkomst met Nestlé Health Science in de prediabetes die de strategie geloofwaardiger heeft gemaakt, (ii) we integreren Totum-854, ontwikkeld in de vermindering van cardiovasculair risico en (iii) we herzien onze schattingen voor Totum-070 bij hypercholesterolemie en voor Totum-448 bij NASH-risico ', zegt Invest Securities.

    Gisteren 15% in de plus.
    Vandaag Valbiotis SAS 4,50 0,20 4,65 % 09:39:21

    Groet, poil
  6. [verwijderd] 12 juni 2020 22:14
    www.businesswire.com/news/home/202006...

    VALBIOTIS geselecteerd tijdens de 80e wetenschappelijke sessies van de American Diabetes Association om klinische fase II-resultaten van TOTUM-63 te presenteren bij prediabetes
    Deze publicatie, uitgebracht tijdens het grootste diabetescongres ter wereld, biedt een ondubbelzinnige wetenschappelijke onderschrijving van de resultaten.
    TOTUM-63, een op planten gebaseerde werkzame stof, toont met Europese multicenter Fase II-studie van 51 prediabetische personen de impact ervan op de nuchtere bloedglucosespiegels aan, een bekende risicofactor voor diabetes type 2.
    De beschikbaarheid ervan in het kader van een wereldwijde overeenkomst met Nestlé Health Science zou voor professionals in de gezondheidszorg de eerste mogelijkheid kunnen zijn om hun prediabetische patiënten te helpen met een klinisch bewezen en plantaardig product.
    June 12, 2020 03:39 AM Eastern Daylight Time
    LA ROCHELLE, Frankrijk--(BUSINESS WIRE)--VALBIOTIS (Parijs: ALVAL) (FR0013254851 – ALVAL / PEA / SME komt in aanmerking), een onderzoeks- en ontwikkelingsbedrijf dat zich inzet voor wetenschappelijke innovatie voor het voorkomen en bestrijden van metabole ziekten, kondigt aan dat de belangrijkste resultaten van zijn Tijdens de 80e wetenschappelijke sessies van de American Diabetes Association (ADA) worden internationale fase II klinische onderzoeken gepresenteerd die de metabole voordelen van TOTUM-63 bij prediabetische patiënten aantonen.

    Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.

    Ter info, poil
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