Inventiva and Hepalys Pharma, Inc. announce exclusive licensing
agreement to develop and commercialize lanifibranor in Japan and
South Korea
- Hepalys Pharma, Inc. is a new company created by Catalys
Pacific and in which Inventiva has a 30% ownership position.
- Under the exclusive licensing agreement, Inventiva will receive
a $10 million upfront payment, and is eligible to receive up to
$ 231 million in clinical, regulatory and commercial milestone
payments in addition to tiered royalties from mid double digits to
low twenties based on net sales of lanifibranor in Japan and South
Korea.
- Pending regulatory approvals, Hepalys Pharma, Inc. is expected
to initiate Phase I PKPD studies in Japanese patients and healthy
volunteers and will be responsible for funding all studies of
lanifibranor necessary to file for a new drug application in Japan
and South Korea.
- In addition to the 30% of shares of Hepalys Pharma, Inc.,
Inventiva already owns, Inventiva has the option to acquire all
outstanding shares of Hepalys Pharma, Inc., at a pre-agreed
multiple of post-money valuation.
- In the event Hepalys receives an offer to sell the license or
rights related to lanifibranor, Inventiva has a right of first
refusal.
Daix
(France), Long Island City (New York,
United States), Tokyo
(Japan),
September 20
2023 – 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) and other
diseases with significant unmet medical needs, and Hepalys Pharma,
Inc., a company incorporated in Japan and incubated by Catalys
Pacific, have entered into an exclusive licensing agreement (the
“Agreement”) to develop and commercialize Inventiva’s proprietary
drug candidate lanifibranor for the treatment of non-alcoholic
steatohepatitis (NASH) in Japan and South Korea.
Hepalys Pharma is a
new company founded by Catalys Pacific, an investment firm
specialized in creating and financing venture capital-backed
biopharmaceutical companies to develop pharmaceutical products in
Asia. Hepalys Pharma is backed by renowned investors including
Catalys Pacific, Mitsubishi UFJ Capital, DBJ Capital, and MEDIPAL
Innovation Fund.
In parallel of the
incorporation of Hepalys Pharma, Inventiva has exercised its right
to own 30% of the company.
Under the terms of
this licensing agreement, Inventiva will receive a $10 million
upfront payment from Hepalys Pharma and will be eligible to receive
up to $231 million in milestone payments if certain clinical,
regulatory and commercial conditions are met. Subject to regulatory
approval, Inventiva has the right to receive tiered royalties from
mid double digits to low twenties based on net sales of
lanifibranor in Japan and South Korea.
In addition, under the
terms of this agreement, Inventiva has the option to acquire the
outstanding shares of Hepalys Pharma at a pre-agreed multiple of
post-money valuation under certain conditions, and has a right of
first refusal if Hepalys Pharma, Inc. receives an offer to sell the
license and rights related to lanifibranor.
This agreement is
expected to accelerate the time to market of lanifibranor in Japan
and South Korea if regulatory approvals are obtained. Both
countries are major markets, with up to 2.7%1 of and up to 5.2%2 of
Japanese and South Koreans, respectively, suffering from NASH,
including about 15% of South Korean patients with significant
fibrosis. Hepalys Pharma, Inc. is expected to start the clinical
development of lanifibranor by conducting two phase I studies in
Japanese patients and healthy volunteers. It is anticipated that
these studies would support, if positive, the initiation of a
dedicated pivotal trial in Japanese and Korean patients with NASH,
which is planned to start once the results of NATiV3, the pivotal
phase III trial currently conducted by Inventiva, are available.
Hepalys Pharma, Inc. will be responsible for conducting and
financing all development trials in Japan and South Korea needed to
file for a new drug application in these territories.
Frederic Cren,
CEO and cofounder of Inventiva, stated:
“We are thrilled to further expand our global reach to Japan and
South Korea through this exclusive licensing agreement with Hepalys
Pharma, Inc. We strongly believe that Hepalys Pharma, Inc. with its
experienced team is the right partner to start and fund the
clinical development of lanifibranor in Japan and South Korea. This
agreement is a great opportunity for Inventiva to speed up the
potential commercialization of its lead asset in these two major
markets and diversify our milestones and royalties’ source of
revenues if regulatory approvals are achieved. With the ongoing
partnership in Greater China and this new agreement in Japan and
Korea, Inventiva is eligible to receive up to an additional $519M
of clinical, regulatory and commercial milestones.”
