- Agreement gives Ipsen global* rights to
develop and commercialize GENFIT’s late-stage, first-in-class PPAR
alpha and delta agonist elafibranor in Primary Biliary Cholangitis
(PBC)
- Investigational treatment elafibranor being
evaluated in the global Phase III trial, ELATIVE™, with topline
data expected early 2023
- GENFIT receives €120m upfront and is eligible
to receive up to €360m in milestone payments as well as tiered
double-digit royalties of up to 20%
- Ipsen becomes 8% shareholder of GENFIT via an
equity investment of €28m
Regulatory News:
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Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and
Euronext: GNFT) have entered into a long-term strategic partnership
for global collaboration between the two companies. The agreement
gives Ipsen exclusive worldwide* license to develop, manufacture
and commercialize GENFIT’s investigational treatment elafibranor,
for people living with Primary Biliary Cholangitis (PBC). The
partnership also gives Ipsen access to future clinical programs led
by GENFIT and combines GENFIT’s scientific expertise and
proprietary technologies in liver disease with Ipsen’s development
and commercialization capabilities. To underscore the long-term
commitment represented by this partnership, Ipsen will also
purchase newly issued GENFIT equity representing 8% post-issuance
through a €28m investment in GENFIT, becoming one of the largest
shareholders.
The ongoing, pivotal Phase III global trial, ELATIVE™,1 is
evaluating the safety and efficacy of elafibranor in 150 people
living with PBC who have an inadequate response or intolerance to
ursodeoxycholic acid (UDCA). Global recruitment is well underway.
There is significant unmet medical need for people with PBC and,
following positive Phase II data,2 elafibranor was granted
Breakthrough Therapy Designation by the U.S. Food and Drug
Administration (FDA) and Orphan Drug Designation by the U.S. FDA
and European Medicines Agency (EMA).3,4 Results from the Phase II
randomized double-blind, placebo controlled trial found that after
12 weeks of dosing with elafibranor, patients with PBC unresponsive
to UDCA experienced significantly reduced levels of
disease-activity markers including alkaline phosphatase (ALP) and
composite endpoints with bilirubin as well as other markers of
disease activity when compared to placebo.2
David Loew, Chief Executive Officer, Ipsen, said,
“Today’s announcement marks an exciting new stage in Ipsen’s
ambitions to expand our portfolio to support more people living
with rare diseases around the world. We are excited by
elafibranor’s data package, demonstrating the potential benefit of
this first-in-class, innovative treatment option to help the PBC
community. We look forward to the results of the ongoing Phase III
program and regulatory submissions around the world to bring this
potential new treatment option to patients. Ipsen is pleased to
partner with GENFIT, a company that shares our common values and
goals of bringing to market first-in-class treatments to improve
the lives of people living with rare conditions like PBC.”
Pascal Prigent, Chief Executive Officer of GENFIT added:
“We are excited to partner with Ipsen and launch this long-term
strategic collaboration, with the goal to accelerate our growth and
generate value for our shareholders. Ipsen’s world-class
development capabilities, well-established global commercial
footprint and excellent track record in delivering therapies to
patient populations with unmet medical need makes it the ideal
partner for GENFIT. Today’s landmark agreement demonstrates our
ability to advance highly promising assets into late-stage
development in-house and derive significant value. While we hope,
above all, that this partnership with Ipsen will be a significant
step towards having a positive impact on the lives of millions of
patients suffering from life-threatening liver diseases, we also
believe our shareholders will recognize the benefit offered by this
collaboration model. The transaction proceeds indeed reinforce
GENFIT’s long-term financial visibility, including further funding
for GENFIT to expand its pipeline, and they also provide
opportunities for targeted business development, as exemplified by
today’s other announcement regarding our in-licensing of a new
molecule.”
PBC is a rare, progressive, chronic autoimmune disease of the
liver.5 Bile is a liquid produced inside the liver that is used to
help digest fats and remove waste products from the body.6 PBC
leads to a slow, progressive destruction of the small bile ducts of
the liver, causing bile and other toxins to build up in the liver
(known as cholestasis).5 Further damage can lead to scarring,
fibrosis and eventually cirrhosis of the liver.5 Common symptoms of
PBC include fatigue and pruritus’ (itching) which can be
debilitating and, in more advanced cases, jaundice.5 Untreated, PBC
can lead to liver failure, or in some cases death. PBC is more
common in women with nine women diagnosed for every man; it is also
a leading cause of liver transplantation.5
GENFIT remains responsible for the Phase III ELATIVE™ trial
until the completion of the double-blind period. Ipsen will assume
responsibility for all additional clinical development, including
completion of the long-term extension period of the ELATIVE™ trial,
and global* commercialization. This newly established strategic
partnership will also provide Ipsen with access to GENFIT’s
research capabilities and other clinical programs through rights to
first negotiation.
