-- 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 --
Galapagos webcast presentation tomorrow, 16
December 2020, at 14:00 CET / 8 AM ET,
www.glpg.com +32 2 793 38 47, code
7689939
Foster City, Calif., and Mechelen,
Belgium, December 15, 2020, 22.15 CET; regulated information
– 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.
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).
Conference call and Webcast
presentation Galapagos will conduct a conference call open
to the public tomorrow, 16 December 2020, at 14:00 CET / 8 AM ET,
which will also be webcasted. To participate in the conference
call, please call one of the following numbers ten minutes prior to
commencement:
CODE: 7689939
Standard International: |
+44 (0) 2071 928338 |
USA: |
+1 646 741 3167 |
UK: |
+44 844 481 9752 |
Netherlands: |
+31 207 95 66 14 |
France: |
+33 1 70 70 0781 |
Belgium: |
+32 2 793 38 47 |
A
question and answer session will follow the presentation. Go to
www.glpg.com to access the live audio webcast. The archived webcast
will also be available for replay shortly after the close of the
call.
Gilead Forward-Looking
StatementThis 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
StatementThis 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.
Contacts Galapagos |
|
Investors: |
Media: |
Elizabeth Goodwin |
Carmen Vroonen |
VP IR |
Global Head of Communications & Public Affairs |
+1 781 460 1784 |
+32 473 824 874 |
|
|
Sofie Van Gijsel |
Anna Gibbins |
Senior Director IR |
Senior Communications Director – Therapeutic Areas |
+32 485 19 14 15 |
+44 (0) 7717 801900 |
ir@glpg.com |
communications@glpg.com |
|
|
Contacts Gilead |
|
Investors: |
Media: |
Monica Tellado |
Arran Attridge |
+1 (650) 219-3882 |
+1 (650) 425-8975 |
- GILEAD AND GALAPAGOS ANNOUNCE NEW COMMERCIALIZATION AND
DEVELOPMENT AGREEMENT FOR JYSELECA® (FILGOTINIB)
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