BT
Slingsby, MD, PhD,
MPH, Representative Director
of Hepalys Pharma,
Inc., stated: “We are delighted to enter
into a licensing agreement with Inventiva. We purposely founded
Hepalys Pharma, Inc. to conduct the clinical development and
potential commercialization of lanifibranor, a drug candidate for
the potential treatment of NASH in Japan and Korea. We are
confident that, if successful in our clinical programs and if
required regulatory approvals are obtained, lanifibranor could
potentially become an effective treatment for patients with NASH in
Japan and South Korea based on the efficacy demonstrated so far on
fibrosis and NASH resolution, and on the cardiometabolic components
of the disease. We are looking forward to starting the clinical
development program of lanifibranor in Japan and South Korea.”
About
Hepalys Pharma, Inc.
Hepalys Pharma, Inc.
is a private venture-backed biopharmaceutical company focused on
the development of novel therapeutics for liver disease, led by a
world-class team and a transpacific clinical advisory board,
committed to develop and commercialize lanifibranor and potentially
other compounds for patients in Asian countries. Hepalys is
headquartered in Tokyo, Japan.
About
Catalys Pacific
Catalys Pacific is a
life sciences venture capital firm whose mission is to provide
healthcare solutions for patients worldwide through the creation
of, and investment in biotech companies. Catalys Pacific is led by
a global team versed in working closely with its partners in
academia, biotech, venture capital and the pharmaceutical industry
worldwide with an emphasis in Japan. The firm maintains offices in
Tokyo, Japan and in San Francisco, California.
About lanifibranor
Lanifibranor, Inventiva’s lead product
candidate, is an orally-available small molecule that acts to
induce anti-fibrotic, anti-inflammatory and beneficial vascular and
metabolic changes in the body by activating all three peroxisome
proliferator-activated receptor (PPAR) isoforms, which are
well-characterized nuclear receptor proteins that regulate gene
expression. Lanifibranor is a PPAR agonist that is designed to
target all three PPAR isoforms in a moderately potent manner, with
a well-balanced activation of PPARα and PPARδ, and a partial
activation of PPARγ. While there are other PPAR agonists that
target only one or two PPAR isoforms for activation, lanifibranor
is the only pan-PPAR agonist in clinical development for the
treatment of NASH. Inventiva believes that lanifibranor’s moderate
and balanced pan-PPAR binding profile contributes to the favorable
tolerability profile that has been observed in clinical trials and
pre-clinical studies to date. The FDA has granted Breakthrough
Therapy and Fast Track designation to lanifibranor for the
treatment of NASH.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical
company focused on the research and development of oral small
molecule therapies for the treatment of patients with NASH (also
known as metabolic dysfunction-associated
steatohepatitis (MASH)), mucopolysaccharidoses (“MPS”) and
other diseases with significant unmet medical need. The Company
benefits from a strong expertise and experience in the domain of
compounds targeting nuclear receptors, transcription factors and
epigenetic modulation. Inventiva is currently advancing one
clinical candidate, has a pipeline of two preclinical programs and
continues to explore other development opportunities to add to its
pipeline.
Inventiva’s lead product candidate,
lanifibranor, is currently in a pivotal Phase III clinical trial,
NATiV3, for the treatment of adult patients with NASH, a common and
progressive chronic liver disease for which there are currently no
approved therapies.
Inventiva’s pipeline also includes odiparcil, a
drug candidate for the treatment of adult MPS VI patients. As part
of Inventiva’s decision to focus clinical efforts on the
development of lanifibranor, it suspended its clinical efforts
relating to odiparcil and is reviewing available options with
respect to its potential further development. Inventiva is also in
the process of selecting an oncology development candidate for its
Hippo signaling pathway program.
