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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.
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.
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.
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.
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.
En gelijk een keurig nette presentatie op de site van Valbiotis
Succes en fijne avond, poil
@poil-1; heb je wel eens naar PARX gekeken.
Ik weet dat dit niet onder dit draadje geplaatst moet worden, maar weet even niet hoe ik het je op een andere manier moet laten weten.
Straks (9u) webcast over hun technieken, inloggen via hun website.
Dit was een prima dag.
enig idee waar de koers naartoe kan gaan binnen M termijn ?
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
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
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
“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.
Head of Development & Medical Affairs of VALBIOTIS
Chief Scientific & Medical Officer of Nestlé Health Science
Er worden (zelfs in deze tijden) stappen gezet die dit bedrijf weer terug gaat brengen waar het een paar jaar geleden begon.
Mijn voorlopige koersdoel 10 euro.
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