GILEAD AND GALAPAGOS ANNOUNCE
POSITIVE EUROPEAN CHMP OPINION FOR
JYSELECA® (FILGOTINIB) FOR THE
TREATMENT OF ADULTS WITH MODERATE
TO SEVERE RHEUMATOID ARTHRITIS
-- Clinical Development Program of Filgotinib
Demonstrated Durable Efficacy Balanced with a Consistent Safety
Profile in Rheumatoid Arthritis Through 52 Weeks --
Foster City, Calif., and Mechelen,
Belgium, July 24 2020, 14:10 CET; regulated information –
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext
& Nasdaq: GLPG) announced today the European Medicines Agency's
(EMA) Committee for Medicinal Products for Human Use (CHMP) has
adopted a positive opinion for Jyseleca® (filgotinib 200 mg and 100
mg tablets), an investigational, once-daily, oral, selective JAK1
inhibitor for the treatment of adults with moderate to severe
rheumatoid arthritis (RA) who have responded inadequately or are
intolerant to one or more disease modifying anti-rheumatic drugs
(DMARDs). The CHMP positive opinion is a scientific recommendation
to the European Commission to grant marketing authorization in
Europe.
The CHMP positive opinion is supported by data
from the Phase 3 FINCH and Phase 2 DARWIN programs, which included
4,544 RA patient-years of experience with filgotinib. All three
FINCH trials, involving a broad range of patients, met their
primary endpoints. In the trials, filgotinib consistently achieved
ACR20/50/70 and other relevant treatment targets, such as
DAS28(CRP)<2.6. Filgotinib also inhibited the progression of
structural joint damage assessed by modified total Sharp score
(mTSS) compared with placebo. Across the FINCH and DARWIN trials,
once-daily filgotinib demonstrated a consistent clinical safety
profile when administered as monotherapy or in combination with
methotrexate (MTX). Rates of serious infections and herpes zoster
were generally similar to adalimumab and MTX, while rates of major
adverse cardiac events (MACE) and venous thromboembolism (VTE) were
infrequently reported.
The CHMP positive opinion will now be reviewed
by the European Commission, which has the authority to authorize
medicines in the 27 countries of the European Union, Norway,
Iceland, Liechtenstein and UK. A Commission decision is expected in
the third quarter of 2020.
Filgotinib is an investigational agent and is
not approved for use by any regulatory authority.
About the FINCH Program
The FINCH Phase 3 program investigated the
efficacy and safety of filgotinib 100 mg and 200 mg once-daily, in
RA patient populations ranging from early stage to
biologic-experienced patients. FINCH 1 was a 52‑week,
randomized, placebo- and adalimumab-controlled trial in combination
with MTX, enrolling 1,759 adult patients with moderately to
severely active RA who had inadequate response to MTX. The primary
endpoint in FINCH 1 was ACR20 at Week 12. The trial included
radiographic assessment at Weeks 24 and 52. FINCH 2 was a
global, 24-week randomized, double-blind, placebo-controlled, Phase
3 study evaluating filgotinib on a background of conventional
synthetic disease-modifying anti-rheumatic drug(s) (csDMARDs) among
449 adult patients with moderately to severely active RA who had
not adequately responded to biologic DMARDs (bDMARDs). The primary
endpoint in FINCH 2 was ACR20 at Week 12. FINCH 3 was a
52‑week, randomized trial in 1,252 MTX-naïve patients to evaluate
filgotinib 200 mg alone and filgotinib 100 mg or 200 mg combined
with MTX versus MTX alone in MTX-naïve patients. The primary
endpoint in FINCH 3 was ACR20 at Week 24. The trial included
radiographic assessment at Weeks 24 and 52. Filgotinib is an oral,
selective JAK inhibitor with preferential activity for JAK1 and JAK
1/3 signaling.
About the Filgotinib
Collaboration1Gilead and Galapagos NV are collaborative
partners in the global development and commercialization of
filgotinib in RA and other inflammatory indications. The
companies have multiple clinical study programs for filgotinib in
inflammatory diseases, including the FINCH Phase 3 program in RA,
the Phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY
Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN trials in
psoriatic arthritis, as well as Phase 2 studies in uveitis and in
small bowel and fistulizing Crohn’s disease.
More information about clinical trials with
filgotinib can be accessed at: www.clinicaltrials.gov.
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 and develops small
molecule medicines with novel modes of action, three 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, osteoarthritis
and other indications. Our ambition is to become a leading global
biopharmaceutical 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
StatementThis press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are subject to risks, uncertainties and
other factors, including the risk that the European Commission may
not approve filgotinib for the treatment of adults with moderate to
severe rheumatoid arthritis in the expected timelines or at all.
There is also the possibility of unfavorable results from ongoing
and additional clinical trials involving filgotinib. Further, it is
possible that the parties may make a strategic decision to
discontinue development of filgotinib, and as a result, filgotinib
may never be successfully commercialized. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These
and other risks are described in detail in Gilead’s Form 10-Q for
the quarter ended March 31, 2020, as filed with the U.S. Securities
and Exchange Commission. 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 inherent uncertainties associated
with competitive developments, clinical trial and product
development activities, and regulatory approval requirements
(including that data from the ongoing and planned clinical research
programs with filgotinib may not support registration or further
development of filgotinib due to safety, efficacy or other
reasons), whether or when regulatory authorities would approve
marketing authorization for filgotinib, Galapagos’ reliance on
collaborations with third parties (including its collaboration
partner for filgotinib, Gilead), the uncertainty regarding
estimating the commercial potential of filgotinib, as well as those
risks and uncertainties identified in our Annual Report on Form
20-F for the year ended December 31, 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
Senior Director Communications+1 781 460
1784
+32 473 824
874
Sofie Van Gijsel
Evelyn FoxSenior Director IR
Director Communications+32 485 19 14
15
+31 6 53 591
999ir@glpg.com
communications@glpg.com
Contacts
GileadInvestors:
Media:Douglas Maffei,
PhD
Arran Attridge, Media+1 650 522
2739
+1 650 425 8975
1 Gilead & Galapagos Filgotinib Clinical Program Trial
Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3
(NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561);
PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839).
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