Inventiva announces major recruitments to accelerate the
development of lanifibranor in NASH
- Seven recruitments with solid track records and complementary
profiles to reinforce Inventiva’s clinical expertise, medical team
and corporate functions
- New recruitments further expand the Company’s footprint in the
United States while consolidating its presence in France
Daix (France), Long Island City (New
York, United States), September 16, 2021 – Inventiva
(Euronext Paris and Nasdaq: IVA), a clinical-stage
biopharmaceutical company focused on the development of oral small
molecule therapies for the treatment of non-alcoholic
steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other
diseases with significant unmet medical need, today announced a
series of recruitments with a view to accelerate the development of
its lead drug candidate lanifibranor for the treatment of NASH.
The complementary profiles of the new arrivals
will allow Inventiva to strengthen its expertise in clinical
operations and drug development while reinforcing its core
corporate functions.
Following the opening of Inventiva’s subsidiary
in the United States in January 2021, these recruitments will
further expand the Company’s footprint in this key geography and
consolidate its presence in France.
Recruitments – Clinical operations and
medical team
With over 20 years of experience in
pharmaceutical and clinical development, Alice
Roudot-Ketelers, PharmD, joins Inventiva as Vice President
Clinical Operations and Pharmaceutical Development and member of
its Executive Committee. Based in France, she will lead and oversee
the Company’s global clinical and pharmaceutical development
activities, particularly focusing on the development of
lanifibranor and the recently launched pivotal NATiV3 Phase III
clinical trial in NASH. Prior to joining Inventiva, Alice was in
charge of all drug development programs and oversaw
cross-functional teams in Chemistry, Manufacturing and Controls
(CMC), non-clinical and clinical development up to Phase III at one
of the major biotech companies in the NASH field.
Jean-Paul Dutertre, MD, joins
the Company as Head of Pharmacovigilance in France, leading
Inventiva’s pharmacovigilance activities with a focus on
lanifibranor. Leveraging 30 years of experience in
pharmacovigilance, Jean Paul worked for large pharmaceutical
groups, including Eli Lilly and Company and GlaxoSmithKline, as
well as biotech companies following his first position as Phase I
physician at Fournier. In his different roles, Jean-Paul has led
the establishment and maintenance of pharmacovigilance systems and
processes. In this context, he frequently interacted with the U.S
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA), and was in charge, amongst others, of drafting the
safety components for the applications of various drug
candidates.
Sanjay Patel, MD, joins
Inventiva in the role of Medical Director, with a proven expertise
in diabetes and orphan diseases. Based in the United Kingdom, he
reinforces Inventiva’s clinical team to support the development of
lanifibranor for the treatment of NASH. Sanjay is an experienced
Global Clinical Research Physician who has over 20 years of
experience in clinical development within both large pharmaceutical
groups, including Eli Lilly and Company, GlaxoSmithKline and
Boehringer Ingelheim, and biotech companies.
Gerardo Rodriguez, MD, PhD,
joins Inventiva as Senior Medical Director, based in the United
States. With more than 17 years of experience in drug development,
he will co-lead the Company’s pivotal Phase III clinical study with
lanifibranor in NASH. Gerardo is a widely recognized cardiovascular
endocrinologist, gene therapist and researcher, with a strong
expertise across hepatology, diabetes, endocrinology and
cardiovascular research, having worked for large pharmaceutical
groups, biotech companies and Contract Research Organizations
(CROs). Prior to joining Inventiva, Gerardo was the Head of
Therapeutic Area of the Liver Disease Program at AbbVie, where he
was involved in the Phase III clinical trial with cenicriviroc in
NASH and led more than 45 Phase II clinical studies in NASH, in big
and small pharmaceutical companies. Previously, Gerardo served as
scientific advisor on NASH, diabetes and cardiovascular diseases
for leading pharmaceutical companies, including Pfizer, Eli Lilly
and Company, and Astra Zeneca.