The Company has a scientific team of
approximately 90 people with deep expertise in the fields of
biology, medicinal and computational chemistry, pharmacokinetics
and pharmacology, and clinical development. It 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 B 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
Inventiva Pascaline ClercVP of Global External
Affairsmedia@inventivapharma.com +1 240 620
9175 |
Brunswick GroupTristan Roquet Montegon /Aude
Lepreux /Matthieu BenoistMedia
relationsinventiva@brunswickgroup.com +33 1 53 96 83
83 |
Westwicke, an ICR CompanyPatricia L. BankInvestor
relationspatti.bank@westwicke.com
+1 415 513-1284 |
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Important Notice
This press release contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in this press
release are forward-looking statements. These statements include,
but are not limited to, forecasts and estimates with respect to
Inventiva’s pre-clinical programs and clinical trials, including
design, duration, timing, recruitment costs, screening and
enrolment for those trials, including the ongoing NATiV3 Phase III
clinical trial with lanifibranor in NASH, clinical trial data
releases and publications, the information, insights and impacts
that may be gathered from clinical trials, the potential
therapeutic benefits of Inventiva’s product candidates, including
lanifibranor, expectations with respect to clinical development and
commercialization by Hepalys Pharma, Inc., including with respect
to potential clinical trials and regulatory approvals, expectations
with respect to the benefits of the agreement with Hepalys Pharma,
Inc., including potential acceleration lanifibranor
commercialization in the event required regulatory approvals are
obtained, potential regulatory submissions and approvals,
achievement of milestones, potential milestone payments and
potential royalties under the agreement with Hepalys Pharma, Inc.,
the rights and obligations under agreements with Hepalys Pharma
Inc., including Inventiva’s right to purchase shares in the company
and right of first refusal, and Inventiva’s pipeline and
preclinical and clinical development plans, future activities,
expectations, plans, growth, potential revenues and prospects.
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”, “would”, “could”, “might”, “should”,
“designed”, “hopefully”, “target”, “potential’, 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, that product candidates will receive the necessary
regulatory approvals, or that any of the anticipated milestones by
Inventiva or its partners will be reached on their expected
timeline, or at all. 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, in the
absence of which, Inventiva may be required to significantly
curtail, delay or discontinue one or more of its research or
development programs or be unable to expand its operations or
otherwise capitalize on its business opportunities and may be
unable to continue as a going concern, 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’s expectations with respect to the
changes to the clinical development plan for lanifibranor for the
treatment of NASH may not be realized and may not support the
approval of a New Drug Application, Inventiva and its partners may
encounter substantial delays in their clinical trials or fail to
demonstrate safety and efficacy to the satisfaction of applicable
regulatory authorities, the ability of Inventiva and its partners
to recruit and retain patients in clinical studies, enrolment 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 and its
partners’ 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 and its
partners’ business, and preclinical studies and clinical
development programs and timelines, its financial condition and
results of operations could be materially and adversely affected by
geopolitical events, such as the conflict between Russia and
Ukraine, related sanctions and related impacts and potential
impacts on the initiation, enrolment and completion of Inventiva’s
and its partners’ clinical trials on anticipated timelines, health
epidemics, and macroeconomic conditions, including global
inflation, uncertain financial markets and disruptions in banking
systems. 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, 2022 filed with the
Autorité des Marchés Financiers on March 30, 2023, and the Annual
Report on Form 20-F for the year ended December 31, 2022 filed with
the Securities and Exchange Commission on March 30, 2023 for other
risks and uncertainties affecting Inventiva, including those
described from time to time under the caption “Risk Factors”. Other
risks and uncertainties of which Inventiva is not currently aware
may also affect its forward-looking statements and may cause actual
results and the timing of events to differ materially from those
anticipated.
All information in this press release is as of
the date of the release. 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.
1Eguchi Y, Wong G, Lee EI, Akhtar O, Lopes R, Sumida Y.
Epidemiology of non-alcoholic fatty liver disease and non-alcoholic
steatohepatitis in Japan: A focused literature review. JGH Open.
2020 May 5;4(5):808-817. 2Park J, Lee EY, Li J, Jun MJ, Yoon E, Ahn
SB, Liu C, Yang H, Rui F, Zou B, Henry L, Lee DH, Jun DW, Cheung
RC, Nguyen MH. NASH/Liver Fibrosis Prevalence and Incidence of
Nonliver Comorbidities among People with NAFLD and Incidence of
NAFLD by Metabolic Comorbidities: Lessons from South Korea. Dig
Dis. 2021;39(6):634-645.
- Inventiva - PR - Japan Licensing Agreement - EN - 09 20
2023
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