Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext
& NASDAQ: GLPG) today announced that Week 52 data from the
registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib, an
investigational, oral, selective JAK1 inhibitor, for the treatment
of moderately-to-severely active rheumatoid arthritis (RA) are
consistent with and support the efficacy, safety and tolerability
profiles demonstrated in the Week 12 and 24 analyses presented
earlier this year.
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“We are encouraged by the durability of both the efficacy and
safety profiles of filgotinib seen in these studies,” said John
Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory
Diseases, Gilead Sciences. “These data suggest that filgotinib if
approved, may play an important role in helping people living with
rheumatoid arthritis achieve sustained, clinically meaningful
responses.”
“These recent updates from the FINCH 1 and 3 trials continue to
provide consistent evidence to support filgotinib’s profile in RA
patients. In the second half of the FINCH 1 and FINCH 3 trials,
filgotinib exhibited the same favorable safety profile seen in the
first 24 weeks, including similar rates of thrombotic events as
previously observed, as well as persistent efficacy,” said Dr.
Walid Abi-Saab, Chief Medical Officer, Galapagos.
Detailed Week 52 results from the FINCH 1 and 3 trials will be
submitted for presentation at a future medical conference.
A Marketing Authorization Application (MAA) for filgotinib for
the treatment of adults with rheumatoid arthritis is now under
evaluation by the European Medicines Agency (EMA) and a New Drug
Application (NDA) for filgotinib has been submitted to the Japanese
Ministry of Health, Labor and Welfare (MHLW). Gilead plans to file
a New Drug Application (NDA) for filgotinib for the treatment of
rheumatoid arthritis in the United States including the FINCH 1 and
FINCH 3 Week 52 data later this year.
Filgotinib is an investigational agent and is not approved
anywhere. Its efficacy and safety have not been established by any
regulatory authorities.
About the FINCH 1 and FINCH 3
Programs
The FINCH Phase 3 program investigated the efficacy and safety
of 100 mg and 200 mg filgotinib 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 methotrexate (MTX)
enrolling 1,759 adult patients with moderately to severely active
RA who had inadequate response to MTX. The primary endpoint was
ACR20 at week 12. The trial included radiographic assessment at
weeks 24 and 52. FINCH 3 was a 52‑week, randomized trial in
1,252 MTX-naïve patients to evaluate filgotinib 200mg alone and
filgotinib 100 mg or 200 mg combined with methotrexate versus
methotrexate alone in methotrexate-naïve patients. The primary
endpoint was ACR20 at week 24. Radiographic progression was also
assessed.
More information about clinical trials with filgotinib can be
accessed at: www.clinicaltrials.gov.
About the Filgotinib
Collaboration
Galapagos and Gilead entered into a global collaboration for the
development and commercialization of filgotinib in inflammatory
indications. The FINCH Phase 3 studies are among several clinical
trials of filgotinib in inflammatory diseases, including the
EQUATOR Phase 2 program in psoriatic arthritis, the TORTUGA Phase 2
study in ankylosing spondylitis, the DIVERSITY Phase 3 trial in
Crohn’s disease (also small bowel and fistulizing Crohn’s disease
Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative
colitis.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) 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 Phase 3
through to discovery 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.
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.
Galapagos Forward-Looking
Statements
This release may contain forward-looking statements with respect
to Galapagos, including statements regarding Galapagos’ strategic
ambitions, the mechanism of action and potential safety and
efficacy of filgotinib, the anticipated timing of clinical studies
with filgotinib and the progression and results of such studies.
Galapagos cautions the reader that forward-looking statements are
not guarantees of future performance. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
which might cause the actual results, financial condition and
liquidity, performance or achievements of Galapagos, or industry
results, to be materially different from any historic or future
results, financial conditions and liquidity, performance or
achievements expressed or implied by such forward-looking
statements. In addition, even if Galapagos’ results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. Among the factors that may
result in differences are 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 may not support registration or further development of
filgotinib due to safety, efficacy or other reasons), Galapagos’
reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead), and estimating the
commercial potential of Galapagos’ product candidates. A further
list and description of these risks, uncertainties and other risks
can be found in Galapagos’ Securities and Exchange Commission (SEC)
filings and reports, including in Galapagos’ most recent annual
report on form 20-F filed with the SEC and subsequent filings and
reports filed by Galapagos with the SEC. Given these uncertainties,
the reader is advised not to place any undue reliance on such
forward-looking statements. These forward-looking statements speak
only as of the date of publication of this document. Galapagos
expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based or
that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements, unless
specifically required by law or regulation.
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 possibility that the final efficacy, safety and
tolerability results from these studies differ materially from
those reported in this press release, the possibility of
unfavorable results from other clinical trials involving
filgotinib, and the risk that the EMA, FDA and other regulatory
agencies may not approve filgotinib for the treatment of RA in the
currently anticipated timelines or at all, and any marketing
approvals, if granted, may have significant limitations on its use.
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 Quarterly Report on Form 10-Q for the quarter ended June
30, 2019, 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.
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Gilead Sung Lee, Investors (650) 524-7792
Arran Attridge, Media (650) 425-8975
Galapagos Elizabeth Goodwin, Investors (781) 460-1784
Sofie Van Gijsel, Investors +32 485 19 14 15
Carmen Vroonen, Media +32 473 824 874
Evelyn Fox, Media +31 6 53 591 999
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