Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext
& NASDAQ: GLPG) today announced that the Marketing
Authorization Application (MAA) for filgotinib, an investigational,
oral, selective JAK1 inhibitor, for the treatment of adults with
rheumatoid arthritis (RA) has been validated and is now under
evaluation by the European Medicines Agency (EMA).
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“We are excited about the validation of this application which
is an important milestone in our ongoing work to improve the lives
of people living with rheumatoid arthritis and other inflammatory
conditions,” said John Sundy, MD, PhD, Senior Vice President,
Inflammation and Respiratory Diseases, Gilead Sciences.
The MAA for filgotinib is supported by 24-week data from the
Phase 3 FINCH clinical trials in which once-daily treatment with
filgotinib achieved improvements in clinical signs and symptoms,
achievement of low disease activity and remission, and inhibition
of structural damage for different sub-populations of patients
living with RA. Across the FINCH program, safety data were
consistent with previously reported results.
“We are very happy with the validation of the filgotinib MAA by
the EMA, as this represents the latest step forward in our
partnership with Gilead to bring filgotinib as a new treatment
option to RA patients across Europe,” said Dr. Walid Abi-Saab,
Chief Medical Officer at Galapagos.
The filgotinib filing will be reviewed by the EMA under the
centralized licensing procedure for all 28 member states of the
European Union, as well as Norway, Iceland and Liechtenstein. In
early July, Gilead announced plans to submit a New Drug Application
(NDA) for filgotinib for the treatment of RA in the United States
before the end of the year.
Filgotinib is an investigational agent and is not approved
anywhere globally. Its efficacy and safety have not been
established by any regulatory authorities.
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 the Galapagos – Gilead
Collaboration
Galapagos and Gilead entered into a global collaboration for the
development and commercialization of filgotinib in inflammatory
indications. The FINCH studies are among several clinical trials of
filgotinib in inflammatory diseases, including the EQUATOR Phase 2
study 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. Its pipeline comprises Phase 3
through to discovery programs in inflammation, fibrosis,
osteoarthritis and other indications. Galapagos’ 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 EMA, the European Commission and other
regulatory agencies may not approve filgotinib for the treatment of
RA, and any marketing approvals, if granted, may have significant
limitations on its use. As a result, filgotinib may never be
successfully commercialized. There is also the possibility that
Gilead may be unable to file an NDA for filgotinib in the United
States in the currently anticipated timelines. Further, there is
the possibility of unfavorable results from ongoing and additional
clinical trials involving filgotinib. 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 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 progression and results of clinical
studies with filgotinib, the regulatory pathway for filgotinib and
the timing of regulatory filings. 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 filgotinib. 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.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on Twitter
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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Gilead Sung Lee, Investors +1 (650) 524-7792 Arran
Attridge, Media +1 (650) 425-8975 Galapagos Elizabeth
Goodwin, Investors +1 (781) 460-1784 Carmen Vroonen, Media +32 473
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