Foster City, Calif. and Mechelen, Belgium; October 11, 2019,
0.00 CET; – 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.
“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 programsThe
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
CollaborationGalapagos 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 GalapagosGalapagos (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 SciencesGilead 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 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 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.
###
Galapagos ContactsInvestors:
Media:Elizabeth
Goodwin
Carmen Vroonen VP IR
Senior Director
Communications+1-781-460-1784
+32 473 824
874
Sofie Van Gijsel
Evelyn FoxDirector IR
Director Communications+32 485 19 14
15
+31 6 53 591
999ir@glpg.com
communications@glpg.com
Gilead
ContactsInvestors:
Media:Sung
Lee
Arran Attridge +1
650-524-7792
+1 650-425-8975
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