Based in the United States, Joseph
Covino, BS, joins the Company as Senior Director Clinical
Operations to lead Inventiva’s clinical operations in the Unites
States, with a primary focus on the Phase III clinical trial with
lanifibranor. Joseph has more than 15 years of experience in drug
development and managing clinical research trials, focusing on
hepatology, cardiology, respiratory and rare diseases as well as
oncology.
Recruitments – Corporate
functions
Based in France, Eric Duranson,
LLM, joins Inventiva in the role of General Counsel and as member
of its Executive Committee. At Inventiva, he will focus on the
acceleration of the Company’s strategy and further expansion. Eric
has over 20 years of experience in the life sciences industry,
supporting companies such as Thermo Fisher Scientific, Sanofi and
bioMerieux, throughout all product development stages, from
research and development to marketing.
Pascaline
Clerc, PhD, joins the Company as Vice President
Global External Affairs to lead Inventiva’s corporate and strategic
communications, patient advocacy and stakeholder engagement to
support the development of its pipeline, with a primary focus on
lanifibranor and NASH. Based in the United States, Pascaline has
more than 15 years of experience in patient engagement,
particularly in the area of NASH as part of a Phase III clinical
trial, public policy and scientific research.
Frédéric Cren, Chairman, CEO and
cofounder of Inventiva, said: “We are
delighted to welcome these important new hires. Reinforcing our
presence in the U.S. and consolidating our footprint in France,
they join us at a critical time, as we advance with the pivotal
development of lanifibranor in NASH and the recently launched Phase
III clinical trial. Their solid track records and complementary
expertise, spanning clinical operations, drug development and
corporate functions, will be a great addition to our teams and key
to accelerate both the development of lanifibranor and our R&D
portfolio at large.”
About Inventiva
Inventiva is a clinical-stage biopharmaceutical
company focused on the development of oral small molecule therapies
for the treatment of NASH, MPS and other diseases with significant
unmet medical need.
Leveraging its expertise and experience in the
domain of compounds targeting nuclear receptors, transcription
factors and epigenetic modulation, Inventiva is currently advancing
two clinical candidates, as well as a deep pipeline of preclinical
programs.
Lanifibranor, its lead product candidate, is
being developed for the treatment of patients with NASH, a common
and progressive chronic liver disease for which there are currently
no approved therapies. In 2020, Inventiva announced positive
topline data from its Phase IIb clinical trial evaluating
lanifibranor for the treatment of patients with NASH and obtained
FDA Breakthrough Therapy and Fast Track designation for
lanifibranor in the treatment of NASH. Lanifibranor is currently
being evaluated in a pivotal Phase III clinical trial.
Inventiva is also developing odiparcil, a second
clinical stage asset, for the treatment of patients with subtypes
of MPS, a group of rare genetic disorders. Inventiva announced
positive topline data from its Phase IIa clinical trial evaluating
odiparcil for the treatment of adult MPS VI patients at the end of
2019 and received FDA Fast Track designation in MPS VI for
odiparcil in October 2020.
In parallel, Inventiva is in the process of
selecting an oncology development candidate for its Hippo
signalling pathway program. Furthermore, the Company has
established a strategic collaboration with AbbVie in the area of
autoimmune diseases. AbbVie has started the clinical development of
ABBV‑157, a drug candidate for the treatment of moderate to severe
psoriasis resulting from its collaboration with Inventiva. This
collaboration enables Inventiva to receive milestone payments upon
the achievement of pre-clinical, clinical, regulatory and
commercial milestones, in addition to royalties on any approved
products resulting from the collaboration.
The Company has a scientific team of
approximately 70 people with deep expertise in the fields of
biology, medicinal and computational chemistry, pharmacokinetics
and pharmacology, as well as in clinical development. It also owns
an extensive library of approximately 240,000 pharmacologically
relevant molecules, approximately 60% of which are proprietary, as
well as a wholly‑owned research and development facility.
