-- Application Based on Results from Pivotal
Phase 2b/3 SELECTION Trial --
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext
& Nasdaq: GLPG) today announced that the application for a new
indication to the approved license for filgotinib 200 mg, an oral
JAK1 preferential inhibitor, has been validated and is now under
evaluation by the European Medicines Agency (EMA). The proposed
indication is for the treatment of adults with moderately to
severely active ulcerative colitis (UC) who have had an inadequate
response with, lost response to, or were intolerant to either
conventional therapy or a biologic agent.
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Ulcerative colitis is a long term, chronic condition which
affects more than 2 million people in the European Union alone.
Symptoms tend to present intermittently, and so patients usually
experience flare-ups and periods of remission. The EMA application
is supported by data from the Phase 2b/3 SELECTION study, which
showed a statistically significantly higher proportion of patients
treated with once-daily, oral, filgotinib 200 mg achieved clinical
remission at week 10 and maintained remission at week 58 compared
with placebo. Additionally, a statistically significantly higher
proportion of patients treated with filgotinib 200 mg achieved
endoscopic, histologic and six-month, corticosteroid-free remission
at week 58 compared with placebo. The SELECTION trial results were
presented at the virtual United European Gastroenterology Week
(UEGW) 2020 Meeting last month.
“Today’s news from the EMA is a welcome step forward in our work
aiming to improve outcomes for people living with inflammatory
diseases, many of whom struggle with ongoing symptoms and are in
need of new treatment options,” said Mark Genovese, MD, Senior Vice
President, Inflammation, Gilead Sciences.
“We are very pleased to have achieved this important milestone
with filgotinib, building on its recent regulatory approvals in
rheumatoid arthritis in the EU and Japan, as we bring this
potential new treatment option one step closer for people living
with UC,” said Dr. Walid Abi-Saab, Chief Medical Officer,
Galapagos.
Initiating assessment of the application begins the formal
evaluation process by the EMA’s Committee for Human Medicinal
Products (CHMP). The filing will be reviewed under the centralized
licensing procedure for all 27 member states of the European Union,
as well as Norway, Iceland and Liechtenstein. Filgotinib is already
licensed in the European Union as Jyseleca®▼ for the
treatment of patients with moderate to severe active rheumatoid
arthritis (RA) who have responded inadequately or are intolerant to
one or more disease modifying anti-rheumatic drugs (DMARDs). The
use of filgotinib for UC is investigational and is not approved
anywhere globally.
About the SELECTION Phase 2b/3
Trial
The SELECTION Phase 2b/3 trial is a multi-center, randomized,
double-blind, placebo-controlled trial that demonstrated sustained
efficacy and safety with filgotinib for the treatment of moderately
to severely active UC. The SELECTION studies tested 100 mg and 200
mg filgotinib versus placebo in bio-naïve and bio-experienced
moderate to severe UC populations, the bio-experienced populations
included more than 50% of UC patients who had experienced two
different mode of action biologics. The SELECTION trial
demonstrated that a statistically significantly higher proportion
of patients treated with filgotinib 200 mg versus placebo achieved
clinical remission at week 10 and maintained remission at week 58.
In addition, statistically significantly more patients achieved
six-month corticosteroid-free remission. Overall, the incidence of
adverse events (AEs), serious AEs and discontinuations due to AEs
were similar in the filgotinib and placebo groups in both the
induction and maintenance periods of the study. Serious infections,
herpes zoster, venous thrombosis, pulmonary embolism and
gastrointestinal perforation were similar across treatment
groups.
About Filgotinib
Filgotinib (200 mg and 100 mg tablets) is approved and marketed
as Jyseleca® 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). Jyseleca® may be used as monotherapy or in
combination with methotrexate (MTX). The full European Summary of
Product Characteristics for filgotinib is available from the EMA at
www.ema.europa.eu and the interview form from the Japanese Ministry
of Health, Labour and Welfare (MHLW) is available at
www.info.pmda.go.jp.
About the Filgotinib
Collaboration
Gilead and Galapagos NV are collaborative partners in the global
development of filgotinib in RA, inflammatory bowel disease and
other inflammatory indications. The companies are conducting global
studies investigating the potential role of filgotinib in a variety
of diseases, including the Phase 3 DIVERSITY trial in 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, 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 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. There
is also the possibility of unfavorable results from ongoing and
additional clinical trials involving filgotinib, including the
SELECTION long-term extension trial and the DIVERSITY trial.
Further, it is possible that the parties may make a strategic
decision to discontinue development of filgotinib for the treatment
of ulcerative colitis or other indications, and as a result,
filgotinib may never be successfully commercialized for the
treatment of ulcerative colitis or other indications. 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 June 30, 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 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 ulcerative
colitis or other indications due to safety, efficacy or other
reasons, the timing or likelihood of regulatory authorities
approval of marketing authorization for filgotinib for ulcerative
colitis or other indications, such regulatory authorities requiring
additional studies, Galapagos’ reliance on collaborations with
third parties, including the collaboration with Gilead for
filgotinib, the uncertainty regarding estimates of 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 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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Gilead Douglas Maffei, PhD, Investors +1 (650)
522-2739
Jennifer Wilson, Media - Europe +44 7920 266-582
Marian Cutler, Media - US +1 (973) 517-0519
Galapagos Elizabeth Goodwin, Investors +1 (781)
460-1784
Carmen Vroonen, Media +32 473 824-874
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