-- Gilead will Not Advance Jyseleca for the
Treatment of Rheumatoid Arthritis (RA) in the U.S. Following FDA
Type A Meeting --
-- Galapagos to Assume Sole Responsibility
in Europe for Jyseleca in RA and Ulcerative Colitis (UC) Plus
Future Indications; Gilead to Receive Royalties on European Sales
Starting in 2024 --
-- Galapagos to Assume Responsibility for
Majority of Ongoing Clinical Trials; Gilead will Pay Galapagos €160
million to Support Ongoing Development and Accelerated Commercial
Buildout in EU --
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext
& Nasdaq: GLPG) today announced that the companies have agreed
to amend their existing arrangement for the commercialization and
development of Jyseleca (filgotinib). This announcement follows a
Type A meeting with the U.S. Food and Drug Administration (FDA) to
discuss the points raised in the Complete Response Letter (CRL)
related to the New Drug Application (NDA) for filgotinib in the
treatment of RA.
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Based on the feedback received from the FDA during the NDA
review process and in the Type A meeting, Gilead will not pursue
FDA approval of filgotinib for RA. While both Gilead and Galapagos
continue to believe in the clinical profile of the 200 mg dose,
Gilead has concluded that this dose is required to be competitive
in RA in the United States and that the 200 mg dose is unlikely to
achieve approval for RA in the U.S. without conducting substantial
additional clinical studies.
Under the new arrangement between the companies, Galapagos will
assume sole responsibility in Europe for filgotinib in RA, where
200 mg and 100 mg doses are approved for the treatment of moderate
to severe RA, and in all future indications. Galapagos will receive
payments from Gilead in connection with changes in responsibility
for the commercialization and development of filgotinib in Europe
and Gilead will receive royalties from European sales of
filgotinib. This is an acceleration of the commercial strategy in
place for products under the separate ten-year research and
development collaboration between the companies, where Galapagos is
also responsible for European commercialization.
Through a phased transition including the transfer of
filgotinib’s marketing authorization to Galapagos, the majority of
activities supporting filgotinib in Europe are expected to be
assumed by Galapagos by the end of 2021. Under the new operating
model, Gilead will retain commercial rights and remain marketing
authorization holder for filgotinib outside of Europe, including in
Japan where filgotinib has recently been approved, and is
co-marketed with Eisai.
“While we believe that the clinical profile of Jyseleca could
help many patients living with RA, we no longer see a viable path
to U.S. approval in this indication,” said Daniel O’Day, Chairman
and Chief Executive Officer, Gilead Sciences. “In this new context,
Gilead and Galapagos believe it makes sense for Galapagos to drive
commercialization in Europe. We are confident that through our
strategic alliance with Galapagos, we will deliver many important
new therapies for inflammatory diseases in the future.”
“Jyseleca is already providing an important new treatment
option, making a difference to the lives of patients living with
RA, where it is available in Europe,” said Onno van de Stolpe,
Chief Executive Officer of Galapagos. “While we are very
disappointed by the outcome of the FDA meeting, we are excited that
we can now accelerate the plan for Galapagos to lead on commercial
activities in Europe in our ongoing collaboration with Gilead, and
fully leverage the commercial organization Galapagos has built for
the Jyseleca launch. This is an important new chapter in Galapagos’
ongoing journey to be a leading European biotech company in
inflammation and fibrosis.”
Filgotinib Development
Under the terms of the amended agreement, Galapagos will assume
operational responsibility for ongoing clinical trials evaluating
filgotinib in RA. Gilead and Galapagos recently paused clinical
trials of filgotinib in psoriatic arthritis (PsA), ankylosing
spondylitis (AS), and non-infectious uveitis following receipt of
the CRL and, without a viable path forward in the United States,
the companies no longer believe it is feasible to continue the
current global development program for filgotinib in these
indications. As a result, these trials will be stopped over the
coming months.