Under the agreement, Ipsen will pay GENFIT up to €480m,
comprising upfront cash payment of €120m, as well as regulatory,
commercial, and sales-based milestone payments up to €360m, plus
tiered double-digit royalties of up to 20%. Ipsen also becomes a
shareholder of GENFIT through the purchase of 3,985,239 newly
issued shares representing 8% of GENFIT S.A. after issuance, via a
€28m investment. The new shares will be issued pursuant to the
twentieth resolution of GENFIT’s 30 June 2021 shareholders’ meeting
and will be subject, upon issuance, to a lock-up period ending, in
the event of positive ELATIVE™ results, on the earlier of the date
on which the EMA makes a formal recommendation to the European
Commission for the marketing authorisation of elafibranor in PBC or
the date on which the U.S. FDA grants approval of elafibranor in
PBC. Issuance of the new shares is expected to take place on or
about December 22, 2021. In addition, the Board of Directors of
GENFIT will propose at the next shareholders’ meeting that Ipsen
becomes a board member.
The transaction is expected to be dilutive to Ipsen’s
profitability over the near term, primarily reflecting R&D and
launch-preparation expenses. This is in line with Ipsen’s
medium-term outlook regarding its strategic focus on building a
high-value and sustainable pipeline through external
innovation.
Conference call A conference call and webcast for
investors and analysts will begin at 14:30 CET today. Participants
should dial in to the call early and can register here; a recording
will be available on ipsen.com, while the webcast can be accessed
here. The event ID is 7296852.
ENDS
Primary Biliary Cholangitis Primary biliary cholangitis
(PBC) is a chronic, autoimmune disease in which bile ducts in the
liver are gradually destroyed. The damage to bile ducts can inhibit
the liver’s ability to rid the body of toxins, and can lead to
scarring of liver tissue, known as cirrhosis. PBC is a disease with
high unmet medical needs, with many patients unable to benefit from
existing therapies. The prevalence of people living with PBC in the
US is estimated to be between 23.9-39.2 per 100,000.7,8
Elafibranor Elafibranor, GENFIT’s lead therapeutic
candidate, is currently under evaluation in ELATIVE™, a Phase III
clinical trial to evaluate its efficacy and safety in patients with
PBC. Elafibranor is an oral, once-daily, first-in-class drug
candidate acting via dual agonism of peroxisome
proliferator-activated alpha/delta receptors. Data from a Phase II
clinical trial demonstrated elafibranor has the potential to become
an efficacious treatment in PBC, a rare liver disease. It was
granted a Breakthrough Therapy designation by the FDA in this
indication. Elafibranor is an investigational compound that has not
been reviewed nor received approval by a regulatory authority.
ELATIVE™ Program ELATIVE™ is a Phase III clinical trial
evaluating the safety and efficacy of elafibranor 80mg versus
placebo in 150 patients with Primary Biliary Cholangitis (PBC) with
an inadequate response to ursodeoxycholic acid (UDCA), which is the
existing first line therapy for PBC. ELATIVE™ is a multicenter,
randomized, double blind study to evaluate the efficacy and safety
of elafibranor versus placebo. Treatment duration until interim
analysis for accelerated approval is 52 weeks. Top line data is
expected in between the end of the first quarter and the middle of
the second quarter 2023.
Ipsen Ipsen is a global, mid-sized biopharmaceutical
company focused on transformative medicines in Oncology, Rare
Disease and Neuroscience; it also has a well-established Consumer
Healthcare business. With Total Sales of over €2.5bn in FY 2020,
Ipsen sells more than 20 medicines in over 115 countries, with a
direct commercial presence in more than 30 countries. The Company’s
research and development efforts are focused on its innovative and
differentiated technological platforms located in the heart of
leading biotechnological and life-science hubs: Paris-Saclay,
France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has
c.5,700 colleagues worldwide and is listed in Paris (Euronext: IPN)
and in the U.S. through a Sponsored Level I American Depositary
Receipt program (ADR: IPSEY). For more information, visit
ipsen.com.
