Gilead submits new drug application to U.S. Food and Drug
Administration under priority review for filgotinib for rheumatoid
arthritis treatment
Foster City, Calif., and Mechelen, Belgium; 19 December 2019,
22.30 CET – Galapagos NV (Euronext & NASDAQ: GLPG) today
announced that its collaboration partner, Gilead Sciences, Inc.
(NASDAQ: GILD) has submitted a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for filgotinib, an
investigational, oral, selective JAK1 inhibitor for the treatment
of adults who are living with moderate-to-severe rheumatoid
arthritis (RA). A priority review voucher was submitted with the
NDA, shortening the anticipated time for review.
The NDA filing is supported by 52-week data from
the global Phase 3 FINCH clinical program, which evaluated the
efficacy and safety of filgotinib in 3,452 patients with moderate
to severely active RA. In the FINCH studies, filgotinib met its
primary endpoints and demonstrated durable efficacy and safety
results across multiple RA patient populations, including in people
with prior inadequate response to methotrexate treatment (MTX),
those who were intolerant to one or more biologic treatments and
those who were MTX treatment-naïve. Safety results were consistent
across the trials and further reinforce the long-term safety and
tolerability profile of filgotinib for a broad range of RA
patients.
As part of the collaboration terms, upon NDA
submission, Galapagos receives a $20 million milestone payment from
Gilead.
This NDA is the third regulatory agency
submission for filgotinib in the past 5 months following
submissions to the European Medicines Agency and Japanese Ministry
of Health, Labor and Welfare earlier this year.
Despite the availability of current therapies,
people living with RA may face persistent disease symptoms and
inadequate responses to currently available therapies. One in five
patients do not achieve complete disease remission during their
lifetimes and remain in need of treatment options.
“The new drug application submission for
filgotinib represents an important step forward in bringing a
potential new treatment option to people living with RA,” said
Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “In
clinical trials, filgotinib has demonstrated an efficacy and
tolerability profile that may offer meaningful improvements in RA
treatment response for patients with this chronic, debilitating
disease.”
“Following submission for approval of filgotinib
in RA with the European and Japanese authorities, today’s
announcement marks another key step in Galapagos’ history: a first
ever NDA submission for one of our programs,” said Dr. Walid
Abi-Saab, Chief Medical Officer at Galapagos. “We are excited about
the progress made, and look forward to hopefully bringing
filgotinib to patients suffering from RA across these
territories.”
Filgotinib is an investigational agent and is
not approved by any regulatory authority. Its efficacy and safety
have not been established.
About the filgotinib collaborationiGilead
and Galapagos are collaborative partners in the global development
and commercialization of filgotinib in RA, and other potential
inflammatory indications. In the U.S., Gilead is solely responsible
for the commercialization of filgotinib, pending approval of
filgotinib by the FDA, and Galapagos is eligible for further
milestones as well as royalties of 20-30% on filgotinib sales in
this territory. If approved, Gilead and Galapagos will
co-commercialize filgotinib in a number of European
territories.
About GalapagosGalapagos (Euronext &
NASDAQ: GLPG) 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. Galapagos’ pipeline comprises Phase 3 through to
discovery programs in inflammation, fibrosis, osteoarthritis and
other indications. The Company’s 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.
Contact
Investors:Elizabeth GoodwinVP Investor Relations +1 781
460 1784
Sofie Van GijselDirector Investor Relations+32 485 19 14
15ir@glpg.com
Media:Carmen VroonenSenior Director Communications &
Public Affairs+32 473 824 874
Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com
Forward-looking statements
This release may contain forward-looking
statements with respect to Galapagos, including statements
regarding Galapagos’ strategic ambitions, the success of Galapagos’
filgotinib collaboration, 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.
i Gilead & Galapagos filgotinib clinical program trial
details: SELECTION (NCT02914522); DIVERSITY (NCT02914561); PENGUIN
1 (NCT04115748); PENGUIN 2 (NCT04115839)
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