Week 26 data from the MANTA and MANTA-RAy studies, including
primary and key secondary endpoints, will be available by mid-2021
and the parties expect to submit the data to regulatory authorities
shortly thereafter. In order to complete their review of filgotinib
in RA or other future indications, the FDA has requested up to Week
52 follow-up data for patients who show >50% decrease in semen
parameters by Week 26 and do not recover in the ongoing MANTA and
MANTA-RAy studies.
Gilead and Galapagos will continue to investigate the potential
for filgotinib to support patients living with Inflammatory Bowel
Disease (IBD). Gilead will retain operational responsibility for
the current trials in Crohn’s disease while Galapagos will assume
operational responsibility for ongoing trials in UC. Filgotinib is
currently under review by the European Medicines Agency (EMA) for
the treatment of UC and is expected to be submitted to the Japanese
Ministry of Health, Labour and Welfare in the first half of 2021.
Gilead and Galapagos expect to have further clarity on the
potential U.S. filing of filgotinib in IBD, after consultation with
FDA, including on the results of the MANTA and MANTA-RAy studies as
described above.
Financial Terms of the Agreement
Under the terms of the new arrangement, Galapagos will assume
all development, manufacturing, commercialization and certain other
rights for filgotinib in Europe. The transfer will be subject to
applicable local legal, regulatory and consultation requirements.
The parties intend to transfer most activities by December 31, 2021
and complete the transition by December 31, 2022. Beginning on
January 1, 2021, Galapagos will bear the future development costs
for certain studies, in lieu of the equal cost split contemplated
by the previous agreement. These studies include the DARWIN3,
FINCH4, FILOSOPHY, and Phase 4 studies and registries in RA, MANTA
and MANTA-RAy, the PENGUIN1 and 2 and EQUATOR2 studies in PsA, the
SEALION1 and 2 studies in AS, the HUMBOLDT study in uveitis in
addition to other clinical and non-clinical expenses supporting
these studies and support for any investigator sponsored trials in
non-IBD conditions and non-clinical costs on all current trials.
The existing 50/50 global development cost sharing arrangement will
continue for the following studies: SELECTION and its long-term
extension study (LTE) in UC, DIVERSITY and its LTE, DIVERGENCE 1
and 2 and their LTEs and support for Phase 4 studies and registries
in Crohn’s disease, pediatric studies and their LTEs in RA, UC and
Crohn’s disease, and support for investigator sponsored trials in
IBD.
All commercial economics on filgotinib in Europe will transfer
to Galapagos as of January 1, 2022, subject to payment of tiered
royalties of 8 to 15 percent of net sales in Europe to Gilead,
starting in 2024. In connection with the amendments to the existing
arrangement for the commercialization and development of
filgotinib, Gilead has agreed to irrevocably pay Galapagos €160
million, which will be split between a €110 million payment in 2021
and a €50 million payment in 2022 and is subject to certain
adjustments for higher than budgeted development costs. In
addition, Galapagos will no longer be eligible to receive any
future milestone payments relating to filgotinib in Europe. Gilead
expects to recognize the full amount of these payments in its
R&D expenses in the fourth quarter of 2020.
Information on Related Party Transaction
The following information is provided by Galapagos pursuant to
article 7:116, paragraph 4 of the Belgian Companies and Association
Code in connection with the term sheet that has been entered into
between Gilead Sciences, Inc. and Galapagos NV on 15 December 2020.
For a summary of the main terms of the term sheet and the amended
terms of the parties' existing agreement for the commercialization
and future development of filgotinib, see above in this press
release. These terms and amendments will be reflected in new
agreements that will be entered into by Gilead and Galapagos on the
basis of the term sheet.