GENFIT GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with severe chronic
liver diseases. GENFIT is a pioneer in the field of nuclear
receptor-based drug discovery, with a rich history and strong
scientific heritage spanning more than two decades. Today, GENFIT
has a robust and diversified pipeline, using different compounds
and technologies evaluated at different development stages and in
different liver diseases. Leveraging its internal assets and
in-house expertise, GENFIT’s R&D is focused on cholestatic
diseases and Acute on Chronic Liver Failure (ACLF): two therapeutic
areas with significant unmet medical needs. Currently, the ELATIVE™
Phase III clinical trial evaluating elafibranor (elafibranor is an
investigational compound that has not been reviewed nor been
approved by a regulatory authority) in patients with Primary
Biliary Cholangitis (PBC). A Phase I clinical program with
nitazoxanide in ACLF has been initiated. GENFIT has facilities in
Lille and Paris, France, and Cambridge, MA, USA. GENFIT is a
publicly traded company listed on the Nasdaq Global Select Market
and on compartment B of Euronext’s regulated market in Paris
(Nasdaq and Euronext: GNFT). www.genfit.com
Ipsen’s forward-looking statements The forward-looking
statements, objectives and targets contained herein are based on
Ipsen’s management strategy, current views and assumptions. Such
statements involve known and unknown risks and uncertainties that
may cause actual results, performance or events to differ
materially from those anticipated herein. All of the above risks
could affect Ipsen’s future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic
conditions based on the information available today. Use of the
words ‘believes’, ‘anticipates’ and ‘expects’ and similar
expressions are intended to identify forward-looking statements,
including Ipsen’s expectations regarding future events, including
regulatory filings and determinations. Moreover, the targets
described in this document were prepared without taking into
account external growth assumptions and potential future
acquisitions, which may alter these parameters. These objectives
are based on data and assumptions regarded as reasonable by Ipsen.
These targets depend on conditions or facts likely to happen in the
future, and not exclusively on historical data. Actual results may
depart significantly from these targets given the occurrence of
certain risks and uncertainties, notably the fact that a promising
product in early development phase or clinical trial may end up
never being launched on the market or reaching its commercial
targets, notably for regulatory or competition reasons. Ipsen must
face or might face competition from generic products that might
translate into a loss of market share. Furthermore, the Research
and Development process involves several stages each of which
involves the substantial risk that Ipsen may fail to achieve its
objectives and be forced to abandon its efforts with regards to a
product in which it has invested significant sums. Therefore, Ipsen
cannot be certain that favorable results obtained during
pre-clinical trials will be confirmed subsequently during clinical
trials, or that the results of clinical trials will be sufficient
to demonstrate the safe and effective nature of the product
concerned. There can be no guarantees a product will receive the
necessary regulatory approvals or that the product will prove to be
commercially successful. If underlying assumptions prove inaccurate
or risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking statements.
Other risks and uncertainties include but are not limited to,
general industry conditions and competition; general economic
factors, including interest rate and currency exchange rate
fluctuations; the impact of pharmaceutical industry regulation and
health care legislation; global trends toward health care cost
containment; technological advances, new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; Ipsen's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of Ipsen’s patents and other protections for
innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions. Ipsen also depends on
third parties to develop and market some of its products which
could potentially generate substantial royalties; these partners
could behave in such ways which could cause damage to Ipsen’s
activities and financial results. Ipsen cannot be certain that its
partners will fulfil their obligations. It might be unable to
obtain any benefit from those agreements. A default by any of
Ipsen’s partners could generate lower revenues than expected. Such
situations could have a negative impact on Ipsen’s business,
financial position or performance. Ipsen expressly disclaims any
obligation or undertaking to update or revise any forward-looking
statements, targets or estimates contained in this press release to
reflect any change in events, conditions, assumptions or
circumstances on which any such statements are based, unless so
required by applicable law. Ipsen’s business is subject to the risk
factors outlined in its registration documents filed with the
French Autorité des Marchés Financiers. The risks and uncertainties
set out are not exhaustive and the reader is advised to refer to
Ipsen’s 2020 Registration Document, available on ipsen.com.