Inventiva is a public company listed on
compartment C of the regulated market of Euronext Paris (ticker:
IVA - ISIN: FR0013233012) and on the Nasdaq Global Market in the
United States (ticker: IVA). www.inventivapharma.com
Contacts
InventivaPascaline ClercVP of Global External
Affairsmedia@inventivapharma.com +1 240 620 9175 |
Brunswick GroupYannick Tetzlaff / Tristan Roquet
Montegon / Aude LepreuxMedia
relationsinventiva@brunswickgroup.com+33 1 53 96 83 83 |
Westwicke, an ICR CompanyPatricia L. Bank Investor
relationsPatti.bank@westwicke.com+1 415 513 1284 |
Important Notice
This press release contains forward-looking
statements, forecasts and estimates with respect to Inventiva’s
clinical trials, clinical trial data releases, clinical development
plans and anticipated future activities of Inventiva. Certain of
these statements, forecasts and estimates can be recognized by the
use of words such as, without limitation, “believes”,
“anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”,
“may”, “will” and “continue” and similar expressions. Such
statements are not historical facts but rather are statements of
future expectations and other forward-looking statements that are
based on management's beliefs. These statements reflect such views
and assumptions prevailing as of the date of the statements and
involve known and unknown risks and uncertainties that could cause
future results, performance or future events to differ materially
from those expressed or implied in such statements. Actual events
are difficult to predict and may depend upon factors that are
beyond Inventiva's control. There can be no guarantees with respect
to pipeline product candidates that the clinical trial results will
be available on their anticipated timeline, that future clinical
trials will be initiated as anticipated, or that candidates will
receive the necessary regulatory approvals. Actual results may turn
out to be materially different from the anticipated future results,
performance or achievements expressed or implied by such
statements, forecasts and estimates, due to a number of factors,
including that Inventiva is a clinical-stage company with no
approved products and no historical product revenues, Inventiva has
incurred significant losses since inception, Inventiva has a
limited operating history and has never generated any revenue from
product sales, Inventiva will require additional capital to finance
its operations, Inventiva's future success is dependent on the
successful clinical development, regulatory approval and subsequent
commercialization of current and any future product candidates,
preclinical studies or earlier clinical trials are not necessarily
predictive of future results and the results of Inventiva's
clinical trials may not support Inventiva's product candidate
claims, Inventiva may encounter substantial delays in its clinical
trials or Inventiva may fail to demonstrate safety and efficacy to
the satisfaction of applicable regulatory authorities, enrollment
and retention of patients in clinical trials is an expensive and
time-consuming process and could be made more difficult or rendered
impossible by multiple factors outside Inventiva's control,
Inventiva's product candidates may cause adverse drug reactions or
have other properties that could delay or prevent their regulatory
approval, or limit their commercial potential, Inventiva faces
substantial competition and Inventiva’s business, and preclinical
studies and clinical development programs and timelines, its
financial condition and results of operations could be materially
and adversely affected by the current COVID-19 pandemic. Given
these risks and uncertainties, no representations are made as to
the accuracy or fairness of such forward-looking statements,
forecasts and estimates. Furthermore, forward-looking statements,
forecasts and estimates only speak as of the date of this press
release. Readers are cautioned not to place undue reliance on any
of these forward-looking statements.
Please refer to the Universal Registration
Document for the year ended December 31, 2020 filed with the
Autorité des Marchés Financiers on March 15, 2021, the Annual
Report on Form 20-F for the year ended December 31, 2020 filed with
the Securities and Exchange Commission on March 15, 2021 as well as
the full-year financial report for the year ended December 31, 2020
for additional information in relation to such factors, risks and
uncertainties.
Except as required by law, Inventiva has no
intention and is under no obligation to update or review the
forward-looking statements referred to above. Consequently,
Inventiva accepts no liability for any consequences arising from
the use of any of the above statements.
- Inventiva - PR - Recruitments - 16 09 2021
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