Gilead has two representatives on the supervisory board of
Galapagos (Daniel O'Day and Linda Higgins). In addition, Gilead
holds (indirectly, through one of its subsidiaries) more than 25%
of the shares in Galapagos. Hence, Gilead is considered a "related
party" of Galapagos in accordance with the International Financial
Reporting Standards as adopted by the European Union. In view
hereof, the supervisory board of Galapagos applied the procedure of
article 7:116 of the Belgian Companies and Association Code in
connection with the approval of term sheet with Gilead. The two
representatives of Gilead on the supervisory board of Galapagos did
not participate in the deliberation and voting by the supervisory
board in relation to the term sheet.
Within the context of the aforementioned procedure, a committee
of three independent members of the supervisory board of Galapagos
(the Committee) issued an advice to the supervisory board in which
the Committee assessed the term sheet. In its advice to the
supervisory board, the Committee concluded the following: "The
Committee believes that under the circumstances the proposed
amendments to Filgotinib Agreements are in the interest of
Galapagos and all of its shareholders, and fully aligned with the
long-term strategy of Galapagos. The proposed amendments offer an
important opportunity to accelerate the plan for Galapagos to lead
on commercial activities in Europe for future compounds in its
ongoing R&D collaboration with Gilead, and to bolster and
further leverage the commercial organization Galapagos has built
for the launch of filgotinib. The return of the rights and
responsibilities for filgotinib to Galapagos also comes with a
number of challenges and risks in terms execution and operation,
but these are not unreasonable and can be managed going forward.
The Committee therefore believes that the proposed amendments to
the collaboration with Gilead, are in the interest of Galapagos,
and in any event not manifestly abusive. In view hereof, the
Committee issues a favorable and unqualified opinion to the
supervisory board of Galapagos." The supervisory board did not
deviate from the Committee's advice.
The assessment by the statutory auditor of Galapagos of the
advice of the committee and the minutes of the supervisory board is
as follows: "Based on our review, we have noted no material
inconsistency between the accounting and financial information
included in the minutes of the supervisory board and in the advice
of the ad hoc committee of the independent members of the
supervisory board compared to the information that we, as the
Company’s statutory auditor, have within the framework of our
mandate."
About Jyseleca (filgotinib)
Filgotinib is approved and marketed as Jyseleca (200 mg and 100
mg tablets) in Europe and Japan for the treatment of adults with
moderately to severely active RA who have responded inadequately or
are intolerant to one or more disease modifying anti-rheumatic
drugs (DMARDs). Filgotinib may be used as monotherapy or in
combination with methotrexate (MTX). The European Summary of
Product Characteristics for filgotinib, which includes
contraindications and special warnings and precautions, is
available at www.ema.europa.eu. The interview form from the
Japanese Ministry of Health, Labour and Welfare is available at
www.info.pmda.go.jp. Filgotinib was submitted to the European
Commission for an extended indication for the treatment of adults
with moderately to severely active ulcerative colitis who have had
an inadequate response with, lost response to, or were intolerant
to either conventional therapy or a biologic agent.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
About Galapagos
Galapagos NV discovers, develops and commercializes small
molecule medicines with novel modes of action, several of which
show promising patient results and are currently in late-stage
development in multiple diseases. Our pipeline comprises discovery
through Phase 3 programs in inflammation, fibrosis and other
indications. Our ambition is to become a leading global biotech
company focused on the discovery, development and commercialization
of innovative medicines. More information at www.glpg.com.
This press release contains inside information within the
meaning of Regulation (EU) No 596/2014 of the European Parliament
and of the Council of 16 April 2014 on market abuse (market abuse
regulation).
