- 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.
Regulatory News:
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.
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
Name: Valbiotis ISIN code: FR0013254851
Mnemonic code: ALVAL
Disclaimer
This press release contains forward-looking statements about
VALBIOTIS' objectives, based on rational hypotheses and the
information available to the company at the present time. However,
in no way does this constitute a guarantee of future performance,
and these projections can be reconsidered based on changes in
economic conditions and financial markets, as well as a certain
number of risks and doubts, including those described in the
VALBIOTIS core document, filed with the French Financial Markets
Regulator (AMF) on 31 July 2019 (application number R19-030) as
well in its supplement approved by the AMF on Octobre 9, 2019.
These documents being available on the Company’s website
(www.valbiotis.com). This press release, as well as the information
contained herein, does not constitute an offer to sell or subscribe
to, or a solicitation to purchase or subscribe to, VALBIOTIS'
shares or securities in any country.
1. TOTUM-854 and TOTUM-448 are active substances from the VAL-63
research program. They are ready to enter Phase II clinical
development.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200205005659/en/
VALBIOTIS / COMMUNICATION CORPORATE Carole ROCHER / Marc
DELAUNAY +33 5 46 28 62 58 media@valbiotis.com
ACTIFIN / COMMUNICATION FINANCIERE Stéphane RUIZ +33 1 56 88 11
14 sruiz@actifin.fr
MADIS PHILEO / RELATIONS MEDIAS Guillaume DE CHAMISSO +33 6 85
91 32 56 guillaume.dechamisso@madisphileo.com
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