GENFIT’s forward-looking statements This press release
contains certain forward-looking statements with respect to GENFIT,
including those within the meaning of the Private Securities
Litigation Reform Act of 1995, including statements regarding the
potential of elafibranor in PBC and the success of the ELATIVE™
trial, including financial success, timelines for release of
top-line results of the ELATIVE™ trial, and our ability to expand
our pipeline through business development activities. The use of
certain words, including “consider”, “contemplate”, “think”, “aim”,
“expect”, “understand”, “should”, “aspire”, “estimate”, “believe”,
“wish”, “may”, “could”, “allow”, “seek”, “encourage” or “have
confidence” or (as the case may be) the negative forms of such
terms or any other variant of such terms or other terms similar to
them in meaning is intended to identify forward-looking statements.
Although the Company believes its projections are based on
reasonable expectations and assumptions of the Company’s
management, these forward-looking statements are subject to
numerous known and unknown risks and uncertainties, which could
cause actual results to differ materially from those expressed in,
or implied or projected by, the forward-looking statements. These
risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including in
relation to safety, biomarkers, progression of, and results from,
its ongoing and planned clinical trials, review and approvals by
regulatory authorities of its drug and diagnostic candidates,
impact of the ongoing COVID-19 pandemic, exchange rate fluctuations
and the Company’s continued ability to raise capital to fund its
development, as well as those risks and uncertainties discussed or
identified in the Company’s public filings with the French Autorité
des Marchés Financiers (“AMF”), including those listed in Chapter 2
“Main Risks and Uncertainties” of the Company’s 2020 Universal
Registration Document filed with the AMF on 23 April 2021 under n°
D.21-0350, which is available on the Company’s website
(www.genfit.com) and on the website of the AMF
(www.amf-france.org), and public filings and reports filed with the
U.S. Securities and Exchange Commission (“SEC”) including the
Company’s 2020 Annual Report on Form 20-F filed with the SEC on
April 23, 2021 and subsequent filings and reports filed with the
AMF or SEC, or otherwise made public by the Company. In addition,
even if the Company’s results, performance, financial condition and
liquidity, and the development of the industry in which it operates
are consistent with such forward-looking statements, they may not
be predictive of results or developments in future periods. These
forward-looking statements speak only as of the date of publication
of this document. Other than as required by applicable law, the
Company does not undertake any obligation to update or revise any
forward-looking information or statements, whether as a result of
new information, future events or otherwise.
References _________________________ * With the exception
of China, Hong Kong, Taiwan, and Macau where Terns Pharmaceuticals
holds the exclusive license to develop and commercialize
elafibranor. 1 ELATIVE. Clinical Trials. Available at :
https://clinicaltrials.gov/ct2/show/NCT04526665?term=ELATIVE&draw=2&rank=1
2 Schattenberg JM, et al. A randomized placebo-controlled trial of
elfibranor in patients with primary bilary cholangitis and
incomplete responses to UDCA. Journal of Hepatology.
2021:74;1344-1354 3 GENFIT Press Release. 2019
https://www.genfit.com/press-release/genfit-announces-fda-grant-of-breakthrough-therapy-designation-to-elafibranor-for-the-treatment-of-pbc/
4 European Medicines Agency. 2019.
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3192182
5 Kimagi T, Heathcote EJ. Orphanet J Rare Dis. 2008; 3:1 6 NHS.
Primary Biliary Cirrhosis.
https://www.nhs.uk/conditions/primary-biliary-cirrhosis-pbc/ 7 Lu
et al Clinical Gastro and Hepatol 2018; 16:1342-1350 8 Galoosian et
al. Journal of Clinical and Transplantation Hepatology 2020;
8:49-60
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Ipsen Investors
Craig Marks Vice President, Investor Relations +44 7584 349
193
Adrien Dupin de Saint-Cyr Investor Relations Manager +33
6 64 26 17 49
Media Jess Smith
Senior Director, Head of Global Communications R&D and Business
Development +44 7557 267 634
Fanny Allaire Global Communications Director +33 6 08 91
92 55
GENFIT GENFIT | Investors +33 3 2016 4000 |
investors@genfit.com
PRESS RELATIONS | Media Stephanie Boyer – Press relations | +33
3 2016 4000 | stephanie.boyer@genfit.com
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