Gilead Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, related to Gilead, Galapagos, the filgotinib collaboration
and the ten-year research and development collaboration that are
subject to risks, uncertainties and other factors, including the
ability of the companies to complete the transaction in a timely
manner or at all, including the ability to successfully transition
the commercialization of filgotinib in Europe from Gilead to
Galapagos in the anticipated timelines; difficulties or
unanticipated expenses in connection with implementing the
transaction; the risk that Gilead may not realize any anticipated
benefits from the collaborations; the potential effects on Gilead's
revenues and earnings; the ability of the companies to discover,
develop and commercialize any products under the collaborations,
including the ability of the companies to commercialize filgotinib
or develop and commercialize filgotinib for additional indications;
the ability of the companies to initiate and complete clinical
trials involving any product candidates under the collaborations,
including filgotinib, in the currently anticipated timelines or at
all; the possibility of unfavorable results from ongoing and
additional clinical trials involving any product candidates under
the collaborations, including filgotinib; uncertainties relating to
regulatory applications and related filing and approval timelines,
including the risk that EMA may not approve filgotinib for the
treatment of UC in the anticipated timelines or at all, and any
marketing approvals, if granted, may have significant limitations
on its use; the possibility that the companies may make a strategic
decision to discontinue development of involving any product
candidates under the collaborations, including filgotinib for the
treatment of RA, UC, PsA, AS, non-infectious uveitis, IBD, Crohn’s
disease or other indications, and as a result, such products may
never be successfully commercialized; and the accuracy of any
assumptions underlying any of the foregoing. These and other risks
are described in detail in Gilead’s periodic reports filed with the
U.S. Securities and Exchange Commission, including current reports
on Form 8-K, quarterly reports on Form 10-Q and annual reports on
Form 10-K. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
forward-looking statements. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements, including all statements regarding the intent, belief
or current expectation of the companies and members of their senior
management team. Investors are cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties and are cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.
Galapagos Forward-Looking
Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, that are subject to risks, uncertainties and
other factors that could cause actual results to differ materially
from those referred to in the forward-looking statements and,
therefore, the reader should not place undue reliance on them.
These risks, uncertainties and other factors include, without
limitation, the risk that the parties would not be able to complete
the contemplated transaction in a timely manner or at all, the risk
that parties may not be able to successfully implement the
transaction and transfer of rights and activities in a timely or
efficient manner or at all, taking into account the need to fulfil
applicable local legal, regulatory and consultation requirements
and other integration risks and expenses, that Galapagos’
expectations regarding the costs and revenues associated with the
transfer of European commercialization rights to filgotinib may be
incorrect, inherent risks associated with clinical trial and
product development activities, competitive developments, and
regulatory approval requirements, including the risk that data from
the ongoing and planned clinical research programs with filgotinib
may not support registration or further development for UC, IBD,
RA, or other indications due to safety, efficacy or other reasons,
the timing or likelihood of regulatory authorities’ approval of
marketing authorization for filgotinib for UC, IBD, RA, or other
indications, including the risk of such regulatory authorities
requiring additional studies, Galapagos’ reliance on collaborations
with third parties, including the collaboration with Gilead, the
uncertainty regarding estimates of the commercial potential of
filgotinib, the risks and costs involved in selling and marketing
filgotinib, the possibility that the companies may make a strategic
decision to discontinue development of any product candidates under
the collaborations, including filgotinib for the treatment of RA,
UC, PsA, AS, non-infectious uveitis, IBD, Crohn’s disease or other
indications, and as a result, such products may never be
successfully commercialized, as well as those risks and
uncertainties identified in our Annual Report on Form 20-F for the
year ended 31 December 2019 and our subsequent filings with the
SEC. All statements other than statements of historical fact are
statements that could be deemed forward-looking statements. The
forward-looking statements contained herein are based on
management’s current expectations and beliefs and speak only as of
the date hereof, and Galapagos makes no commitment to update or
publicly release any revisions to forward-looking statements in
order to reflect new information or subsequent events,
circumstances or changes in expectations.
Jyseleca®, Gilead and the Gilead logo are
trademarks of Gilead Sciences, Inc. or its related companies.
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version on businesswire.com: https://www.businesswire.com/news/home/20201215006105/en/
Gilead Monica Tellado, Investors +1 (650) 219-3882
Arran Attridge, Media +1 (650) 425-8975
Galapagos Elizabeth Goodwin, Investors +1 (781)
460-1784
Carmen Vroonen, Media +32 473 824-874
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