– Confirmation of VALBIOTIS’s capacity to produce VALEDIA® in
compliance with North American and European industrial standards.
– A key stage in the health claim application for the two leading
markets worldwide, North America and Europe.
– An accomplishment due to the combined expertise of VALBIOTIS and the
Pierre Fabre Group, which specializes in the industrial manufacture of
plant-based products.
LA ROCHELLE, France–(BUSINESS WIRE)–Regulatory News:
VALBIOTIS (FR0013254851 – ALVAL / PEA/SME eligible), a French Research &
Development company committed to scientific innovation for preventing
and combating metabolic diseases, announces the successful industrial
production of VALEDIA® (active substance TOTUM-63), the most
advanced product in the VALBIOTIS portfolio. This achievement is the
result of a collaboration with the Pierre Fabre group, a world-renowned
expert in the industrial production of plant-based active substances.
Since securing industrial property rights in Europe and the United
States, VALBIOTIS has made another major breakthrough by demonstrating
its capacity to produce VALEDIA® industrially, and in
accordance with the regulations governing these two markets.
Sébastien Peltier, CEO of VALBIOTIS, comments: “The industrial
production of VALEDIA® has come at the best
possible time for VALBIOTIS, after obtaining strong preclinical and
clinical results and securing the industrial property rights, in the
lead-up to the publication of our Phase IIA clinical results. This is an
important milestone, thus completing our health claim application and
supporting our negotiations with a partner company to market the product
in 2021. This development confirms the sustainability of our project to
market plant-based products which target the causal mechanisms of
metabolic diseases. To achieve this, we are following the regulatory
process for dietary supplements with a health claim, while maintaining
almost pharmaceutical-grade development standards.”
VALEDIA® will be the first of a new class of products, aiming
to prevent and combat metabolic diseases.
Industrial batches for future studies
VALBIOTIS is currently developing VALEDIA® for two
labels: prediabetes and hepatic steatosis. The results of the Phase IIA
clinical trial for prediabetes are expected by 31 July, 2019. They will
be followed in the second half of the year by the launch of the European
Phase IIB clinical study (REVERSE-IT) and the Phase IIB study
(PREVENT-IT) in North America. The data from these studies will be used
to submit the application to European and North American regulatory
authorities, for a health claim to reduce the risk of type 2 diabetes,
with a view to marketing the product in 2021.
Murielle Cazaubiel, Director of Development and Medical Affairs at
VALBIOTIS, comments: “The success of this industrial production
means we can progress to the next stages of clinical development with
complete confidence. The new production capacities established with the
Pierre Fabre group will be used in our two upcoming confirmation
studies. This collaboration has enabled VALBIOTIS to benefit from
leading expertise in the production of plant-based active substances,
from extraction to standardization, ensuring that these results can be
reproduced with both large and small quantities.”
“In 2015, we put our expertise in extracting plant-based active
substances at the service of VALBIOTIS and accompanied them in their
development. We produce 3 plant extracts that make up VALEDIA®
at our Gaillac (Tarn) extraction site. Today, we are happy to accompany
them in this industrial transposition by manufacturing the capsules on
our Cahors (Gers) production site specialized in phytotherapy and
aromatherapy,” adds François MACAREZ, Business Developer at Pierre
Fabre Médicament.
About TOTUM-63, the active substance of VALEDIA®
Prediabetes is a growing public health issue worldwide that has been
acknowledged by international organizations. Without appropriate
management, 70% to 90% of prediabetic subjects will develop type 2
diabetes.
VALEDIA® intend to be be the first natural and clinically
proven solution specifically designed for prediabetics. VALEDIA®
contains the active substance TOTUM-63, a unique and patented
combination of 5 plant extracts, with high potential to target the
physiopathological mechanisms of type 2 diabetes.
The launch of VALEDIA® is planned for 2021, with a health
claim for reducing the risk 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 first international Phase IIA study are expected
before 31 July 2019.
ABOUT VALBIOTIS
VALBIOTIS is a French Research & Development company committed to
scientific innovation for preventing and combating metabolic diseases.
Its products are made for major players in the health care sector.
VALBIOTIS particularly focuses on solutions to prevent type 2 diabetes,
NASH (nonalcoholic steatohepatitis), obesity and cardiovascular diseases.
VALBIOTIS was founded in La Rochelle in early 2014 and has formed
numerous partnerships with top academic centers in France and abroad,
including La Rochelle University, the CNRS and Clermont Auvergne
University located in Clermont-Ferrand. These partnerships have enabled
Valbiotis to benefit from strong financial leverage, particularly thanks
to experts and technical partners who support its projects. The Company
has established three sites in France – Périgny, La Rochelle (17) and
Riom (63) – and an American office in Boston (MA).
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.
Find out more about VALBIOTIS: http://valbiotis.com/
Name: VALBIOTIS
ISIN code: FR0013254851
Mnemonic code: ALVAL
Disclaimer
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 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 5 April 2017 (application number I.17-012), as well
as in the 2017 annual financial report, filed with AMF on 3 April 2018.
These documents are available on the Company’s website (www.valbiotis.com).
VALBIOTIS does not accept any liability regarding the update or revision
of these forward-looking statements. 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.
Contacts
VALBIOTIS
CORPORATE COMMUNICATION
Carole Rocher /
Marc
Delaunay
+33 5 46 28 62 58
medias@valbiotis.com
FINANCIAL COMMUNICATION
ACTIFIN
Stéphane Ruiz
+33 1 56 88
11 14
sruiz@actifin.fr
MEDIA RELATIONS
MADIS PHILEO
Guillaume De Chamisso
+33 6
85 91 32 56
guillaume.dechamisso@madisphileo.com
UNITED STATES
SOLEBURY TROUT
Rebecca John / Patrick Till
+1
646 378 2935
rjohn@troutgroup.com
ptill@troutgroup.com