-- Clinical Development Program of
Filgotinib Demonstrated Durable Efficacy Balanced with a Consistent
Safety Profile in Rheumatoid Arthritis Through 52 Weeks --
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.
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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
Collaboration1
Gilead 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
Gilead Forward-Looking
Statement
This 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
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 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.
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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Gilead Douglas Maffei, PhD, Investors +1 (650) 522-2739
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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